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					Pharmacircle Results-Products & Pipeline : Therapeutic Category contains 'asthma'
Product_Pipeline     Therapeutic            Phases (inc.        Molecules           Product Type   Product Owner
Name                 Categories (inc.       partners)
                     partners)

159797               ·COPD·Asthma            ·Phase2Ongoing·Pha -                   NCE            Theravance Inc.
                                             se2




159802               ·COPD·Asthma            ·Phase2Ongoing·Pha -                   NCE            Theravance Inc.
                                             se2




256066 Inhaled       ·Asthma·COPD            ·Phase2Ongoing·Pha -                   NCE            GlaxoSmithKline Plc
                                             se2Ongoing

274150               ·RheumatoidArthritis·   ·Phase2Discontinued· -                 NCE            GlaxoSmithKline Plc
                     Migraine·Asthma         Phase2Discontinued·
                                             Phase2Discontinued




678007               ·COPD·Asthma            ·Phase2Ongoing·Pha -                   NCE            Theravance Inc.
                                             se2Ongoing
679586               ·Asthma                 ·Phase2Ongoing     -                   BLA            GlaxoSmithKline Plc


799943               ·Asthma·COPD            ·Phase2Discontinued· -                 NCE            GlaxoSmithKline Plc
                                             Phase2Discontinued
870086    ·Asthma           ·Phase2Ongoing        -   NCE   GlaxoSmithKline Plc




ABN912    ·Asthma·COPD      ·Phase1Discontinued· -    BLA   Novartis AG
                            Phase1Discontinued

ADC3322   ·Asthma·COPD      ·PreClinicalOngoing·P -   NCE   Argenta Discovery
                            reClinicalOngoing


ADC3680   ·Asthma·Allergy   ·PreClinicalOngoing·P -   NCE   Argenta Discovery
                            reClinicalOngoing

ADC4022   ·Asthma·COPD      ·Phase2Ongoing·Pha -      NCE   Argenta Discovery
                            se2Ongoing
AEROSPAN             ·Asthma           ·Marketed           flunisolide   new formulation   Forest Laboratories
Inhalation Aerosol                                                                         Inc(USA)




AFM19                ·Allergy·Asthma   ·ResearchOngoing·Re -             BLA               Affimed Therapeutics
                                       searchOngoing                                       AG

AG NCA805            ·Asthma           ·Research           -             NCE               Ahn-Gook
                                                                                           Pharmaceutical
                                                                                           Co.,Ltd.
AGI-Series for         ·Asthma   ·PreClinicalDiscontinu -   NCE   AtheroGenics, Inc.
Respiratory Diseases             ed
AI-128            ·Asthma   ·Phase1Finished       -                 new formulation   Acusphere Inc.




AIR Albuterol     ·Asthma   ·Phase2Discontinued albuterol sulfate   new formulation   Alkermes, Inc.




AIR GSK Program   ·Asthma   ·Phase1Discontinued -                   NCE               GlaxoSmithKline Plc
AIR645       ·Asthma·Allergy   ·Phase1Finished·Pre -   NCE   Altair Therapeutics Inc.
                               Clinical




AKELA CGRP   ·Asthma           ·Phase2             -   NCE   Akela Pharma Inc.
ALEGYSAL Dry syrup ·Asthma·Allergy   ·Marketed·Marketed   pemirolast potassium   new formulation   Mitsubishi Tanabe
                                                                                                   Pharma
                                                                                                   Corporation(Japan)
ALEGYSAL Tablets     ·Allergy·Asthma   ·Marketed·Marketed   pemirolast potassium   NCE   Mitsubishi Tanabe
                                                                                         Pharma
                                                                                         Corporation(Japan)




ALK-Abello 2nd       ·Asthma           ·Research            -                      BLA   ALK-Abello
Generation Tablets
AM-103    ·Asthma·Cardiovascul ·Phase2Ongoing·Pha -    NCE   Amira
          ar                   se2Ongoing                    Pharmaceuticals




AM211     ·Asthma·Allergy·COP   ·Phase1Ongoing·Pha -   NCE   Amira
          D                     se1Ongoing·Phase1O           Pharmaceuticals
                                ngoing




AMG 009   ·Asthma·Allergy       ·Phase1·Phase1     -   NCE   Amgen Inc.

AMG 317   ·Asthma               ·Phase2Ongoing     -   BLA   Amgen Inc.
AMG 853              ·Asthma               ·Phase1Ongoing         -         NCE               Amgen Inc.




AP768                ·Asthma·AtopicDermat ·Phase1·Phase1          -         NCE               Boehringer Ingelheim
                     itis
APC-366              ·Asthma              ·Phase2                 APC 366   NCE               Celera Corp.(UK)

ARD-1700             ·Asthma·COPD          ·PreClinicalOngoing·P -          new combination   Aradigm Corp.
                                           reClinicalOngoing




AT-1003              ·Asthma·COPD          ·Research·Research     -         NCE               Alba Therapeutics
                                                                                              Corporation
ATL 1102 Inhaled     ·Asthma               ·PreClinical           -         new formulation   ISIS Pharmaceuticals
                                                                                              Inc.


ATL-844              ·Asthma·Diabetes,Typ ·PreClinical·PreClinica -         NCE               Clinical Data Inc.
                     e2                   l

ATL-907              ·Asthma               ·PreClinical           -         NCE               Clinical Data Inc.


AV 1101 Spray Form   ·Antiinflammatory/Imm ·Phase2·Undisclosed -            NCE               A-Viral
                     une·Asthma
AVAC Asthma,         ·Asthma               ·Phase1Discontinued -            NCE               Genesis Research &
Genesis/SR Pharma                                                                             Development Corp.
AVE 0675   ·Asthma·Allergy   ·Phase1Ongoing·Pha -     NCE   Pfizer Inc.
                             se1Ongoing
AVE 7279   ·Asthma·Allergy   ·Phase1Discontinued· -   NCE   Pfizer Inc.
                             Phase1Discontinued




AVE8923    ·Asthma           ·Phase1Ongoing       -   NCE   Sanofi-Aventis
AVP-13358   ·Asthma·Allergy   ·Phase1OnHold·Phas -   NCE   Avanir
                              e1OnHold                     Pharmaceuticals
AVT-01                ·Asthma        ·Phase2Ongoing         -          NCE   Avontec




AWD 12-281, Inhaled   ·COPD·Asthma   ·Phase2Discontinued· AWD 12-281   NCE   elbion NV
                                     Phase2Discontinued

AZD1419               ·Asthma·COPD   ·PreClinicalFinished·P -          NCE   Dynavax
                                     reClinical                              Technologies Corp.
AZD1678               ·Asthma        ·PreClinicalDiscontinu -          NCE   AstraZeneca Plc
                                     ed
AZD1981   ·Asthma·COPD   ·Phase2Ongoing·Pha -       NCE   AstraZeneca Plc
                         se2Ongoing




AZD2098   ·Asthma        ·PreClinicalDiscontinu -   NCE   AstraZeneca Plc(USA)
                         ed
AZD2392   ·Asthma        ·PreClinicalDiscontinu -   NCE   AstraZeneca Plc
                         ed
AZD3199   ·Asthma·COPD   ·Phase2·Phase2         -   NCE   AstraZeneca Plc


AZD3778   ·Asthma        ·Phase1Discontinued -      NCE   AstraZeneca Plc

AZD3825   ·Asthma        ·PreClinical       -       NCE   AstraZeneca Plc
AZD5985   ·Asthma·COPD   ·Phase1Ongoing·Pha -       NCE   AstraZeneca Plc
                         se1Ongoing


AZD8075   ·Asthma·COPD   ·Phase1Ongoing·Pha -       NCE   AstraZeneca Plc
                         se1Ongoing
AZD8848   ·Asthma        ·Phase1            -       NCE   AstraZeneca Plc




AZD9215   ·Asthma        ·PreClinicalDiscontinu -   NCE   AstraZeneca Plc
                         ed
AZX100               ·WoundCare·Asthma· ·Phase2Ongoing·Pre -                           NCE               Capstone
                     MuscleSpasm·Idiopath ClinicalOngoing·PreCl                                          Therapeutics(World)
                     icPulmonaryFibrosis  inical·PreClinicalOngo
                                          ing



Aarane N             ·Asthma              ·Marketed            triazolam· reproterol   new combination   Sanofi-
                                                                                                         Aventis(Germany)




Ablynx Respiratory   ·Asthma              ·Research            -                       BLA               Ablynx NV(World)
Program
Accolate Tablets   ·Asthma   ·Marketed   zafirlukast   NCE   AstraZeneca Plc(USA)
AccuNeb Inhalation   ·Asthma             ·Marketed            albuterol sulfate   new formulation   DEY L.P.(USA)
Solution




AccuNeb Inhalation   ·Bronchospasm·Asthm ·Approved·Approved   albuterol sulfate   generic           Watson
Solution, Generic    a                                                                              Pharmaceuticals
Watson                                                                                              Inc.(USA)
Actimis Respiratory   ·Asthma·Allergy   ·PreClinical·PreClinica -                  NCE               Actimis
and Inflammatory                        l                                                            Pharmaceuticals
Disease Program




Acuair                ·Asthma           ·Phase2Discontinued fluticasone propionate new formulation   Ventaira
Advair Diskus   ·Asthma·COPD   ·Marketed·Marketed   fluticasone            new combination   GlaxoSmithKline
                                                    propionate· salmeterol                   Plc(USA,Europe,Japa
                                                    xinafoate                                n)
Advair HFA   ·Asthma   ·Marketed   fluticasone            new formulation   GlaxoSmithKline
                                   propionate· salmeterol                   Plc(USA)
                                   xinafoate
AeRx HCQ   ·Asthma·COPD   ·Phase2Discontinued· hydroxychloroquine   new formulation   APT Pharmaceuticals
                          Phase2Discontinued sulfate




Aeriva     ·Asthma        ·ResearchOngoing     -                    BLA               Arriva
                                                                                      Pharmaceuticals
AeroVant   ·Asthma   ·Phase2Ongoing   pitrakinra   BLA   Aerovance, Inc.
Aerobid   ·Asthma   ·Marketed   flunisolide   new formulation   Forest Laboratories
                                                                Inc(USA)
Aerodose Albuterol   ·Asthma   ·Phase1Discontinued albuterol   new formulation   Nektar Therapeutics
Inhaler
Aerodose Budesonide ·Asthma   ·Phase1Discontinued budesonide   new formulation   Nektar Therapeutics
Inhaler
Aeron                 ·Asthma·Bronchitis   ·Marketed·Marketed   ipratropium bromide   NCE               Arrow
                                                                anhydrous                               Pharmaceuticals
                                                                                                        Ltd.(Australia)




AerovectRx            ·Asthma              ·Research            -                     new formulation   AerovectRx Corp.
Respiratory Program
Afonilum Retard        ·Asthma·COPD   ·Marketed·Marketed   theophylline   generic   Eurand N.V.(Europe)




Albuterol Inhalation   ·Asthma        ·Marketed            albuterol      generic   GenPharm(USA)
Aerosol, GenPharm
Albuterol Inhalation   ·Asthma   ·Marketed   albuterol   generic   Teva Pharmaceutical
Aerosol, Ivax                                                      Industries Ltd.(USA)
Albuterol Inhalation   ·Asthma   ·Marketed   albuterol sulfate   generic   Martec
Aerosol, Martec                                                            Pharmaceutical
                                                                           Inc.(USA)
Albuterol Inhalation   ·Asthma   ·Marketed   albuterol   generic   Barr Pharmaceuticals
Aerosol, Pliva                                                     Inc.(USA)
Albuterol Mystic   ·Asthma   ·UndisclosedDiscontin albuterol   new formulation   Ventaira(USA)
                             ued
Albuterol Sulfate      ·Asthma   ·Marketed   albuterol sulfate   generic   DEY L.P.(USA)
Inhalation Solution,
Dey




Albuterol Sulfate      ·Asthma   ·Marketed   albuterol sulfate   generic   Wockhardt Ltd.(USA)
Inhalation Solution,
Morton G.
Albuterol Sulfate      ·Asthma   ·Marketed   albuterol sulfate   generic   Nephron
Inhalation Solution,                                                       Pharmaceuticals
Nephron                                                                    Corp.(USA)
Albuterol Sulphate,   ·Asthma           ·PreClinical         albuterol sulfate   new formulation   Chrysalis
Chrysalis                                                                                          Technologies




Albuterol analog      ·Asthma           ·ResearchDiscontinue -                   NCE               ARYx Therapeutics
                                        d
Alesion Tablets       ·Allergy·Asthma   ·Marketed·Marketed epinastine            new formulation   Boehringer
                                                             hydrochloride                         Ingelheim(Japan,Kore
                                                                                                   a)



Alexion IV Eculizumab ·Asthma           ·Phase1Finished      eculizumab          new formulation   Alexion
                                                                                                   Pharmaceuticals Inc.
Alexion Nebulized   ·Asthma   ·Phase2   eculizumab   new formulation   Alexion
Eculizumab                                                             Pharmaceuticals Inc.
Allegra Tablets   ·Allergy·SkinDisorders ·Marketed·Marketed·   fexofenadine    new formulation   Sepracor Inc.
                  ·Asthma·AtopicDermat Phase3·Phase3           hydrochloride
                  itis
Allergica Asthma     ·Asthma    ·Phase1              -                     NCE                Allergica
Program




Allergospas Novolizer ·Asthma   ·PreClinicalDiscontinu sodium cromoglycate· new combination   Meda AB
                                ed                     reproterol
Allergospasmin   ·Asthma·COPD·Bronc ·Marketed·Marketed·   sodium cromoglycate· new combination   Meda AB(Germany)
                 hitis              Marketed              reproterol




Alluvant         ·Asthma             ·PreClinical         -                    new formulation   AirPharma
Alphaprot   ·Emphysema·Asthma· ·PreClinical·PreClinica alpha1-proteinase   new formulation   geneRx+ Inc.
            CysticFibrosis     l·PreClinical           inhibitor, human
Alupent Inhalation   ·Asthma   ·Marketed   metaproterenol   NCE   Boehringer
Aerosol                                    sulphate               Ingelheim(USA)
Alupent Inhalation   ·Asthma   ·Marketed   metaproterenol   new formulation   Boehringer
Solution                                   sulphate                           Ingelheim(USA)
Alupent Inhalation    ·Asthma   ·Marketed   metaproterenol   generic   DEY L.P.(USA)
Solution, Generic DEY                       sulphate
Alupent Inhalation   ·Asthma   ·Marketed   metaproterenol   generic   Wockhardt Ltd.(USA)
Solution, Generic                          sulphate
Morton Grove
Alupent Inhalation   ·Asthma   ·Marketed   metaproterenol   generic   Nephron
Solution, Generic                          sulphate                   Pharmaceuticals
Nephron                                                               Corp.(USA)
Alvesco 80 and 160    ·Asthma·Allergy·Asth   ·Marketed·Phase1     ciclesonide           NCE                 Nycomed(USA)
Inhalers              ma




Alvesco Combination   ·Asthma                ·Phase2              ciclesonide· formoterol new combination   Nycomed(ex-US)




Ambrx FCER1 Ab        ·Asthma                ·PreClinical         -                     BLA                 Ambrx, Inc.
Program
Amsol-SR              ·Asthma·Bronchitis     ·Marketed·Marketed   ambroxol              generic             Themis Laboratories
                                                                  hydrochloride                             Private Ltd.(ex-US)
Andolast              ·Asthma·Allergy·COP   ·Phase3·Phase1·Pha andolast   NCE   Rottapharm
                      D                     se2




Anti-Chitinase MAb,   ·Asthma·COPD·Antiinf ·PreClinicalDiscontinu -       BLA   Medimmune Inc.
Medimmune             lammatory/Immune     ed·PreClinicalDisconti
                                           nued·PreClinical
Anti-IL13 program,    ·Asthma              ·Phase2                -       NCE   Genentech Inc.
Genentech


Antitope/NKT          ·Asthma               ·Research             -       NCE   Antitope Ltd.
Antibody Program
Aridol Test Kit   ·Asthma·COPD·Imagi ·Marketed·Phase2Fini mannitol   NCE   Pharmaxis
                  ng&Diagnostics     shed·Approved                         Ltd.(Asia,Europe,Austr
                                                                           alia,Germany,Korea,U
                                                                           K)
Arzileuton Program,     ·Asthma·COPD·Athero ·Phase1·Phase1·Pha zileuton   new formulation   Cornerstone
Critical Therapeutics   sclerosis           se1                                             Therapeutics Inc.
Asmabec Clickhaler   ·Asthma   ·Marketed   beclomethasone   new formulation   Vectura Group Plc
                                           dipropionate




Asmacure Asthma      ·Asthma   ·Research   -                NCE               Asmacure, Inc.
Program
Asmanex Twisthaler   ·Asthma   ·Marketed   mometasone furoate   new formulation   Schering-Plough
                                                                                  Corp.(USA,Europe,Jap
                                                                                  an)
Asmasal Clickhaler   ·Asthma   ·Marketed   albuterol   new formulation   Vectura Group Plc
Assist/Asmair       ·Asthma·COPD   ·Research·Research     -   new formulation   Bang and Olufsen
Actuated Inhaler                                                                Medicom AS
Programs




Asthma Program,     ·Asthma        ·PreClinicalDiscontinu -   NCE               Barr Pharmaceuticals
Barr/Vectura                       ed                                           Inc.
Asthma Program,     ·Asthma        ·UndisclosedDiscontin -    new formulation   Pfizer Inc.
Eiffel/Meridica                    ued




Asthma Program,     ·Asthma        ·PreClinicalOngoing    -   NCE               Immune Control Inc.
Immune Control
Asthma Program,     ·Asthma        ·Undisclosed           -   NCE               NascaCell
Selecore                                                                        Technologies AG
Asthma Vaccine,     ·Asthma        ·ResearchDiscontinue -     BLA               Genesis Research &
Genesis/SR Pharma                  d                                            Development Corp.
Asthma/Allergy   ·Allergy·Asthma   ·PreClinical·PreClinica -   NCE   7TM Pharma A/S
Program, 7TM                       l
Asthmolysin Tab.   ·Asthma   ·Marketed   proxyphylline·   new combination   Maruho
                                         ephedrine                          Co.,Ltd.(Japan)
                                         hydrochloride·
                                         phenobarbital
Ataroc Syrup   ·Asthma·Bronchitis·E   ·Marketed·Marketed·   procaterol      generic   Novell Pharmaceutical
               mphysema               Marketed              hydrochloride             Laboratories
Ataroc Tablets   ·Asthma·Bronchitis·E   ·Marketed·Marketed·   procaterol      generic   Novell Pharmaceutical
                 mphysema               Marketed              hydrochloride             Laboratories
Atrovent Aerocaps   ·COPD·Asthma·Bronc ·Marketed·Marketed·   ipratropium bromide   new formulation   Boehringer
                    hospasm            Marketed              hydrate                                 Ingelheim(Europe)
Atrovent Inhalation   ·Asthma   ·MarketedDiscontinue ipratropium bromide   NCE   Boehringer
Aerosol-CFC                     d                    hydrate                     Ingelheim(USA)
Atrovent Inhalation   ·Asthma   ·Marketed   ipratropium bromide   new formulation   Boehringer
Solution                                    hydrate                                 Ingelheim(ex-US)
Avidia Asthma       ·Asthma             ·PreClinical        -               BLA               Amgen Inc.
Program




Avrina NF-κB   ·Asthma·RheumatoidA ·Research·Research· -               NCE               Anesiva, Inc.
Decoy               rthritis·IBD        PreClinical

Axikin Asthma       ·Asthma             ·PreClinical        -               NCE               Axikin
Program                                                                                       Pharmaceuticals
Azmacort HFA        ·Asthma             ·Approvable         triamcinolone   new formulation   Abbott Laboratories
                                                            acetonide                         Inc.(USA)
Azmacort MDI   ·Asthma   ·Marketed   triamcinolone   new formulation   Abbott Laboratories
                                     acetonide                         Inc.(USA)
BDP Modulite   ·Asthma   ·Marketed   beclomethasone   new formulation   Chiesi Farmaceutici
                                     dipropionate                       SpA(Europe)
BEA 2180 BR    ·COPD·Asthma         ·Phase2·Phase2       -   NCE   Boehringer Ingelheim




BFPT-2603      ·Asthma              ·PreClinical         -   BLA   Barofold

BI 1744 CL     ·COPD·Asthma         ·Phase3·Phase2       -   NCE   Boehringer Ingelheim




BIBW 2948 BS   ·COPD·Asthma·Bronc ·Phase2·Phase2·Pha -       NCE   Boehringer Ingelheim
               hitis              se2

BIW-8405       ·Asthma              ·Phase2Ongoing       -   BLA   Kyowa Hakko Kirin
                                                                   Co., Ltd.(USA)




BN83470        ·Asthma·COPD·Allerg ·PreClinicalOngoing·P -   NCE   Funxional
               y                   reClinicalOngoing·Pre           Therapeutics, Ltd.
                                   ClinicalOngoing
BT-061             ·RheumatoidArthritis·P ·Phase2Ongoing·Pha -                 BLA               Biotest AG
                   soriasis·Asthma·Allerg se2Ongoing·PreClinic
                   y                      al·PreClinical

Bambec Tablets     ·Asthma·Bronchospas ·Marketed·Marketed      bambuterol      NCE               AstraZeneca Plc(ex-
                   m                                           hydrochloride                     US)




Battelle/Eiffel     ·Asthma             ·PreClinicalDiscontinu -               new formulation   Ventaira
Technologies Asthma                     ed
Program
Beclazone Easi-        ·Asthma   ·Marketed           beclomethasone    new formulation   Teva Pharmaceutical
Breathe 50, 100, 250                                 dipropionate                        Industries Ltd.(Europe)
mcg Inhaler




Becloforte DiskHaler   ·Asthma   ·MarketedDiscontinue beclomethasone   new formulation   GlaxoSmithKline
                                 d                    dipropionate                       Plc(UK)
Beclomet EasyHaler   ·Asthma   ·Marketed   beclomethasone   new formulation   Orion Corp.(Europe)
                                           dipropionate




Beclomethasone       ·Asthma   ·Marketed   beclomethasone   new formulation   Teva Pharmaceutical
Cyclohaler                                 dipropionate                       Industries Ltd.(Europe)
Becotide Aerosol   ·Asthma   ·Marketed   beclomethasone   new formulation   Orion Corp.(USA)
                                         dipropionate
Berodual/Duovent   ·Asthma   ·Marketed   fenoterol             new combination   Boehringer
Respimat                                 hydrobromide·                           Ingelheim(Germany)
                                         ipratropium bromide
                                         hydrate
Berotec Inhalation   ·Asthma    ·Marketed   fenoterol      new formulation   Boehringer Ingelheim
Solution                                    hydrobromide




Berotec/Berotec Forte ·Asthma   ·Marketed   fenoterol      new formulation   Boehringer
                                            hydrobromide                     Ingelheim(USA)
Betagen               ·Asthma·IBD          ·PreClinical           -                 NCE               geneRx+ Inc.




Betaprot              ·Asthma·RheumatoidA ·PreClinical            -                 BLA               geneRx+ Inc.
                      rthritis·IBD




Bionasal Amphoterin B ·Sinusitis·Asthma    ·PreClinical·PreClinica amphotericin B   new formulation   BioDelivery Sciences
                                           l                                                          International Inc.




Bosatria              ·BloodCellDisorders·E ·Registration·Phase2 mepolizumab        BLA               GlaxoSmithKline
                      sophagitis·Asthma     Ongoing·Phase2Ongo                                        Plc(Europe)
                                            ing
Brethine Injectable   ·Asthma   ·Marketed   terbutaline sulfate   new formulation   Novartis AG(USA)




Brethine Tablet       ·Asthma   ·Marketed   terbutaline sulfate   NCE               Novartis AG(USA)
Bricanyl              ·Asthma          ·Marketed            terbutaline sulfate   new formulation   AstraZeneca Plc(ex-
Inhaler/Aerosol                                                                                     US)




Bricanyl Turbohaler   ·Asthma·Asthma   ·Marketed·Marketed   terbutaline sulfate   new formulation   Sanofi-
                                                                                                    Aventis(Europe)




Bronica Tablets       ·Asthma          ·Marketed            seratrodast           NCE               Takeda
                                                                                                    Pharmaceutical Co.
                                                                                                    Ltd.(Japan)
Budesonid-ratiopharm ·Asthma   ·Marketed   budesonide   new formulation   RatioPharm
Auto-Jethaler                                                             GmbH(Germany)




Budesonid-ratiopharm ·Asthma   ·Marketed   budesonide   new formulation   RatioPharm
Jethaler                                                                  GmbH(Germany)
Budesonide           ·Asthma    ·Marketed   budesonide   new formulation   Teva Pharmaceutical
Airmax/Spiromax                                                            Industries
                                                                           Ltd.(Denmark,German
                                                                           y)




Budesonide Clickhaler ·Asthma   ·Marketed   budesonide   generic           Vectura Group Plc
Budesonide Cyclohaler ·Asthma   ·Marketed             budesonide    new formulation   Teva Pharmaceutical
                                                                                      Industries Ltd.(Europe)




Budesonide HFA       ·Asthma    ·Discontinued/Inactive budesonide   new formulation   SkyePharma Plc
SkyeFine
Budesonide Inhalation ·Asthma            ·Marketed           budesonide    generic           Teva Pharmaceutical
Suspension, Ivax                                                                             Industries Ltd.(USA)




Budesonide MMX       ·Asthma·Allergy·Crohn ·Phase3Ongoing·Pha budesonide   new formulation   Cosmo
                     'sDisease·UlcerativeC se3Ongoing·Phase3O                                Pharmaceuticals
                     olitis                ngoing·Phase3Ongoin                               S.p.A.(USA,Canada)
                                           g
Budesonide Modulite   ·Asthma   ·Marketed   budesonide   new formulation   Chiesi Farmaceutici
                                                                           SpA(Germany)
Budesonide Mystic   ·Asthma·COPD   ·UndisclosedDiscontin budesonide   new formulation   Ventaira
                                   ued·UndisclosedDisco
                                   ntinued




Budesonide          ·Asthma·COPD   ·Phase3·Phase3       budesonide    new formulation   Direct-Haler A/S
PowderWhirl
Butovent Pulvinal   ·Asthma   ·Marketed   albuterol   new formulation   Chiesi Farmaceutici
                                                                        SpA(Europe)
Buventol EasyHaler   ·Asthma   ·Marketed        albuterol   new formulation   Orion Corp.(Europe)




CAT-354              ·Asthma   ·Phase2Ongoing   -           BLA               AstraZeneca Plc
CC-10004   ·PsoriaticArthritis·Psori ·Phase2Ongoing·Pha apremilast   NCE   Celgene Corp.(USA)
           asis·Lupus·Behcet'sDi se2Ongoing·Phase1O
           sease·Asthma              ngoing·Phase2Ongoin
                                     g·Undisclosed




CEP-1347   ·Asthma·Parkinson's·A ·Phase2Finished·Pha -               NCE   Kyowa Hakko Kirin
           sthma                 se2Discontinued·Phas                      Co., Ltd.
                                 e2
CHF 4226   ·Asthma·COPD          ·Phase2·Phase2       carmoterol     NCE   Chiesi Farmaceutici
                                                                           SpA(Europe)
CHF 5188          ·Asthma·COPD         ·Phase2·Phase2       carmoterol·   new combination   Chiesi Farmaceutici
                                                            budesonide                      SpA




CK-2018509        ·Asthma·PulmonaryHy ·PreClinicalOngoing·P -             NCE               Cytokinetics, Inc.
                  pertension·COPD       reClinicalOngoing·Pre
                                        ClinicalOngoing
CLEANAL Tablets   ·Bronchitis·Asthma·Tu ·Marketed·Marketed· fudosteine    NCE               Mitsubishi
                  berculosis            Marketed                                            Pharmaceutical
                                                                                            Corp.(Japan)
CP-141          ·Asthma             ·UndisclosedDiscontin -               new formulation   BTG International
                                    ued                                                     Limited




CP-325366copd   ·Asthma·COPD        ·Phase2Discontinued· tofimilast       NCE               Pfizer Inc.
                                    Phase2Discontinued

CP-4112         ·Asthma·Antiinflammat ·ResearchOngoing·Re betamethasone   NCE               Clavis Pharma ASA
                ory/Immune            searchOngoing
CP-4114               ·Asthma·Antiinflammat ·Research·Research        prednisolone   new formulation   Clavis Pharma ASA
                      ory/Immune




CR 3465               ·Asthma·InterstitialCys ·PreClinical·PreClinica -              NCE               Rottapharm
                      titis                   l




CRTH2 Antagonist      ·Allergy·Asthma         ·Phase2·Undisclosed -                  NCE               Actelion Ltd.
Program, Actelion
CRTh2 Receptor        ·Asthma·Allergy         ·Research·Research      -              NCE               Argenta Discovery
Antagonist Program,
Argenta Discovery
CRx-170 MR Program ·ChronicPain·Asthma   ·Phase2OnHold·Phas prednisolone·   new combination   CombinatoRx Inc.
                                         e2                 nortriptyline
CRx-170   ·Asthma·ChronicPain   ·Phase2Finished·Pha prednisolone·   new combination   CombinatoRx Inc.
                                se2OnHold           nortriptyline
CTT Bromelain   ·Asthma   ·Research        bromelains   new indication   Competitive
                                                                         Technologies, Inc.




CVT-6883        ·Asthma   ·Phase1Ongoing   -            NCE              Gilead Sciences
                                                                         Inc.(World)
CYT003-QbG10   ·Allergy·AtopicDermatit ·Phase2Finished·Pha -   BLA   Cytos Biotechnology
               is·Asthma               se2·Phase2Ongoing             AG
CYT005-AllQbG10   ·Allergy·Asthma   ·Phase2·Phase2   -   new combination   Cytos Biotechnology
Vaccine                                                                    AG(USA)
Calcort Tablets     ·RheumatoidArthritis·A ·Marketed·Marketed· deflazacort   NCE               Shire
                    sthma·Crohn'sDisease Marketed·Marketed·M                                   Pharmaceuticals
                    ·Cancer,Leukemia·Ca arketed·Marketed                                       Group PLC(UK)
                    ncer,Lymphoid·Organ
                    Transplantation




Captisol-Enabled      ·Asthma·COPD        ·Phase2·Phase2       budesonide    new formulation   Verus
Budesonide Inhalation                                                                          Pharmaceuticals
Solution
Celera Allergy and   ·Asthma·Allergy   ·PreClinical·PreClinica -   NCE   Celera Corp.
Asthma Program                         l




Celltech/UCB/Merck   ·Asthma·COPD      ·Phase1·Phase1          -   NCE   UCB Pharma
PDE4 Inhibitor
Cellzome Itk Program   ·Allergy·Asthma·Atopic ·Research·Research· -       NCE   Cellzome AG
                       Dermatitis             Research




Cellzome PI3K          ·RheumatoidArthritis·A ·PreClinical·PreClinica -   NCE   Cellzome AG
Gamma Program          sthma                  l
Chiesi PDE-IV          ·Asthma·COPD           ·Research·Research -        NCE   Chiesi Farmaceutici
Inhibitors Program                                                              SpA
Choledyl SA ER        ·Emphysema·Asthma· ·Marketed·Marketed·   oxtriphylline          generic           Pfizer Inc.
Tablets               Bronchitis         Marketed




Choledyl SR Tablets   ·Asthma·PulmonaryEd ·Marketed·Marketed   choline theophylline   OTC               Galenica S.A.(Greece)
                      ema


Ciclesonide Nebules   ·Asthma             ·Phase1              ciclesonide            new formulation   Nycomed
Cintredekin          ·Asthma·IdiopathicPul ·PreClinical·PreClinica cintredekin besudotox BLA   NeoPharm Inc.
Besudotox, Inhaled   monaryFibrosis        l
Cipla/LTT         ·RheumatoidArthritis·A ·PreClinical·PreClinica -                new formulation   LTT Bio-Pharma Co
Nanosteroids      sthma                  l                                                          Ltd




Clenil Pulvinal   ·Asthma                ·Marketed               beclomethasone   new formulation   Chiesi Farmaceutici
                                                                 dipropionate                       SpA(Europe)
Combivent   ·Asthma   ·Marketed   ipratropium bromide   new combination   Boehringer
                                  hydrate· albuterol                      Ingelheim(USA)
                                  sulfate
Concept1 Formoterol   ·Asthma   ·Phase2             formoterol      new formulation   Novartis AG




Contramid Xopenex     ·Asthma   ·Phase2Discontinued levalbuterol    new formulation   Sepracor Inc.
                                                    hydrochloride
Corus 1030   ·Asthma   ·Phase2Discontinued lidocaine   new formulation   Gilead Sciences Inc.
Cromogen Easi-   ·Asthma   ·Marketed   cromolyn sodium   new formulation   Teva Pharmaceutical
Breathe                                                                    Industries Ltd.(USA)
Cromolyn Depot   ·Asthma   ·UndisclosedDiscontin cromolyn sodium   new formulation   Durect Corporation
                           ued
Cromolyn Mystic     ·Asthma·COPD      ·UndisclosedDiscontin cromolyn     NCE   Ventaira
                                      ued·UndisclosedDisco
                                      ntinued




Cue Astma Program   ·Asthma           ·Research              -           NCE   Caden Biosciences
                                                                               Inc.
DMI 8393            ·Asthma           ·PreClinical           -           NCE   DMI BioSciences, Inc.

DRF-2546            ·COPD·Asthma      ·PreClinicalFinished·P -           NCE   Dr. Reddys
                                      reClinicalFinished                       Laboratories Ltd.
DSP-3025            ·Allergy·Asthma   ·PreClinicalFinished·P -           -     Dainippon Sumitomo
                                      reClinicalFinished                       Pharmaceutical(Japan
                                                                               )




Daxas               ·COPD·Asthma      ·Registration·Phase3 roflumilast   NCE   Nycomed(USA,Switzer
                                                                               land)
Diffumal 24   ·Asthma·COPD   ·Marketed·Marketed   theophylline   generic   Eurand N.V.(Europe)




Dom0910       ·Asthma        ·Research            -              BLA       Domantis Limited
Domenan Tablets   ·Asthma   ·Marketed   ozagrel hydrochloride   NCE   Kissei Pharmaceutical
                                                                      Company(Japan)
Dual PI3K              ·RheumatoidArthritis·S ·ResearchFinished·Re -    NCE               Cellzome AG
gamma/delta inhibitors LE·Asthma              searchFinished·Resea
                                              rchFinished




DuoHaler Project #1   ·Asthma·COPD           ·Phase2·Phase2         -   new formulation   Vectura Group Plc


DuoHaler Project #2   ·Asthma·COPD           ·Phase2·Phase2         -   new formulation   Vectura Group Plc


Durason               ·Asthma                ·Phase2                -   NCE               Epigenesis
                                                                                          Pharmaceuticals Inc.




EP-012637             ·Asthma                ·PreClinicalDiscontinu -   NCE               Enanta
                                             ed                                           Pharmaceuticals
EP-314         ·Asthma        ·PreClinicalDiscontinu -                    NCE                Enanta
                              ed                                                             Pharmaceuticals




EPI-12323      ·Asthma·COPD   ·Phase1·Phase1         undisclosed small     new combination   Epigenesis
Combinations                                         molecule· undisclosed                   Pharmaceuticals Inc.
                                                     small molecule
ETX9101               ·Asthma   ·Phase2               -   new indication    e-Therapeutics plc




Eiffel/Oriel Asthma   ·Asthma   ·UndisclosedDiscontin -   new formulation   Oriel Therapeutics Inc.
Program                         ued
Eligen Cromolyn   ·Allergy·Asthma   ·Phase1Discontinued· cromolyn sodium   new formulation   Emisphere
Sodium                              Phase1Discontinued                                       Technologies, Inc.
Epinephrine Mist     ·Asthma   ·Marketed   epinephrine   OTC   Amphastar
Inhalation Aerosol                                             Pharmaceuticals
                                                               Inc.(USA)
Euphyllin Retard   ·Asthma·COPD   ·Marketed·Marketed   theophylline   generic   Nycomed(ex-US)
Euphylong             ·Asthma·COPD      ·Marketed·Marketed   theophylline   new formulation   Nycomed




Euroscreen/Alchemia   ·Obesity·Asthma   ·ResearchOngoing·Re -               NCE               Euroscreen S.A.
GPCR Program                            searchOngoing
Excellair          ·Asthma·Allergy·ARDS      ·PreClinical·PreClinica -   NCE   ZaBeCor
                   ·COPD·Infections,Avia     l·PreClinical·PreClinic           Pharmaceuticals, LLC
                   nFlu·Antiinflammatory/    al·PreClinical·PreClini
                   Immune                    cal




FAR404             ·MS,RelapsingRemittin     ·RegistrationOngoing· -     NCE   Farmacija
                   g·Asthma·Crohn'sDise      Phase3Ongoing·Phas
                   ase·UlcerativeColitis·L   e2Ongoing·Phase2On
                   upus                      going·Phase1Ongoing




FM-TP3000 Series   ·Asthma·COPD·Hypert ·UndisclosedDiscontin -           NCE   Forbes Medi-Tech
                   ension              ued·UndisclosedDisco
                                       ntinued·UndisclosedDi
                                       scontinued
FOSTER Modulite   ·Asthma·COPD·COPD ·Marketed·Phase3      beclomethasone        new combination   Chiesi Farmaceutici
                                                          dipropionate·                           SpA(Europe,Russia)
                                                          formoterol fumarate




FP0522            ·Asthma·COPD·Cance ·ResearchDiscontinue -                     NCE               Domain Therapeutics
                  r·Glaucoma         d·ResearchDiscontinu
                                     ed·ResearchDiscontin
                                     ued·ResearchDisconti
                                     nued
Flixotide Diskhaler   ·Asthma              ·Marketed             fluticasone propionate new formulation   GlaxoSmithKline
                                                                                                          Plc(UK)




Flo-Pred Oral         ·Antiinflammatory/Imm ·Approved·Approved· prednisolone acetate   new formulation    Taro Pharmaceutical
Suspension            une·Asthma·Allergy    Approved                                                      Industries Ltd.(USA)
Flovent CFC Aerosol   ·Asthma   ·MarketedDiscontinue fluticasone propionate new formulation   GlaxoSmithKline
                                d                                                             Plc(World)




Flovent Diskus        ·Asthma   ·Marketed            fluticasone propionate new formulation   GlaxoSmithKline
                                                                                              Plc(USA)
Flovent-HFA/Flixotide   ·Asthma   ·Marketed   fluticasone propionate new formulation   GlaxoSmithKline
EvoHaler                                                                               Plc(USA,UK)
Fluasterone           ·LipidLowering·Diabete ·PreClinical·Research fluasterone           NCE                Hollis-Eden
                      s,Type2·Psoriasis·Ast ·Research·Research·                                             Pharmaceuticals Inc.
                      hma·RheumatoidArthri Research·Research
                      tis·MultipleSclerosis




Fluticasone Miat-Haler ·Asthma              ·PreClinical           fluticasone propionate new formulation   Miat Spa
Flutiform HFA       ·Asthma        ·RegistrationOngoing formoterol· fluticasone new combination   SkyePharma Plc
                                                        propionate




Foradil AeroLizer   ·Asthma·COPD   ·Marketed·Marketed   formoterol fumarate    NCE                Novartis AG(USA)
Foradil AirMax   ·Asthma·COPD   ·PreClinicalDiscontinu formoterol fumarate   new formulation   Novartis AG
                                ed·PreClinicalDisconti
                                nued
Foradil Certihaler   ·Asthma·COPD   ·MarketedDiscontinue formoterol fumarate   new formulation   Novartis AG
                                    d·MarketedDiscontinu
                                    ed
Formatris        ·Asthma   ·Marketed            formoterol           NCE               Meda AB(Europe)




Formoterol HFA   ·Asthma   ·Phase2Discontinued formoterol fumarate   new formulation   SkyePharma Plc
Formoterol Modulite   ·Asthma    ·Marketed   formoterol fumarate   new formulation   Chiesi Farmaceutici
                                                                                     SpA(France,Germany,
                                                                                     Greece,Italy,UK)




Formoterol            ·Asthma    ·Phase3     formoterol fumarate   new formulation   Direct-Haler A/S
PowderWhirl




Formoterol, Miat-Haler ·Asthma   ·Phase3     formoterol            new formulation   Miat Spa
Foster DPI   ·Asthma·COPD   ·Phase2·Phase2   beclomethasone        new formulation   Chiesi Farmaceutici
                                             dipropionate·                           SpA
                                             formoterol fumarate
Frenolyn Budesonide   ·Asthma              ·Marketed               budesonide   new formulation   Miat Spa(ex-US)
DPI




GOIL13s               ·Allergy·Asthma      ·UndisclosedDiscontin -              BLA               GenOdyssee
                                           ued·UndisclosedDisco
                                           ntinued
GRC 3886              ·Asthma·COPD         ·Phase2Ongoing·Pha oglemilast        NCE               Glenmark
                                           se2Ongoing                                             Pharmaceuticals


GRO0501               ·Asthma·Psoriasis    ·PreClinical·PreClinica -            NCE               Novozymes GroPep
                                           lDiscontinued                                          Ltd.




GSK/Sirna             ·Asthma·Infections,RS ·Research·Research     -            NCE               Merck and Co Inc.
Respiratory Program   V

GSK1160724            ·Asthma·COPD         ·Phase1Ongoing·Pha MABA              NCE               Theravance Inc.
                                           se1Ongoing
GSK233705 Inhaled   ·COPD·Asthma   ·Phase2Ongoing·Pha darotropium bromide    NCE               GlaxoSmithKline Plc
                                   se1Discontinued




GW597901X           ·COPD·Asthma   ·Phase1Finished·Pha -                     NCE               Theravance Inc.
                                   se1Finished

GW685698X DPI       ·Asthma        ·Phase2Ongoing      fluticasone furoate   new formulation   GlaxoSmithKline Plc
GW685698X/GW6424 ·Asthma·COPD            ·Phase2Ongoing·Pha fluticasone furoate   NCE,new combination GlaxoSmithKline Plc
44M Combination                          se2Ongoing




Galapagos Drug      ·RheumatoidArthritis·O ·Research·Research· -                  NCE                  Galapagos NV
Discovery Program   steoarthritis·Osteoporo Research·Research·R
                    sis·Alzheimer's·Asthm esearch
                    a
Galileo 5-LO Program ·Asthma·Atheroscleros ·PreClinical·PreClinica -                NCE       Galileo
                     is                    l                                                  Pharmaceuticals, Inc.

Gen-Ipratropium       ·Bronchospasm·Asthm ·Marketed·Marketed· ipratropium bromide   generic   GenPharm(ex-US)
Inhalation            a·COPD·Emphysema· Marketed·Marketed·M hydrate
                      Bronchitis          arketed
Gen-Ipratropium   ·Bronchospasm·Asthm ·Marketed·Marketed· ipratropium bromide   generic   GenPharm(ex-US)
Sterinebs         a·COPD·Bronchitis·E Marketed·Marketed·M hydrate
                  mphysema            arketed
Gen-Salbutamol         ·Asthma·Bronchospas ·Marketed·Marketed   albuterol sulfate   generic   GenPharm(ex-US)
Respirator Solution,   m
Genpharm




Gen-Salbutamol         ·Bronchospasm·Asthm ·Marketed·Marketed   albuterol sulfate   generic   GenPharm(ex-US)
Sterinebs              a




Generex/Stallergenes ·Asthma·Allergy       ·Research·Research   -                   NCE       Generex
Drug Discovery                                                                                Biotechnology Corp.
Program
Generic PULMICORT ·Asthma   ·Approved   budesonide   generic   Apotex
RESPULES, Apotex
Giona EasyHaler   ·Asthma   ·Marketed   budesonide   new formulation   Orion Corp.(USA)
Giona                ·Asthma·COPD   ·Phase3·Phase3   budesonide·   new formulation   Orion Corp.
EasyHaler/Formoterol                                 formoterol
Combination
Glycopyrrolate   ·Asthma·COPD   ·PreClinicalDiscontinu glycopyrrolate bromide new formulation   Almirall
Novolizer                       ed·PreClinicalDisconti
                                nued




HAE1             ·Asthma        ·Phase2Discontinued -                        BLA                Genentech Inc.
HF 1020           ·RheumatoidArthritis·I ·PreClinicalDiscontinu -                    BLA        Hunter-Fleming
                  BD·Asthma              ed·PreClinicalDisconti
                                         nued·PreClinicalDisco
                                         ntinued




HFA Combination   ·Asthma                ·PreClinicalDiscontinu undisclosed small     generic   Inyx Inc.
Product                                  ed                     molecule· undisclosed
                                                                small molecule
HIV, Cardio, Asthma,   ·Infections,HIV/AIDS·A ·ResearchOngoing·Re -   NCE   Spring Bank
COPD Program,          sthma·COPD             searchOngoing·Resea           Technologies, Inc
Spring Bank                                   rchOngoing

HSP20 Hit Series       ·Asthma·COPD         ·PreClinicalOngoing·P -   NCE   Prolexys
                                            reClinicalOngoing
Hokunalin Tape       ·Asthma·COPD·Bronc ·Marketed·Marketed·   tulobuterol   NCE   Abbott Laboratories
                     hitis              Marketed                                  Inc.(Japan)




Hutchison             ·Asthma            ·Research            -             NCE   Hutchison China
Inflammation/pulmonar                                                             Meditech
y Program
IG-RD-001            ·Asthma               ·Phase3                -   NCE   Indigene
                                                                            Pharmaceuticals, Inc.

IG-RD-002            ·Asthma               ·PreClinical           -   NCE   Indigene
                                                                            Pharmaceuticals, Inc.

IG-RD-003            ·Asthma               ·Undisclosed           -   NCE   Indigene
                                                                            Pharmaceuticals, Inc.

IG-RD-004            ·Asthma·COPD          ·Undisclosed·Undisclo -    NCE   Indigene
                                           sed                              Pharmaceuticals, Inc.

IL-4 and IL-13       ·Asthma               ·Research              -   NCE   Synairgen
Blocking Peptide
Program, Synairgen



IL-4/13 Trap         ·Allergy·Asthma·Antiinf ·Phase1Discontinued· -   BLA   Regeneron
                     lammatory/Immune        Phase1Discontinued·            Pharmaceuticals Inc.
                                             Phase1Discontinued
IL13-PE38QQR          ·Cancer,Glioma/Gliobl ·Phase3Finished·Pre cintredekin besudotox BLA   NeoPharm Inc.
                      astomaMultiform·Asth Clinical·PreClinical
                      ma·IdiopathicPulmona
                      ryFibrosis




IL4 Target Program,   ·Asthma·Allergy      ·ResearchOngoing·Re -                     NCE    Cosmix
Cosmix                                     searchOngoing
IL5Qb                 ·Asthma              ·PreClinicalFinished -                    BLA    Cytos Biotechnology
                                                                                            AG
IMA-638        ·Asthma               ·Phase1                anrukinzumab         BLA                  Wyeth


INV102         ·Asthma               ·Phase2Ongoing         nadolol              new indication,new   Inverseon, Inc.
                                                                                 formulation




IPD Capsules   ·Allergy·Asthma·Atopic ·Marketed·Marketed·   suplatast tosilate   NCE                  Taiho Pharmaceutical
               Dermatitis             Marketed                                                        Co., Ltd.(Japan)
IPD Dry Syrup          ·Asthma·Allergy·Atopic ·Marketed·Marketed·   suplatast tosilate   NCE               Taiho Pharmaceutical
                       Dermatitis             Marketed                                                     Co., Ltd.(Japan)




IPL512,602             ·Asthma               ·Phase2Discontinued -                       NCE               Orexo AB




IPL576,092             ·Asthma               ·Phase2Discontinued -                       NCE               Orexo AB




Icatibant Inhalation   ·Asthma               ·Phase2                icatibant            new formulation   Shire
                                                                                                           Pharmaceuticals
                                                                                                           Group PLC




Inflammasome           ·RheumatoidArthritis·G ·ResearchOngoing·Re -                      NCE               Opsona Therapeutics
Program, Opsona        out·Asthma             searchOngoing·Resea                                          Ltd.
                                              rchOngoing
Inflammide Novolizer   ·Asthma   ·Marketed              budesonide         OTC               Boehringer Ingelheim




Inhale Interleukin-1   ·Asthma   ·UndisclosedDiscontin -                   NCE               Nektar Therapeutics
Receptor Program                 ued
Inhaled Albuterol,     ·Asthma   ·PreClinical          albuterol sulfate   new formulation   Next Safety, Inc.
Next Safety




Inhaled ISS for        ·Asthma   ·Phase2                -                  BLA               Dynavax
Asthma                                                                                       Technologies Corp.
Intal Aerosol A   ·Asthma   ·Marketed   cromolyn sodium   new formulation   Astellas Pharma
                                                                            Inc.(Japan)
Intal Capsules 20mg   ·Asthma·Allergy   ·Marketed·Marketed   cromolyn sodium   NCE   Astellas Pharma
                                                                                     Inc.(Japan)
Intal HFA   ·Asthma   ·UndisclosedDiscontin cromolyn sodium   new formulation   King Pharmaceuticals
                      ued                                                       Inc.
Intal Inhaler   ·Asthma   ·Marketed   cromolyn sodium   new formulation   Sanofi-Aventis
Intal Nebulizer Solution ·Asthma   ·Marketed   cromolyn sodium   new formulation   Sanofi-
                                                                                   Aventis(Europe)
Intal Nebulizer       ·Asthma   ·Marketed   cromolyn sodium   generic   DEY L.P.(USA)
Solution, Generic Dey
Intal Nebulizer     ·Asthma   ·Marketed   cromolyn sodium   generic   Morton Grove
Solution, Generic                                                     Pharmaceuticals
Morton Grove                                                          Inc.(USA)
Intal SpinCap   ·Asthma   ·Marketed   cromolyn sodium   new formulation   Sanofi-
                                                                          Aventis(Europe)
Intal-Forte CFC Free   ·Asthma   ·Marketed   cromolyn sodium   new formulation   Sanofi-
                                                                                 Aventis(Australia)
Ipratropium Cyclohaler ·Asthma   ·Marketed   ipratropium bromide   new formulation   Teva Pharmaceutical
                                             hydrate                                 Industries Ltd.(Europe)
Ipratropium           ·Asthma·COPD   ·MarketedDiscontinue ipratropium bromide   new formulation   Galen Limited(UK)
Steripoules Nebuliser                d·MarketedDiscontinu hydrate
Solution                             ed
IsoCrom   ·Asthma               ·Phase2Ongoing         sodium cromoglycate   new formulation   Pari Pharma GmbH




J51C      ·Asthma               ·Research              -                     NCE               Jado Technologies
                                                                                               GmbH
KB002     ·RheumatoidArthritis·A ·Phase1·PreClinical   -                     BLA               KaloBios
          sthma                                                                                Pharmaceuticals
KCA-757   ·Asthma·InterstitialCys ·Phase3Ongoing·Pha tipelukast   NCE   Kyorin
          titis                   se2                                   Pharmaceutical(Japan
                                                                        )
KI03219     ·Asthma·COPD           ·PreClinical·PreClinica undisclosed small     NCE   Abbott Laboratories
                                   l                       molecule· undisclosed       Inc.
                                                           small molecule




KI04204     ·Asthma                ·PreClinical            -                   NCE     Abbott Laboratories
                                                                                       Inc.
KM 278      ·Osteoarthritis·Asthma ·PreClinical·PreClinica -                   NCE     Cellceutix
                                   l                                                   Pharmaceuticals, Inc.

KP-496DPI   ·Asthma                ·Phase2Discontinued -                       NCE     Kaken
                                                                                       Pharmaceutical Co
KPE06001   ·Asthma·Arthritis    ·Phase1Ongoing·Pha -                     NCE   Kemin Pharma
                                se1Ongoing
KUR-1246   ·PregnancyRelated·As ·Phase1·Phase2     bedoradrine sulfate   NCE   Kissei Pharmaceutical
           thma                                                                Company(Asia,Japan)
KW-4490           ·Asthma                 ·Phase2                 -           NCE   Kyowa Hakko Kirin
                                                                                    Co., Ltd.(France,UK)




Ketas Capsules    ·Asthma·CNS·Multiple ·Marketed·Marketed·        ibudilast   NCE   Kyorin
                  Sclerosis            Phase2Finished                               Pharmaceutical(Japan,
                                                                                    South Korea)




L-97-1, Inhaled   ·Asthma                 ·PreClinical            -           NCE   Endacea, Inc.

L-97-1, Oral      ·Infections,Bacterial·A ·PreClinical·PreClinica -           NCE   Endacea, Inc.
                  sthma                   l
LAS 101057        ·Asthma                 ·Phase1Discontinued -               NCE   Almirall

LAS 186368        ·Asthma·COPD            ·PreClinical·PreClinica -           NCE   Almirall
                                          l
LAS100977         ·Asthma·COPD            ·Phase2Ongoing·Pha -                NCE   Almirall
                                          se2Ongoing




Laevo-Bambutero   ·Asthma                 ·Phase1                 -           NCE   Lotus
                                                                                    Pharmaceuticals
                                                                                    Inc.(China)
Laonian Kechuan      ·Asthma              ·Marketed             -   NCE   Tianyin
Tablets                                                                   Pharmaceutical Co.,
                                                                          Inc.(China)
Leech-derived        ·Asthma·Autoimmune ·PreClinical·PreClinica -   NCE   Proteo Biotech AG
Tryptase Inhibitor   Diseases           l
Lodotra             ·RheumatoidArthritis·A ·Approved·Phase2On prednisone   new formulation   Nitec Pharma
                    sthma·PolymyalgiaRhe going·Phase1                                        AG(Europe)
                    umatica




Long-Acting Beta    ·Asthma·COPD         ·PreClinical·PreClinica -         NCE               Sepracor Inc.
Agonists Program,                        l
Sepracor
Loteprednol           ·Allergy·Asthma   ·Phase2·Phase2   loteprednol etabonate new formulation   Meda AB
Etabonate Nasal Spray
Loteprednol           ·Asthma   ·PreClinicalDiscontinu loteprednol etabonate new formulation   Almirall
Etabonate Novolizer             ed
Lufyllin Tablets   ·Asthma   ·Marketed   diphylline   NCE   Meda AB(USA)
Lumiliximab/Anti-   ·Asthma·Allergy      ·Phase1Discontinued· lumiliximab   BLA               Biogen Idec Inc.(USA)
CD23 mAb                                 Phase1Discontinued




M40403              ·PostOperativeIleus·Or ·Phase1·Phase1·Pha -             NCE               ActivBiotics
                    alMucositis·Asthma·C se1·Phase1
                    OPD

MAP Inhaled Steroids ·Asthma             ·PreClinical         -             new formulation   MAP Pharmaceuticals
                                                                                              Inc.
MAP0005   ·Asthma·COPD      ·Phase2Ongoing·Pha budesonide·   new formulation   MAP Pharmaceuticals
                            se2Ongoing         formoterol                      Inc.




MCC-847   ·Asthma·Allergy   ·Phase3·Phase2     -             NCE               AstraZeneca Plc(UK)
MEDI-528   ·Asthma                 ·Phase2            -   BLA   Medimmune Inc.




MEM 1414   ·Asthma·Depression·     ·Phase2Ongoing·Pha -   NCE   Memory
           MildCognitiveImpairme   se1·Phase1Finished·          Pharmaceuticals Corp.
           nt·Dementia·Alzheimer   Phase1Finished·Phas
           's                      e1Finished
MEPTIN Air 10 ug   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
                                                             hydrochloride                     Pharmaceutical Co.,
                                                                                               Ltd.(Japan)
MEPTIN Drysyrup   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
0.005%                                                      hydrochloride                     Pharmaceutical Co.,
                                                                                              Ltd.(Japan)
MEPTIN Granules   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
                                                            hydrochloride                     Pharmaceutical Co.,
                                                                                              Ltd.(Japan)
MEPTIN Inhalation   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
Solution                                                      hydrochloride                     Pharmaceutical Co.,
                                                                                                Ltd.(Japan)
MEPTIN Kid Air 5 ug   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
                                                                hydrochloride                     Pharmaceutical Co.,
                                                                                                  Ltd.(Japan)
MEPTIN Syrup   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
                                                         hydrochloride                     Pharmaceutical Co.,
                                                                                           Ltd.(Japan)
MEPTIN Tablets   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      NCE   Otsuka
                                                           hydrochloride         Pharmaceutical Co.,
                                                                                 Ltd.(Japan)
MEPTIN-Mini Tablets   ·Asthma·Bronchitis   ·Marketed·Marketed   procaterol      new formulation   Otsuka
                                                                hydrochloride                     Pharmaceutical Co.,
                                                                                                  Ltd.(Japan)
MK-0633             ·Asthma·Atheroscleros ·Phase2Ongoing·Pha etoricoxib        new formulation   Merck and Co Inc.
                    is·COPD               se2OnHold·Phase2O
                                          ngoing




MK6105              ·Asthma                ·PreClinical           -            BLA               CSL Ltd.




MLN6095             ·Asthma·Allergy         ·PreClinicalDiscontinu -           NCE               Millennium
                                            ed·PreClinicalDisconti                               Pharmaceuticals
                                            nued                                                 Inc.(North America)
MN-001 Once A Day   ·Asthma·InterstitialCys ·Undisclosed·Undisclo tipelukast   NCE               Kyorin
                    titis                   sed                                                  Pharmaceutical(Japan
                                                                                                 )
MORAb-022           ·RheumatoidArthritis· ·PreClinical·PreClinica -            BLA               Eisai Co. Ltd
                    MultipleSclerosis·Asth l·PreClinical
                    ma
MP41                ·Respiratory·Asthma ·PreClinical·PreClinica -              NCE               AnGes MG Inc.
                                           l




MP8                 ·Sepsis·Asthma·Multip ·PreClinical·PreClinica -            NCE               Meyer
                    leSclerosis           l·PreClinical                                          Pharmaceuticals
MaxAir AutoHaler   ·Asthma   ·Marketed   pirbuterol acetate   NCE   Graceway
                                                                    Pharmaceuticals LLC
Meptin Clickhaler    ·Asthma        ·Marketed               procaterol      new formulation   Otsuka
                                                            hydrochloride                     Pharmaceutical Co.,
                                                                                              Ltd.(Japan)




Miat-Haler           ·Asthma        ·PreClinical            -               new formulation   Miat Spa
Combinations

Microdose/Novartis   ·Asthma·COPD   ·PreClinical·PreClinica -               new formulation   Novartis AG
Program                             l
Miflonide AirMax   ·Asthma   ·UndisclosedDiscontin budesonide   new formulation   Novartis AG
                             ued
Mometasone/Formoter ·Asthma·COPD   ·Registration·Registrat mometasone furoate·   new combination   Novartis AG
ol Combination MDI                 ion                     formoterol
Montelukast Injection   ·Asthma   ·Phase3   montelukast sodium   new formulation   Merck and Co
                                                                                   Inc.(USA)
N115               ·COPD·CysticFibrosis·     ·Phase2Finished·Pha sodium pyruvate   NCE               EmphyCorp, Inc.
                   InterstitialLungDisease   se1Ongoing·Undisclo
                   ·Emphysema·Asthma·        sed·Undisclosed·Phas
                   Bronchitis                e2Ongoing·Undisclos
                                             ed




N30-201            ·CysticFibrosis·Asthm ·Phase1·Phase1          -                 NCE               N30 Pharma
                   a




NAL6266 3 Day Patch ·Asthma                  ·Undisclosed        -                 new formulation   NAL Pharmaceuticals
                                                                                                     Ltd.
NL6328 1 Day Patch   ·Asthma              ·Undisclosed           tulobuterol   generic           NAL Pharmaceuticals
                                                                                                 Ltd.




NM100100             ·Asthma              ·PreClinicalDiscontinu -             new formulation   NexMed, Inc.
                                          ed
NS-126               ·Allergy·Asthma      ·Phase3·Phase2         -             NCE               Hisamitsu
                                                                                                 Pharmaceutical Co.
                                                                                                 Inc.
NT-702               ·IntermittentClaudicati ·Phase3Ongoing·Pha -              NCE               Taisho
                     on·PeripheralVascular se2·Phase2                                            Pharmaceutical Co.,
                     Diseases·Asthma                                                             Ltd.(Japan)
Naturasone   ·Asthma·COPD·Allerg ·Phase2·Phase2·Pha -   NCE   Epigenesis
             y                   se1                          Pharmaceuticals Inc.
Neophyllin Injection   ·Asthma·Bronchitis·He ·Marketed·Marketed· aminophylline   NCE   Eisai Co. Ltd(Japan)
                       artFailure·PulmonaryE Marketed·Marketed·M
                       dema·AnginaPectoris· arketed·Marketed
                       CerebralPalsy
Neophyllin Powder   ·Asthma·Bronchitis·Re ·Marketed·Marketed·   aminophylline   NCE   Eisai Co. Ltd(Japan)
                    spiratory·HeartFailure Marketed·Marketed
Neophyllin Tablets   ·Asthma·Bronchitis·Re ·Marketed·Marketed·   aminophylline   NCE   Eisai Co. Ltd(Japan)
                     spiratory·HeartFailure Marketed·Marketed
Nepadutant Injectable ·Asthma·IBD          ·Phase2·Phase2        nepadutant   NCE   A. Menarini Pharma




Neu-105              ·Asthma·COPD·Alzhei ·PreClinical·PreClinica -            NCE   Neurim
                     mer's               l·PreClinical                              Pharmaceuticals




Neutrazumab          ·RheumatoidArthritis·S ·Phase1·Phase1·Pha neutrazumab    BLA   G2 Therapies Pty Ltd.
                     troke·Asthma·COPD·S se1·Phase1·Phase1·
                     LE·RheumatoidArthriti Phase1
                     s
Neuzym Fine Granules ·Sinusitis·Periodontitis/ ·Marketed·Marketed· lysozyme      new formulation   Eisai Co. Ltd(Japan)
                     Gingivitis·Bronchitis·A Marketed·Marketed·M hydrochloride
                     sthma·Bronchiectasis arketed
Neuzym Granules   ·Sinusitis·Periodontitis/ ·Marketed·Marketed· lysozyme      new formulation   Eisai Co. Ltd(Japan)
                  Gingivitis·Bronchitis·A Marketed·Marketed·M hydrochloride
                  sthma·Bronchiectasis arketed
Neuzym Tablets   ·Sinusitis·Periodontitis/ ·Marketed·Marketed· lysozyme      new formulation   Eisai Co. Ltd(Japan)
                 Gingivitis·Bronchitis·A Marketed·Marketed·M hydrochloride
                 sthma·Bronchiectasis arketed
Nitric Oxide-        ·Cancer·PainManage       ·Research·Research· -             NCE               Nitromed Inc.
Enhancing PDE        ment·CNS·Asthma·Er       Research·Research·R
Inhibitors           ectileDysfunction·Pulm   esearch·Research
                     onaryHypertension
Nitric Oxide-        ·Allergy·Asthma          ·Research·Research   -            NCE               Nitromed Inc.
Enhancing Steroids




Novopulmon           ·Asthma·COPD             ·Marketed            budesonide   new formulation   Meda AB(Europe)
Nuelin SA Tablets   ·Bronchospasm·Asthm ·Marketed·Marketed·       theophylline   new formulation   Meda AB(ex-US)
                    a·COPD              Marketed




ODC9101             ·Asthma               ·Phase2                 -              NCE               Oxagen Ltd

OX-2477             ·Asthma·COPD          ·PreClinical·PreClinica -              NCE               Orexo AB
                                          l

OX-914              ·Asthma·COPD·Allerg ·Phase2Ongoing·Pha -                     NCE               Orexo AB
                    y                   se2Ongoing·Phase2O
                                        ngoing



OX-CLI              ·Asthma·COPD·Allerg ·PreClinical·PreClinica -                NCE               Orexo AB
                    y                   l·PreClinical
OX-LSAID         ·Asthma                ·Phase2                 -   new formulation   Orexo AB




OX40             ·Cancer·Infections·Aut ·PreClinical·PreClinica -   BLA               Celtic Pharma
                 oimmuneDiseases·Ast l·PreClinical·PreClinic                          Management L.P.
                 hma                    al




OX40, La Jolla   ·Asthma                ·Research               -   NCE               La Jolla
                                                                                      Pharmaceutical Co.
OX914            ·COPD·Asthma·Allerg ·Phase2·Phase2·Pha -    NCE               Orexo AB
                 y                   se2




Omron MicroAir   ·Asthma·COPD       ·Marketed·Marketed   -   new formulation   Omron HealthCare
Nebulizer
Onon Capsules   ·Asthma·Allergy·COP   ·Marketed·Marketed· pranlukast hydrate   NCE   Ono Pharmaceutical
                D·Sinusitis           Phase2·Phase3Disco                             Co., Ltd.(Japan)
                                      ntinued
Onon Dry Syrup   ·Asthma   ·Marketed      pranlukast hydrate   new formulation   Ono Pharmaceutical
                                                                                 Co., Ltd.(Japan)




Optime Topical   ·Asthma   ·Undisclosed   -                    new formulation   OPTIME
Asthma                                                                           Therapeutics, Inc.
OraPred Oral Solution ·Asthma·Allergy·SkinA ·Marketed·Marketed· prednisolone sodium   NCE   Biomarin
                      ntiinflammatory·Cance Marketed·Marketed·M phosphate                   Pharmaceutical Inc.
                      r,Leukemia·EyeAntiinfl arketed·Marketed
                      ammatory·Rheumatoid
                      Arthritis
Orapred ODT   ·Asthma·Allergy·SkinA ·Marketed·Marketed· prednisolone sodium   new formulation   Biomarin
              ntiinflammatory·Cance Marketed·Marketed·M phosphate                               Pharmaceutical Inc.
              r,Leukemia·EyeAntiinfl arketed·Marketed
              ammatory·Rheumatoid
              Arthritis
Osonide HFA Inhaler   ·Asthma                   ·Marketed             ciclesonide           generic   Ranbaxy Laboratories
                                                                                                      Ltd.(India)




Oxagen GPCR           ·Antiinflammatory/Imm     ·Undisclosed·Undisclo -                     NCE       Oxagen Ltd
Program               une·IBD·RheumatoidA       sed·Undisclosed·Undi
                      rthritis·Psoriasis·Asth   sclosed·Undisclosed
                      ma
Oxis Turbohaler       ·Asthma·COPD              ·Marketed             formoterol fumarate   NCE       AstraZeneca
                                                                                                      Plc(Europe)




PAC-G31P              ·ARDS·Asthma·COPD ·PreClinicalOngoing·P -                             NCE       Pacgen
                                        reClinicalOngoing·Pre                                         Biopharmaceuticals
                                        ClinicalOngoing                                               Corp.



PF-3893787            ·Asthma                   ·Phase1Ongoing        -                     NCE       Pfizer Inc.
PF-4191834         ·Asthma                   ·Phase2Ongoing      -           NCE   Pfizer Inc.




PF-610355          ·Asthma·COPD              ·Phase2·Phase2      -           NCE   Pfizer Inc.(World)

PI3 Kinase delta   ·RheumatoidArthritis·A    ·PreClinicalOngoing·R -         NCE   Roche
inhibitor          sthma·Cancer,Haemat       esearchOngoing·PreC
                   ological                  linicalOngoing
PLA-695            ·Asthma·RheumatoidA       ·Phase1·Phase1·Pha giripladib   NCE   Wyeth
                   rthritis·Osteoarthritis   se1




POL6014            ·COPD·Asthma              ·ResearchOngoing·Re -           NCE   Polyphor Ltd
                                             searchOngoing
PROAIR HFA   ·Asthma·Bronchospas ·Marketed·Marketed   albuterol sulfate   generic   Teva Pharmaceutical
             m                                                                      Industries Ltd.(USA)
PRS-060    ·Asthma                  ·PreClinical           -   BLA               Pieris AG




PS291822   ·COPD·Asthma·Psoria ·Phase2·Phase2·Pha -            NCE               Ligand
           sis                 se2                                               Pharmaceuticals Inc.




PS460644   ·Asthma·Allergy          ·Phase1·Phase1         -   NCE               Ligand
                                                                                 Pharmaceuticals Inc.

PW3101     ·Asthma                  ·UndisclosedDiscontin -    new formulation   Penwest
                                    ued                                          Pharmaceuticals Co.




PXS25      ·IdiopathicPulmonaryFi   ·PreClinicalFinished·P -   NCE               Pharmaxis Ltd.
           brosis·Asthma·Multiple   reClinicalOngoing·Pre
           Sclerosis·AcuteLungInj   ClinicalOngoing·PreCl
           ury                      inicalOngoing
PXS4159    ·Asthma                  ·PreClinicalOngoing    -   NCE               Pharmaxis Ltd.
PXS64                   ·MultipleSclerosis·Asth ·PreClinical·PreClinica -                 new formulation   Pharmaxis Ltd.
                        ma·AcuteLungInjury      l·PreClinical




PXS74                   ·Asthma                   ·Research               -               NCE               Pharmaxis Ltd.
Palau Pharma DP-1       ·Asthma·AtopicDermat      ·PreClinical·PreClinica -               NCE               Palau Pharma
                        itis·SLE·MultipleSclero   l·PreClinical·PreClinic
                        sis·OrganTransplantati    al·PreClinical
                        on
Phyllocontin Continus   ·Asthma                   ·Marketed               aminophylline   generic           Napp
                                                                          dihydrate                         Pharmaceuticals
                                                                                                            Ltd.(UK)
Phyllocontin Forte   ·Asthma   ·Marketed   aminophylline   generic   Napp
Continus                                   dihydrate                 Pharmaceuticals
                                                                     Ltd.(UK)
Phyllocontin Pediatric   ·Asthma          ·Marketed               aminophylline   generic   United
Continus                                                          dihydrate                 Pharmaceuticals(Middl
                                                                                            e East)




Phylogica/Opsona    ·Asthma·Autoimmune ·ResearchOngoing·Re -                      NCE       Phylogica Ltd.
Discovery Programme Diseases·AtopicDerma searchOngoing·Resea
                    titis·Antiinflammatory/I rchOngoing·Research
                    mmune                    Ongoing



Phytopharma Asthma       ·Asthma·COPD     ·PreClinical·PreClinica -               NCE       Phytopharm Plc
Program                                   l
Pleconaril   ·Infections,Viral·Asthm ·Phase2·Phase2·Pha pleconaril   NCE   Schering-Plough Corp.
             a·CoughandCold          se2
PreHistin Sublingual   ·Allergy·Migraine·Asth ·Phase3·Phase2·Undi cyanocobalamin   OTC   Cobalis Corp.
Lozenge                ma·AtopicDermatitis    sclosed·Undisclosed
Premaire Albuterol    ·Asthma   ·Phase2Discontinued albuterol sulfate   new formulation   Sheffield
                                                                                          Pharmaceuticals
                                                                                          Inc(USA)




Premaire Budesonide   ·Asthma   ·Phase1Discontinued budesonide          new formulation   Sheffield
                                                                                          Pharmaceuticals Inc
Premaire Sodium   ·Asthma   ·PreClinicalDiscontinu sodium cromoglycate   new formulation   Sheffield
Cromoglycate                ed                                                             Pharmaceuticals Inc
Primatene Mist   ·Asthma   ·Marketed   epinephrine   OTC   Wyeth(USA)
ProAir EasiBreathe   ·Asthma·Bronchospas ·Registration·Registrat albuterol sulfate   -   Teva Pharmaceutical
                     m                   ion                                             Industries Ltd.(USA)
Profilar Tablets   ·Asthma   ·Marketed   ketotifen fumarate   generic   United
                                                                        Pharmaceuticals(Middl
                                                                        e East)
Proteomics          ·Asthma   ·Research             -                  NCE   Synairgen
Program,Synairgen




Proventil CFC       ·Asthma   ·MarketedDiscontinue albuterol sulfate   NCE   Schering-Plough Corp.
                              d
Proventil-HFA   ·Asthma   ·Marketed   albuterol sulfate   new formulation   Schering-Plough
                                                                            Corp.(USA)
Pulmicort HFA       ·Asthma   ·Marketed   budesonide   new formulation   AstraZeneca Plc(ex-
                                                                         US,Europe,Denmark,F
                                                                         inland,Hungary,Portug
                                                                         al,Spain)




Pulmicort Inhaler   ·Asthma   ·Marketed   budesonide   new formulation   AstraZeneca Plc(USA)
Pulmicort Respules    ·Asthma   ·Marketed   budesonide   new formulation   AstraZeneca
                                                                           Plc(USA,UK)




Pulmicort Respules,   ·Asthma   ·Marketed   budesonide   generic           Par Pharmaceutical
Generic Par Pharma                                                         Companies Inc.(USA)
Pulmicort TurboHaler   ·Asthma        ·Marketed             budesonide   new formulation   AstraZeneca
                                                                                           Plc(USA,UK)




PulmoSphere            ·Asthma        ·UndisclosedDiscontin albuterol    new formulation   Nektar Therapeutics
Albuterol                             ued




QAB149 CertiHaler      ·COPD·Asthma   ·Phase3Discontinued· indacaterol   NCE               Novartis AG
                                      Phase3Discontinued




QAE397                 ·Asthma        ·Phase2             -              NCE               Novartis AG
QAP642                 ·Asthma        ·Phase1Discontinued -              NCE               Novartis AG
QAX935   ·Asthma·Allergy   ·Phase1·Phase1   -   NCE   Idera Pharmaceuticals
                                                      Inc.
QMF149   ·COPD·Asthma   ·Phase2·Phase2   indacaterol·         new combination   Novartis AG(World)
                                         mometasone furoate
Qvar 50 and 100 MDI   ·Asthma   ·Marketed   beclomethasone   generic           Teva Pharmaceutical
                                            dipropionate                       Industries Ltd.(Europe)




Qvar AutoHaler        ·Asthma   ·Marketed   beclomethasone   new formulation   Teva Pharmaceutical
                                            dipropionate                       Industries Ltd.(Europe)
Qvar Easi-Breathe   ·Asthma   ·Marketed   beclomethasone   new formulation   Teva Pharmaceutical
                                          dipropionate                       Industries Ltd.(UK)




Qvar HFA            ·Asthma   ·Marketed   beclomethasone   new formulation   3M Health Care
                                          dipropionate
R1671         ·Asthma        ·Phase1Ongoing        -   BLA   Genmab(World)




R343, Rigel   ·Asthma·COPD   ·Phase1·PreClinical   -   NCE   Rigel
                                                             Pharmaceuticals, Inc.
R411      ·Asthma        ·Phase2               valategrast       NCE               Roche
                                               hydrochloride




R4930     ·Asthma        ·Phase1Ongoing        -                 BLA               Genmab




RESP001   ·Asthma·COPD   ·Phase1Finished·Pha albuterol sulfate   new formulation   Respirics Inc.
                         se1Finished
RIZABEN Dry syrup   ·Asthma·Allergy·Atopic ·Marketed·Marketed·   tranilast   new formulation   Kissei Pharmaceutical
                    Dermatitis             Marketed                                            Company(Japan)
RIZABEN Fine   ·Asthma·Allergy·Atopic ·Marketed·Marketed·    tranilast   NCE   Kissei Pharmaceutical
granules       Dermatitis             Marketed                                 Company(Japan)




RPL554 Nasal   ·Antiinflammatory/Imm ·PreClinical·PreClinica -           NCE   Verona Pharma Plc
               une·Bronchitis·Allergy· l·PreClinical·Phase1
               Asthma
RX-10001              ·Asthma·IBD·Rheumat ·PreClinical·PreClinica -                  NCE       Resolvyx
                      oidArthritis·Cardiovasc l·PreClinical·PreClinic                          Pharmaceuticals Inc.
                      ular                    al




Racepinephrine        ·Asthma                ·Marketed              racepinephrine   generic   Nephron
Inhalation Solution                                                                            Pharmaceuticals
                                                                                               Corp.(USA)
Reslizumab    ·Esophagitis·Asthma   ·Phase3Ongoing·Pha reslizumab              BLA     Ception Therapeutics
                                    se2Ongoing




Respicort     ·Asthma               ·Phase2              etiprednol dicloacetate NCE   Teva Pharmaceutical
                                                                                       Industries Ltd.(USA)


Respivert     ·Asthma·COPD          ·Research·Research   -                     NCE     Respivert, Inc
Asthma/COPD
Respontin Nebules   ·Asthma              ·Marketed              ipratropium bromide   new formulation   GlaxoSmithKline
                                                                hydrate                                 Plc(UK)




Respriva            ·Emphysema·COPD·C ·Phase2·Phase1·Pre        -                     BLA               Arriva
                    ysticFibrosis·Asthma Clinical·PreClinical                                           Pharmaceuticals
Rizaben Tablets       ·Allergy·Asthma   ·Marketed·Marketed   tranilast    new formulation   Kissei Pharmaceutical
                                                                                            Company(Japan)




Romet Fine Granules   ·Asthma           ·Marketed            repirinast   NCE               Mitsubishi
For Children                                                                                Pharmaceutical
                                                                                            Corp.(Japan)

Romet Tablets         ·Asthma           ·Marketed            repirinast   NCE               Mitsubishi
                                                                                            Pharmaceutical
                                                                                            Corp.(Japan)
S-5751       ·Asthma               ·Phase2Discontinued S-5751                 NCE               Shionogi and Co., Ltd.


SAR 398171   ·Asthma               ·PreClinicalDiscontinu   -                 NCE               Sanofi-Aventis
                                   ed
SAR137272    ·Asthma·COPD          ·PreClinicalOngoing·P    -                 NCE               Sanofi-Aventis
                                   reClinicalOngoing
SAR21609     ·Asthma·Infections,Re ·Phase1Ongoing·Pha       -                 NCE               Sanofi-Aventis(USA)
             spiratoryTract        se1Ongoing
SAR389644    ·Asthma·Allergy       ·Phase1Ongoing·Pha       -                 NCE               Sanofi-Aventis(USA)
                                   se1Ongoing
SG003        ·Asthma               ·Phase1                  interferon beta   new formulation   Dr. Rentschler
                                                                                                Holding GmbH & Co.
                                                                                                KG




SG004        ·Asthma·COPD          ·Phase1Ongoing·Pha interferon beta         new formulation   Dr. Rentschler
                                   se1Ongoing                                                   Holding GmbH & Co.
                                                                                                KG




SG005        ·Asthma·COPD          ·Phase1·Phase1      -                      NCE               Synairgen
SG006        ·Asthma·COPD          ·Phase1·Undisclosed -                      NCE               Synairgen

SG007        ·Asthma               ·Undisclosed             -                 NCE               Synairgen
SG008        ·Asthma               ·Undisclosed             -                 NCE               Synairgen
SMP-028     ·Asthma        ·Phase1                -                 NCE               Dainippon Sumitomo
                                                                                      Pharmaceutical(USA)


SNG-1       ·Asthma        ·Phase1                interferon beta   new formulation   Synairgen




SNG-3       ·Asthma        ·PreClinical           -                 BLA               Synairgen




SRP312      ·Asthma        ·ResearchDiscontinue -                   NCE               Silence Therapeutics
                           d                                                          Plc




SSR161421   ·Asthma·COPD   ·PreClinicalDiscontinu -                 NCE               Sanofi-Aventis
                           ed·PreClinicalDisconti
                           nued
SUN-S 461   ·Asthma·COPD   ·PreClinicalOngoing·P -                  new formulation   Sun Pharmaceutical
                           reClinicalOngoing                                          Industries
Salamol Easi Breathe   ·Bronchospasm·Asthm ·Marketed·Marketed     albuterol   new formulation   Teva Pharmaceutical
CFC Free               a                                                                        Industries
                                                                                                Ltd.(Europe,Mexico)




Salamol Easi Breathe   ·Bronchospasm·Asthm ·UndisclosedDiscontin albuterol    new formulation   Teva Pharmaceutical
                       a                   ued·UndisclosedDisco                                 Industries
                                           ntinued                                              Ltd.(Europe,Mexico)
Salbunova HFA        ·Asthma    ·Marketed      albuterol   new formulation   Lavipharm SA(ex-US)




Salbutamol Cyclohaler ·Asthma   ·Marketed      albuterol   new formulation   Teva Pharmaceutical
                                                                             Industries Ltd.(Europe)




Salbutamol HFA, Inyx ·Asthma    ·PreClinical   albuterol   new formulation   Phares Drug Delivery
                                                                             AG
Salbutamol          ·Asthma·Bronchitis·E   ·Marketed·Marketed·   albuterol   new formulation   Galen Limited
Steripoules         mphysema               Marketed




Salbutamol Taifun   ·Asthma                ·Marketed             albuterol   new formulation   Akela Pharma
                                                                                               Inc.(Europe)
Senicapoc        ·Asthma·Antiinflammat ·Phase2Ongoing·Pre senicapoc     NCE               ICAgen Inc.(World)
                 ory/Immune·SickleCell Clinical·Phase3Discon
                                       tinued




Sepracor/Arrow   ·Asthma             ·Research            ciclesonide   new formulation   Sepracor Inc.
Ciclesonide
Seretide EvoHaler   ·Asthma   ·Marketed   salmeterol xinafoate· new formulation   GlaxoSmithKline
                                          fluticasone propionate                  Plc(Europe)
Serevent Diskhaler   ·Asthma·COPD   ·Marketed·Marketed   salmeterol xinafoate   new formulation   GlaxoSmithKline
                                                                                                  Plc(UK)
Serevent Diskus     ·Asthma·COPD   ·Marketed            salmeterol xinafoate   new formulation   GlaxoSmithKline
                                                                                                 Plc(USA,UK)




Serevent Evohaler   ·Asthma·COPD   ·Marketed·Marketed   salmeterol xinafoate   new formulation   GlaxoSmithKline
                                                                                                 Plc(Europe)
Serevent Inhalation   ·Asthma   ·MarketedDiscontinue salmeterol xinafoate   NCE   GlaxoSmithKline
Aerosol - CFC                   d                                                 Plc(USA,Europe)
Simponi   ·RheumatoidArthritis·A ·Approved·Approved· golimumab   BLA   Centocor
          nkylosingSpondylitis·P Approved·Phase2·Ph
          soriaticArthritis·Asthm ase3
          a·UlcerativeColitis
Singulair Chewable   ·Asthma·Allergy   ·Marketed·Marketed   montelukast sodium   new formulation   Merck and Co
Tablets                                                                                            Inc.(USA,UK)
Singulair Granules   ·Asthma·Allergy   ·Marketed·Marketed   montelukast sodium   new formulation   Merck and Co
                                                                                                   Inc.(USA)
Singulair Tablets   ·Asthma·Allergy   ·Marketed·Marketed   montelukast sodium   NCE   Merck and Co
                                                                                      Inc.(USA)




Sirna Asthma Program ·Asthma          ·PreClinical         -                    NCE   Merck and Co Inc.
Solfa Tablets   ·Asthma·Allergy   ·Marketed·Marketed   amlexanox   new formulation   Takeda
                                                                                     Pharmaceutical Co.
                                                                                     Ltd.(Japan)
Spiriva Respimat   ·Asthma·COPD   ·Marketed·Marketed   tiotropium bromide   new formulation   Boehringer
                                                       monohydrate                            Ingelheim(Europe)
Spiriva   ·Asthma·COPD·Cystic ·Marketed·Marketed·   tiotropium bromide   NCE   Boehringer
          Fibrosis            Undisclosed           monohydrate                Ingelheim(Europe)
Spiropent Tablets   ·Asthma·OveractiveBl ·Marketed·Marketed   clenbuterol     NCE   Boehringer Ingelheim
                    adder                                     hydrochloride
Symbicort SMART   ·Asthma·COPD   ·Marketed·Approved   budesonide·           new combination   AstraZeneca Plc(USA)
MDI                                                   formoterol fumarate
                                                      dihydrate
Symbicort Turbuhaler   ·Asthma·COPD   ·Marketed·Marketed   budesonide·   new combination   AstraZeneca Plc(ex-
                                                           formoterol                      US)
Synairgen Inhaled     ·Asthma                ·Research             -   BLA   Synairgen
Growth Factor




Synta/Roche          ·Antiinflammatory/Imm ·PreClinical·PreClinica -   NCE   Synta
Inflammatory Program une·RheumatoidArthrit l·PreClinical·PreClinic           Pharmaceuticals Corp.
                     is·Asthma·COPD·Aller al·PreClinical
                     gy
TARG-ALLERG I-200 ·Asthma                  ·Undisclosed            -   NCE   Targepeutics, Inc.




TARG-ALLERG I-201 ·Asthma                    ·Undisclosed          -   NCE   Targepeutics, Inc.
TARG-ALLERG I-202 ·Asthma               ·Undisclosed          -                     NCE   Targepeutics, Inc.




TBC1269           ·COPD·Asthma·Psoria ·Phase2Ongoing·Pha bimosiamose                NCE   Revotar
                  sis·ARDS            se2Ongoing·Phase2O                                  Biopharmaceuticals
                                      ngoing·Phase1Finishe                                AG
                                      d
TBC4095           ·Asthma             ·UndisclosedDiscontin -                       NCE   Encysive
                                      ued                                                 Pharmaceuticals Inc.
TBC4746           ·Asthma             ·Phase1               -                       NCE   Pfizer Inc.

TG100115          ·Cardiovascular·Asthm ·Phase1·PreClinical   -                     NCE   TargeGen Inc.
                  a




TJ-29             ·CoughandCold·Bronc ·Marketed·Marketed·     -                     NCE   Tsumura & Co.(Japan)
                  hitis·Asthma         Marketed
TNX-650           ·Cancer,Hodgkin'sLym ·Phase1·Phase1         -                     BLA   Tanox, Inc.
                  phoma·Asthma




TPI-1020          ·Asthma·COPD          ·Phase2·Phase2Disco nitric oxide-donating   NCE   Nicox SA
                                        ntinued             derivative of
                                                            budesonide
TPI-ASM8           ·Asthma   ·Phase2Ongoing   -   NCE   Topigen
                                                        Pharmaceuticals Inc.




TRPA1 antagonist   ·Asthma   ·PreClinical     -   NCE   Hydra Biosciences
Program, Hydra
TUSSI-12D    ·CoughandCold·Asthm ·Marketed·Marketed·   carbetapentane        new combination   Meda AB(USA)
Suspension   a·Bronchitis        Marketed              tannate· pyrilamine
                                                       tannate·
                                                       phenylephrine tannate
TUSSI-12D Tablet   ·CoughandCold·Asthm ·Marketed·Marketed·   carbetapentane        new combination   Meda AB(USA)
                   a·Bronchitis        Marketed              tannate· pyrilamine
                                                             tannate·
                                                             phenylephrine tannate
Taifun Budesonide   ·Asthma   ·Phase3     budesonide       generic           Akela Pharma Inc.




Taifun Formoterol   ·Asthma   ·Phase1     formoterol       generic           Akela Pharma Inc.




Taunus DPI          ·Asthma   ·Marketed   beclomethasone   new formulation   Kyowa Hakko Kirin
                                          dipropionate                       Co., Ltd.(Japan)
Tempo Fluticasone   ·Asthma   ·Phase1   fluticasone propionate new formulation   MAP Pharmaceuticals
                                                                                 Inc.
Teosona SOL   ·Asthma   ·Marketed   theophylline   generic   Osmotica
                                                             Pharmaceutical
Terbutaline Mystic   ·Asthma·COPD   ·UndisclosedDiscontin terbutaline sulfate   new formulation   Ventaira(USA)
                                    ued·UndisclosedDisco
                                    ntinued
Theo-Dur Extended   ·Asthma·Bronchitis   ·MarketedDiscontinue theophylline   new formulation   Schering-Plough
Release Tablets                          d·MarketedDiscontinu                                  Corp.(USA)
                                         ed
Theo-Dur Sprinkle   ·Asthma   ·MarketedDiscontinue theophylline   new formulation   Schering-Plough Corp.
Sustained Action              d
Capsules
TheoDur, Generic Able ·Asthma   ·MarketedDiscontinue theophylline   generic   Sun Pharmaceutical
                                d                                             Industries(USA)




TheoDur, Generic URL ·Asthma    ·Marketed            theophylline   generic   URL Pharma, Inc.
Theolin SR Capsules   ·Asthma   ·Marketed   theophylline   generic   United
                                                                     Pharmaceuticals(Middl
                                                                     e East)
Theolong SR Granules ·Asthma·Bronchitis   ·Marketed·Marketed   theophylline   new formulation   Eisai Co. Ltd(Japan)
Theolong SR Tablets   ·Asthma·Bronchitis   ·Marketed·Marketed   theophylline   new formulation   Eisai Co. Ltd(Japan)
Theophyline LP     ·Asthma   ·PreClinical   theophylline   generic   Galenix




Theophylline CDT   ·Asthma   ·PreClinical   theophylline   generic   SCOLR Pharma Inc.
Theophylline ER     ·Asthma   ·Marketed   theophylline   generic   Forest Laboratories
Capsules Generic,                                                  Inc(USA)
Forest




Theophylline ER     ·Asthma   ·Marketed   theophylline   generic   Forest Laboratories
Tablets Generic,                                                   Inc(USA)
Forest
Tilade CFC Free   ·Asthma   ·Marketed   nedocromil sodium   new formulation   Sanofi-
Inhaler                                                                       Aventis(Europe,Austral
                                                                              ia)
Tilade Inhalation   ·Asthma·Asthma   ·MarketedDiscontinue nedocromil sodium   NCE   Sanofi-Aventis
Aerosol - CFC                        d·Marketed
Triamicinolone Mystic   ·Asthma·COPD   ·UndisclosedDiscontin triamcinolone   new formulation   Ventaira
                                       ued·UndisclosedDisco acetonide
                                       ntinued




Tulobuterol Tape        ·Asthma        ·Marketed             tulobuterol     new formulation   Nipro Patch Co.
EMEC                                                                                           Ltd.(Japan)
Tulobuterol-TDS        ·Asthma        ·Phase1                 tulobuterol   new formulation   LTS Lohmann




Undisclosed Captisol   ·Asthma·COPD   ·PreClinical·PreClinica -             new formulation   CyDex
Inhalation                            l                                                       Pharmaceuticals, Inc


Undisclosed            ·Asthma        ·PreClinicalDiscontinu -              NCE               Ventaira
compound, Ventaira                    ed


Undisclosed            ·Asthma        ·PreClinicalDiscontinu -              NCE               Abbott Laboratories
compound,                             ed                                                      Inc.
Ventaira/Abbott
Undisclosed            ·Asthma        ·PreClinicalDiscontinu -              NCE               Viasys Healthcare
compound,                             ed
Ventaira/Viasys
Uniphyl Tablets     ·Asthma·Bronchitis·E   ·Marketed·Marketed·   theophylline   generic           Otsuka
                    mphysema               Marketed                                               Pharmaceutical Co.,
                                                                                                  Ltd.(Japan)




Unit Dose Budesonide ·Asthma               ·Phase3Ongoing        budesonide     new formulation   MAP Pharmaceuticals
                                                                                                  Inc.(USA)




Uriach Asthma       ·Asthma                ·Research             -              NCE               Grupo Uriach
Program
VR315   ·Asthma        ·Phase2                undisclosed small     generic           Vectura Group Plc
                                              molecule· undisclosed
                                              small molecule




VR632   ·Asthma·COPD   ·Phase2·Phase2         -                     generic           Vectura Group Plc




VR694   ·Asthma        ·PreClinicalDiscontinu -                     new formulation   Vectura Group Plc
                       ed
Vaccines Against       ·Asthma·Allergy         ·PreClinicalDiscontinu -    BLA   GlaxoSmithKline Plc
Allergy and Allergic                           ed·PreClinicalDisconti
Asthma                                         nued
Vagonixen              ·Asthma·COPD            ·PreClinical·PreClinica -   NCE   Cordex Pharma, Inc.
                                               l




Vantox                 ·Asthma·CysticFibrosi   ·PreClinical·PreClinica -   NCE   PowerVerde Systems,
                       s·ARDS·Antiinflammat    l·PreClinical·PreClinic           Inc.
                       ory/Immune·Emphyse      al·PreClinical·PreClini
                       ma·COPD                 cal
Vectura/BI DPI   ·Asthma·COPD   ·PreClinical·PreClinica -   NCE   Boehringer
Program                         l                                 Ingelheim(World)
Ventide Inhaler   ·Asthma   ·Marketed   albuterol·       new combination   GlaxoSmithKline
                                        beclomethasone                     Plc(ex-US)
                                        dipropionate
Ventide Rotocaps   ·Asthma   ·Marketed   albuterol sulfate·   new combination   GlaxoSmithKline
                                         beclomethasone                         Plc(Europe)
                                         dipropionate
Ventilastin Novolizer   ·Asthma   ·Marketed   albuterol   new formulation   Meda AB(Europe)
Ventodisks   ·Asthma   ·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                                                                         Plc(UK)
Ventolin Accuhaler   ·Asthma·Bronchospas ·Marketed·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                     m                                                                              Plc(UK)
Ventolin Inhalation   ·Asthma·Bronchospas ·MarketedDiscontinue albuterol   NCE   GlaxoSmithKline
Aerosol - CFC         m                   d·MarketedDiscontinu                   Plc(USA)
                                          ed
Ventolin Inhalation   ·Asthma             ·Marketed            albuterol           generic           Amphastar
Aerosol - CFC,                                                                                       Pharmaceuticals
Generic Armstrong                                                                                    Inc.(USA)




Ventolin Inhaled      ·Bronchospasm·Asthm ·Marketed·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
Solution              a                                                                              Plc(Europe)
Ventolin Nebules    ·Bronchospasm·Asthm ·Marketed·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                    a                                                                              Plc(Europe)




Ventolin RotoCaps   ·Asthma·Bronchospas ·Marketed·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                    m                                                                              Plc(Europe)
Ventolin Syrup   ·Asthma   ·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                                                                             Plc(UK)
Ventolin-HFA   ·Asthma   ·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                                                                           Plc(USA)
Veramyst                ·Allergy·Asthma   ·Marketed·Phase2On fluticasone furoate   NCE   GlaxoSmithKline
                                          going                                          Plc(USA)




Verus Short-Acting      ·Asthma           ·Undisclosed         -                   NCE   AstraZeneca Plc
Beta Agonist Solution
Volare Easi-Breathe   ·Asthma   ·Phase3       albuterol   new formulation   Teva Pharmaceutical
                                                                            Industries Ltd.




Volare MDI            ·Asthma   ·Approvable   albuterol   new formulation   Teva Pharmaceutical
                                                                            Industries Ltd.(USA)
Volmax Tablets   ·Asthma·Bronchospas ·Marketed·Marketed   albuterol sulfate   new formulation   GlaxoSmithKline
                 m                                                                              Plc(UK)
Xcelovair Formoterol   ·Asthma           ·Phase1            formoterol   new formulation   Pfizer Inc.




Xolair Injection       ·Asthma·Allergy   ·Marketed·Phase2   omalizumab   BLA               Tanox, Inc.(USA)
Xolair Prefilled Syringe ·Asthma   ·Phase2   omalizumab   new formulation   Genentech Inc.
Xopenex HFA   ·Asthma·COPD   ·Marketed·Marketed   levalbuterol tartrate   new formulation   Sepracor Inc.(USA)
Xopenex Inhalation    ·Asthma   ·Approved   levalbuterol    generic   DEY L.P.(USA)
Solution, Generic Dey                       hydrochloride
ZYFLO Tablets   ·Asthma·COPD   ·Marketed·Phase3   zileuton   NCE   Abbott Laboratories
                                                                   Inc.
Zenapax         ·OrganTransplantation   ·Marketed·Phase2On daclizumab   BLA               Facet Biotech
                ·MultipleSclerosis·GV   going·Undisclosed·Ph                              Corporation(USA,Euro
                HD·Asthma·MS,Relap      ase2Discontinued·Ph                               pe)
                singRemitting           ase2




Zesulan Fine    ·Asthma·Allergy         ·Marketed·Marketed   -          new formulation   Asahi Kasei
Granules 0.6%                                                                             Pharma(Japan)
Zesulan Syrup       ·Asthma·Allergy        ·Marketed·Marketed    mequitazine   new formulation   Asahi Kasei
                                                                                                 Pharma(Japan)

Zesulan Tablet      ·Asthma·Allergy        ·Marketed·Marketed    mequitazine   NCE               Asahi Kasei
                                                                                                 Pharma(Japan)

Zileuton I.V.       ·Asthma                ·Phase2Ongoing        zileuton      new formulation   Abbott Laboratories
                                                                                                 Inc.




Znomics/OHSU Drug   ·RheumatoidArthritis·A ·PreClinical·PreClinica -           NCE               Znomics, Inc.
Discovery Program   sthma·IBD              l·PreClinical
Zofac               ·Asthma                ·Phase2                 pumactant   NCE               Britannia
                                                                                                 Pharmaceuticals
Zyflo CR   ·Asthma   ·Marketed   zileuton   new formulation   Abbott Laboratories
                                                              Inc.
aeroSRT           ·CysticFibrosis·AcuteL ·Phase2Ongoing·Pre -          NCE   Discovery
                  ungInjury·COPD·Asth Clinical·Research·Res                  Laboratories Inc.
                  ma                     earch




anti YKL40 MAb,   ·Asthma·COPD           ·PreClinical·PreClinica   -   BLA   Medimmune Inc.
Medimmune                                l
cgi1316           ·RheumatoidArthritis·S ·UndisclosedDiscontin     -   NCE   CGI Pharmaceuticals
                  LE·Asthma              ued·UndisclosedDisco
                                         ntinued·UndisclosedDi
                                         scontinued
cgi1746           ·RheumatoidArthritis·S ·UndisclosedDiscontin     -   NCE   CGI Pharmaceuticals
                  LE·Asthma              ued·UndisclosedDisco
                                         ntinued·UndisclosedDi
                                         scontinued
deCODE Asthma     ·Asthma                ·Phase2                   -   NCE   deCODE Genetics Inc.
Program
rEV131   ·ARDS·DryEye·Asthm ·PreClinical·Phase2Di -                       BLA   Evolutec Group plc
         a·EyeAntiinflammatory scontinued·Phase2Dis
         ·Allergy              continued·Phase2Disc
                               ontinued·Phase2Disc
                               ontinued




rhAAT    ·Emphysema·CysticFi ·PreClinicalOngoing·P alpha-1 antitrypsin,   BLA   GTC Biotherapeutics
         brosis·COPD·Asthma· reClinicalOngoing·Res recombinant human            Inc.(ex-Europe)
         ARDS                earch·PreClinicalOng
                             oing·PreClinicalOngoi
                             ng
rhuMAb-OX40L            ·Asthma   ·Phase1        -   BLA   Celtic Pharma
                                                           Management L.P.




ß-Tryptase inhibitors   ·Asthma   ·Undisclosed   -   NCE   NascaCell
                                                           Technologies AG
Partners              Drug Delivery Route    Dosing                 Mechanism Type           Mechanisms            Molecule Type
                                                                                             Explanation


· GlaxoSmithKline Plc ·LiquidInhalers/Nebuliz Dosage Strengths :    Beta 2 Adrenergic        -                     small molecule
                      ers·DryPowderInhalers 0.01, 0.015, 0.02       Agonists
                      -DPI                    milligram ; Dosing
                                              Frequency: Once a
                                              day
-                     ·DryPowderInhalers-    -                      Beta 2 Adrenergic        Long-acting beta2     small molecule
                      DPI                                           Agonists··Beta 2         agonist
                                                                    Adrenergic Agonists



-                     ·INHALATION            -                      PDE-4                    PDE IV inhibitor      -
                                                                    (Phosphodiesterase
                                                                    4) Inhibitors
-                     ·ORALDRUGDELIVE        Dosage Strength : 90   iNOS (Inducible Nitric   Selective iNOS        -
                      RY                     milligram              Oxide Synthase)          inhibitor
                                                                    Inhibitors




-                     ·INHALATION            -                      Beta 2 Adrenergic        long-acting beta2      small molecule
                                                                    Agonists                 agonist
-                     ·INJECTABLES           -                      -                        Monoclonal antibody antibodies
                                                                                             with undisclosed
                                                                                             mechanism of action
-                     ·INHALATION            -                      GR Agonists              Glucocorticoid agonist -
-                   ·INHALATION       ; Dosing Frequency: 1 GR Agonists         Novel glucocorticoid   -
                                      per day                                   agonist




-                   ·INJECTABLES      -                     Anti-CCL2           Human anti-            antibodies
                                                                                CCL2/MCP-1
                                                                                monoclonal antibody
· Dr. Reddys        ·INHALATION       -                     -                   -                      -
Laboratories Ltd.


-                   ·ORALDRUGDELIVE   ; Dosing Frequency: 1 CRTH2 Antagonists   Oral prostaglandin D2 small molecule
                    RY                per day                                   (PGD2) receptor
                                                                                antagonist (CRTH2)
-                   ·INHALATION       ; Dosing Frequency: 2 -                   -                     small molecule
                                      per day
-   ·Metered-          Dosage                    Corticosteroids   ·Corticosteroid:   ·small molecule:
    DoseInhalers-MDI   Strength(flunisolide) :                     flunisolide        flunisolide
                       0.08 milligram ;
                       Dosing Frequency: 2
                       per day




-   ·INJECTABLES       -                         -                 It is an           antibodies
                                                                   immunoglobulin
                                                                   antibody
-   -                  -                         -                 -                  -
-   -   -   -   V-Protectants® are       small molecule
                drugs that block a
                class of signals, called
                oxidant signals, which
                are generated within
                endothelial cells.
                These oxidant signals
                activate genes, which
                produce inflammatory
                proteins. The protein
                products of these
                selected genes,
                including VCAM-1,
                attract white blood
                cells to the site of
                chronic inflammation.
-   ·DryPowderInhalers-   ; Dosing Frequency: 1 -                   -                         -
    DPI                   per day




-   ·DryPowderInhalers-   -                     Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DPI                                         Agonists            racemic form of           albuterol sulfate
                                                                    albuterol and a
                                                                    relatively selective
                                                                    beta 2 -adrenergic
                                                                    bronchodilator:
                                                                    albuterol sulfate




-   ·DryPowderInhalers-   -                     -                   -                         -
    DPI
-   ·INHALATION           Dosage Strengths :     Interleukin 4 Receptor Second-generation      oligonucleotide
                          20, 30 milligram ;     Antagonists            antisense inhibitor of
                          Dosing Frequency: 1                           the alpha subunit of
                          a day                                         the interleukin 4
                                                                        receptor, IL4R-alpha.
                                                                        Potently reduces IL4R-
                                                                        alpha: mRNA and
                                                                        protein levels


-   ·DryPowderInhalers-   Dosage Strength : 5    -                      LAB CGRP is a 37        peptide
    DPI                   milligram ; Dosing                            amino acid natural
                          Frequency: 2 per day                          neuropeptide
                                                                        produced in the lung
                                                                        in response to allergic
                                                                        stimuli. As a potential
                                                                        drug, it has
                                                                        demonstrated in
                                                                        preclinical studies a
                                                                        profile that could
                                                                        make it an ideal anti-
                                                                        asthmatic drug
                                                                        candidate with
                                                                        bronchodilator,
                                                                        bronchoprotector and
                                                                        anti-inflammatory
                                                                        properties.
-   ·ORALDRUGDELIVE   Dosage                 H1 (Histamine 1)   ·Pemirolast binds to    ·small molecule:
    RY                Strength(pemirolast    Antagonists        the histamine H1        pemirolast potassium
                      potassium) : 0.5                          receptor. This blocks
                      percent ; Dosing                          the action of
                      Frequency: 2 per day                      endogenous
                                                                histamine, which
                                                                subsequently leads to
                                                                temporary relief of the
                                                                negative symptoms
                                                                brought on by
                                                                histamine. Pemirolast
                                                                has also been
                                                                observed to block
                                                                antigen-stimulated
                                                                calcium ion influx into
                                                                mast cells. Pemirolast
                                                                inhibits the
                                                                chemotaxis of
                                                                eosinophils into ocular
                                                                tissue, and prevents
                                                                inflammatory mediator
                                                                release from human
                                                                eosinophils.:
                                                                pemirolast potassium
-   ·ORALDRUGDELIVE        Dosage                 H1 (Histamine 1)   ·Pemirolast binds to    ·small molecule:
    RY                     Strengths(pemirolast   Antagonists        the histamine H1        pemirolast potassium
                           potassium) : 5, 10                        receptor. This blocks
                           milligram ; Dosing                        the action of
                           Frequency: 2 per day                      endogenous
                                                                     histamine, which
                                                                     subsequently leads to
                                                                     temporary relief of the
                                                                     negative symptoms
                                                                     brought on by
                                                                     histamine. Pemirolast
                                                                     has also been
                                                                     observed to block
                                                                     antigen-stimulated
                                                                     calcium ion influx into
                                                                     mast cells. Pemirolast
                                                                     inhibits the
                                                                     chemotaxis of
                                                                     eosinophils into ocular
                                                                     tissue, and prevents
                                                                     inflammatory mediator
                                                                     release from human
                                                                     eosinophils.:
                                                                     pemirolast potassium




-   ·OralVaccineDelivery   -                      -                  -                      vaccine
· GlaxoSmithKline Plc ·ORALDRUGDELIVE   Dosage Strength :      FLAP Inhibitors       5-lipoxygenase-        small molecule
(World)               RY                1000 milligram ;                             activating protein
                                        Dosing Frequency: 1                          (FLAP) inhibitor
                                        a day




-                    ·ORALDRUGDELIVE    -                      CRTH2 Antagonists     Selective antagonist   -
                     RY                                                              of the receptor DP2
                                                                                     (also known as
                                                                                     CRTH2 or
                                                                                     chemoattractant
                                                                                     receptor-homologous
                                                                                     molecule expressed
                                                                                     on Th2 lymphocytes)
-                    ·ORALDRUGDELIVE    -                      -                     -                      small molecule
                     RY
· Takeda             ·INJECTABLES       Dosage Strengths :     Anti-IL-4·Anti-IL13   A monoclonal            antibodies
Pharmaceutical Co.                      75, 150, 300 milligram                       antibody that blocks
Ltd. (Japan)                             ; Dosing Frequency:                         the actions of
                                        1 per week                                   interleukin-4 (IL-4)
                                                                                     and interleukin-13 (IL-
                                                                                     13), cytokines that are
                                                                                     believed to play a role
                                                                                     in asthma.
-                      ·ORALDRUGDELIVE         -                     Prostaglandin         antagonist of the           -
                       RY                                            (Prostanoid) Receptor receptors of
                                                                     Antagonists           prostaglandin D2 (D-
                                                                                           prostanoid and
                                                                                           chemoattractant
                                                                                           receptor-homologous
                                                                                           molecule expressed
                                                                                           on Th2 cells)
· Actimis              -                       ; Dosing Frequency: 1 CRTH2 Antagonists        Antagonist against the   small molecule
Pharmaceuticals                                per day                                        receptor CRTH2
-                      ·DryPowderInhalers-     -                     Tryptase Inhibitors      ·Tryptase inhibitor:     ·small molecule: APC
                       DPI                                                                    APC 366                  366
· CyDex                ·LiquidInhalers/Nebuliz -                     mACh (Muscarinic         Beta 2 Adrenergic        small molecule
Pharmaceuticals, Inc   ers·Cyclodextrins/Solu                        Acetylcholine)           agonist ,
                       bilizers-Inhalation                           Receptor                 Corticosteroids
                                                                     Antagonists··Beta 2
                                                                     Adrenergic
                                                                     Agonists·Corticosteroi
                                                                     ds
-                      -                       -                     -                        -                        -

· Antisense            ·INHALATION             -                     alpha4beta1 (VLA-4)      It is a second-          oligonucleotide
Therapeutics Ltd.                                                    Integrin Antagonists     generation antisense
                                                                                              inhibitor of VLA-4

· Novartis AG          ·ORALDRUGDELIVE         -                     A2B Adenosine            Selective A2B            small molecule
                       RY                                            Receptor Antagonists     adenosine receptor
                                                                                              antagonists
-                      -                       -                     A2B Adenosine            Selective A2B            small molecule
                                                                     Receptor Antagonists     adenosine receptor
                                                                                              antagonists
· Sanquin              ·INHALATION             -                     -                        Inhibition of cytokine   -
                                                                                              production
· Silence Therapeutics ·NasalDelivery          -                     -                        -                        -
Plc
· Sanofi-Aventis (USA) ·INHALATION   -   TLR9 (Toll-like         TLR-9 agonist          small molecule
                                         receptors 9) Agonists
· Sanofi-Aventis     ·INHALATION     -   TLR9 (Toll-like         Coley’s TLR       oligonucleotide
                                         receptors 9) Agonists   Therapeutic
                                                                 compounds for
                                                                 respiratory diseases
                                                                 stimulate TLR9 and
                                                                 initiate an immune
                                                                 system cascade that
                                                                 mimics the effects of
                                                                 an infection, thereby
                                                                 switching the immune
                                                                 system away from the
                                                                 Th2 state. Once the
                                                                 immune system has
                                                                 switched away from
                                                                 the Th2 state, an
                                                                 inappropriate allergic
                                                                 reaction will no longer
                                                                 occur in response to
                                                                 that stimulus




-                    -               -   Tryptase Inhibitors     Tryptase ß inhibitor   small molecule
-   ·ORALDRUGDELIVE   Dosage Strengths : 1, Immunomodulators   The compound            small molecule
    RY                5 milligram ; Dosing                     selectively inhibits or
                      Frequency:                               prevents the
                                                               production of
                                                               immunoglobulin
                                                               epsilon (IgE)
                                                               antibodies. It has also
                                                               demonstrated an
                                                               ability to suppress the
                                                               antigen-stimulated IL-
                                                               4 and IL-5 responses
                                                               with potencies similar
                                                               to those observed for
                                                               IgE suppression.
· AnGes MG Inc.     ·LiquidInhalers/Nebuliz -   -                       Double-stranded so-      oligonucleotide
(Asia)              ers·GeneDelivery                                    called decoy
                                                                        oligodeoxynucleotides
                                                                        (decoy ODNs) target
                                                                        transcription factors,
                                                                        each of which bear
                                                                        one or more DNA
                                                                        binding domains that
                                                                        attach themselves to
                                                                        DNA in a sequence-
                                                                        specific manner.
                                                                        Decoy ODNs mimic
                                                                        these sequences and
                                                                        remove the
                                                                        corresponding
                                                                        transcription factors
                                                                        from further
                                                                        interactions,
                                                                        effectively neutralizing
                                                                        such factors




· GlaxoSmithKline Plc ·INHALATION           -   PDE-4                   ·PDE4 inhibitor : AWD ·small molecule: AWD
                                                (Phosphodiesterase      12-281                12-281
                                                4) Inhibitors
· AstraZeneca Plc   -                       -   TLR9 (Toll-like         Second-generation       -
(World)                                         receptors 9) Agonists   TLR-9 agonists
-                   -                       -   -                       -                       -
-   ·ORALDRUGDELIVE        Dosage Strengths :     CRTH2 Antagonists    CRTh2 receptor       small molecule
    RY                     50, 400, 1000                               antagonist (2008
                           milligram ; Dosing                          company report, page
                           Frequency: 2 per day                        5)




-   -                      -                      -                    -                      small molecule

-   -                      -                      -                    -                      small molecule

-   ·InhalationFormulation -                      -                    iLABA(2008 company small molecule
    s,DPI                                                              report, page 6)

-   -                      -                      Chemokine Receptor   Chemokine receptor     small molecule
                                                  Antagonists          antagonist
-   -                      -                      -                    -                      small molecule
-   ·ORALDRUGDELIVE        -                      CRTH2 Antagonists    CRTh2                  -
    RY                                                                 antagonist(2008
                                                                       company report, page
                                                                       6)
-   ·ORALDRUGDELIVE ; Dosing Frequency: 1 CRTH2 Antagonists            CRTh2 antagonist       -
    RY                  per day
-   ·NasalSprayPumps/De -                 -                            -                      -
    vices




-   -                      -                      -                    -                      -
-   -                  -   -                      AZX100 is a 24-amino peptide
                                                  acid peptide that has
                                                  the ability to relax
                                                  smooth muscle in
                                                  multiple tissue types.

-   ·Metered-          -   Benzodiazepines·Beta ·Triazolam is a short- ·small molecule:
    DoseInhalers-MDI       2 Adrenergic Agonists acting benzodiazepine triazolam·small
                                                 with general            molecule: reproterol
                                                 properties similar to
                                                 those of diazepam. It
                                                 is used as a hypnotic
                                                 in the short-term
                                                 management of
                                                 insomnia.: triazolam·A
                                                 direct-acting
                                                 sympathomimetic with
                                                 predominantly beta-
                                                 adrenergic activity and
                                                 a selective action on
                                                 beta(2) receptors (a
                                                 beta(2) agonist). :
                                                 reproterol




-   -                  -   -                      Asthma Protein        antibodies
                                                  Neutralizing Nanobody
· AstraZeneca Plc   ·ORALDRUGDELIVE   Dosage                   LT (Leukotriene)       ·A synthetic, selective ·small molecule:
(UK)                RY                Strengths(zafirlukast)   Receptor Antagonists   peptide leukotriene     zafirlukast
                                      : 10, 20 milligram ;                            receptor antagonist
                                      Dosing Frequency: 2                             (LTRA): zafirlukast
                                      per day
-   ·LiquidInhalers/Nebuliz Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                     Strengths(albuterol    Agonists            racemic form of           albuterol sulfate
                            sulfate) : 0.75, 1.5                       albuterol and a
                            milligram ; Dosing                         relatively selective
                            Frequency: 3-4 a day                       beta 2 -adrenergic
                                                                       bronchodilator:
                                                                       albuterol sulfate




-   ·LiquidInhalers/Nebuliz -                      Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                                            Agonists            racemic form of           albuterol sulfate
                                                                       albuterol and a
                                                                       relatively selective
                                                                       beta 2 -adrenergic
                                                                       bronchodilator:
                                                                       albuterol sulfate
-   -                       -   -                 Antagonist of 7-        small molecule
                                                  transmembrane G-
                                                  protein coupled
                                                  receptors on
                                                  leukocytes,
                                                  eosinophils,
                                                  basophils, mast cells
                                                  and lymphocytes


-   ·LiquidInhalers/Nebuliz -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                                           mainly glucocorticoid fluticasone propionate
                                                  activity. It has weak
                                                  affinity for the
                                                  progesterone
                                                  receptor, and virtually
                                                  no affinity for the
                                                  mineralocorticoid,
                                                  estrogen, or androgen
                                                  receptors.: fluticasone
                                                  propionate
· Almirall (Spain)·   ·DryPowderInhalers-   Dosage                   Corticosteroids·Beta 2   ·Corticosteroid with      ·small molecule:
Schwarz Pharma AG DPI                       Strengths(fluticasone Adrenergic Agonists         mainly glucocorticoid     fluticasone
(Germany)· Mitsubishi                       propionate) : 0.1,                                activity. It has weak     propionate·small
Tanabe Pharma                               0.25, 0.5 milligram                               affinity for the          molecule: salmeterol
Corporation (Japan)                         Dosage                                            progesterone              xinafoate
                                            Strengths(salmeterol                              receptor, and virtually
                                            xinafoate) : 0.05, 0.05,                          no affinity for the
                                            0.05 milligram ;                                  mineralocorticoid,
                                            Dosing Frequency: 2                               estrogen, or androgen
                                            a day                                             receptors.: fluticasone
                                                                                              propionate·A long-
                                                                                              acting beta 2 -
                                                                                              adrenergic agonist:
                                                                                              salmeterol xinafoate
-   ·Metered-          Dosage                 Corticosteroids·Beta 2   ·Corticosteroid with      ·small molecule:
    DoseInhalers-MDI   Strengths(fluticasone Adrenergic Agonists       mainly glucocorticoid     fluticasone
                       propionate) : 0.045,                            activity. It has weak     propionate·small
                       0.115, 0.23 milligram                           affinity for the          molecule: salmeterol
                       Dosage                                          progesterone              xinafoate
                       Strengths(salmeterol                            receptor, and virtually
                       xinafoate) : 0.021,                             no affinity for the
                       0.021, 0.021 milligram                          mineralocorticoid,
                        ; Dosing Frequency:                            estrogen, or androgen
                       2 a day                                         receptors.: fluticasone
                                                                       propionate·A long-
                                                                       acting beta 2 -
                                                                       adrenergic agonist:
                                                                       salmeterol xinafoate
-   ·LiquidInhalers/Nebuliz -   Antimalarial,     ·The drug possesses ·small molecule:
    ers                         Aminoquinolines   antimalarial actions   hydroxychloroquine
                                                  and also exerts a      sulfate
                                                  beneficial effect in
                                                  lupus erythematosus
                                                  (chronic discoid or
                                                  systemic) and acute
                                                  or chronic rheumatoid
                                                  arthritis. The precise
                                                  mechanism of action
                                                  is not known.:
                                                  hydroxychloroquine
                                                  sulfate




-   -                       -   -                 a fusion protein that  protein
                                                  combines Secretory
                                                  Leukocyte Protease
                                                  Inhibitor (SLPI) and
                                                  rAAT. It inhibits
                                                  neutrophil elastase,
                                                  chymase, cathepsin G
                                                  and kallikrein through
                                                  the rAAT portion and
                                                  inhibits neutrophil
                                                  elastase and tryptase
                                                  through SLPI.
-   ·DryPowderInhalers-   Dosage                  Interleukin 4 Receptor    ·Non-glycosylated 14 ·protein: pitrakinra
    DPI                   Strengths(pitrakinra) : Antagonists·Interleukin   kDa IL-4 variant that
                          1, 3, 10, 25, 60         13 Receptor              binds tightly to IL4Ra
                          milligram ; Dosing      Antagonists               receptor subunit. Two
                          Frequency: 1-2 a day                              amino acid
                                                                            substitutions repel IL-
                                                                            2Rg receptor subunit.
                                                                            It is a potent inhibitor
                                                                            of both the IL-4 and IL-
                                                                            13 receptors.:
                                                                            pitrakinra
-   ·Metered-          Dosage                    Corticosteroids   ·Corticosteroid:   ·small molecule:
    DoseInhalers-MDI   Strength(flunisolide) :                     flunisolide        flunisolide
                       0.25 milligram ;
                       Dosing Frequency: 2
                       per day
-   ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    ers                         Agonists                                     albuterol
-   ·LiquidInhalers/Nebuliz -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                                           mainly glucocorticoid   budesonide
                                                  activity : budesonide
-   ·LiquidInhalers/Nebuliz Dosage                  mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    ers                     Strengths(ipratropium   Acetylcholine)         is an anticholinergic   ipratropium bromide
                            bromide anhydrous) :    Receptor Antagonists   (parasympatholytic)     anhydrous
                            0.25, 0.5 milligram                            agent which, based on
                                                                           animal studies,
                                                                           appears to inhibit
                                                                           vagally mediated
                                                                           reflexes by
                                                                           antagonizing the
                                                                           action of
                                                                           acetylcholine, the
                                                                           transmitter agent
                                                                           released from the
                                                                           vagus nerve.
                                                                           Anticholinergics
                                                                           prevent the increases
                                                                           in intracellular
                                                                           concentration of cyclic
                                                                           guanosine
                                                                           monophosphate
                                                                           (cyclic GMP) which
                                                                           are caused by
                                                                           interaction of
                                                                           acetylcholine with the
                                                                           muscarinic receptor
                                                                           on bronchial smooth
                                                                           muscle.: ipratropium
                                                                           bromide anhydrous




-   ·NasalDelivery         -                        -                      -                      -
-   ·OralBarrierFilmTablet Dosage                  Xanthines           ·Theophylline has two ·small molecule:
    &Microcaps             Strengths(theophylline)                     distinct actions in the theophylline
                           : 125, 250, 375, 500                        airways of patients
                           milligram                                   with reversible
                                                                       obstruction; smooth
                                                                       muscle relaxation
                                                                       (i.e., bronchodilation)
                                                                       and suppression of
                                                                       the response of the
                                                                       airways to stimuli

                                                                       : theophylline




-   ·Metered-              Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI       Strength(albuterol) :   Agonists                                     albuterol
                           0.09 milligram
-   ·Metered-          Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI   Strength(albuterol) :   Agonists                                     albuterol
                       0.09 milligram
-   ·Metered-          -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DoseInhalers-MDI       Agonists            racemic form of           albuterol sulfate
                                               albuterol and a
                                               relatively selective
                                               beta 2 -adrenergic
                                               bronchodilator:
                                               albuterol sulfate
· Pliva (USA)   ·Metered-          Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
                DoseInhalers-MDI   Strength(albuterol) :   Agonists                                     albuterol
                                   0.09 milligram
-   ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    ers                         Agonists                                     albuterol
-   ·LiquidInhalers/Nebuliz Dosage                 Beta 2 Adrenergic     ·Albuterol sulfate, the   ·small molecule:
    ers                     Strength(albuterol     Agonists              racemic form of           albuterol sulfate
                            sulfate) : 0.083                             albuterol and a
                            percent ; Dosing                             relatively selective
                            Frequency: 3-4 a day                         beta 2 -adrenergic
                                                                         bronchodilator:
                                                                         albuterol sulfate




-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                     Strength(albuterol       Agonists            racemic form of           albuterol sulfate
                            sulfate) : 0.083 percent                     albuterol and a
                                                                         relatively selective
                                                                         beta 2 -adrenergic
                                                                         bronchodilator:
                                                                         albuterol sulfate
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                     Strengths(albuterol      Agonists            racemic form of           albuterol sulfate
                            sulfate) : 0.042, 0.083,                     albuterol and a
                            0.5 percent                                  relatively selective
                                                                         beta 2 -adrenergic
                                                                         bronchodilator:
                                                                         albuterol sulfate
-                     ·LiquidInhalers/Nebuliz Dosage                    Beta 2 Adrenergic    ·Albuterol sulfate, the   ·small molecule:
                      ers                     Strength(albuterol        Agonists             racemic form of           albuterol sulfate
                                              sulfate) : 0.5 percent                         albuterol and a
                                                                                             relatively selective
                                                                                             beta 2 -adrenergic
                                                                                             bronchodilator:
                                                                                             albuterol sulfate




-                     -                       -                         Beta 2 Adrenergic    Albuterol analog with     small molecule
                                                                        Agonists             no systemic analog
· Daiichi Sankyo Co   ·ORALDRUGDELIVE         Dosage                    H1 (Histamine 1)     ·Direct H1-receptor       ·small molecule:
Ltd. (Japan)          RY                      Strengths(epinastine      Antagonists          antagonist : epinastine   epinastine
                                              hydrochloride) : 10, 20                        hydrochloride             hydrochloride
                                              milligram

-                     ·INJECTABLES            -                         Anti-C5 Complement   ·C5 complement          ·antibodies:
                                                                                             inhibitor that prevents eculizumab
                                                                                             the cleavage of
                                                                                             human complement
                                                                                             component C5 into its
                                                                                             pro-inflammatory
                                                                                             components:
                                                                                             eculizumab
-   ·LiquidInhalers/Nebuliz -   Anti-C5 Complement   ·C5 complement          ·antibodies:
    ers                                              inhibitor that prevents eculizumab
                                                     the cleavage of
                                                     human complement
                                                     component C5 into its
                                                     pro-inflammatory
                                                     components:
                                                     eculizumab
· Sanofi-Aventis   ·ORALDRUGDELIVE   Dosage                 H1 (Histamine 1)   ·An antihistamine with ·small molecule:
(USA,Europe)       RY                Strengths(fexofenadin Antagonists         selective peripheral H fexofenadine
                                     e hydrochloride) : 30,                    1 -receptor antagonist hydrochloride
                                     60, 120, 180 milligram                    activity: fexofenadine
                                      ; Dosing Frequency:                      hydrochloride
                                     1-2 per day
-   ·INHALATION·CellPen -     Mast Cell Stabilizers   the inhibition of a   peptide
    etratingPeptides(CPPs                             specific signal
    )                                                 transduction pathways
                                                      in mast cells by
                                                      unique cell-permeable
                                                      molecules.

-   ·DryPowderInhalers-   -   Mast Cell               ·Although its precise     ·small molecule:
    DPI                       Stabilizers·Beta 2      mode of action            sodium
                              Adrenergic Agonists     remains uncertain,        cromoglycate·small
                                                      sodium cromoglycate       molecule: reproterol
                                                      is believed to act
                                                      primarily by
                                                      preventing release of
                                                      mediators of
                                                      inflammation from
                                                      sensitised mast cells
                                                      through stabilisation
                                                      of mast-cell
                                                      membranes. : sodium
                                                      cromoglycate·A direct-
                                                      acting
                                                      sympathomimetic with
                                                      predominantly beta-
                                                      adrenergic activity and
                                                      a selective action on
                                                      beta(2) receptors (a
                                                      beta(2) agonist). :
                                                      reproterol
-   ·Metered-             Dosage                 Mast Cell            ·Although its precise     ·small molecule:
    DoseInhalers-MDI      Strength(sodium        Stabilizers·Beta 2   mode of action            sodium
                          cromoglycate) : 0.914 Adrenergic Agonists   remains uncertain,        cromoglycate·small
                          milligram Dosage                            sodium cromoglycate       molecule: reproterol
                          Strength(reproterol) :                      is believed to act
                          0.5 milligram ; Dosing                      primarily by
                          Frequency: 4 a day                          preventing release of
                                                                      mediators of
                                                                      inflammation from
                                                                      sensitised mast cells
                                                                      through stabilisation
                                                                      of mast-cell
                                                                      membranes. : sodium
                                                                      cromoglycate·A direct-
                                                                      acting
                                                                      sympathomimetic with
                                                                      predominantly beta-
                                                                      adrenergic activity and
                                                                      a selective action on
                                                                      beta(2) receptors (a
                                                                      beta(2) agonist). :
                                                                      reproterol




-   ·DryPowderInhalers-   -                     -                     -                         small molecule
    DPI
-   ·INJECTABLES   -   Elastase Inhibitors   Alpha-1 antitrypsin-    ·protein: alpha1-
                                             membrane                proteinase inhibitor,
                                             translocation signal    human
                                             (MTS) recombinant
                                             fusion
                                             protein.···Elastase
                                             inhibitor: alpha1-
                                             proteinase inhibitor,
                                             human
-   ·Metered-          Dosage                Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
    DoseInhalers-MDI   Strength(metaproteren Agonists            vivo pharmacologic       metaproterenol
                       ol sulphate) : 0.65                       studies have             sulphate
                       milligram ; Dosing                        demonstrated that
                       Frequency: 4-6 a day                      metaproterenol sulfate
                                                                 has a preferential
                                                                 effect on beta-2
                                                                 adrenergic receptors
                                                                 compared with
                                                                 isoproterenol. The
                                                                 pharmacologic effects
                                                                 of beta adrenergic
                                                                 agonist drugs are at
                                                                 least in part
                                                                 attributable to
                                                                 stimulation through
                                                                 beta
                                                                 adrenergic receptors
                                                                 of intracellular adenyl
                                                                 cyclase, the enzyme
                                                                 which
                                                                 catalyzes the
                                                                 conversion of
                                                                 adenosine
                                                                 triphosphate (ATP) to
                                                                 cyclic-3',5'-
                                                                 adenosine
                                                                 monophosphate (c-
                                                                 AMP). Increased c-
                                                                 AMP levels are
                                                                 associated with
                                                                 relaxation of bronchial
                                                                 smooth muscle and
                                                                 inhibition of
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
    ers                     Strengths(metaprotere Agonists               vivo pharmacologic       metaproterenol
                            nol sulphate) : 0.4, 0.6                     studies have             sulphate
                            percent ; Dosing                             demonstrated that
                            Frequency: 4-6 a day                         metaproterenol sulfate
                                                                         has a preferential
                                                                         effect on beta-2
                                                                         adrenergic receptors
                                                                         compared with
                                                                         isoproterenol. The
                                                                         pharmacologic effects
                                                                         of beta adrenergic
                                                                         agonist drugs are at
                                                                         least in part
                                                                         attributable to
                                                                         stimulation through
                                                                         beta
                                                                         adrenergic receptors
                                                                         of intracellular adenyl
                                                                         cyclase, the enzyme
                                                                         which
                                                                         catalyzes the
                                                                         conversion of
                                                                         adenosine
                                                                         triphosphate (ATP) to
                                                                         cyclic-3',5'-
                                                                         adenosine
                                                                         monophosphate (c-
                                                                         AMP). Increased c-
                                                                         AMP levels are
                                                                         associated with
                                                                         relaxation of bronchial
                                                                         smooth muscle and
                                                                         inhibition of
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
    ers                     Strengths(metaprotere Agonists               vivo pharmacologic       metaproterenol
                            nol sulphate) : 0.4, 0.6                     studies have             sulphate
                            percent ; Dosing                             demonstrated that
                            Frequency: 4-6 a day                         metaproterenol sulfate
                                                                         has a preferential
                                                                         effect on beta-2
                                                                         adrenergic receptors
                                                                         compared with
                                                                         isoproterenol. The
                                                                         pharmacologic effects
                                                                         of beta adrenergic
                                                                         agonist drugs are at
                                                                         least in part
                                                                         attributable to
                                                                         stimulation through
                                                                         beta
                                                                         adrenergic receptors
                                                                         of intracellular adenyl
                                                                         cyclase, the enzyme
                                                                         which
                                                                         catalyzes the
                                                                         conversion of
                                                                         adenosine
                                                                         triphosphate (ATP) to
                                                                         cyclic-3',5'-
                                                                         adenosine
                                                                         monophosphate (c-
                                                                         AMP). Increased c-
                                                                         AMP levels are
                                                                         associated with
                                                                         relaxation of bronchial
                                                                         smooth muscle and
                                                                         inhibition of
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
    ers                     Strengths(metaprotere Agonists               vivo pharmacologic       metaproterenol
                            nol sulphate) : 0.4, 0.6                     studies have             sulphate
                            percent                                      demonstrated that
                                                                         metaproterenol sulfate
                                                                         has a preferential
                                                                         effect on beta-2
                                                                         adrenergic receptors
                                                                         compared with
                                                                         isoproterenol. The
                                                                         pharmacologic effects
                                                                         of beta adrenergic
                                                                         agonist drugs are at
                                                                         least in part
                                                                         attributable to
                                                                         stimulation through
                                                                         beta
                                                                         adrenergic receptors
                                                                         of intracellular adenyl
                                                                         cyclase, the enzyme
                                                                         which
                                                                         catalyzes the
                                                                         conversion of
                                                                         adenosine
                                                                         triphosphate (ATP) to
                                                                         cyclic-3',5'-
                                                                         adenosine
                                                                         monophosphate (c-
                                                                         AMP). Increased c-
                                                                         AMP levels are
                                                                         associated with
                                                                         relaxation of bronchial
                                                                         smooth muscle and
                                                                         inhibition of
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
    ers                     Strengths(metaprotere Agonists               vivo pharmacologic       metaproterenol
                            nol sulphate) : 0.4, 0.6                     studies have             sulphate
                            percent                                      demonstrated that
                                                                         metaproterenol sulfate
                                                                         has a preferential
                                                                         effect on beta-2
                                                                         adrenergic receptors
                                                                         compared with
                                                                         isoproterenol. The
                                                                         pharmacologic effects
                                                                         of beta adrenergic
                                                                         agonist drugs are at
                                                                         least in part
                                                                         attributable to
                                                                         stimulation through
                                                                         beta
                                                                         adrenergic receptors
                                                                         of intracellular adenyl
                                                                         cyclase, the enzyme
                                                                         which
                                                                         catalyzes the
                                                                         conversion of
                                                                         adenosine
                                                                         triphosphate (ATP) to
                                                                         cyclic-3',5'-
                                                                         adenosine
                                                                         monophosphate (c-
                                                                         AMP). Increased c-
                                                                         AMP levels are
                                                                         associated with
                                                                         relaxation of bronchial
                                                                         smooth muscle and
                                                                         inhibition of
· Nycomed             ·Metered-                Dosage                 Corticosteroids        ·New generation         ·small molecule:
(Europe,Brazil,Canada DoseInhalers-MDI         Strengths(ciclesonide)                        inhaled corticosteroid ciclesonide
,Mexico,UK)· Teijin                            : 0.08, 0.16 milligram                        with novel
Pharma Ltd. (Japan)·                           ; Dosing Frequency:                           pharmacokinetic
Sepracor Inc. (USA)·                           Once a day                                    properties: ciclesonide
Trudell Medical
International



· Sepracor Inc. (USA)   ·DryPowderInhalers-    -                      Corticosteroids·Beta 2 ·New generation        ·small molecule:
                        DPI                                           Adrenergic Agonists    inhaled corticosteroid ciclesonide·small
                                                                                             with novel             molecule: formoterol
                                                                                             pharmacokinetic
                                                                                             properties:
                                                                                             ciclesonide·Selective
                                                                                             long-acting (12 hours)
                                                                                             ß2-adrenergic
                                                                                             stimulant
                                                                                             (bronchodilator):
                                                                                             formoterol


-                       -                      -                      -                      -                      antibodies

-                       ·OralBarrierFilmTablet Dosage                 -                      ·Mucolytic agent:      ·small molecule:
                        &Microcaps             Strengths(ambroxol                            ambroxol               ambroxol
                                               hydrochloride) : 75,                          hydrochloride          hydrochloride
                                               120 milligram ;
                                               Dosing Frequency: 1
                                               per day
-                     ·DryPowderInhalers-   Dosage                  BK (Ca2+-activated  ·Airway specific anti- ·small molecule:
                      DPI                   Strengths(andolast) :   K+) Channel Openers inflammatory agent,    andolast
                                            2, 4, 8 milligram                           belonging to a new
                                                                                        class of calcium-
                                                                                        activated potassium
                                                                                        (K+) channel openers.
                                                                                        The compound is also
                                                                                        able to reduce the
                                                                                        expression of IgE
                                                                                        triggered by specific
                                                                                        cytokines in
                                                                                        lymphocytes taken
                                                                                        from asthmatic
                                                                                        patients.: andolast




-                     ·INJECTABLES          -                       Anti-Chitinase       Anti-Chitinase            antibodies
                                                                                         monoclonal antibody

-                     -                     -                       Anti-IL13            humanized                 -
                                                                                         monoclonal antibody
                                                                                         that binds specifically
                                                                                         to IL-13
· NKT Therapeutics,   -                     -                       -                    -                         antibodies
Inc.
· Pharmaxis Ltd.       ·DryPowderInhalers-   -   Osmotic Diuretics   Aridol is a patented  ·small molecule:
(USA)· Trimedal AG     DPI                                           biomarker for airway  mannitol
(Switzerland)· Nigaard                                               inflammation···Osmoti
Pharma AS                                                            c diuretic: mannitol
(Denmark,Finland,Icel
and,Norway,Sweden)·
Allertec Hellas A.E.
(Greece)
-   ·ORALDRUGDELIVE   -   5-lipoxygenase   R(+) Isomer of        ·small molecule:
    RY                    Inhibitors       Zileuton···Active     zileuton
                                           inhibitor of 5-
                                           lipoxygenase, the
                                           enzyme that catalyzes
                                           the formation of
                                           leukotrienes from
                                           arachidonic acid.:
                                           zileuton
· UCB Pharma          ·DryPowderInhalers-   Dosage               Corticosteroids   ·Corticosteroid with    ·small molecule:
(France,Ireland,UK)   DPI                   Strengths(beclometha                   mainly glucocorticoid   beclomethasone
                                            sone dipropionate) :                   activity:               dipropionate
                                            0.2, 0.4 milligram ;                   beclomethasone
                                            Dosing Frequency: 2                    dipropionate
                                            per day




-                     -                     -                     -                -                       -
-   ·DryPowderInhalers-   Dosage                 Corticosteroids   ·The precise            ·small molecule:
    DPI                   Strengths(mometason                      mechanism of            mometasone furoate
                          e furoate) : 1.1, 0.2,                   corticosteroid action
                          0.4 milligram ; Dosing                   on allergic rhinitis is
                          Frequency: 1-2 per                       not known.
                          day                                      Corticosteroids have
                                                                   been shown to have a
                                                                   wide range of effects
                                                                   on multiple cell types
                                                                   (e.g., mast cells,
                                                                   eosinophils,
                                                                   neutrophils,
                                                                   macrophages, and
                                                                   lymphocytes) and
                                                                   mediators (e.g.,
                                                                   histamine,
                                                                   eicosanoids,
                                                                   leukotrienes, and
                                                                   cytokines) involved in
                                                                   inflammation.
                                                                   : mometasone furoate
· UCB Pharma          ·DryPowderInhalers-   Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
(Europe,France,Irelan DPI                   Strength(albuterol) :   Agonists                                     albuterol
d,UK)                                       0.114 milligram ;
                                            Dosing Frequency: 3-
                                            4 per day
· Bespak             ·Metered-             -   -                     -                       small molecule
                     DoseInhalers-MDI




-                    ·DryPowderInhalers- -     -                     Inhaled NCE steroid     small molecule
                     DPI
-                    ·SCF,Inhalation·DryPo -   -                     -                       -
                     wderInhalers-DPI




-                    ·ORALDRUGDELIVE       -   -                     serotonin receptors     -
                     RY
-                    -                     -   Tryptase Inhibitors   ß-Tryptase inhibitors   small molecule

· Silence Therapeutics ·INJECTABLES        -   -                     -                       vaccine
Plc
· Ortho-McNeil    ·ORALDRUGDELIVE   -   CRTH2 Antagonists   CRTH2 receptor         -
Pharmaceuticals   RY                                        (chemoattractant
(World)                                                     receptor expressed on
                                                            T Helper type 2 cells)
                                                            antagonist
-   ·ORALDRUGDELIVE   -   Alpha Adrenergic        ·: proxyphylline·alpha     ·small molecule:
    RY                    Agonists·Beta           and beta                   proxyphylline·small
                          Adrenergic              adrenergenic agonist :     molecule: ephedrine
                          Agonists·Anticonvulsa   ephedrine                  hydrochloride·small
                          nts, Barbiturates       hydrochloride·Phenob       molecule:
                                                  arbital, the longest-      phenobarbital
                                                  acting barbiturate,
                                                  acts on GABAA
                                                  receptors, increasing
                                                  synaptic inhibition.
                                                  This has the effect of
                                                  elevating seizure
                                                  threshold and
                                                  reducing the spread of
                                                  seizure activity from a
                                                  seizure focus.
                                                  Phenobarbital may
                                                  also inhibit calcium
                                                  channels, resulting in
                                                  a decrease in
                                                  excitatory transmitter
                                                  release. The sedative-
                                                  hypnotic effects of
                                                  phenobarbital are
                                                  likely the result of its
                                                  effect on the
                                                  polysynaptic midbrain
                                                  reticular formation,
                                                  which controls CNS
                                                  arousal.
                                                  : phenobarbital
-   ·ORALDRUGDELIVE   -   Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                    Agonists            procaterol           procaterol
                                              hydrochloride        hydrochloride
-   ·ORALDRUGDELIVE   Dosage                  Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strengths(procaterol    Agonists            procaterol           procaterol
                      hydrochloride) : 0.025,                     hydrochloride        hydrochloride
                      0.05 milligram
-   ·DryPowderInhalers-   Dosage                 mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    DPI                   Strength(ipratropium   Acetylcholine)         is an anticholinergic   ipratropium bromide
                          bromide hydrate) :     Receptor Antagonists   (parasympatholytic)     hydrate
                          0.04 milligram ;                              agent which, based on
                          Dosing Frequency: 3-                          animal studies,
                          4 a day                                       appears to inhibit
                                                                        vagally mediated
                                                                        reflexes by
                                                                        antagonizing the
                                                                        action of
                                                                        acetylcholine, the
                                                                        transmitter agent
                                                                        released from the
                                                                        vagus nerve.
                                                                        Anticholinergics
                                                                        prevent the increases
                                                                        in intracellular
                                                                        concentration of cyclic
                                                                        guanosine
                                                                        monophosphate
                                                                        (cyclic GMP) which
                                                                        are caused by
                                                                        interaction of
                                                                        acetylcholine with the
                                                                        muscarinic receptor
                                                                        on bronchial smooth
                                                                        muscle.: ipratropium
                                                                        bromide hydrate
-   ·Metered-          Dosage                 mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    DoseInhalers-MDI   Strength(ipratropium   Acetylcholine)         is an anticholinergic   ipratropium bromide
                       bromide hydrate) :     Receptor Antagonists   (parasympatholytic)     hydrate
                       0.018 milligram ;                             agent which, based on
                       Dosing Frequency: 4                           animal studies,
                       per day                                       appears to inhibit
                                                                     vagally mediated
                                                                     reflexes by
                                                                     antagonizing the
                                                                     action of
                                                                     acetylcholine, the
                                                                     transmitter agent
                                                                     released from the
                                                                     vagus nerve.
                                                                     Anticholinergics
                                                                     prevent the increases
                                                                     in intracellular
                                                                     concentration of cyclic
                                                                     guanosine
                                                                     monophosphate
                                                                     (cyclic GMP) which
                                                                     are caused by
                                                                     interaction of
                                                                     acetylcholine with the
                                                                     muscarinic receptor
                                                                     on bronchial smooth
                                                                     muscle.: ipratropium
                                                                     bromide hydrate
· Boehringer      ·LiquidInhalers/Nebuliz Dosage                mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
Ingelheim (USA)   ers                     Strength(ipratropium  Acetylcholine)         is an anticholinergic   ipratropium bromide
                                          bromide hydrate) :    Receptor Antagonists   (parasympatholytic)     hydrate
                                          0.02 percent ; Dosing                        agent which, based on
                                          Frequency: 3-4 per                           animal studies,
                                          day                                          appears to inhibit
                                                                                       vagally mediated
                                                                                       reflexes by
                                                                                       antagonizing the
                                                                                       action of
                                                                                       acetylcholine, the
                                                                                       transmitter agent
                                                                                       released from the
                                                                                       vagus nerve.
                                                                                       Anticholinergics
                                                                                       prevent the increases
                                                                                       in intracellular
                                                                                       concentration of cyclic
                                                                                       guanosine
                                                                                       monophosphate
                                                                                       (cyclic GMP) which
                                                                                       are caused by
                                                                                       interaction of
                                                                                       acetylcholine with the
                                                                                       muscarinic receptor
                                                                                       on bronchial smooth
                                                                                       muscle.: ipratropium
                                                                                       bromide hydrate
-                        ·INJECTABLES       -                      -                 Avimer compound         protein
                                                                                     that inhibits IgE.
                                                                                     Avimers originate
                                                                                     from the
                                                                                     recombination of
                                                                                     families of human
                                                                                     serum proteins. They
                                                                                     are single protein
                                                                                     chains composed of
                                                                                     modular binding
                                                                                     domains


· Transcription Factor   -                  -                      -                 -                       oligonucleotide
Therapeutics, LLC
(World)
-                        -                  -                      -                 -                       small molecule

-                        ·Metered-          Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
                         DoseInhalers-MDI   Strengths(triamcinolon                   mainly glucocorticoid   triamcinolone
                                            e acetonide) : 0.075,                    activity, anti-         acetonide
                                            0.225 milligram ;                        inflammatory.:
                                            Dosing Frequency: 2-                     triamcinolone
                                            4 a day                                  acetonide
-   ·Metered-          Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strength(triamcinolone                   mainly glucocorticoid   triamcinolone
                       acetonide) : 0.1                         activity, anti-         acetonide
                       milligram ; Dosing                       inflammatory.:
                       Frequency: 2-4 a day                     triamcinolone
                                                                acetonide
· GlaxoSmithKline Plc ·Metered-          Dosage               Corticosteroids   ·Corticosteroid with    ·small molecule:
(France,UK)           DoseInhalers-MDI   Strengths(beclometha                   mainly glucocorticoid   beclomethasone
                                         sone dipropionate) :                   activity:               dipropionate
                                         0.05, 0.1, 0.2, 0.25                   beclomethasone
                                         milligram                              dipropionate
-                   ·LiquidInhalers/Nebuliz Dosage Strengths :     -                    -                         -
                    ers                     0.05, 0.1, 0.2
                                            milligram ; Dosing
                                            Frequency: 1 per day




-                   ·INJECTABLES           -                       -                    -                         antibodies

-                   ·LiquidInhalers/Nebuliz Dosage Strengths :    -                     -                         -
                    ers                     0.005, 0.01 milligram
                                            ; Dosing Frequency: 1
                                            per day



-                   ·DryPowderInhalers-    -                       -                    -                         -
                    DPI

· AstraZeneca Plc   ·INJECTABLES           -                       Anti-IL-5R           Anti-interleukin-5 (IL-   antibodies
(USA)                                                                                   5) receptor MAb




-                   ·ORALDRUGDELIVE        -                       Chemokine Receptor   N-substituted           small molecule
                    RY                                             Antagonists          aminocaprolactam.
                                                                                        BN83470 is a potent
                                                                                        inhibitor of chemokine-
                                                                                        induced leukocyte
                                                                                        migration in vitro
                                                                                        (EC50 = 0.1nM) and
                                                                                        LPS-induced
                                                                                        leukocyte recruitment
                                                                                        in vivo (ED50 = 0.002
                                                                                        mg/kg).
· Boehringer Ingelheim ·INJECTABLES          -                      -                    Activation of           antibodies
                                                                                         regulatory T-cells
                                                                                         (2008 company
                                                                                         report, page 6)
-                    ·ORALDRUGDELIVE         Dosage                  Beta 2 Adrenergic   ·An active precursor    ·small molecule:
                     RY                      Strengths(bambuterol Agonists               of the selective        bambuterol
                                             hydrochloride) : 10, 20                     β2-adrenergic      hydrochloride
                                             milligram ; Dosing                          agonist terbutaline.:
                                             Frequency: 1 per day                        bambuterol
                                                                                         hydrochloride




· Telesso            ·SCF,Inhalation·LiquidI -                      -                    -                       -
Technologies         nhalers/Nebulizers
-   ·Metered-             Dosage               Corticosteroids      ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI      Strengths(beclometha                      mainly glucocorticoid   beclomethasone
                          sone dipropionate) :                      activity:               dipropionate
                          0.05, 0.1, 0.25                           beclomethasone
                          milligram                                 dipropionate




-   ·DryPowderInhalers-   Dosage                  Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                   Strength(beclomethas                      mainly glucocorticoid   beclomethasone
                          one dipropionate) : 0.4                   activity:               dipropionate
                          milligram ; Dosing                        beclomethasone
                          Frequency: 2 a day                        dipropionate
· HRA Pharma   ·DryPowderInhalers-   Dosage               Corticosteroids      ·Corticosteroid with    ·small molecule:
(France)       DPI                   Strengths(beclometha                      mainly glucocorticoid   beclomethasone
                                     sone dipropionate) :                      activity:               dipropionate
                                     0.1, 0.2 milligram                        beclomethasone
                                                                               dipropionate




-              ·DryPowderInhalers-   Dosage                  Corticosteroids   ·Corticosteroid with    ·small molecule:
               DPI                   Strengths(beclometha                      mainly glucocorticoid   beclomethasone
                                     sone dipropionate) :                      activity:               dipropionate
                                     0.1, 0.2, 0.4 milligram                   beclomethasone
                                                                               dipropionate
-   ·Metered-          Dosage               Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(beclometha                   mainly glucocorticoid   beclomethasone
                       sone dipropionate) :                   activity:               dipropionate
                       0.05, 0.1, 0.2                         beclomethasone
                       milligram ; Dosing                     dipropionate
                       Frequency: 2 per day
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic      ·The bronchodilating      ·small molecule:
    ers                     Strength(fenoterol       Agonists·mACh          effect of fenoterol is    fenoterol
                            hydrobromide) : 1.25     (Muscarinic            produced primarily by     hydrobromide·small
                            milligram Dosage         Acetylcholine)         stimulation of b2-        molecule: ipratropium
                            Strength(ipratropium     Receptor Antagonists   receptors in the          bromide hydrate
                            bromide hydrate) : 0.5                          bronchial smooth
                            milligram                                       muscles.: fenoterol
                                                                            hydrobromide·Ipratropi
                                                                            um bromide is an
                                                                            anticholinergic
                                                                            (parasympatholytic)
                                                                            agent which, based on
                                                                            animal studies,
                                                                            appears to inhibit
                                                                            vagally mediated
                                                                            reflexes by
                                                                            antagonizing the
                                                                            action of
                                                                            acetylcholine, the
                                                                            transmitter agent
                                                                            released from the
                                                                            vagus nerve.
                                                                            Anticholinergics
                                                                            prevent the increases
                                                                            in intracellular
                                                                            concentration of cyclic
                                                                            guanosine
                                                                            monophosphate
                                                                            (cyclic GMP) which
                                                                            are caused by
                                                                            interaction of
                                                                            acetylcholine with the
                                                                            muscarinic receptor
                                                                            on bronchial smooth
-   ·LiquidInhalers/Nebuliz Dosage                  Beta 2 Adrenergic   ·The bronchodilating     ·small molecule:
    ers                     Strengths(fenoterol     Agonists            effect of fenoterol is   fenoterol
                            hydrobromide) : 0.25,                       produced primarily by    hydrobromide
                            0.625 milligram                             stimulation of b2-
                                                                        receptors in the
                                                                        bronchial smooth
                                                                        muscles.: fenoterol
                                                                        hydrobromide




-   ·Metered-              Dosage                   Beta 2 Adrenergic   ·The bronchodilating     ·small molecule:
    DoseInhalers-MDI       Strengths(fenoterol      Agonists            effect of fenoterol is   fenoterol
                           hydrobromide) : 0.1,                         produced primarily by    hydrobromide
                           0.2 milligram                                stimulation of b2-
                                                                        receptors in the
                                                                        bronchial smooth
                                                                        muscles.: fenoterol
                                                                        hydrobromide
-                    ·Liposomes,Inhalation· -   Transcription factor   A potent anti-         gene
                     Lipid(Cationic)Vectors     inhibitor              inflammatory agent
                                                                       consisting of the gene
                                                                       for p20 (transcription
                                                                       factor inhibitor).

-                    ·INJECTABLES           -   Transcription factor   A potent anti-         protein
                                                inhibitor              inflammatory agent
                                                                       consisting of the gene
                                                                       for p20 (transcription
                                                                       factor inhibitor).



· Accentia           ·NasalDelivery         -   Antifungals, Polyene   ·Acts by binding to the ·small molecule:
Biopharmaceuticals                                                     sterol component of a amphotericin B
Inc. (USA)                                                             cell membrane
                                                                       leading to alterations
                                                                       in cell permeability
                                                                       and cell death.:
                                                                       amphotericin B




· GlaxoSmithKline Plc ·INJECTABLES          -   Anti-IL-5R             ·anti-IL5 monoclonal  ·antibodies:
(USA)                                                                  antibody: mepolizumab mepolizumab
· AAIPharma (USA)   ·INJECTABLES      Dosage                  Beta 2 Adrenergic   ·Brethine is a beta-     ·small molecule:
                                      Strength(terbutaline    Agonists            adrenergic receptor      terbutaline sulfate
                                      sulfate) : 0.25                             agonist. In vitro and in
                                      milligram                                   vivo pharmacologic
                                                                                  studies have
                                                                                  demonstrated that
                                                                                  terbutaline exerts a
                                                                                  preferential effect on
                                                                                  beta2-adrenergic
                                                                                  receptors.: terbutaline
                                                                                  sulfate



· AAIPharma (USA)   ·ORALDRUGDELIVE   Dosage                  Beta 2 Adrenergic   ·Brethine is a beta-     ·small molecule:
                    RY                Strengths(terbutaline   Agonists            adrenergic receptor      terbutaline sulfate
                                      sulfate) : 2.5, 5                           agonist. In vitro and in
                                      milligram ; Dosing                          vivo pharmacologic
                                      Frequency: 3 per day                        studies have
                                                                                  demonstrated that
                                                                                  terbutaline exerts a
                                                                                  preferential effect on
                                                                                  beta2-adrenergic
                                                                                  receptors.: terbutaline
                                                                                  sulfate
-                     ·Metered-              Dosage                 Beta 2 Adrenergic     ·Brethine is a beta-     ·small molecule:
                      DoseInhalers-MDI       Strength(terbutaline   Agonists              adrenergic receptor      terbutaline sulfate
                                             sulfate) : 0.25                              agonist. In vitro and in
                                             milligram ; Dosing                           vivo pharmacologic
                                             Frequency: 4 per day                         studies have
                                                                                          demonstrated that
                                                                                          terbutaline exerts a
                                                                                          preferential effect on
                                                                                          beta2-adrenergic
                                                                                          receptors.: terbutaline
                                                                                          sulfate



· Sanofi-Aventis (USA) ·DryPowderInhalers-   Dosage                   Beta 2 Adrenergic   ·Brethine is a beta-     ·small molecule:
                       DPI                   Strength(terbutaline     Agonists            adrenergic receptor      terbutaline sulfate
                                             sulfate) : 0.5 milligram                     agonist. In vitro and in
                                              ; Dosing Frequency:                         vivo pharmacologic
                                             1-4 per day                                  studies have
                                                                                          demonstrated that
                                                                                          terbutaline exerts a
                                                                                          preferential effect on
                                                                                          beta2-adrenergic
                                                                                          receptors.: terbutaline
                                                                                          sulfate



-                     ·ORALDRUGDELIVE        Dosage                 TXA2 (Thromboxane     ·Thromboxane A2          ·small molecule:
                      RY                     Strengths(seratrodast) A2) Receptor          receptor antagonist:     seratrodast
                                             : 40, 80 milligram ;   Antagonists           seratrodast
                                             Dosing Frequency: 1
                                             per day
-   ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                                         mainly glucocorticoid   budesonide
                                                activity : budesonide




-   ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                                         mainly glucocorticoid   budesonide
                                                activity : budesonide
-                      ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
                       DPI                                         mainly glucocorticoid   budesonide
                                                                   activity : budesonide




· Merck KGaA           ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
(Europe)· Mylan Inc.   DPI                                         mainly glucocorticoid   budesonide
(Europe)                                                           activity : budesonide
-   ·DryPowderInhalers-   Dosage                Corticosteroids    ·Corticosteroid with    ·small molecule:
    DPI                   Strengths(budesonide)                    mainly glucocorticoid   budesonide
                          : 0.2, 0.4 milligram                     activity : budesonide




-   ·Metered-             Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI      Strength(budesonide)                     mainly glucocorticoid   budesonide
                          : 0.2 milligram                          activity : budesonide
-                     ·LiquidInhalers/Nebuliz ; Dosing Frequency: 2 Corticosteroids   ·Corticosteroid with    ·small molecule:
                      ers                     per day                                 mainly glucocorticoid   budesonide
                                                                                      activity : budesonide




· Ferring              ·ColonicRelease       Dosage                Corticosteroids    ·Corticosteroid with    ·small molecule:
Pharmaceuticals                              Strengths(budesonide)                    mainly glucocorticoid   budesonide
(Asia,Latin                                  : 6, 9 milligram                         activity : budesonide
America,Europe,ex-
Japan)· Santarus, Inc.
(USA)
-   ·Metered-          Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strength(budesonide)                     mainly glucocorticoid   budesonide
                       : 0.2 milligram ;                        activity : budesonide
                       Dosing Frequency: 1
                       per day
-   ·LiquidInhalers/Nebuliz -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                                           mainly glucocorticoid   budesonide
                                                  activity : budesonide




-   ·DryPowderInhalers-     -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                                           mainly glucocorticoid   budesonide
                                                  activity : budesonide
· Trinity Biotech Plc   ·DryPowderInhalers-   Dosage                 Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
                        DPI                   Strength(albuterol) :  Agonists                                     albuterol
                                              0.2 milligram ; Dosing
                                              Frequency: 1-4 per
                                              day
· HRA Pharma     ·DryPowderInhalers-   Dosage                   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
(France)         DPI                   Strengths(albuterol) :   Agonists                                     albuterol
                                       0.1, 0.2 milligram




· Synairgen·     ·INJECTABLES          ; Dosing Frequency: 1 Anti-IL13              Human anti-IL13         antibodies
Medimmune Inc.                         per month                                    monoclonal antibody
-                   ·ORALDRUGDELIVE    Dosage                  PDE-4                ·CC-10004 is a           ·small molecule:
                    RY                 Strengths(apremilast)   (Phosphodiesterase   member of a              apremilast
                                       : 10, 20, 30, 40        4) Inhibitors·TNF-   proprietary pipeline of
                                       milligram ; Dosing      alpha Inhibitors     novel small molecules
                                       Frequency: 1-2 per                           with anti-inflammatory
                                       day                                          activities that inhibit
                                                                                    the production of
                                                                                    multiple
                                                                                    proinflammatory
                                                                                    mediators including,
                                                                                    PDE-4, TNF-alpha,
                                                                                    interleukin-2 (IL-2),
                                                                                    interferon-gamma,
                                                                                    leukotrienes, and
                                                                                    nitric oxide synthase. :
                                                                                    apremilast




· deCODE Genetics   ·ORALDRUGDELIVE    -                       MAP3K9 Inhibitors    MAP3K9 inhibitor        small molecule
Inc.                RY

· 3M Health Care    ·Metered-          Dosage                Beta 2 Adrenergic      ·Beta-2 agonist:        ·small molecule:
(USA)· Mitsubishi   DoseInhalers-MDI   Strengths(carmoterol) Agonists               carmoterol              carmoterol
Tanabe Pharma                          : 0.001, 0.002, 0.004
Corporation                            milligram ; Dosing
(Asia,Japan)                           Frequency: 1 per day
-   ·Metered-          -                        Beta 2 Adrenergic      ·Beta-2 agonist:          ·small molecule:
    DoseInhalers-MDI                            Agonists·Corticosteroi carmoterol·Corticoster carmoterol·small
                                                ds                     oid with mainly           molecule: budesonide
                                                                       glucocorticoid activity :
                                                                       budesonide




-   ·INHALATION        -                        muscle myosin          Smooth muscle           -
                                                inhibitors             myosin inhibitors

-   ·ORALDRUGDELIVE    Dosage                   Mucolytic Agents       ·Mucoactive cysteine    ·small molecule:
    RY                 Strength(fudosteine) :                          derivative acts as an   fudosteine
                       200 milligram ;                                 expectorant.:
                       Dosing Frequency: 3                             fudosteine
                       per day
-   ·OralLiquidMR       -   -                    -                       -




-   ·NasalDelivery      -   PDE-4                ·PDE4 inhibitor:        ·small molecule:
                            (Phosphodiesterase   tofimilast              tofimilast
                            4) Inhibitors
-   ·Prodrugs,LowMWAtta -   Corticosteroids      ·Corticosteroid with    ·small molecule:
    chments                                      mainly glucocorticoid   betamethasone
                                                 activity :
                                                 betamethasone
-   ·Prodrugs,LowMWAtta -   Corticosteroids        ·Synthetic               ·small molecule:
    chments                                        glucocorticoid with      prednisolone
                                                   anti-inflammatory
                                                   effects.: prednisolone




-   ·ORALDRUGDELIVE     -   LT (Leukotriene)       CR 3465 is the           -
    RY                      Receptor Antagonists   optimised lead of a
                                                   new series of
                                                   derivatives that are
                                                   potent, selective and
                                                   orally effective Cys-
                                                   leukotriene (Cys-LT1,
                                                   formerly LTD4)
                                                   receptor antagonists.
-   -                   -   CRTH2 Antagonists      CRTH2 receptor        -
                                                   antagonist
-   ·ORALDRUGDELIVE     -   CRTH2 Antagonists      Oral prostaglandin D2 -
    RY                                             (CRTh2) receptor
                                                   antagonist
-   ·OralModifiedRel.(MR) ; Dosing Frequency: 1 Corticosteroids·Tricycli cytokine                 ·small molecule:
                          per day               c Antidepressants        modulator···Synthetic prednisolone·small
                                                                         glucocorticoid with      molecule: nortriptyline
                                                                         anti-inflammatory
                                                                         effects.:
                                                                         prednisolone·Similar
                                                                         to protriptyline,
                                                                         nortriptyline is a
                                                                         tricyclic
                                                                         antidepressant of the
                                                                         dibenzocycloheptene
                                                                         type and is the active
                                                                         metabolite of
                                                                         amitriptyline. It is
                                                                         believed that
                                                                         nortriptyline either
                                                                         inhibits the reuptake
                                                                         of the
                                                                         neurotransmitter
                                                                         serotonin at the
                                                                         neuronal membrane
                                                                         or acts at beta-
                                                                         adrenergic receptors.
                                                                         Tricyclic
                                                                         antidepressants do
                                                                         not inhibit monoamine
                                                                         oxidase nor do they
                                                                         affect dopamine
                                                                         reuptake.: nortriptyline
-   ·ORALDRUGDELIVE   -   Corticosteroids·Tricycli cytokine                 ·small molecule:
    RY                    c Antidepressants        modulator···Synthetic prednisolone·small
                                                   glucocorticoid with      molecule: nortriptyline
                                                   anti-inflammatory
                                                   effects.:
                                                   prednisolone·Similar
                                                   to protriptyline,
                                                   nortriptyline is a
                                                   tricyclic
                                                   antidepressant of the
                                                   dibenzocycloheptene
                                                   type and is the active
                                                   metabolite of
                                                   amitriptyline. It is
                                                   believed that
                                                   nortriptyline either
                                                   inhibits the reuptake
                                                   of the
                                                   neurotransmitter
                                                   serotonin at the
                                                   neuronal membrane
                                                   or acts at beta-
                                                   adrenergic receptors.
                                                   Tricyclic
                                                   antidepressants do
                                                   not inhibit monoamine
                                                   oxidase nor do they
                                                   affect dopamine
                                                   reuptake.: nortriptyline
-   -                 -                     -                      ·Protein-digesting and ·protein: bromelains
                                                                   milk-clotting enzymes
                                                                   found in pineapple
                                                                   fruit juice and stem
                                                                   tissue: bromelains




-   ·ORALDRUGDELIVE   ; Dosing Frequency: 1 A2B Adenosine          Selective A2B-         small molecule
    RY                per day               Receptor Antagonists   adenosine receptor
                                                                   antagonist
-   ·INJECTABLES   Dosage Strength : 0.3 -   The compound             vaccine
                   milligram                 consists of the
                                             ImmunodrugTM
                                             candidate QbG10
                                             which is comprised of
                                             the virus-like particle
                                             Qb filled with an
                                             immunostimulatory
                                             DNA sequence called
                                             G10. CYT003-QbG10
                                             is designed to induce
                                             a potent Th1 type
                                             immune response in
                                             order to suppress
                                             “llergic“
                                             a         Th2 type
                                             immune responses.
                                             CYT003-QbG10
                                             combined with house
                                             dust mite allergen
                                             extract (CYT005-
                                             AllQbG10) showed
                                             significant efficacy for
                                             house dust mite
                                             allergy. Additionally,
                                             first clinical data with
                                             CYT003-
                                             QbG10 in grass pollen
                                             allergy (monotherapy)
                                             indicate that the
                                             QbG10 component
                                             itself acts
                                             through an allergen-
                                             independent
                                             mechanism of action
-   ·INJECTABLES   Dosage Strength : 0.3 -   Based on its versatile vaccine
                   milligram                 Immunodrug“   “
                                             platform, Cytos
                                             Biotechnology is
                                             developing a novel
                                             type of vaccines
                                             designed for induction
                                             of an efficient
                                             "non-allergic" Th1
                                             type immune
                                             response.The
                                             Immunodrug“
                                             candidates comprise
                                             an
                                             allergen extract of
                                             choice mixed with
                                             the
                                             Immunodrug“    carrier
                                             QbG10. QbG10
                                             consists of the virus-
                                             like particle Qb
                                             packaged with an
                                             immunostimulatory
                                             sequence called G10.
                                             G10 serves as an
                                             adjuvant enhancing
                                             the establishment of a
                                             Th1 type immune
                                             response
-                   ·ORALDRUGDELIVE         Dosage                 Corticosteroids   ·A glucocorticoid:      ·small molecule:
                    RY                      Strengths(deflazacort)                   deflazacort             deflazacort
                                            : 1, 6, 30 milligram




· AstraZeneca Plc   ·Cyclodextrins/Solubili -                      Corticosteroids   ·Corticosteroid with    ·small molecule:
(North America)     zers-                                                            mainly glucocorticoid   budesonide
                    Inhalation·LiquidInhale                                          activity : budesonide
                    rs/Nebulizers
-                     -   -   Tryptase Inhibitors   Tryptase is a secreted -
                                                    serine protease,
                                                    stored in granules and
                                                    released from mast
                                                    cells upon
                                                    degranulation after
                                                    allergen challenge.
                                                    Elevated tryptase
                                                    levels have been
                                                    detected in serum and
                                                    bronchoalveolar
                                                    lavage fluid of patients
                                                    with allergic asthma.
                                                    Celera Genomics has
                                                    identified different
                                                    classes of compounds
                                                    that potently and
                                                    selectively inhibit
                                                    human tryptase.




· Merck and Co Inc.   -   -   PDE-4                 PDE-4 Inhibitor        small molecule
                              (Phosphodiesterase
                              4) Inhibitors
-   -   -   Itk Inhibitors        Itk (IL2-inducible T-    small molecule
                                  cell kinase) inhibitors.
                                  A member of the
                                  protein tyrosine-
                                  kinase family. Itk
                                  regulates the activity
                                  of at least two types of
                                  cells in the immune
                                  system, T-
                                  lymphocytes and mast
                                  cells. Itk transduces
                                  the signal which is
                                  generated when the
                                  receptors on these
                                  cells are stimulated,
                                  leading to the
                                  production of
                                  cytokines and to the
                                  proliferation of these
                                  cells.




-   -   -   PI3K-gamma Inhibitors PI3Kδ inhibitor   small molecule

-   -   -   PDE-4                 PDE-IV Inhibitors      -
            (Phosphodiesterase
            4) Inhibitors
· Warner Chilcott Ltd.   ·OralMatrixMR           Dosage                   Xanthines·PDE         ·Bronchodilator;        ·small molecule:
(USA)                                            Strengths(oxtriphylline) (phosphodiesterase)   asthma                  oxtriphylline
                                                 : 400, 600 milligram ; Inhibitors                            T
                                                                                                prophylactic“heophylli
                                                 Dosing Frequency: 2                            ne directly relaxes
                                                 per day                                        smooth muscle in the
                                                                                                bronchial airways and
                                                                                                pulmonary blood
                                                                                                vessels. This action is
                                                                                                believed to be
                                                                                                mediated by selective
                                                                                                inhibition of specific
                                                                                                phosphodiesterases
                                                                                                (PDEs), which in turn
                                                                                                produces an increase
                                                                                                in intracellular cyclic
                                                                                                3´, 5´-adenosine
                                                                                                monophosphate
                                                                                                (cyclic AMP).:
                                                                                                oxtriphylline




-                        ·OralMatrixMR           Dosage                 -                       Bronchodilator            ·small molecule:
                                                 Strengths(choline                              agents···Bronchodilato    choline theophylline
                                                 theophylline) : 400,                           r agents : choline
                                                 600 milligram                                  theophylline
-                        ·LiquidInhalers/Nebuliz -                      Corticosteroids         ·New generation           ·small molecule:
                         ers                                                                    inhaled corticosteroid    ciclesonide
                                                                                                with novel
                                                                                                pharmacokinetic
                                                                                                properties: ciclesonide
· National Institute of   ·LiquidInhalers/Nebuliz -   Antibiotics,     ·Cintredekin            ·protein: cintredekin
Health (NIH)              ers                         Antineoplastic   besudotox is a          besudotox
                                                                       recombinant protein
                                                                       consisting of a single
                                                                       molecule composed
                                                                       of two parts: a tumor-
                                                                       targeting molecule
                                                                       (Interleukin-13) and a
                                                                       cytotoxic agent
                                                                       (Pseudomonas
                                                                       Exotoxin, or PE). IL13
                                                                       receptors are present
                                                                       in appreciable
                                                                       numbers on malignant
                                                                       glioma cells, but only
                                                                       to a minimal amount if
                                                                       at all on healthy brain
                                                                       cells. The IL13 portion
                                                                       binds to receptors on
                                                                       the tumor like a key
                                                                       fits into a lock. The
                                                                       cancer cell latches
                                                                       onto and absorbs the
                                                                       IL13 and the attached
                                                                       PE, causing
                                                                       destruction of the
                                                                       cancer cell.:
                                                                       cintredekin besudotox
· Cipla Ltd.   ·NanoparticlesOther,In -                      Corticosteroids    -                       small molecule
               jectable




-              ·DryPowderInhalers-    Dosage                  Corticosteroids   ·Corticosteroid with    ·small molecule:
               DPI                    Strengths(beclometha                      mainly glucocorticoid   beclomethasone
                                      sone dipropionate) :                      activity:               dipropionate
                                      0.1, 0.2, 0.4 milligram                   beclomethasone
                                      ; Dosing Frequency: 2-                    dipropionate
                                      4 per day
-   ·Metered-          Dosage                 mACh (Muscarinic      ·Ipratropium bromide      ·small molecule:
    DoseInhalers-MDI   Strength(ipratropium   Acetylcholine)        is an anticholinergic     ipratropium bromide
                       bromide hydrate) :     Receptor              (parasympatholytic)       hydrate·small
                       0.018 milligram        Antagonists·Beta 2    agent which, based on     molecule: albuterol
                       Dosage                 Adrenergic Agonists   animal studies,           sulfate
                       Strength(albuterol                           appears to inhibit
                       sulfate) : 0.09                              vagally mediated
                       milligram ; Dosing                           reflexes by
                       Frequency: 4 per day                         antagonizing the
                                                                    action of
                                                                    acetylcholine, the
                                                                    transmitter agent
                                                                    released from the
                                                                    vagus nerve.
                                                                    Anticholinergics
                                                                    prevent the increases
                                                                    in intracellular
                                                                    concentration of cyclic
                                                                    guanosine
                                                                    monophosphate
                                                                    (cyclic GMP) which
                                                                    are caused by
                                                                    interaction of
                                                                    acetylcholine with the
                                                                    muscarinic receptor
                                                                    on bronchial smooth
                                                                    muscle.: ipratropium
                                                                    bromide
                                                                    hydrate·Albuterol
                                                                    sulfate, the racemic
                                                                    form of albuterol and
                                                                    a relatively selective
                                                                    beta 2 -adrenergic
                                                                    bronchodilator:
-   ·INHALATION     -   Beta 2 Adrenergic   ·Selective long-acting   ·small molecule:
                        Agonists            (12 hours) ß2-           formoterol
                                            adrenergic stimulant
                                            (bronchodilator):
                                            formoterol



-   ·OralMatrixMR   -   Beta 2 Adrenergic   ·A beta-agonist for the ·small molecule:
                        Agonists            treatment of reversible levalbuterol
                                            bronchospasm.:          hydrochloride
                                            levalbuterol
                                            hydrochloride
-   ·LiquidInhalers/Nebuliz -   Sodium Channel        Inhaled formulation of ·small molecule:
    ers                         Blockers·Local        lidocaine which has     lidocaine
                                Anesthetics, Amides   been shown to cause
                                                      cell death of
                                                      eosinophils, white
                                                      blood cells that exist
                                                      at elevated levels in
                                                      asthmatics. This
                                                      effect on eosinophils
                                                      is the same as seen
                                                      with steroid therapies.
                                                      The therapy may
                                                      therefore eliminate the
                                                      need for steroids,
                                                      which can have
                                                      unwanted side
                                                      effects···Lidocaine is
                                                      an amide-type local
                                                      anesthetic agent and
                                                      is suggested to
                                                      stabilize neuronal
                                                      membranes by
                                                      inhibiting the ionic
                                                      fluxes required for the
                                                      initiation and
                                                      conduction of
                                                      impulses. : lidocaine
-   ·Metered-          Dosage                  NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    DoseInhalers-MDI   Strength(cromolyn       Steroidal          non-steroidal anti-       cromolyn sodium
                       sodium) : 5 milligram   Antiinflammatory   allergy medication, is
                                               Drugs)             an FDA-approved
                                                                  drug for the
                                                                  management of mild-
                                                                  to-moderate
                                                                  persistent asthma. It
                                                                  inhibits the release of
                                                                  mediators of
                                                                  inflammation, induced
                                                                  by specific antigens
                                                                  as well as nonspecific
                                                                  mechanisms, such as
                                                                  exercise, from mast
                                                                  cells. Cromolyn may
                                                                  also inhibit the activity
                                                                  of other cell types that
                                                                  produce inflammation.
                                                                  It is the only
                                                                  antiasthmatic that
                                                                  blocks both early and
                                                                  late asthmatic
                                                                  responses induced by
                                                                  allergen inhalation
                                                                  and exercise. :
                                                                  cromolyn sodium
-   ·Biodeg(PLGA)Microc -   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    aps/Rods                Steroidal          non-steroidal anti-       cromolyn sodium
                            Antiinflammatory   allergy medication, is
                            Drugs)             an FDA-approved
                                               drug for the
                                               management of mild-
                                               to-moderate
                                               persistent asthma. It
                                               inhibits the release of
                                               mediators of
                                               inflammation, induced
                                               by specific antigens
                                               as well as nonspecific
                                               mechanisms, such as
                                               exercise, from mast
                                               cells. Cromolyn may
                                               also inhibit the activity
                                               of other cell types that
                                               produce inflammation.
                                               It is the only
                                               antiasthmatic that
                                               blocks both early and
                                               late asthmatic
                                               responses induced by
                                               allergen inhalation
                                               and exercise. :
                                               cromolyn sodium
-                      ·LiquidInhalers/Nebuliz -                         -                    ·Cromolyn is a          ·small molecule:
                       ers                                                                    synthetic compound      cromolyn
                                                                                              that is used to prevent
                                                                                              some allergic
                                                                                              reactions. : cromolyn




-                      -                       -                         -                    Targeted at the B2AR small molecule
                                                                                              receptor
-                      -                       -                         -                    -                    -

· Argenta Discovery    ·INHALATION             -                         -                    -                      -

· AstraZeneca Plc (ex- -                       -                         TLR7 Agonists        An immune response -
Asia,Europe)                                                                                  modifier with agonistic
                                                                                              activity against Toll-
                                                                                              like receptor 7 (TLR7).



· Mitsubishi Tanabe    ·ORALDRUGDELIVE         Dosage                    PDE-4                ·Roflumilast is a      ·small molecule:
Pharma Corporation     RY                      Strengths(roflumilast)    (Phosphodiesterase   phosphodiesterase      roflumilast
(Japan)                                        : 0.25, 0.5 milligram ;   4) Inhibitors        type-4 inhibitor.:
                                               Dosing Frequency: 1                            roflumilast
                                               per day
-   ·OralMatrixMR   Dosage                  Xanthines            ·Theophylline has two ·small molecule:
                    Strengths(theophylline)                      distinct actions in the theophylline
                     : 100, 200, 350                             airways of patients
                    milligram ; Dosing                           with reversible
                    Frequency: Once a                            obstruction; smooth
                    day                                          muscle relaxation
                                                                 (i.e., bronchodilation)
                                                                 and suppression of
                                                                 the response of the
                                                                 airways to stimuli

                                                                 : theophylline




-   ·INJECTABLES    -                      Anti-IL-4·Anti-IL13   Dual Target inhibitor   antibodies
                                                                 of key cytokines in
                                                                 asthma pathogenesis
                                                                 targets IL-4 + IL-13
-   ·ORALDRUGDELIVE   Dosage                  Thromboxane             ·Selective              ·small molecule:
    RY                Strengths(ozagrel       Synthetase Inhibitors   thromboxane             ozagrel hydrochloride
                      hydrochloride) : 100,                           synthetase inhibitor:
                      200 milligram                                   ozagrel hydrochloride
-                       -                     -   PI3K-delta         Dual PI3K                -
                                                  Inhibitors·PI3K-   gamma/delta
                                                  gamma Inhibitors   inhibitors, which retain
                                                                     their selectivity over
                                                                     the other members of
                                                                     the PI-kinase family

-                       ·DryPowderInhalers-   -   -                  -                        -
                        DPI

-                       ·DryPowderInhalers-   -   -                  -                        -
                        DPI

· Chiesi Farmaceutici   ·Metered-             -   A1A Adenosin       An antisense            oligonucleotide
SpA                     DoseInhalers-MDI          Receptor Related   oligonucleotide for the
                                                                     treatment of asthma
                                                                     developed to
                                                                     attenuate the
                                                                     production of the
                                                                     adenosine A1
                                                                     receptor in the cells
                                                                     lining the lung.
-                       ·Topical              -   CN (Calcineurin)   Cyclosporine A       -
                                                  Inhibitors         analog. Calcineurin
                                                                     inhibitor;
                                                                     demonstrated to
                                                                     suppress some
                                                                     humoral immunity and
                                                                     to a greater extent,
                                                                     cell-mediated immune
                                                                     reactions.
-   ·Topical           -   CN (Calcineurin)   Cyclosporine A       -
                           Inhibitors         analog. Calcineurin
                                              inhibitor;
                                              demonstrated to
                                              suppress some
                                              humoral immunity and
                                              to a greater extent,
                                              cell-mediated immune
                                              reactions.
-   ·Metered-          -   -                  Combination of EPI-        ·small molecule:
    DoseInhalers-MDI                          12323 with a long          undisclosed small
                                              acting beta agonist.···:   molecule·small
                                              undisclosed small          molecule: undisclosed
                                              molecule·:                 small molecule
                                              undisclosed small
                                              molecule
-   ·ORALDRUGDELIVE       -   -   The compound has        small molecule
    RY                            the potential to reduce
                                  exacerbation of
                                  asthma and to reduce
                                  the intake of inhaled
                                  corticosteroids and
                                  bronchodilators,
                                  thereby reducing their
                                  side-effects.


-   ·DryPowderInhalers-   -   -   -                      -
    DPI·SCF,Inhalation
-   ·OralSolubleDrugsIncr -   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    easedAbsorption           Steroidal          non-steroidal anti-       cromolyn sodium
                              Antiinflammatory   allergy medication, is
                              Drugs)             an FDA-approved
                                                 drug for the
                                                 management of mild-
                                                 to-moderate
                                                 persistent asthma. It
                                                 inhibits the release of
                                                 mediators of
                                                 inflammation, induced
                                                 by specific antigens
                                                 as well as nonspecific
                                                 mechanisms, such as
                                                 exercise, from mast
                                                 cells. Cromolyn may
                                                 also inhibit the activity
                                                 of other cell types that
                                                 produce inflammation.
                                                 It is the only
                                                 antiasthmatic that
                                                 blocks both early and
                                                 late asthmatic
                                                 responses induced by
                                                 allergen inhalation
                                                 and exercise. :
                                                 cromolyn sodium
-   ·Metered-          Dosage                Alpha Adrenergic      ·Most potent stimulant ·small molecule:
    DoseInhalers-MDI   Strength(epinephrine) Agonists·Beta         (sympathomimetic) of epinephrine
                       : 0.22 milligram      Adrenergic Agonists   adrenergic alpha and
                                                                   beta-receptors,
                                                                   resulting in increased
                                                                   heart rate and force of
                                                                   contraction,
                                                                   vasoconstriction or
                                                                   vasodilation,
                                                                   relaxation of
                                                                   bronchiolar and
                                                                   intestinal smooth
                                                                   muscle: epinephrine
-   ·OralEnteric/DelayedR Dosage                 Xanthines   ·Theophylline has two ·small molecule:
    el.                   Strength(theophylline)             distinct actions in the theophylline
                          : 250 milligram ;                  airways of patients
                          Dosing Frequency: 2-               with reversible
                          3 per day                          obstruction; smooth
                                                             muscle relaxation
                                                             (i.e., bronchodilation)
                                                             and suppression of
                                                             the response of the
                                                             airways to stimuli

                                                             : theophylline
-                 ·INJECTABLES   ; Dosing Frequency: 1 Xanthines      ·Theophylline has two ·small molecule:
                                 per day                              distinct actions in the theophylline
                                                                      airways of patients
                                                                      with reversible
                                                                      obstruction; smooth
                                                                      muscle relaxation
                                                                      (i.e., bronchodilation)
                                                                      and suppression of
                                                                      the response of the
                                                                      airways to stimuli

                                                                      : theophylline




· Alchemia Ltd.   -              -                    P2Y2 Receptor   Compounds targeting   peptide
(Australia)                                           Agonists        G protein-coupled
                                                                      receptors (GPCRs)
-   -              -   Anti-inflammatory   A molecular approach siRNA
                                           using a unique siRNA
                                           and antisense DNA
                                           treatments to prevent
                                           the production of Syk
                                           kinase which is a
                                           molecule in
                                           inflammatory cells
                                           required for the
                                           release of mediators
                                           and cytokines that
                                           cause organ damage.



-   ·INJECTABLES   -   -                   Inhibits the production peptide
                                           of inflammatory
                                           cytokines.




-   -              -   VPAC2 Agonists      VPAC2 agonists           -
                                           suppress the release
                                           of inflammatory
                                           mediators (TNF-
                                           alpha, IL-12), as well
                                           as suppressing the
                                           eosinophil response
                                           to stimuli.
· Chiesi Farmaceutici ·Metered-          Dosage                  Corticosteroids·Beta 2   ·Corticosteroid with      ·small molecule:
SpA (USA)· Orient     DoseInhalers-MDI   Strength(beclomethas Adrenergic Agonists         mainly glucocorticoid     beclomethasone
Europharma Co. Ltd.                      one dipropionate) : 0.1                          activity:                 dipropionate·small
(Taiwan)· Novartis AG                    milligram Dosage                                 beclomethasone            molecule: formoterol
(Europe)                                 Strength(formoterol                              dipropionate·Long-        fumarate
                                         fumarate) : 0.006                                acting beta(2) agonist:
                                         milligram ; Dosing                               formoterol fumarate
                                         Frequency: 1-2 a day




-                    -                   -                      A3A Adenosine             A3 antagonist             -
                                                                Receptor Antagonists
-   ·DryPowderInhalers-   Dosage                  Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                   Strengths(fluticasone                     mainly glucocorticoid fluticasone propionate
                          propionate) : 0.05,                       activity. It has weak
                          0.1, 0.25, 0.5                            affinity for the
                          milligram ; Dosing                        progesterone
                          Frequency: 2 a day                        receptor, and virtually
                                                                    no affinity for the
                                                                    mineralocorticoid,
                                                                    estrogen, or androgen
                                                                    receptors.: fluticasone
                                                                    propionate




-   ·TasteMasking         -                       Corticosteroids   ·Prednisolone is a        ·small molecule:
                                                                    corticosteroid with       prednisolone acetate
                                                                    mainly glucocorticoid
                                                                    activity : prednisolone
                                                                    acetate
-                    ·Metered-             Dosage                   Corticosteroids   ·Corticosteroid with    ·small molecule:
                     DoseInhalers-MDI      Strengths(fluticasone                      mainly glucocorticoid fluticasone propionate
                                           propionate) : 0.044,                       activity. It has weak
                                           0.11, 0.22 milligram ;                     affinity for the
                                           Dosing Frequency: 2                        progesterone
                                           per day                                    receptor, and virtually
                                                                                      no affinity for the
                                                                                      mineralocorticoid,
                                                                                      estrogen, or androgen
                                                                                      receptors.: fluticasone
                                                                                      propionate




· Almirall (Spain)   ·DryPowderInhalers-   Dosage                   Corticosteroids   ·Corticosteroid with    ·small molecule:
                     DPI                   Strengths(fluticasone                      mainly glucocorticoid fluticasone propionate
                                           propionate) : 0.05,                        activity. It has weak
                                           0.1, 0.25 milligram ;                      affinity for the
                                           Dosing Frequency: 2                        progesterone
                                           for 2 days                                 receptor, and virtually
                                                                                      no affinity for the
                                                                                      mineralocorticoid,
                                                                                      estrogen, or androgen
                                                                                      receptors.: fluticasone
                                                                                      propionate
-   ·Metered-          Dosage                   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(fluticasone                      mainly glucocorticoid fluticasone propionate
                       propionate) : 0.044,                       activity. It has weak
                       0.11, 0.22 milligram ;                     affinity for the
                       Dosing Frequency: 2                        progesterone
                       a day                                      receptor, and virtually
                                                                  no affinity for the
                                                                  mineralocorticoid,
                                                                  estrogen, or androgen
                                                                  receptors.: fluticasone
                                                                  propionate
-   -                     -   Androgens         Fluasterone will be an ·small molecule:
                                                alternative to fibrates fluasterone
                                                for lowering
                                                triglyceride in
                                                combination therapy
                                                with a statin in insulin-
                                                resistant patients. It
                                                also inhibits NF-kB
                                                activation and
                                                reduces oxidative
                                                stress.···Fluasterone
                                                is a synthetically
                                                stable adrenocortical
                                                steroid analogue
                                                of
                                                dehydroepiandrosteron
                                                e (DHEA). It also
                                                inhibits NF-kB
                                                activation and
                                                reduces oxidative
                                                stress.: fluasterone


-   ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                                         mainly glucocorticoid fluticasone propionate
                                                activity. It has weak
                                                affinity for the
                                                progesterone
                                                receptor, and virtually
                                                no affinity for the
                                                mineralocorticoid,
                                                estrogen, or androgen
                                                receptors.: fluticasone
                                                propionate
· Abbott Laboratories   ·Metered-             Dosage                  Beta 2 Adrenergic      ·Selective long-acting     ·small molecule:
Inc. (USA)·             DoseInhalers-MDI      Strengths(formoterol) Agonists·Corticosteroi   (12 hours) ß2-             formoterol·small
Mundipharma AG                                : 0.01, 0.01 milligram ds                      adrenergic stimulant       molecule: fluticasone
(Europe)· Kyorin                              Dosage                                         (bronchodilator):          propionate
Pharmaceutical                                Strengths(fluticasone                          formoterol·Corticoster
(Japan)                                       propionate) : 0.1, 0.25                        oid with mainly
                                              milligram ; Dosing                             glucocorticoid activity.
                                              Frequency: 2 per day                           It has weak affinity for
                                                                                             the progesterone
                                                                                             receptor, and virtually
                                                                                             no affinity for the
                                                                                             mineralocorticoid,
                                                                                             estrogen, or androgen
                                                                                             receptors.: fluticasone
                                                                                             propionate




· Novartis AG (UK)·     ·DryPowderInhalers-   Dosage                 Beta 2 Adrenergic       ·Long-acting beta(2)       ·small molecule:
Schering-Plough         DPI                   Strength(formoterol    Agonists                agonist: formoterol        formoterol fumarate
Corp. (USA)                                   fumarate) : 0.012                              fumarate
                                              milligram ; Dosing
                                              Frequency: 2 per day
· Astellas Pharma Inc. ·DryPowderInhalers-   -   Beta 2 Adrenergic   ·Long-acting beta(2)   ·small molecule:
                       DPI                       Agonists            agonist: formoterol    formoterol fumarate
                                                                     fumarate
· Novartis AG        ·DryPowderInhalers-   ; Dosing Frequency: 2 Beta 2 Adrenergic   ·Long-acting beta(2)   ·small molecule:
(Europe,Germany,Swit DPI                   per day               Agonists            agonist: formoterol    formoterol fumarate
zerland)· SkyePharma                                                                 fumarate
Plc (USA)
-   ·DryPowderInhalers-   Dosage                  Beta 2 Adrenergic   ·Selective long-acting   ·small molecule:
    DPI                   Strengths(formoterol)   Agonists            (12 hours) ß2-           formoterol
                          : 0.006, 0.012                              adrenergic stimulant
                          milligram                                   (bronchodilator):
                                                                      formoterol




-   ·Metered-             -                       Beta 2 Adrenergic   ·Long-acting beta(2)     ·small molecule:
    DoseInhalers-MDI                              Agonists            agonist: formoterol      formoterol fumarate
                                                                      fumarate
· Novartis AG       ·Metered-             Dosage                Beta 2 Adrenergic   ·Long-acting beta(2)     ·small molecule:
(Europe)· Nycomed   DoseInhalers-MDI      Strength(formoterol   Agonists            agonist: formoterol      formoterol fumarate
(Canada)                                  fumarate) : 0.012                         fumarate
                                          milligram




-                   ·DryPowderInhalers-   -                     Beta 2 Adrenergic   ·Long-acting beta(2)     ·small molecule:
                    DPI                                         Agonists            agonist: formoterol      formoterol fumarate
                                                                                    fumarate




-                   ·DryPowderInhalers-   -                     Beta 2 Adrenergic   ·Selective long-acting   ·small molecule:
                    DPI                                         Agonists            (12 hours) ß2-           formoterol
                                                                                    adrenergic stimulant
                                                                                    (bronchodilator):
                                                                                    formoterol
-   ·DryPowderInhalers-   -   Corticosteroids·Beta 2 ·Corticosteroid with      ·small molecule:
    DPI                       Adrenergic Agonists    mainly glucocorticoid     beclomethasone
                                                     activity:                 dipropionate·small
                                                     beclomethasone            molecule: formoterol
                                                     dipropionate·Long-        fumarate
                                                     acting beta(2) agonist:
                                                     formoterol fumarate
-                       ·DryPowderInhalers-   -                    Corticosteroids       ·Corticosteroid with    ·small molecule:
                        DPI                                                              mainly glucocorticoid   budesonide
                                                                                         activity : budesonide




-                       -                     -                    -                     IL-13 is a central      protein
                                                                                         mediator of T helper
                                                                                         cell (Th2 responses).
· Forest Laboratories   ·ORALDRUGDELIVE       ; Dosing Frequency: 1 PDE-4                ·A highly selective     ·small molecule:
Inc (North America)·    RY                    per day               (Phosphodiesterase   PDE-4 inhibitor:        oglemilast
Teijin Pharma Ltd.                                                  4) Inhibitors        oglemilast
(Japan)
-                       -                     -                    -                     Reduce the number of peptide
                                                                                         respitatory
                                                                                         inflammatory cells and
                                                                                         their marker enzymes
                                                                                         in a rodent model of
                                                                                         allergic asthma.

-                       ·INHALATION           -                    -                     RNA interference       siRNA
                                                                                         (RNAi)-based
                                                                                         therapeutics
· GlaxoSmithKline Plc ·INHALATION             -                    mACh (Muscarinic      ·Inhaled bifunctional, ·small molecule:
                                                                   Acetylcholine)        muscarinic antagonist/ MABA
                                                                   Receptor              beta2 agonist: MABA
                                                                   Antagonists·Beta 2
                                                                   Adrenergic Agonists
-                   ·DryPowderInhalers-   ; Dosing Frequency: 1 mACh (Muscarinic        ·Muscarinic            ·small molecule:
                    DPI                   per day               Acetylcholine)          acetylcholine          darotropium bromide
                                                                Receptor Antagonists    antagonist:
                                                                                        darotropium bromide




-                   ·INHALATION           -                       Beta 2 Adrenergic     Long-acting beta2      small molecule
                                                                  Agonists··Beta 2      agonist
                                                                  Adrenergic Agonists
· Theravance Inc.   ·DryPowderInhalers-   Dosage                  Corticosteroids       ·Corticosteroid with    ·small molecule:
                    DPI                   Strengths(fluticasone                         mainly glucocorticoid fluticasone furoate
                                          furoate) : 0.025, 0.8                         activity. It has weak
                                          milligram ; Dosing                            affinity for the
                                          Frequency: 2 a day                            progesterone
                                                                                        receptor, and virtually
                                                                                        no affinity for the
                                                                                        mineralocorticoid,
                                                                                        estrogen, or androgen
                                                                                        receptors.: fluticasone
                                                                                        furoate
· Theravance Inc.   ·DryPowderInhalers-   -   Corticosteroids··Cortic A combination of the ·small molecule:
                    DPI                       osteroids·Beta 2        corticosteroid           fluticasone furoate
                                              Adrenergic Agonists     GW685698X and the
                                                                      long-acting ß2-agonist
                                                                      GW642444M···Cortico
                                                                      steroid with mainly
                                                                      glucocorticoid activity.
                                                                      It has weak affinity for
                                                                      the progesterone
                                                                      receptor, and virtually
                                                                      no affinity for the
                                                                      mineralocorticoid,
                                                                      estrogen, or androgen
                                                                      receptors.: fluticasone
                                                                      furoate




-                   -                     -   -                       Galapagos has used small molecule
                                                                      the knock-in and
                                                                      knock-down
                                                                      adenoviral vector
                                                                      technology to discover
                                                                      and validate novel
                                                                      small molecule
                                                                      drugable targets in
                                                                      rheumatoid arthritis,
                                                                      osteoarthritis and
                                                                      osteoporosis.
                                                                      Potential drug targets
                                                                      have been identified
                                                                      for all three of its core
                                                                      disease area as well
                                                                      as in Alzheimer“   s
                                                                      disease and asthma.
-   -                      -                       5-lipoxygenase         Leukotriene inhibitor     small molecule
                                                   Inhibitors             that acts on 5-
                                                                          lipoxygenase (5-LO)
-   ·LiquidInhalers/Nebuliz Dosage                 mACh (Muscarinic       ·Ipratropium bromide      ·small molecule:
    ers                     Strength(ipratropium   Acetylcholine)         is an anticholinergic     ipratropium bromide
                            bromide hydrate) :     Receptor Antagonists   (parasympatholytic)       hydrate
                            0.025 percent                                 agent which, based on
                                                                          animal studies,
                                                                          appears to inhibit
                                                                          vagally mediated
                                                                          reflexes by
                                                                          antagonizing the
                                                                          action of
                                                                          acetylcholine, the
                                                                          transmitter agent
                                                                          released from the
                                                                          vagus nerve.
                                                                          Anticholinergics
                                                                          prevent the increases
                                                                          in intracellular
                                                                          concentration of cyclic
                                                                          guanosine
                                                                          monophosphate
                                                                          (cyclic GMP) which
                                                                          are caused by
                                                                          interaction of
                                                                          acetylcholine with the
                                                                          muscarinic receptor
                                                                          on bronchial smooth
                                                                          muscle.: ipratropium
                                                                          bromide hydrate
-   ·LiquidInhalers/Nebuliz Dosage                 mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    ers                     Strength(ipratropium   Acetylcholine)         is an anticholinergic   ipratropium bromide
                            bromide hydrate) :     Receptor Antagonists   (parasympatholytic)     hydrate
                            0.025 percent                                 agent which, based on
                                                                          animal studies,
                                                                          appears to inhibit
                                                                          vagally mediated
                                                                          reflexes by
                                                                          antagonizing the
                                                                          action of
                                                                          acetylcholine, the
                                                                          transmitter agent
                                                                          released from the
                                                                          vagus nerve.
                                                                          Anticholinergics
                                                                          prevent the increases
                                                                          in intracellular
                                                                          concentration of cyclic
                                                                          guanosine
                                                                          monophosphate
                                                                          (cyclic GMP) which
                                                                          are caused by
                                                                          interaction of
                                                                          acetylcholine with the
                                                                          muscarinic receptor
                                                                          on bronchial smooth
                                                                          muscle.: ipratropium
                                                                          bromide hydrate
-                    ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
                     ers                         Agonists            racemic form of           albuterol sulfate
                                                                     albuterol and a
                                                                     relatively selective
                                                                     beta 2 -adrenergic
                                                                     bronchodilator:
                                                                     albuterol sulfate




-                    ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
                     ers                         Agonists            racemic form of           albuterol sulfate
                                                                     albuterol and a
                                                                     relatively selective
                                                                     beta 2 -adrenergic
                                                                     bronchodilator:
                                                                     albuterol sulfate




· Antigen Express,   ·INJECTABLES            -   -                   Ii-Key/allergen epitope peptide
Inc.· Stallergenes                                                   hybrid peptides
-   ·LiquidInhalers/Nebuliz -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                                           mainly glucocorticoid   budesonide
                                                  activity : budesonide
-   ·DryPowderInhalers-   Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                   Strength(budesonide)                     mainly glucocorticoid   budesonide
                          : 0.1 milligram ;                        activity : budesonide
                          Dosing Frequency: 2
                          per day
-   ·DryPowderInhalers-   -   Corticosteroids·Beta 2 ·Corticosteroid with   ·small molecule:
    DPI                       Adrenergic Agonists    mainly glucocorticoid budesonide·small
                                                     activity :             molecule: formoterol
                                                     budesonide·Selective
                                                     long-acting (12 hours)
                                                     ß2-adrenergic
                                                     stimulant
                                                     (bronchodilator):
                                                     formoterol
-   ·DryPowderInhalers-   -   mACh (Muscarinic       ·LAMA.                  ·small molecule:
    DPI                       Acetylcholine)         Glycopyrrolate binds    glycopyrrolate bromide
                              Receptor Antagonists   to the muscarinic
                                                     acetylcholine receptor.
                                                     Like other
                                                     anticholinergic
                                                     (antimuscarinic)
                                                     agents, inhibits the
                                                     action of acetylcholine
                                                     on structures
                                                     innervated by
                                                     postganglionic
                                                     cholinergic nerves
                                                     and on smooth
                                                     muscles that respond
                                                     to acetylcholine but
                                                     lack cholinergic
                                                     innervation.:
                                                     glycopyrrolate bromide




-   ·GeneDelivery         -   Anti-IgE               HAE1 binds to            antibodies
                                                     circulating IgE thereby
                                                     blocking the binding of
                                                     IgE to the high affinity
                                                     receptor on mast cells
                                                     and inhibiting
                                                     inflammatory mediator
                                                     release.
-   -                  -   -   T-regulatory cell      protein
                               activator providing
                               blockade of
                               inapporopriate
                               inflammatory
                               response without
                               broad or unspecific
                               immune suppression.
-   ·Metered-          -   -   ·: undisclosed small   ·small molecule:
    DoseInhalers-MDI           molecule·:             undisclosed small
                               undisclosed small      molecule·small
                               molecule               molecule: undisclosed
                                                      small molecule
-   -   -   -              -                   -




-   -   -   HSP20 signal   Small molecule      small molecule
            modulators     modulators of the
                           HSP20 signal.
· Maruho Co.,Ltd.     ·PatchesDrug-in-   Dosage                    Beta 2 Adrenergic   ·Adrenergic beta2-       ·small molecule:
(Japan)· Aveva Drug   Adhesive           Strengths(tulobuterol)    Agonists            agonist similar to       tulobuterol
Delivery Systems                         : 0.5, 1, 2 milligram ;                       albuterol: tulobuterol
                                         Dosing Frequency:
                                         Once a day




-                     -                  -                         -                   kinase inhibitor project -
-   -              -   -                       -                       -


-   -              -   -                       -                       -


-   -              -   -                       -                       -


-   -              -   -                       -                       -


-   -              -   Interleukin 4 Receptor Supresses signalling     peptide
                       Antagonists·Interleukin of the cytokines IL-4
                        13 Receptor            and IL-13
                       Antagonists

-   ·INJECTABLES   -   Anti-IL-4·Anti-IL13     Protein-based product protein
                                               candidate designed to
                                               bind both the
                                               interleukin-4 and
                                               interleukin-13 (called
                                               IL-4 and IL-13)
                                               cytokines and prevent
                                               their interaction with
                                               cell surface receptors.
· Nippon Kayaku Co.,     ·ConvectionEnhanced -   Antibiotics,     ·Cintredekin            ·protein: cintredekin
Ltd. (Japan)· National   Delivery·Prodrugs,Hig   Antineoplastic   besudotox is a          besudotox
Institute of Health      hMWAttach.(PEGetc.)                      recombinant protein
(NIH)                                                             consisting of a single
                                                                  molecule composed
                                                                  of two parts: a tumor-
                                                                  targeting molecule
                                                                  (Interleukin-13) and a
                                                                  cytotoxic agent
                                                                  (Pseudomonas
                                                                  Exotoxin, or PE). IL13
                                                                  receptors are present
                                                                  in appreciable
                                                                  numbers on malignant
                                                                  glioma cells, but only
                                                                  to a minimal amount if
                                                                  at all on healthy brain
                                                                  cells. The IL13 portion
                                                                  binds to receptors on
                                                                  the tumor like a key
                                                                  fits into a lock. The
                                                                  cancer cell latches
                                                                  onto and absorbs the
                                                                  IL13 and the attached
                                                                  PE, causing
                                                                  destruction of the
                                                                  cancer cell.:
                                                                  cintredekin besudotox




-                        ·INJECTABLES        -   -                Targets IL-4            peptide

-                        ·INJECTABLES        -   -                -                       vaccine
-   ·INJECTABLES          -                     Anti-IL13               ·A humanized              ·antibodies:
                                                                        antibody to human IL-     anrukinzumab
                                                                        13: anrukinzumab
-   ·OralModifiedRel.(MR) -                     Beta Blockers, Non-     INV102 is an oral,        ·small molecule:
                                                selective               daily therapy that acts   nadolol
                                                                        as a beta inverse
                                                                        agonist up-regulating
                                                                        the corresponding
                                                                        receptors .···Non-
                                                                        selective beta-blocker:
                                                                        nadolol




-   ·ORALDRUGDELIVE       Dosage                Interleukin 4 Receptor ·Inhibits the release of ·small molecule:
    RY                    Strengths(suplatast   Antagonists            cytokines (IL-4, IL-5)   suplatast tosilate
                          tosilate) : 50, 100                          from Th2 cells without
                          milligram                                    effects on IFN-gamma
                                                                       from Th1 cells in vitro.
                                                                       : suplatast tosilate
-                  ·ORALDRUGDELIVE   Dosage                  Interleukin 4 Receptor ·Inhibits the release of ·small molecule:
                   RY                Strength(suplatast      Antagonists            cytokines (IL-4, IL-5)   suplatast tosilate
                                     tosilate) : 5 percent                          from Th2 cells without
                                                                                    effects on IFN-gamma
                                                                                    from Th1 cells in vitro.
                                                                                    : suplatast tosilate

· Helicon (USA)·   ·ORALDRUGDELIVE   Dosage Strength : 20    LSAID (Leukocyte        An oral, second         small molecule
Sanofi-Aventis     RY                milligram ; Dosing      Selective Anti-         generation
                                     Frequency: 1 per day    Inflammatory Drug)      LSAID(TM)
                                                                                     (Leukocyte Selective
                                                                                     Anti-Inflammatory
                                                                                     Drug)
-                  ·ORALDRUGDELIVE   -                       -                       An oral LSAID(TM)       small molecule
                   RY                                                                (Leukocyte Selective
                                                                                     Anti-Inflammatory
                                                                                     Drug),
-                  ·INHALATION       -                       BDKRB2 (Bradykinin      ·Icatibant is a potent  ·peptide: icatibant
                                                             Receptor B2)            and highly specific
                                                             Antagonists             competitive antagonist
                                                                                     of the bradykinin B2
                                                                                     receptor. Bradykinin is
                                                                                     a peptide hormone
                                                                                     that is formed locally
                                                                                     in the body, very often
                                                                                     as a response to
                                                                                     trauma. Bradykinin
                                                                                     increases vascular
                                                                                     permeability, dilates
                                                                                     blood vessels:
                                                                                     icatibant



-                  -                 -                       Interleukin-1 beta      IL-1ß inhibitors        small molecule
                                                             inhibitor
-   ·DryPowderInhalers-     Dosage                 Corticosteroids     ·Corticosteroid with      ·small molecule:
    DPI                     Strength(budesonide)                       mainly glucocorticoid     budesonide
                            : 0.4 milligram                            activity : budesonide




-   ·DryPowderInhalers- -                          -                   Interleukin-1 receptor    -
    DPI
-   ·LiquidInhalers/Nebuliz -                      Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                                            Agonists            racemic form of           albuterol sulfate
                                                                       albuterol and a
                                                                       relatively selective
                                                                       beta 2 -adrenergic
                                                                       bronchodilator:
                                                                       albuterol sulfate




-   ·INHALATION             -                      -                   Formulated ISS for     vaccine
                                                                       pulmonary delivery
                                                                       with no linked
                                                                       allergen, relying on
                                                                       natural exposure to
                                                                       multiple allergens to
                                                                       produce specific long-
                                                                       term immunity
-   ·Metered-          Dosage                  NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    DoseInhalers-MDI   Strength(cromolyn       Steroidal          non-steroidal anti-       cromolyn sodium
                       sodium) : 2 milligram   Antiinflammatory   allergy medication, is
                       ; Dosing Frequency: 4   Drugs)             an FDA-approved
                       per day                                    drug for the
                                                                  management of mild-
                                                                  to-moderate
                                                                  persistent asthma. It
                                                                  inhibits the release of
                                                                  mediators of
                                                                  inflammation, induced
                                                                  by specific antigens
                                                                  as well as nonspecific
                                                                  mechanisms, such as
                                                                  exercise, from mast
                                                                  cells. Cromolyn may
                                                                  also inhibit the activity
                                                                  of other cell types that
                                                                  produce inflammation.
                                                                  It is the only
                                                                  antiasthmatic that
                                                                  blocks both early and
                                                                  late asthmatic
                                                                  responses induced by
                                                                  allergen inhalation
                                                                  and exercise. :
                                                                  cromolyn sodium
-   ·DryPowderInhalers-   Dosage                   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    DPI                   Strength(cromolyn        Steroidal          non-steroidal anti-       cromolyn sodium
                          sodium) : 20 milligram   Antiinflammatory   allergy medication, is
                           ; Dosing Frequency:     Drugs)             an FDA-approved
                          3-4 per day                                 drug for the
                                                                      management of mild-
                                                                      to-moderate
                                                                      persistent asthma. It
                                                                      inhibits the release of
                                                                      mediators of
                                                                      inflammation, induced
                                                                      by specific antigens
                                                                      as well as nonspecific
                                                                      mechanisms, such as
                                                                      exercise, from mast
                                                                      cells. Cromolyn may
                                                                      also inhibit the activity
                                                                      of other cell types that
                                                                      produce inflammation.
                                                                      It is the only
                                                                      antiasthmatic that
                                                                      blocks both early and
                                                                      late asthmatic
                                                                      responses induced by
                                                                      allergen inhalation
                                                                      and exercise. :
                                                                      cromolyn sodium
-   ·Metered-          -   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    DoseInhalers-MDI       Steroidal          non-steroidal anti-       cromolyn sodium
                           Antiinflammatory   allergy medication, is
                           Drugs)             an FDA-approved
                                              drug for the
                                              management of mild-
                                              to-moderate
                                              persistent asthma. It
                                              inhibits the release of
                                              mediators of
                                              inflammation, induced
                                              by specific antigens
                                              as well as nonspecific
                                              mechanisms, such as
                                              exercise, from mast
                                              cells. Cromolyn may
                                              also inhibit the activity
                                              of other cell types that
                                              produce inflammation.
                                              It is the only
                                              antiasthmatic that
                                              blocks both early and
                                              late asthmatic
                                              responses induced by
                                              allergen inhalation
                                              and exercise. :
                                              cromolyn sodium
· King                 ·Metered-          Dosage                  NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
Pharmaceuticals Inc.   DoseInhalers-MDI   Strength(cromolyn       Steroidal          non-steroidal anti-       cromolyn sodium
(USA,Canada,Puerto                        sodium) : 5 milligram   Antiinflammatory   allergy medication, is
Rico)· Astellas                           ; Dosing Frequency: 4   Drugs)             an FDA-approved
Pharma Inc. (Japan)                       per day                                    drug for the
                                                                                     management of mild-
                                                                                     to-moderate
                                                                                     persistent asthma. It
                                                                                     inhibits the release of
                                                                                     mediators of
                                                                                     inflammation, induced
                                                                                     by specific antigens
                                                                                     as well as nonspecific
                                                                                     mechanisms, such as
                                                                                     exercise, from mast
                                                                                     cells. Cromolyn may
                                                                                     also inhibit the activity
                                                                                     of other cell types that
                                                                                     produce inflammation.
                                                                                     It is the only
                                                                                     antiasthmatic that
                                                                                     blocks both early and
                                                                                     late asthmatic
                                                                                     responses induced by
                                                                                     allergen inhalation
                                                                                     and exercise. :
                                                                                     cromolyn sodium
· King                  ·LiquidInhalers/Nebuliz Dosage                   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
Pharmaceuticals Inc.    ers                     Strength(cromolyn        Steroidal          non-steroidal anti-       cromolyn sodium
(USA)· Catalent                                 sodium) : 20 milligram   Antiinflammatory   allergy medication, is
Pharma Solutions,                                ; Dosing Frequency:     Drugs)             an FDA-approved
Inc.· Astellas Pharma                           4 per day                                   drug for the
Inc. (Japan)                                                                                management of mild-
                                                                                            to-moderate
                                                                                            persistent asthma. It
                                                                                            inhibits the release of
                                                                                            mediators of
                                                                                            inflammation, induced
                                                                                            by specific antigens
                                                                                            as well as nonspecific
                                                                                            mechanisms, such as
                                                                                            exercise, from mast
                                                                                            cells. Cromolyn may
                                                                                            also inhibit the activity
                                                                                            of other cell types that
                                                                                            produce inflammation.
                                                                                            It is the only
                                                                                            antiasthmatic that
                                                                                            blocks both early and
                                                                                            late asthmatic
                                                                                            responses induced by
                                                                                            allergen inhalation
                                                                                            and exercise. :
                                                                                            cromolyn sodium
-   ·LiquidInhalers/Nebuliz Dosage                  NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    ers                     Strength(cromolyn       Steroidal          non-steroidal anti-       cromolyn sodium
                            sodium) : 1 percent ;   Antiinflammatory   allergy medication, is
                            Dosing Frequency: 4     Drugs)             an FDA-approved
                            a day                                      drug for the
                                                                       management of mild-
                                                                       to-moderate
                                                                       persistent asthma. It
                                                                       inhibits the release of
                                                                       mediators of
                                                                       inflammation, induced
                                                                       by specific antigens
                                                                       as well as nonspecific
                                                                       mechanisms, such as
                                                                       exercise, from mast
                                                                       cells. Cromolyn may
                                                                       also inhibit the activity
                                                                       of other cell types that
                                                                       produce inflammation.
                                                                       It is the only
                                                                       antiasthmatic that
                                                                       blocks both early and
                                                                       late asthmatic
                                                                       responses induced by
                                                                       allergen inhalation
                                                                       and exercise. :
                                                                       cromolyn sodium
-   ·LiquidInhalers/Nebuliz Dosage                NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
    ers                     Strength(cromolyn     Steroidal          non-steroidal anti-       cromolyn sodium
                            sodium) : 1 percent   Antiinflammatory   allergy medication, is
                                                  Drugs)             an FDA-approved
                                                                     drug for the
                                                                     management of mild-
                                                                     to-moderate
                                                                     persistent asthma. It
                                                                     inhibits the release of
                                                                     mediators of
                                                                     inflammation, induced
                                                                     by specific antigens
                                                                     as well as nonspecific
                                                                     mechanisms, such as
                                                                     exercise, from mast
                                                                     cells. Cromolyn may
                                                                     also inhibit the activity
                                                                     of other cell types that
                                                                     produce inflammation.
                                                                     It is the only
                                                                     antiasthmatic that
                                                                     blocks both early and
                                                                     late asthmatic
                                                                     responses induced by
                                                                     allergen inhalation
                                                                     and exercise. :
                                                                     cromolyn sodium
· Sanofi-Aventis (USA) ·DryPowderInhalers-   Dosage                   NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
                       DPI                   Strength(cromolyn        Steroidal          non-steroidal anti-       cromolyn sodium
                                             sodium) : 20 milligram   Antiinflammatory   allergy medication, is
                                              ; Dosing Frequency:     Drugs)             an FDA-approved
                                             4 per day                                   drug for the
                                                                                         management of mild-
                                                                                         to-moderate
                                                                                         persistent asthma. It
                                                                                         inhibits the release of
                                                                                         mediators of
                                                                                         inflammation, induced
                                                                                         by specific antigens
                                                                                         as well as nonspecific
                                                                                         mechanisms, such as
                                                                                         exercise, from mast
                                                                                         cells. Cromolyn may
                                                                                         also inhibit the activity
                                                                                         of other cell types that
                                                                                         produce inflammation.
                                                                                         It is the only
                                                                                         antiasthmatic that
                                                                                         blocks both early and
                                                                                         late asthmatic
                                                                                         responses induced by
                                                                                         allergen inhalation
                                                                                         and exercise. :
                                                                                         cromolyn sodium
· King                 ·Metered-          Dosage                  NSAIDs (Non        ·Cromolyn sodium, a ·small molecule:
Pharmaceuticals Inc.   DoseInhalers-MDI   Strength(cromolyn       Steroidal          non-steroidal anti-       cromolyn sodium
(USA)                                     sodium) : 5 milligram   Antiinflammatory   allergy medication, is
                                          ; Dosing Frequency: 4   Drugs)             an FDA-approved
                                          per day                                    drug for the
                                                                                     management of mild-
                                                                                     to-moderate
                                                                                     persistent asthma. It
                                                                                     inhibits the release of
                                                                                     mediators of
                                                                                     inflammation, induced
                                                                                     by specific antigens
                                                                                     as well as nonspecific
                                                                                     mechanisms, such as
                                                                                     exercise, from mast
                                                                                     cells. Cromolyn may
                                                                                     also inhibit the activity
                                                                                     of other cell types that
                                                                                     produce inflammation.
                                                                                     It is the only
                                                                                     antiasthmatic that
                                                                                     blocks both early and
                                                                                     late asthmatic
                                                                                     responses induced by
                                                                                     allergen inhalation
                                                                                     and exercise. :
                                                                                     cromolyn sodium
-   ·DryPowderInhalers-   -   mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    DPI                       Acetylcholine)         is an anticholinergic   ipratropium bromide
                              Receptor Antagonists   (parasympatholytic)     hydrate
                                                     agent which, based on
                                                     animal studies,
                                                     appears to inhibit
                                                     vagally mediated
                                                     reflexes by
                                                     antagonizing the
                                                     action of
                                                     acetylcholine, the
                                                     transmitter agent
                                                     released from the
                                                     vagus nerve.
                                                     Anticholinergics
                                                     prevent the increases
                                                     in intracellular
                                                     concentration of cyclic
                                                     guanosine
                                                     monophosphate
                                                     (cyclic GMP) which
                                                     are caused by
                                                     interaction of
                                                     acetylcholine with the
                                                     muscarinic receptor
                                                     on bronchial smooth
                                                     muscle.: ipratropium
                                                     bromide hydrate
-   ·LiquidInhalers/Nebuliz -   mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
    ers                         Acetylcholine)         is an anticholinergic   ipratropium bromide
                                Receptor Antagonists   (parasympatholytic)     hydrate
                                                       agent which, based on
                                                       animal studies,
                                                       appears to inhibit
                                                       vagally mediated
                                                       reflexes by
                                                       antagonizing the
                                                       action of
                                                       acetylcholine, the
                                                       transmitter agent
                                                       released from the
                                                       vagus nerve.
                                                       Anticholinergics
                                                       prevent the increases
                                                       in intracellular
                                                       concentration of cyclic
                                                       guanosine
                                                       monophosphate
                                                       (cyclic GMP) which
                                                       are caused by
                                                       interaction of
                                                       acetylcholine with the
                                                       muscarinic receptor
                                                       on bronchial smooth
                                                       muscle.: ipratropium
                                                       bromide hydrate
-   ·LiquidInhalers/Nebuliz Dosage              Mast Cell Stabilizers   ·Although its precise ·small molecule:
    ers                     Strength(sodium                             mode of action        sodium cromoglycate
                            cromoglycate) : 1                           remains uncertain,
                            percent                                     sodium cromoglycate
                                                                        is believed to act
                                                                        primarily by
                                                                        preventing release of
                                                                        mediators of
                                                                        inflammation from
                                                                        sensitised mast cells
                                                                        through stabilisation
                                                                        of mast-cell
                                                                        membranes. : sodium
                                                                        cromoglycate


-   -                      -                    -                       -                         -

-   ·INJECTABLES           -                    -                       Blocking the function     antibodies
                                                                        of a particular protein
                                                                        target with the
                                                                        neutralizing
                                                                        antibody.[17872]
· MediciNova, Inc. (ex- ·ORALDRUGDELIVE   Dosage                  LT (Leukotriene)       ·A sulfidopeptide        ·small molecule:
Asia)                   RY                Strengths(tipelukast) : Receptor Antagonists   leukotriene receptor     tipelukast
                                          500, 750 milligram ;                           antagonist: tipelukast
                                          Dosing Frequency: 1-
                                          2 per day
-   ·Metered-          -   Corticosteroids·Beta 2 ·: undisclosed small   ·small molecule:
    DoseInhalers-MDI       Adrenergic Agonists    molecule·:             undisclosed small
                                                  undisclosed small      molecule·small
                                                  molecule               molecule: undisclosed
                                                                         small molecule




-   ·Metered-          -   -                      -                      small molecule
    DoseInhalers-MDI
-   -                  -   -                      -                      small molecule


-   -                  -   LTD4 Receptor          Leukotriene D(4) and   -
                           Antagonists·TXA2       Thromboxane A(2)
                           (Thromboxane A2)       Receptor dual
                           Receptor Antagonists   antagonist
-                    -                 -   -                   -                       carbohydrate

· MediciNova, Inc. (ex- ·INJECTABLES   -   Beta 2 Adrenergic   ·Selective beta2-       ·small molecule:
Japan)                                     Agonists            adenoreceptor           bedoradrine sulfate
                                                               agonist. The drug's
                                                               selectivity for the
                                                               beta2 receptor is
                                                               hoped to limit
                                                               cardiological side
                                                               effects.: bedoradrine
                                                               sulfate
-                      -                     -                     PDE-4                  Phosphodiesterase       -
                                                                   (Phosphodiesterase     (PDE)-IV inhibitor with
                                                                   4) Inhibitors          a higher anti-
                                                                                          inflammatory activity
                                                                                          than that of
                                                                                          leukotrienes
· MediciNova, Inc.     ·ORALDRUGDELIVE       Dosage                PDE                    ·Non-selective          ·small molecule:
(USA)· Handok          RY                    Strength(ibudilast) : (phosphodiesterase)    phosphodiesterase       ibudilast
Pharmaceuticals Co.,                         10 milligram ; Dosing Inhibitors             (PDE) inhibitor.
Ltd (Korea)                                  Frequency: 2-3 per                           Approved molecule in
                                             day                                          Japan: ibudilast




-                      ·INHALATION           -                     A1A Adenosine          -                       small molecule
                                                                   Receptor Antagonists
-                      ·ORALDRUGDELIVE       -                     A1A Adenosine          -                       small molecule
                       RY                                          Receptor Antagonists
-                      -                     -                     A2B Adenosine          A2B adenosine        -
                                                                   Receptor Antagonists   antagonist
-                      ·DryPowderInhalers-   -                     -                      backup for LAS100977 -
                       DPI
-                      ·DryPowderInhalers-   ; Dosing Frequency: 1 -                      -                       -
                       DPI                   per day




-                      -                     -                     -                      -                       -
-   ·ORALDRUGDELIVE   Dosage Strength :   -                     -                        -
    RY                250 milligram

-   -                 -                   Tryptase Inhibitors   LDTI has been            -
                                                                successfully
                                                                expressed in yeasts
                                                                and is an inhibitor of
                                                                human mast cell
                                                                tryptase and inhibits
                                                                tryptase-induced
                                                                human fibroblast
                                                                proliferation.
· Merck KGaA       ·ColonicRelease·OralP Dosage                Corticosteroids   ·Corticosteroid with    ·small molecule:
(Austria)· Nitec   ulsedMR               Strengths(prednisone)                   mainly glucocorticoid   prednisone
Pharma AG (USA)·                         : 1, 2, 5 milligram                     activity: prednisone
Mundipharma AG·
Merck KGaA
(Germany)




-                  -                     -                     Beta Agonists     Long-Acting Beta        -
                                                                                 Agonists
-   ·NasalDelivery   Dosage                   Corticosteroids   ·Loteprednol            ·small molecule:
                     Strengths(loteprednol                      etabonate is a          loteprednol etabonate
                     etabonate) : 0.1, 0.2,                     corticosteroid used for
                     0.4 milligram                              its glucocorticoid
                                                                activity in the topical
                                                                management of
                                                                inflammatory and
                                                                allergic disorders of
                                                                the eye.: loteprednol
                                                                etabonate
-   ·DryPowderInhalers-   -   Corticosteroids   ·Loteprednol            ·small molecule:
    DPI                                         etabonate is a          loteprednol etabonate
                                                corticosteroid used for
                                                its glucocorticoid
                                                activity in the topical
                                                management of
                                                inflammatory and
                                                allergic disorders of
                                                the eye.: loteprednol
                                                etabonate
-   ·ORALDRUGDELIVE   Dosage                    Xanthines·PDE         ·Dyphylline is a        ·small molecule:
    RY                Strengths(diphylline) :   (phosphodiesterase)   xanthine derivative     diphylline
                      200, 400 milligram ;      Inhibitors            with pharmacologic
                      Dosing Frequency: 4                             actions similar to
                      a day                                           theophylline and other
                                                                      members of this class
                                                                      of drugs. Its primary
                                                                      action is that of
                                                                      bronchodilation, but it
                                                                      also exhibits
                                                                      peripheral
                                                                      vasodilatory and other
                                                                      smooth muscle
                                                                      relaxant activity to a
                                                                      lesser degree. The
                                                                      bronchodilatory action
                                                                      of dyphylline, as with
                                                                      other xanthines, is
                                                                      thought to be
                                                                      mediated through
                                                                      competitive inhibition
                                                                      of phosphodiesterase
                                                                      with a resulting
                                                                      increase in cyclic AMP
                                                                      producing relaxation
                                                                      of bronchial smooth
                                                                      muscle. : diphylline
-   ·INJECTABLES      -   Anti-CD23   ·An antibody against    ·antibodies:
                                      CD23 which is an        lumiliximab
                                      important protein on
                                      leukemia cells and
                                      certain cells in the
                                      body's immune
                                      system: lumiliximab




-   -                 -   -           M40403 may be able      small molecule
                                      to supplement the
                                      activity of naturally
                                      occurring SODs
-   ·SCF,Inhalation   -   -           Undisclosed steroids    small molecule
-                     ·SCF,Inhalation·Meter Dosage                Corticosteroids·Beta 2   ·Corticosteroid with   ·small molecule:
                      ed-DoseInhalers-MDI Strengths(budesonide) Adrenergic Agonists        mainly glucocorticoid budesonide·small
                                             : 0.104, 0.312                                activity :             molecule: formoterol
                                            milligram Dosage                               budesonide·Selective
                                            Strengths(formoterol)                          long-acting (12 hours)
                                            : 0.0054, 0.0162                               ß2-adrenergic
                                            milligram                                      stimulant
                                                                                           (bronchodilator):
                                                                                           formoterol




· Mitsubishi Tanabe   -                     -                      LTD4 Receptor           Leukotriene D4          small molecule
Pharma Corporation                                                 Antagonists             antagonist with
(Japan)                                                                                    inhibition of
                                                                                           bronchoconstriction
                                                                                           and allergic response
· Genaera Corp.   ·INJECTABLES      Dosage Strengths :   Anti-IL-9            The companies            antibodies
                                    0.3, 1, 3, 9                              believe that either the
                                    milligram/kg                              systemic delivery of
                                                                              an anti-IL-9 product
                                                                              (an antibody or a
                                                                              recombinant
                                                                              molecule) to the lung
                                                                              will block the
                                                                              interaction of IL-9 with
                                                                              its receptor.




-                 ·ORALDRUGDELIVE   Dosage Strength :    PDE-4                Inhibits PDE-4,         small molecule
                  RY                600 milligram        (Phosphodiesterase   phosphodiesterase,
                                                         4) Inhibitors        the enzyme that
                                                                              breaks down cAMP
                                                                              levels in the brain.
-   ·Metered-          Dosage                  Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    DoseInhalers-MDI   Strength(procaterol     Agonists            procaterol           procaterol
                       hydrochloride) : 0.01                       hydrochloride        hydrochloride
                       milligram ; Dosing
                       Frequency: 1-2 a day
-   ·ORALDRUGDELIVE   Dosage                  Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strength(procaterol     Agonists            procaterol           procaterol
                      hydrochloride) : 0.05                       hydrochloride        hydrochloride
                      milligram
-   ·ORALDRUGDELIVE   Dosage                 Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strength(procaterol    Agonists            procaterol           procaterol
                      hydrochloride) : 0.1                       hydrochloride        hydrochloride
                      milligram
-   ·INHALATION   Dosage                   Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
                  Strengths(procaterol     Agonists            procaterol           procaterol
                  hydrochloride) : 0.03,                       hydrochloride        hydrochloride
                  0.05 milligram
-   ·Metered-          Dosage                 Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    DoseInhalers-MDI   Strength(procaterol    Agonists            procaterol           procaterol
                       hydrochloride) : 0.005                     hydrochloride        hydrochloride
                       milligram
-   ·ORALDRUGDELIVE   Dosage                  Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strength(procaterol     Agonists            procaterol           procaterol
                      hydrochloride) : 0.05                       hydrochloride        hydrochloride
                      milligram
-   ·ORALDRUGDELIVE   Dosage                  Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strength(procaterol     Agonists            procaterol           procaterol
                      hydrochloride) : 0.05                       hydrochloride        hydrochloride
                      milligram ; Dosing
                      Frequency: 1-2 per
                      day
-   ·ORALDRUGDELIVE   Dosage                 Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    RY                Strength(procaterol    Agonists            procaterol           procaterol
                      hydrochloride) : 0.025                     hydrochloride        hydrochloride
                      milligram ; Dosing
                      Frequency: 1-2 per
                      day
-                     ·ORALDRUGDELIVE         Dosage                  COX-2                ·An oral, selective      ·small molecule:
                      RY                      Strengths(etoricoxib) : (Cyclooxygenase-2)   cyclo-oxygenase2         etoricoxib
                                              5, 100 milligram        Inhibitors           (COX2) inhibitor :
                                                                                           etoricoxib




· Merck and Co Inc.   ·INJECTABLES            -                     Anti-IL13              Monoclonal antibodies antibodies
                                                                                           which target the
                                                                                           interleukin-13 (IL-13)
                                                                                           receptor alpha1
                                                                                           subunit
                                                                                           to�inhibit IL-
                                                                                           13 activity
· Sanofi-Aventis      -                       -                     Anti-CRTH2             CrTh2 receptor           small molecule
(World)                                                                                    antagonist

· MediciNova, Inc. (ex- ·OralModifiedRel.(MR) ; Dosing Frequency: 1 LT (Leukotriene)       ·A sulfidopeptide        ·small molecule:
Asia)                                         per day               Receptor Antagonists   leukotriene receptor     tipelukast
                                                                                           antagonist: tipelukast
· Morphotek Inc.      ·INJECTABLES            -                     -                      -                        antibodies


· Meyer               ·LiquidInhalers/Nebuliz -                     NF-kB Inhibitors       A decoy that works      oligonucleotide
Pharmaceuticals       ers                                                                  against NF κB,
(North                                                                                     a genetic transcription
America,Europe)                                                                            gene that functions as
                                                                                           a genetic switch to
                                                                                           activate the
                                                                                           immunological
                                                                                           reaction.


-                     ·INJECTABLES            -                     -                      Cytokine Receptor        -
                                                                                           Regulation
· Meda AB (Europe)   ·Metered-          Dosage                Beta 2 Adrenergic   ·In vitro studies and in ·small molecule:
                     DoseInhalers-MDI   Strength(pirbuterol   Agonists            vivo pharmacologic       pirbuterol acetate
                                        acetate) : 0.2                            studies have
                                        milligram ; Dosing                        demonstrated that
                                        Frequency: 4-6 per                        pirbuterol has a
                                        day                                       preferential effect on
                                                                                  beta-2 adrenergic
                                                                                  receptors compared
                                                                                  with isoproterenol.:
                                                                                  pirbuterol acetate
-   ·DryPowderInhalers-   -   Beta 2 Adrenergic   ·A beta-2 agonist:   ·small molecule:
    DPI                       Agonists            procaterol           procaterol
                                                  hydrochloride        hydrochloride




-   ·DryPowderInhalers-   -   -                   -                    small molecule
    DPI

-   ·DryPowderInhalers-   -   -                   -                    -
    DPI
-   ·DryPowderInhalers-   -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DPI                                         mainly glucocorticoid   budesonide
                                                activity : budesonide
-   ·Metered-          Dosage                 Corticosteroids·Beta 2   ·The precise              ·small molecule:
    DoseInhalers-MDI   Strengths(mometason Adrenergic Agonists         mechanism of              mometasone
                       e furoate) : 0.2, 0.4                           corticosteroid action     furoate·small
                       milligram Dosage                                on allergic rhinitis is   molecule: formoterol
                       Strengths(formoterol)                           not known.
                       : 0.01, 0.01 milligram                          Corticosteroids have
                       ; Dosing Frequency: 2                           been shown to have a
                       a day                                           wide range of effects
                                                                       on multiple cell types
                                                                       (e.g., mast cells,
                                                                       eosinophils,
                                                                       neutrophils,
                                                                       macrophages, and
                                                                       lymphocytes) and
                                                                       mediators (e.g.,
                                                                       histamine,
                                                                       eicosanoids,
                                                                       leukotrienes, and
                                                                       cytokines) involved in
                                                                       inflammation.
                                                                       : mometasone
                                                                       furoate·Selective long-
                                                                       acting (12 hours) ß2-
                                                                       adrenergic stimulant
                                                                       (bronchodilator):
                                                                       formoterol
· Kyorin         ·INJECTABLES   -   LT (Leukotriene)       ·Inhibits              ·small molecule:
Pharmaceutical                      Receptor Antagonists   bronchoconstriction    montelukast sodium
                                                           due to antigen
                                                           challenge.
                                                           Montelukast is a
                                                           selective leukotriene
                                                           receptor antagonist of
                                                           the cysteinyl
                                                           leukotriene CysLT 1
                                                           receptor.: montelukast
                                                           sodium
-   ·LiquidInhalers/Nebuliz -                     -   ·Sodium pyruvate is a ·small molecule:
    ers                                               reactive oxygen          sodium pyruvate
                                                      species (ROS)
                                                      antagonist that has
                                                      been shown to
                                                      neutralize oxygen
                                                      radicals (specifically
                                                      lowering the
                                                      overproduction of
                                                      superoxide anions),
                                                      regulate the
                                                      production and level
                                                      of other inflammatory
                                                      mediators, and
                                                      regulate the synthesis
                                                      of nitric oxide. Sodium
                                                      pyruvate also
                                                      increases cellular
                                                      levels of glutathione
                                                      which is reduced
                                                      dramatically in antigen-
                                                      induced lung disease
                                                      patients.: sodium
                                                      pyruvate


-   ·LiquidInhalers/Nebuliz -                     -   -                      -
    ers




-   ·Transdermal            ; Dosing Frequency:   -   -                      -
                            Once a day
-                     ·Transdermal        ; Dosing Frequency:    Beta 2 Adrenergic        ·Adrenergic beta2-       ·small molecule:
                                          Once a day             Agonists                 agonist similar to       tulobuterol
                                                                                          albuterol: tulobuterol




-                     ·TransdermalEnhance -                      -                        -                        small molecule
                      rs/Gels
· Nippon-Shinyaku     ·NasalDelivery      -                      -                        -                        -
Co., LTD. (Japan)

· Nissan Chemical     ·ORALDRUGDELIVE     Dosage Strengths : 4, PDE                       An orally active         -
Industries (USA)·     RY                  8 milligram ; Dosing  (phosphodiesterase)       inhibitor of
Indigo                                    Frequency: 2 per day Inhibitors·Thromboxan      phosphodiesterase
Pharmaceuticals                                                 e Synthetase Inhibitors   and thromboxane
(World)· Nissan                                                                           synthetase.
Chemical Industries
(Japan)
-   ·Metered-          ; Dosing Frequency: 1 -   An inhaled non-           small molecule
    DoseInhalers-MDI   per day                   glucocorticoid steroid
                                                 that targets the
                                                 inflammatory and
                                                 airway obstruction
                                                 cascade in the
                                                 asthmatic lung by
                                                 inhibiting the build-up
                                                 of adenosine in the
                                                 lung
-   ·INJECTABLES   Dosage                 Xanthines   ·Aminophylline, a        ·small molecule:
                   Strength(aminophylline             complex of               aminophylline
                   ) : 250 milligram ;                theophylline with
                   Dosing Frequency: 1-               ethylenediamine,
                   2 per day                          readily liberates
                                                      theophylline in the
                                                      body. Aminophylline
                                                      has the actions and
                                                      uses of theophylline.:
                                                      aminophylline
-   ·INJECTABLES   Dosage                 Xanthines   ·Aminophylline, a        ·small molecule:
                   Strength(aminophylline             complex of               aminophylline
                   ) : 100 milligram ;                theophylline with
                   Dosing Frequency: 3-               ethylenediamine,
                   4 per day                          readily liberates
                                                      theophylline in the
                                                      body. Aminophylline
                                                      has the actions and
                                                      uses of theophylline.:
                                                      aminophylline
-   ·ORALDRUGDELIVE   Dosage                 Xanthines   ·Aminophylline, a        ·small molecule:
    RY                Strength(aminophylline             complex of               aminophylline
                      ) : 100 milligram ;                theophylline with
                      Dosing Frequency: 3-               ethylenediamine,
                      4 per day                          readily liberates
                                                         theophylline in the
                                                         body. Aminophylline
                                                         has the actions and
                                                         uses of theophylline.:
                                                         aminophylline
-                    ·INJECTABLES   -   NK2 (Neurokinin-2)     Tachykinin NK2           ·peptide: nepadutant
                                        Antagonists            receptor
                                                               antagonist···A
                                                               Tachykinin NK2
                                                               receptor antagonist. :
                                                               nepadutant
-                    -              -   5HT2 [5-               inhibition of            -
                                        hydroxytryptamine2     leukotriene pathway,
                                        (serotonin)]           antioxidation and 5-
                                        Antagonists·LT         HT2b blocking
                                        (Leukotriene)
                                        Receptor Antagonists
· Novo Nordisk A/S   ·INJECTABLES   -   C5a Receptor           ·C5a receptor            ·antibodies:
                                        Antagonists            antagonist; blocks       neutrazumab
                                                               C5a activity and
                                                               prevent chemotaxis. :
                                                               neutrazumab
-   ·ORALDRUGDELIVE   Dosage                 -   ·Lysozyme activity has ·protein: lysozyme
    RY                Strength(lysozyme          been demonstrated to hydrochloride
                      hydrochloride) : 200       be effective in
                      milligram ; Dosing         attacking the cell wall
                      Frequency: 3 per day       polysaccharide of
                                                 different bacterial
                                                 species leading to
                                                 break down of the cell
                                                 wall and killing the
                                                 micro-organisms.
                                                 Lysozyme is most
                                                 effective in
                                                 hydrolysing a
                                                 tetrasaccharide found
                                                 most often in Gram-
                                                 positive bacteria.
                                                 Model studies indicate
                                                 that Lysozyme, under
                                                 certain conditions,
                                                 either alone or in
                                                 presence of
                                                 potentiating
                                                 compounds, has
                                                 antibacterial activity
                                                 against the following
                                                 pathogenic
                                                 organisms: Lysteria
                                                 monocytogenes,
                                                 Clostridium botulinum,
                                                 Campylobacter jejuni,
                                                 Pseudomonas spp.,
                                                 Salmonella enteritidis
                                                 and the food spoilage
                                                 organisms:
-   ·ORALDRUGDELIVE   Dosage                 -   ·Lysozyme activity has ·protein: lysozyme
    RY                Strength(lysozyme          been demonstrated to hydrochloride
                      hydrochloride) : 100       be effective in
                      milligram ; Dosing         attacking the cell wall
                      Frequency: 3 per day       polysaccharide of
                                                 different bacterial
                                                 species leading to
                                                 break down of the cell
                                                 wall and killing the
                                                 micro-organisms.
                                                 Lysozyme is most
                                                 effective in
                                                 hydrolysing a
                                                 tetrasaccharide found
                                                 most often in Gram-
                                                 positive bacteria.
                                                 Model studies indicate
                                                 that Lysozyme, under
                                                 certain conditions,
                                                 either alone or in
                                                 presence of
                                                 potentiating
                                                 compounds, has
                                                 antibacterial activity
                                                 against the following
                                                 pathogenic
                                                 organisms: Lysteria
                                                 monocytogenes,
                                                 Clostridium botulinum,
                                                 Campylobacter jejuni,
                                                 Pseudomonas spp.,
                                                 Salmonella enteritidis
                                                 and the food spoilage
                                                 organisms:
-   ·ORALDRUGDELIVE   Dosage                  -   ·Lysozyme activity has ·protein: lysozyme
    RY                Strengths(lysozyme          been demonstrated to hydrochloride
                      hydrochloride) : 30, 90     be effective in
                      milligram ; Dosing          attacking the cell wall
                      Frequency: 3 per day        polysaccharide of
                                                  different bacterial
                                                  species leading to
                                                  break down of the cell
                                                  wall and killing the
                                                  micro-organisms.
                                                  Lysozyme is most
                                                  effective in
                                                  hydrolysing a
                                                  tetrasaccharide found
                                                  most often in Gram-
                                                  positive bacteria.
                                                  Model studies indicate
                                                  that Lysozyme, under
                                                  certain conditions,
                                                  either alone or in
                                                  presence of
                                                  potentiating
                                                  compounds, has
                                                  antibacterial activity
                                                  against the following
                                                  pathogenic
                                                  organisms: Lysteria
                                                  monocytogenes,
                                                  Clostridium botulinum,
                                                  Campylobacter jejuni,
                                                  Pseudomonas spp.,
                                                  Salmonella enteritidis
                                                  and the food spoilage
                                                  organisms:
-   -                     -                      PDE                   Nitric Oxide-           small molecule
                                                 (phosphodiesterase)   Enhancing PDE
                                                 Inhibitors            Inhibitors

-   -                     -                      -                     Nitric Oxide-           small molecule
                                                                       Enhancing Steroids
                                                                       provides faster onset
                                                                       of action; increased
                                                                       airway circulation
-   ·DryPowderInhalers-   Dosage                 Corticosteroids       ·Corticosteroid with    ·small molecule:
    DPI                   Strengths(budesonide)                        mainly glucocorticoid   budesonide
                          : 0.2, 0.4 milligram ;                       activity : budesonide
                          Dosing Frequency: 1-
                          2 per day
-   ·OralModifiedRel.(MR) Dosage                  Xanthines           ·Theophylline has two ·small molecule:
                          Strengths(theophylline)                     distinct actions in the theophylline
                          : 175, 250 milligram ;                      airways of patients
                          Dosing Frequency: 2                         with reversible
                          per day                                     obstruction; smooth
                                                                      muscle relaxation
                                                                      (i.e., bronchodilation)
                                                                      and suppression of
                                                                      the response of the
                                                                      airways to stimuli

                                                                      : theophylline




-   ·ORALDRUGDELIVE       -                      CRTH2 Antagonists    CRTH2 antagonist        small molecule
    RY
-   ·ORALDRUGDELIVE       -                      Eoxin Inhibitor      inhibits the 15-        small molecule
    RY                                                                lipoxygenase enzyme
                                                                      (15-LO)
-   ·ORALDRUGDELIVE       Dosage Strengths :     PDE-4                PDE4 inhibitor          -
    RY                    15, 50 milligram       (Phosphodiesterase
                                                 4) Inhibitors



-   ·ORALDRUGDELIVE       -                      PDE-4                Dual-acting drug with   -
    RY                                           (Phosphodiesterase   bronchodilating and
                                                 4) Inhibitors        anti-inflammatory
                                                                      effects
-                  -              -   -   -                       -




-                  ·INJECTABLES   -   -   OX40 Ligand             protein
                                          expressed on
                                          activated T cells
                                          (OX40L), and on
                                          antigen presenting
                                          cells, are a pair of
                                          interacting cell-
                                          surface proteins which
                                          are important for the
                                          induction and
                                          regulation of
                                          immunity. The
                                          therapeutic potential
                                          of these cell-surface
                                          proteins lies in their
                                          ability to modulate the
                                          immune system.
                                          Manipulation of the
                                          immune system
                                          through the use of
                                          OX40 or OX40 Ligand
                                          fusion proteins (OX40
                                          - lgG or OX40L-lgG)
                                          or antibodies that bind
                                          to OX40 Ligand or
                                          OX40



· Medimmune Inc.   ·INJECTABLES   -   -   -                       protein
-   ·ORALDRUGDELIVE         Dosage Strengths :   PDE-4                -   -
    RY                      15, 50 milligram     (Phosphodiesterase
                                                 4) Inhibitors




-   ·LiquidInhalers/Nebuliz -                    -                    -   small molecule
    ers
· Schering-Plough   ·ORALDRUGDELIVE   Dosage                 LT (Leukotriene)       ·A selective,          ·small molecule:
Corp. (Latin        RY                Strength(pranlukast    Receptor Antagonists   competitive antagonist pranlukast hydrate
America,Mexico)                       hydrate) : 112.5                              of the cysteinyl
                                      milligram ; Dosing                            leukotrienes (LT)
                                      Frequency: 2 per day                          C(4), LTD(4) and
                                                                                    LTE(4). : pranlukast
                                                                                    hydrate
· Schering-Plough   ·ORALDRUGDELIVE   Dosage                  LT (Leukotriene)       ·A selective,          ·small molecule:
Corp. (Latin        RY                Strength(pranlukast     Receptor Antagonists   competitive antagonist pranlukast hydrate
America,Mexico)                       hydrate) : 70                                  of the cysteinyl
                                      milligram/kg ; Dosing                          leukotrienes (LT)
                                      Frequency: 2 per day                           C(4), LTD(4) and
                                                                                     LTE(4). : pranlukast
                                                                                     hydrate




-                   ·Topical          -                       -                      -                      -
· Shionogi and Co.,    ·TasteMasking   Dosage                Corticosteroids   ·Prednisolone is a       ·small molecule:
Ltd. (North America)                   Strength(prednisolone                   corticosteroid with      prednisolone sodium
                                       sodium phosphate) :                     mainly glucocorticoid    phosphate
                                       20.2 milligram                          activity: prednisolone
                                                                               sodium phosphate
· Sciele Pharma, Inc.   ·ConventionalMeltTabl Dosage                Corticosteroids   ·Prednisolone is a       ·small molecule:
(North America)         ets·TasteMasking      Strengths(prednisolon                   corticosteroid with      prednisolone sodium
                                              e sodium phosphate) :                   mainly glucocorticoid    phosphate
                                              10, 15, 30 milligram                    activity: prednisolone
                                                                                      sodium phosphate
-   ·Metered-             Dosage                 Corticosteroids     ·New generation         ·small molecule:
    DoseInhalers-MDI      Strengths(ciclesonide)                     inhaled corticosteroid ciclesonide
                          : 0.08, 0.16 milligram                     with novel
                                                                     pharmacokinetic
                                                                     properties: ciclesonide




-   -                     -                      -                   G-protein coupled      -
                                                                     receptors.


-   ·DryPowderInhalers-   Dosage                 Beta 2 Adrenergic   ·Long-acting beta(2)   ·small molecule:
    DPI                   Strength(formoterol    Agonists            agonist: formoterol    formoterol fumarate
                          fumarate) : 0.009                          fumarate
                          milligram ; Dosing
                          Frequency: 1-2 per
                          day




-   -                     -                      CXCR1               PAC-G31P is a           peptide
                                                 Antagonists·CXCR2   selective antagonist of
                                                 Antagonists         interleukin-8 (IL-8)
                                                                     binding to CXCR1 and
                                                                     CXCR2 receptors
-   ·ORALDRUGDELIVE       ; Dosing Frequency: 2 -                    -                      -
    RY                    per day
-   ·ORALDRUGDELIVE   -                     -                      -                       -
    RY




-   ·INHALATION       ; Dosing Frequency: 1 Beta 2 Adrenergic     Long-Acting Beta 2       small molecule
                      per day               Agonists              Agonist
-   -                 -                     PI3K-gamma Inhibitors PI3 Kinase inhibitor     small molecule


-   ·ORALDRUGDELIVE   Dosage                  Cytosolic            ·Cytosolic              ·small molecule:
    RY                Strengths(giripladib) : Phospholipase A2     phospholipase A2        giripladib
                      50, 200, 400 milligram Inhibitors            inhibitor: giripladib
                       ; Dosing Frequency:
                      1-2 per day




-   -                 -                     Serine Protease        Serine protease         small molecule
                                            Inhibitors             inhibitors
· UCB Pharma (USA)   ·Metered-          Dosage               Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
                     DoseInhalers-MDI   Strength(albuterol   Agonists            racemic form of           albuterol sulfate
                                        sulfate) : 0.09                          albuterol and a
                                        milligram ; Dosing                       relatively selective
                                        Frequency: 4-6 per                       beta 2 -adrenergic
                                        day                                      bronchodilator:
                                                                                 albuterol sulfate
-                       ·INHALATION       -                    -                    The mode of action of protein
                                                                                    the Anticalin®
                                                                                    candidate is via
                                                                                    modulation of the site
                                                                                    of binding for multiple
                                                                                    ligands
· Schering-Plough       ·ORALDRUGDELIVE   Dosage Strengths : 1, CXCR2 Antagonists   CXCR2 antagonist       small molecule
Corp. (USA)             RY                30 milligram




· Daiichi               -                 -                    VCAM Antagonists     A vascular cell        small molecule
Pharmaceutical                                                                      adhesion molecule
Corporation (USA)                                                                   (VCAM) antagonist
· Teva                  ·OralMatrixMR     -                    -                    -                      small molecule
Pharmaceutical
Industries Ltd. (USA)



-                       -                 -                    -                    Inhibits immune cell   small molecule
                                                                                    trafficking


-                       -                 -                    -                    Targets SSAO/VAP-1 -
                                                                                    protein (2008
                                                                                    company report page
                                                                                    7)
-                  ·OralModifiedRel.(MR) -                     -                  -                        small molecule




-                  -                     -                     -                  -                        -
-                  -                     -                     H4 (Histamine 4)   H4 (Histamine 4)         -
                                                               Antagonists        Antagonists


· United           ·OralMatrixMR         Dosage                 Xanthines         ·Aminophylline, a        ·small molecule:
Pharmaceuticals·                         Strength(aminophylline                   complex of               aminophylline
Mundipharma AG                           dihydrate) : 225                         theophylline with        dihydrate
(Switzerland)                            milligram ; Dosing                       ethylenediamine,
                                         Frequency: 2 per day                     readily liberates
                                                                                  theophylline in the
                                                                                  body. Aminophylline
                                                                                  has the actions and
                                                                                  uses of theophylline :
                                                                                  aminophylline
                                                                                  dihydrate
· United           ·OralMatrixMR   Dosage                 Xanthines   ·Aminophylline, a        ·small molecule:
Pharmaceuticals·                   Strength(aminophylline             complex of               aminophylline
Mundipharma AG                     dihydrate) : 350                   theophylline with        dihydrate
(Switzerland)                      milligram ; Dosing                 ethylenediamine,
                                   Frequency: 2 per day               readily liberates
                                                                      theophylline in the
                                                                      body. Aminophylline
                                                                      has the actions and
                                                                      uses of theophylline :
                                                                      aminophylline
                                                                      dihydrate
-                   ·OralMatrixMR   Dosage                 Xanthines   ·Aminophylline, a        ·small molecule:
                                    Strength(aminophylline             complex of               aminophylline
                                    dihydrate) : 100                   theophylline with        dihydrate
                                    milligram                          ethylenediamine,
                                                                       readily liberates
                                                                       theophylline in the
                                                                       body. Aminophylline
                                                                       has the actions and
                                                                       uses of theophylline :
                                                                       aminophylline
                                                                       dihydrate




· Opsona            -               -                     -            Phylomer® drugs          -
Therapeutics Ltd.                                                      target Toll-like
                                                                       Receptors and other
                                                                       inflammatory
                                                                       associated pathways.

-                   -               -                     -            Undisclosed              small molecule
-   ·ORALDRUGDELIVE   Dosage                  -   an orally active, broad- ·small molecule:
    RY                Strengths(pleconaril) :     spectrum                   pleconaril
                      200, 400 milligram ;        antipicornaviral agent
                      Dosing Frequency: 2-        which demonstrates
                      3 per day                   excellent penetration
                                                  into the central
                                                  nervous system, liver,
                                                  and nasal
                                                  epithelium···Pleconaril
                                                  is an orally active
                                                  broad-spectrum
                                                  antiviral agent.
                                                  Pleconaril, like similar
                                                  [(oxazolylphenoxy)alkyl
                                                  ]isoxazole
                                                  compounds, inhibits
                                                  viral replication at the
                                                  site of viral
                                                  attachment and
                                                  uncoating. These
                                                  hydrophobic
                                                  compounds insert
                                                  themselves into a
                                                  pocket beneath the
                                                  canyon site on the
                                                  icosahedral face of
                                                  the virion, raising the
                                                  floor of the canyon
                                                  and thus altering the
                                                  ability of the virus to
                                                  attach to the cellular
                                                  receptor. Additionally,
                                                  these agents increase
                                                  the stability of the viral
-   ·OralLozenge   Dosage                 -   ·A synthetic form of     ·small molecule:
                   Strength(cyanocobala       vitamin B12 with         cyanocobalamin
                   min) : 3.3 milligram ;     equivalent vitamin
                   Dosing Frequency: 2        B12 activity. Vitamin
                   a day                      B12 is essential to
                                              growth, cell
                                              reproduction,
                                              hematopoiesis, and
                                              nucleoprotein and
                                              myelin synthesis.
                                              Cells
                                              characterized by rapid
                                              division (e.g.,
                                              epithelial cells, bone
                                              marrow, myeloid cells)
                                              appear to have the
                                              greatest requirement
                                              for vitamin B12.
                                              Cyanocobalamin is
                                              the most stable and
                                              widely used form of
                                              vitamin B12, and has
                                              hematopoietic activity
                                              apparently identical to
                                              that of the antianemia
                                              factor in purified liver
                                              extract.:
                                              cyanocobalamin
-   ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    ers                         Agonists            racemic form of           albuterol sulfate
                                                    albuterol and a
                                                    relatively selective
                                                    beta 2 -adrenergic
                                                    bronchodilator:
                                                    albuterol sulfate




-   ·LiquidInhalers/Nebuliz -   Corticosteroids     ·Corticosteroid with      ·small molecule:
    ers                                             mainly glucocorticoid     budesonide
                                                    activity : budesonide
-   ·LiquidInhalers/Nebuliz -   Mast Cell Stabilizers   ·Although its precise ·small molecule:
    ers                                                 mode of action        sodium cromoglycate
                                                        remains uncertain,
                                                        sodium cromoglycate
                                                        is believed to act
                                                        primarily by
                                                        preventing release of
                                                        mediators of
                                                        inflammation from
                                                        sensitised mast cells
                                                        through stabilisation
                                                        of mast-cell
                                                        membranes. : sodium
                                                        cromoglycate
-   ·Metered-          Dosage                Alpha Adrenergic      ·Most potent stimulant ·small molecule:
    DoseInhalers-MDI   Strength(epinephrine) Agonists·Beta         (sympathomimetic) of epinephrine
                       : 0.22 milligram      Adrenergic Agonists   adrenergic alpha and
                                                                   beta-receptors,
                                                                   resulting in increased
                                                                   heart rate and force of
                                                                   contraction,
                                                                   vasoconstriction or
                                                                   vasodilation,
                                                                   relaxation of
                                                                   bronchiolar and
                                                                   intestinal smooth
                                                                   muscle: epinephrine
-   ·Metered-          -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DoseInhalers-MDI       Agonists            racemic form of           albuterol sulfate
                                               albuterol and a
                                               relatively selective
                                               beta 2 -adrenergic
                                               bronchodilator:
                                               albuterol sulfate
-   ·ORALDRUGDELIVE   Dosage                 H1 (Histamine 1)   ·Histamine H1          ·small molecule:
    RY                Strength(ketotifen     Antagonists        receptor antagonist:   ketotifen fumarate
                      fumarate) : 1                             ketotifen fumarate
                      milligram ; Dosing
                      Frequency: 2 per day
-   -                  -   -                   Synairgen is using      -
                                               proteomic approaches
                                               to perform protein
                                               expression profiling
                                               on epithelial
                                               secretions obtained
                                               from tissue models
                                               using clinical samples
                                               obtained from donors
                                               without or with asthma.



-   ·Metered-          -   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DoseInhalers-MDI       Agonists            racemic form of           albuterol sulfate
                                               albuterol and a
                                               relatively selective
                                               beta 2 -adrenergic
                                               bronchodilator:
                                               albuterol sulfate
-   ·Metered-          Dosage               Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DoseInhalers-MDI   Strength(albuterol   Agonists            racemic form of           albuterol sulfate
                       sulfate) : 0.12                          albuterol and a
                       milligram ; Dosing                       relatively selective
                       Frequency: 4-6 per                       beta 2 -adrenergic
                       day                                      bronchodilator:
                                                                albuterol sulfate
-   ·Metered-          Dosage                Corticosteroids    ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(budesonide)                    mainly glucocorticoid   budesonide
                       : 0.1, 0.2 milligram                     activity : budesonide




-   ·Metered-          Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strength(budesonide)                     mainly glucocorticoid   budesonide
                       : 0.2 milligram ;                        activity : budesonide
                       Dosing Frequency: 2
                       per day
-   ·LiquidInhalers/Nebuliz Dosage                Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                     Strengths(budesonide)                   mainly glucocorticoid   budesonide
                            : 1, 2 milligram ;                      activity : budesonide
                            Dosing Frequency: 2
                            per day




-   ·LiquidInhalers/Nebuliz ; Dosing Frequency: 2 Corticosteroids   ·Corticosteroid with    ·small molecule:
    ers                     per day                                 mainly glucocorticoid   budesonide
                                                                    activity : budesonide
-   ·DryPowderInhalers-    Dosage                Corticosteroids       ·Corticosteroid with    ·small molecule:
    DPI                    Strengths(budesonide)                       mainly glucocorticoid   budesonide
                           : 0.1, 0.2, 0.4                             activity : budesonide
                           milligram ; Dosing
                           Frequency: 2 per day




-   ·InhalationFormulation -                      Beta 2 Adrenergic    ·Beta agonist: albuterol ·small molecule:
    s                                             Agonists                                      albuterol




-   ·DryPowderInhalers-    Dosage                  Beta 2 Adrenergic   ·A long-acting beta2-   ·small molecule:
    DPI                    Strengths(indacaterol) Agonists             agonist: indacaterol    indacaterol
                           : 0.075, 0.15, 0.3, 0.6
                           milligram ; Dosing
                           Frequency: 1 per day

-   ·INHALATION            -                      -                    Glucocorticosteroid     -
-   -                      -                      CCR3 Antagonists     CCR3 antagonist         -
· Novartis AG (USA)   -   -   TLR9 (Toll-like         TLR9 agonists are       oligonucleotide
                              receptors 9) Agonists   strong inducers of
                                                      Th1-type cytokines,
                                                      and animal models of
                                                      allergic asthma show
                                                      that IMO“ compounds
                                                      discovered by Idera
                                                      reversed the
                                                      imbalance of Th2
                                                      activity and improved
                                                      lung function.
-   ·DryPowderInhalers-   ; Dosing Frequency: 1 Beta 2 Adrenergic      ·A long-acting beta2-     ·small molecule:
    DPI                   a day                 Agonists·Corticosteroi agonist:                  indacaterol·small
                                                ds                     indacaterol·The           molecule:
                                                                       precise mechanism of      mometasone furoate
                                                                       corticosteroid action
                                                                       on allergic rhinitis is
                                                                       not known.
                                                                       Corticosteroids have
                                                                       been shown to have a
                                                                       wide range of effects
                                                                       on multiple cell types
                                                                       (e.g., mast cells,
                                                                       eosinophils,
                                                                       neutrophils,
                                                                       macrophages, and
                                                                       lymphocytes) and
                                                                       mediators (e.g.,
                                                                       histamine,
                                                                       eicosanoids,
                                                                       leukotrienes, and
                                                                       cytokines) involved in
                                                                       inflammation.
                                                                       : mometasone furoate
-   ·Metered-          Dosage               Corticosteroids    ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(beclometha                    mainly glucocorticoid   beclomethasone
                       sone dipropionate) :                    activity:               dipropionate
                       0.5, 0.1 milligram ;                    beclomethasone
                       Dosing Frequency: 2                     dipropionate
                       per day




-   ·Metered-          Dosage                Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(beclometha                    mainly glucocorticoid   beclomethasone
                       sone dipropionate) :                    activity:               dipropionate
                       0.05, 0.1 milligram ;                   beclomethasone
                       Dosing Frequency: 2                     dipropionate
                       per day
· 3M Health Care         ·Metered-          Dosage                Corticosteroids    ·Corticosteroid with    ·small molecule:
                         DoseInhalers-MDI   Strengths(beclometha                     mainly glucocorticoid   beclomethasone
                                            sone dipropionate) :                     activity:               dipropionate
                                            0.05, 0.1 milligram ;                    beclomethasone
                                            Dosing Frequency: 2                      dipropionate
                                            a day




· Teva                   ·Metered-          Dosage                 Corticosteroids   ·Corticosteroid with    ·small molecule:
Pharmaceutical           DoseInhalers-MDI   Strengths(beclometha                     mainly glucocorticoid   beclomethasone
Industries Ltd. (USA)·                      sone dipropionate) :                     activity:               dipropionate
Lavipharm SA·                               0.04, 0.08 milligram ;                   beclomethasone
Dainippon Sumitomo                          Dosing Frequency: 2                      dipropionate
Pharmaceutical                              per day
(Japan)· Schering-
Plough Corp. (Japan)
· Roche                 ·INJECTABLES          Dosage Strength :   -                     -                     antibodies
                                              0.0015 milligram




· Pfizer Inc. (World)   ·DryPowderInhalers-   -                   SYK (Spleen Tyrosine Syk kinase inhibitor    small molecule
                        DPI                                       Kinase) Inhibitors   that is designed to
                                                                                       bind to syk in mast
                                                                                       cells and interrupt
                                                                                       the
                                                                                       signal from the IgE
                                                                                       receptor, thus
                                                                                       preventing cellular
                                                                                       activation and
                                                                                       subsequent chemical
                                                                                       mediator release, and
                                                                                       potentially blocking an
                                                                                       allergic
                                                                                       response in allergic
                                                                                       asthma.
-         ·ORALDRUGDELIVE       Dosage                 alpha4beta1 (VLA-4)    ·A selective integrin  ·small molecule:
          RY                    Strength(valategrast   Integrin Antagonists   receptor antagonist.   valategrast
                                hydrochloride) : 200                          This drug acts through hydrochloride
                                milligram                                     a non-steroidal
                                                                              mechanism, blocking
                                                                              VLA-4 integrin
                                                                              receptor sites:
                                                                              valategrast
                                                                              hydrochloride



· Roche   ·INJECTABLES          -                      Anti-CD134             Anti-CD134/OX40.          antibodies
                                                                              Antibody which
                                                                              selectively blocks the
                                                                              interaction of the
                                                                              OX40 ligand and its
                                                                              receptor. [29913]
-         ·DryPowderInhalers-   -                      Beta 2 Adrenergic      ·Albuterol sulfate, the   ·small molecule:
          DPI                                          Agonists               racemic form of           albuterol sulfate
                                                                              albuterol and a
                                                                              relatively selective
                                                                              beta 2 -adrenergic
                                                                              bronchodilator:
                                                                              albuterol sulfate
-   ·ORALDRUGDELIVE   Dosage                    -   ·Anti-inflammatory      ·small molecule:
    RY                Strength(tranilast) : 5       and anti-angiogenic     tranilast
                      milligram/kg                  agent. Exerts its
                                                    effects by inhibiting
                                                    the expression of
                                                    mediators such as
                                                    MCP-1, TGF-β,
                                                    TNF-α induced
                                                    vascular cell adhesion
                                                    molecule-1 (VCAM-1),
                                                    intracellular adhesion
                                                    molecule-1 (ICAM-1)
                                                    and E-selectin. It also
                                                    inhibits antigen-
                                                    specific T cell
                                                    proliferation, skews a
                                                    TH1-type T cell
                                                    response to TH2 and
                                                    suppresses the
                                                    activation of antigen
                                                    presenting cells by
                                                    interfering with signal
                                                    transducer and
                                                    activator of
                                                    transcription (STAT)
                                                    pathways.: tranilast
-   ·ORALDRUGDELIVE   Dosage                  -                    ·Anti-inflammatory      ·small molecule:
    RY                Strength(tranilast) :                        and anti-angiogenic     tranilast
                      100 milligram ;                              agent. Exerts its
                      Dosing Frequency: 3                          effects by inhibiting
                      per day                                      the expression of
                                                                   mediators such as
                                                                   MCP-1, TGF-β,
                                                                   TNF-α induced
                                                                   vascular cell adhesion
                                                                   molecule-1 (VCAM-1),
                                                                   intracellular adhesion
                                                                   molecule-1 (ICAM-1)
                                                                   and E-selectin. It also
                                                                   inhibits antigen-
                                                                   specific T cell
                                                                   proliferation, skews a
                                                                   TH1-type T cell
                                                                   response to TH2 and
                                                                   suppresses the
                                                                   activation of antigen
                                                                   presenting cells by
                                                                   interfering with signal
                                                                   transducer and
                                                                   activator of
                                                                   transcription (STAT)
                                                                   pathways.: tranilast




-   ·NasalDelivery    -                       PDE-4                Novel long acting      small molecule
                                              (Phosphodiesterase   inhibitor of both
                                              4) Inhibitors        phosphodiesterase 3
                                                                   and
                                                                   phosphodiesterase 4
                                                                   enzymes
-   ·ORALDRUGDELIVE        -                      -                      Resolvins are anti-   small molecule
    RY                                                                   inflammatory lipid
                                                                         mediators generated
                                                                         through the oxidation
                                                                         of the omega-3 fatty
                                                                         acids
                                                                         eicosapentaenoic acid
                                                                         (EPA) and
                                                                         docosahexaenoic acid
                                                                         (DHA).
                                                                         (Pubmed id:15890784)


-   ·LiquidInhalers/Nebuliz Dosage                 Beta Adrenergic       ·Racepinephrine is a ·small molecule:
    ers                     Strength(racepinephrin Agonists·Alpha        racemic mixture of the racepinephrine
                            e) : 2.25 percent      Adrenergic Agonists   enantiomorphs of
                                                                         epinephrine and
                                                                         refers to the mixture
                                                                         of 'd' and 'l' isomers of
                                                                         epinephrine in equal
                                                                         parts. Epinephrine is a
                                                                         potent stimulant
                                                                         (sympathomimetic) of
                                                                         adrenergic alpha and
                                                                         beta-receptors,
                                                                         resulting in increased
                                                                         heart rate and force of
                                                                         contraction,
                                                                         vasoconstriction or
                                                                         vasodilation,
                                                                         relaxation of
                                                                         bronchiolar and
                                                                         intestinal smooth
                                                                         muscle.:
                                                                         racepinephrine
-   ·INJECTABLES          Dosage                   Anti-IL-5R··Anti-IL-5R Reslizumab is a          ·antibodies:
                          Strengths(reslizumab)                           humanized mAb            reslizumab
                          : 1, 2, 3 milligram/kg ;                        against IL-
                          Dosing Frequency: 1                             5···treatment of
                          per month                                       bronchial asthma as
                                                                          well as a
                                                                          pharmacological tool
                                                                          to elucidate the role of
                                                                          IL-5 in human
                                                                          eosinophilic
                                                                          diseases
                                                                          : reslizumab
-   ·DryPowderInhalers-   -                       Corticosteroids         ·Anti-inflammatory      ·small molecule:
    DPI                                                                   corticosteroid.:        etiprednol dicloacetate
                                                                          etiprednol dicloacetate

-   -                     -                       -                       -                        -
-                        ·LiquidInhalers/Nebuliz Dosage                  mACh (Muscarinic       ·Ipratropium bromide ·small molecule:
                         ers                     Strengths(ipratropium   Acetylcholine)         is an anticholinergic   ipratropium bromide
                                                 bromide hydrate) :      Receptor Antagonists   (parasympatholytic)     hydrate
                                                 0.1, 0.5 milligram ;                           agent which, based on
                                                 Dosing Frequency: 1-                           animal studies,
                                                 4 per day                                      appears to inhibit
                                                                                                vagally mediated
                                                                                                reflexes by
                                                                                                antagonizing the
                                                                                                action of
                                                                                                acetylcholine, the
                                                                                                transmitter agent
                                                                                                released from the
                                                                                                vagus nerve.
                                                                                                Anticholinergics
                                                                                                prevent the increases
                                                                                                in intracellular
                                                                                                concentration of cyclic
                                                                                                guanosine
                                                                                                monophosphate
                                                                                                (cyclic GMP) which
                                                                                                are caused by
                                                                                                interaction of
                                                                                                acetylcholine with the
                                                                                                muscarinic receptor
                                                                                                on bronchial smooth
                                                                                                muscle.: ipratropium
                                                                                                bromide hydrate




· Baxter International   ·LiquidInhalers/Nebuliz Dosage Strengths :      -                      Recombinant Alpha 1- protein
Inc.                     ers                     10, 50, 100, 200                               antitrypsin (rAAT)
                                                 milligram
-   ·ORALDRUGDELIVE   Dosage                   -   ·Anti-inflammatory      ·small molecule:
    RY                Strength(tranilast) :        and anti-angiogenic     tranilast
                      100 milligram ;              agent. Exerts its
                      Dosing Frequency: 3          effects by inhibiting
                      per day                      the expression of
                                                   mediators such as
                                                   MCP-1, TGF-β,
                                                   TNF-α induced
                                                   vascular cell adhesion
                                                   molecule-1 (VCAM-1),
                                                   intracellular adhesion
                                                   molecule-1 (ICAM-1)
                                                   and E-selectin. It also
                                                   inhibits antigen-
                                                   specific T cell
                                                   proliferation, skews a
                                                   TH1-type T cell
                                                   response to TH2 and
                                                   suppresses the
                                                   activation of antigen
                                                   presenting cells by
                                                   interfering with signal
                                                   transducer and
                                                   activator of
                                                   transcription (STAT)
                                                   pathways.: tranilast




-   ·ORALDRUGDELIVE   Dosage                   -   ·Anti-allergic drug    ·small molecule:
    RY                Strength(repirinast) :       which inhibits         repirinast
                      10 percent                   chemical mediator
                                                   release: repirinast
-   ·ORALDRUGDELIVE   Dosage                   -   ·Anti-allergic drug    ·small molecule:
    RY                Strength(repirinast) :       which inhibits         repirinast
                      150 milligram                chemical mediator
                                                   release: repirinast
-             ·ORALDRUGDELIVE   -   DP Antagonists         ·Prostaglandin D2       ·small molecule: S-
              RY                                           receptor antagonist: S- 5751
                                                           5751
-             -                 -   CRTH2 Antagonists      Cr Th2 antagonist       -

-             -                 -   A3A Adenosine          A3A antagonist          -
                                    Receptor Antagonists
-             -                 -   TRL9 Agonist           TRL9 agonist            -

-             -                 -   DP1 Antagonist         DP1 antagonist          -

· Synairgen   ·INHALATION       -   Interferons            ·Interferons are a      ·protein: interferon
                                                           family of naturally     beta
                                                           occurring proteins that
                                                           are produced by
                                                           eukaryotic cells in
                                                           response to viral
                                                           infection and other
                                                           biological inducers.:
                                                           interferon beta
· Synairgen   ·INHALATION       -   Interferons            ·Interferons are a      ·protein: interferon
                                                           family of naturally     beta
                                                           occurring proteins that
                                                           are produced by
                                                           eukaryotic cells in
                                                           response to viral
                                                           infection and other
                                                           biological inducers.:
                                                           interferon beta
-             -                 -   -                      -                       -
-             -                 -   -                      -                       -

-             -                 -   -                      -                       -
-             -                 -   -                      -                       -
-   ·ORALDRUGDELIVE         -                     -                      It suppresses         -
    RY                                                                   inflammatory mediator
                                                                         release/production

-   ·LiquidInhalers/Nebuliz -                     Interferons            ·Interferons are a      ·protein: interferon
    ers                                                                  family of naturally     beta
                                                                         occurring proteins that
                                                                         are produced by
                                                                         eukaryotic cells in
                                                                         response to viral
                                                                         infection and other
                                                                         biological inducers.:
                                                                         interferon beta
-   -                       -                     -                      reorganises and re-     protein
                                                                         establishes the barrier
                                                                         without promoting
                                                                         unwanted structural
                                                                         changes
                                                                         in the lung
-   -                       -                     -                      The Company has          -
                                                                         isolated a novel
                                                                         molecule from
                                                                         Mycobacterium
                                                                         vaccae that is potently
                                                                         active in a pre-clinical
                                                                         model of asthma.
                                                                         SRP312 is a A
                                                                         synthetic version of
                                                                         this molecule.
-   -                       -                     A3A Adenosine          Adenosine A3             small molecule
                                                  Receptor Antagonists   antagonist

-   ·DryPowderInhalers-     ; Dosing Frequency: 1 Corticosteroids        Soft corticosteroid.     small molecule
    DPI                     a day                                        Glucocorticoid
                                                                         receptor agonist.
-   ·Metered-          Dosage                 Beta 2 Adrenergic    ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI   Strength(albuterol) :  Agonists                                      albuterol
                       0.1 milligram ; Dosing
                       Frequency: 1-4 a day




-   ·Metered-          Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI   Strength(albuterol) :   Agonists                                     albuterol
                       0.1 milligram
-   ·Metered-             Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI      Strength(albuterol) :   Agonists                                     albuterol
                          0.1 milligram




-   ·DryPowderInhalers-   -                       Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DPI                                           Agonists                                     albuterol




-   ·Metered-             -                       Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-                                 Agonists                                     albuterol
    MDI·InhalationFormula
    tions
-   ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    ers                     Strengths(albuterol) :   Agonists                                     albuterol
                            2.5, 5 milligram ;
                            Dosing Frequency: 4
                            per day




-   ·DryPowderInhalers-     Dosage                   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DPI                     Strengths(albuterol) :   Agonists                                     albuterol
                            0.05, 0.1 milligram ;
                            Dosing Frequency: 1-
                            4 a day
-                      ·ORALDRUGDELIVE         ; Dosing Frequency: 1 Potassium Channel   Small molecule          ·small molecule:
                       RY                      per day               Blockers            inhibitor of the KCa3.1 senicapoc
                                                                                         potassium ion
                                                                                         channel···Senicapoc
                                                                                         is an inhibitor of the
                                                                                         Gardos calcium-
                                                                                         activated potassium
                                                                                         channel. It is expected
                                                                                         to inhibit RBC
                                                                                         dehydration and thus
                                                                                         should prevent or
                                                                                         delay the sickling
                                                                                         process. By reducing
                                                                                         sickled cells, an
                                                                                         improvement in
                                                                                         anemia, a reduction in
                                                                                         painful crises, and
                                                                                         ultimately, less end-
                                                                                         organ disease is
                                                                                         anticipated. :
                                                                                         senicapoc




· Arrow                ·LiquidInhalers/Nebuliz -                    Corticosteroids      ·New generation         ·small molecule:
Pharmaceuticals Ltd.   ers                                                               inhaled corticosteroid ciclesonide
                                                                                         with novel
                                                                                         pharmacokinetic
                                                                                         properties: ciclesonide
-   ·Metered-          Dosage                Beta 2 Adrenergic        ·A long-acting beta 2 -    ·small molecule:
    DoseInhalers-MDI   Strength(salmeterol   Agonists·Corticosteroi   adrenergic agonist:        salmeterol
                       xinafoate) : 0.025    ds                       salmeterol                 xinafoate·small
                       milligram Dosage                               xinafoate·Corticosteroi    molecule: fluticasone
                       Strengths(fluticasone                          d with mainly              propionate
                       propionate) : 0.05,                            glucocorticoid activity.
                       0.125, 0.25 milligram                          It has weak affinity for
                       ; Dosing Frequency: 2                          the progesterone
                       per day                                        receptor, and virtually
                                                                      no affinity for the
                                                                      mineralocorticoid,
                                                                      estrogen, or androgen
                                                                      receptors.: fluticasone
                                                                      propionate
-   ·DryPowderInhalers-   Dosage                Beta 2 Adrenergic   ·A long-acting beta 2 - ·small molecule:
    DPI                   Strength(salmeterol   Agonists            adrenergic agonist:     salmeterol xinafoate
                          xinafoate) : 0.05                         salmeterol xinafoate
                          milligram ; Dosing
                          Frequency: 2 for 2
                          days
· Almirall (Spain)   ·DryPowderInhalers-   Dosage                Beta 2 Adrenergic   ·A long-acting beta 2 - ·small molecule:
                     DPI                   Strength(salmeterol   Agonists            adrenergic agonist:     salmeterol xinafoate
                                           xinafoate) : 0.05                         salmeterol xinafoate
                                           milligram ; Dosing
                                           Frequency: Once a
                                           day




-                    ·Metered-             Dosage                Beta 2 Adrenergic   ·A long-acting beta 2 - ·small molecule:
                     DoseInhalers-MDI      Strength(salmeterol   Agonists            adrenergic agonist:     salmeterol xinafoate
                                           xinafoate) : 0.025                        salmeterol xinafoate
                                           milligram ; Dosing
                                           Frequency: 2 a day
-   ·Metered-          Dosage                 Beta 2 Adrenergic   ·A long-acting beta 2 - ·small molecule:
    DoseInhalers-MDI   Strength(salmeterol    Agonists            adrenergic agonist:     salmeterol xinafoate
                       xinafoate) : 0.021                         salmeterol xinafoate
                       milligram ; Dosing
                       Frequency: 2 per day
· Medarex Inc.        ·DisposableAutoinjecto Dosage                 Anti-TNF   ·A human monoclonal ·antibodies:
(USA,Canada)·         rs·PrefillableSyringes/ Strength(golimumab) :            antibody that binds to golimumab
Schering-Plough       Cartridges              50 milligram ; Dosing            both the soluble and
Corp. (Europe)·                               Frequency: 1 a month             transmembrane
Janssen                                                                        bioactive forms of
Pharmaceutica                                                                  human TNF?.:
Products, LP (Japan)·                                                          golimumab
Mitsubishi Tanabe
Pharma Corporation
(Japan)
-   ·ChewableTablets/Gu Dosage                LT (Leukotriene)       ·Inhibits              ·small molecule:
    m                   Strengths(montelukast Receptor Antagonists   bronchoconstriction    montelukast sodium
                        sodium) : 4, 5                               due to antigen
                        milligram ; Dosing                           challenge.
                        Frequency: 1 per day                         Montelukast is a
                                                                     selective leukotriene
                                                                     receptor antagonist of
                                                                     the cysteinyl
                                                                     leukotriene CysLT 1
                                                                     receptor.: montelukast
                                                                     sodium
· Merck and Co Inc.   ·ORALDRUGDELIVE   Dosage                LT (Leukotriene)      ·Inhibits              ·small molecule:
(UK)· Kyorin          RY                Strength(montelukast Receptor Antagonists   bronchoconstriction    montelukast sodium
Pharmaceutical                          sodium) : 4 milligram                       due to antigen
(Japan)                                 ; Dosing Frequency: 1                       challenge.
                                        per day                                     Montelukast is a
                                                                                    selective leukotriene
                                                                                    receptor antagonist of
                                                                                    the cysteinyl
                                                                                    leukotriene CysLT 1
                                                                                    receptor.: montelukast
                                                                                    sodium
· Merck and Co Inc.   ·ORALDRUGDELIVE   Dosage                LT (Leukotriene)       ·Inhibits              ·small molecule:
(UK)· Kyorin          RY                Strengths(montelukast Receptor Antagonists   bronchoconstriction    montelukast sodium
Pharmaceutical                          sodium) : 10, 5                              due to antigen
(Japan)                                 milligram ; Dosing                           challenge.
                                        Frequency: 1 per day                         Montelukast is a
                                                                                     selective leukotriene
                                                                                     receptor antagonist of
                                                                                     the cysteinyl
                                                                                     leukotriene CysLT 1
                                                                                     receptor.: montelukast
                                                                                     sodium




-                     ·INHALATION       -                     -                      siRNA based product     siRNA
                                                                                     targeting key
                                                                                     cytokines that play a
                                                                                     critical role in
                                                                                     inflammation and
                                                                                     bronchconstriction.
-   ·ORALDRUGDELIVE   Dosage               Interleukins   ·As a benzopyrano-       ·small molecule:
    RY                Strengths(amlexanox)                bipyridine carboxylic    amlexanox
                      : 25, 50 milligram ;                acid derivative,
                      Dosing Frequency: 3                 amlexanox has anti-
                      per day                             inflammatory and
                                                          antiallergic properties.
                                                          It inhibits chemical
                                                          mediatory release of
                                                          the slow-reacting
                                                          substance of
                                                          anaphylaxis (SRS-A)
                                                          and may have
                                                          antagonistic effects on
                                                          interleukin-3.:
                                                          amlexanox
· Pfizer Inc.   ·LiquidInhalers/Nebuliz Dosage                 mACh (Muscarinic       ·Tiotropium bromide     ·small molecule:
                ers                     Strength(tiotropium    Acetylcholine)         is a new long-acting    tiotropium bromide
                                        bromide                Receptor Antagonists   inhaled anticholinergic monohydrate
                                        monohydrate) : 0.025                          agent: tiotropium
                                        milligram ; Dosing                            bromide monohydrate
                                        Frequency: 1 per day
· Pfizer Inc. (World)   ·DryPowderInhalers-   Dosage                 mACh (Muscarinic       ·Tiotropium bromide     ·small molecule:
                        DPI                   Strength(tiotropium    Acetylcholine)         is a new long-acting    tiotropium bromide
                                              bromide                Receptor Antagonists   inhaled anticholinergic monohydrate
                                              monohydrate) : 0.018                          agent: tiotropium
                                              milligram ; Dosing                            bromide monohydrate
                                              Frequency: 1 per day
· Teijin Pharma Ltd.   ·ORALDRUGDELIVE   Dosage                   Beta 2 Adrenergic   ·A direct-acting        ·small molecule:
(Japan)                RY                Strengths(clenbuterol    Agonists            sympathomimetic with clenbuterol
                                         hydrochloride) : 0.01,                       predominantly beta-     hydrochloride
                                         0.02 milligram ;                             adrenergic activity and
                                         Dosing Frequency: 2                          a selective action on
                                         per day                                      beta2 receptors (a
                                                                                      beta2 agonist).:
                                                                                      clenbuterol
                                                                                      hydrochloride
-   ·Metered-          Dosage                  Corticosteroids·Beta 2   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI   Strengths(budesonide) Adrenergic Agonists        mainly glucocorticoid   budesonide·small
                        : 0.08, 0.16 milligram                          activity :              molecule: formoterol
                       Dosage                                           budesonide·Selective    fumarate dihydrate
                       Strengths(formoterol                             beta-2-agonist:
                       fumarate dihydrate) :                            formoterol fumarate
                       0.0045, 0.0045                                   dihydrate
                       milligram ; Dosing
                       Frequency: 2 per day
-   ·DryPowderInhalers-   Dosage                Corticosteroids·Beta 2   ·Corticosteroid with   ·small molecule:
    DPI                   Strengths(budesonide) Adrenergic Agonists      mainly glucocorticoid budesonide·small
                           : 0.08, 0.16, 0.32                            activity :             molecule: formoterol
                          milligram Dosage                               budesonide·Selective
                          Strengths(formoterol)                          long-acting (12 hours)
                          : 0.0045, 0.0045,                              ß2-adrenergic
                          0.009 milligram ;                              stimulant
                          Dosing Frequency: 1-                           (bronchodilator):
                          2 per day                                      formoterol
-         ·INHALATION   -   Growth Factors         Synairgen is            protein
                                                   developing the
                                                   inhalable formulation
                                                   of a novel growth
                                                   factor based on the
                                                   idea that severe
                                                   asthma can be
                                                   regarded as a chronic
                                                   w       of
                                                   “ound“ the
                                                   conducting airways in
                                                   which there is an
                                                   increased
                                                   susceptibility of the
                                                   lining of the asthmatic
                                                   airway (the
                                                   “pithelium“to injury
                                                   e           )
                                                   and a delayed or
                                                   impaired epithelial
                                                   repair response.

· Roche   -             -   CRAC Channel           Calcium release-       small molecule
                            Inhibitors             activated calcium
                                                   modulator (CRACM)
                                                   channel inhibitor
-         ·INHALATION   -   Interleukin 13         Genetically            -
                            Receptor Antagonists   engineered IL-13
                                                   antagonists applied to
                                                   block the IL-13
                                                   receptors and their
                                                   signalling pathway.
-         ·INHALATION   -   Interleukin 13         Genetically            -
                            Receptor Antagonists   engineered IL-13
                                                   antagonists applied to
                                                   block the IL-13
                                                   receptors and their
                                                   signalling pathway.
-                      ·INHALATION             -                      Interleukin 13         Genetically            -
                                                                      Receptor Antagonists   engineered IL-13
                                                                                             antagonists applied to
                                                                                             block the IL-13
                                                                                             receptors and their
                                                                                             signalling pathway.
-                      ·INHALATION             -                      Selectin Antagonists   ·Pan-selectin            ·small molecule:
                                                                                             antagonist:              bimosiamose
                                                                                             bimosiamose

-                      -                       -                      CCR3 Antagonists       CCR3 antagonist          -

· Schering-Plough      ·ORALDRUGDELIVE -                              alpha4beta1 (VLA-4)    VLA-4 antagonists        small molecule
Corp. (World)          RY                                             Integrin Antagonists
-                      ·Cyclodextrins/Solubili -                      Selective PI3          Selective PI3 kinase     small molecule
                       zers-Injectable                                (Phosphoinositide 3)   with the ability to
                                                                      kinase                 suppress vascular
                                                                                             leakage and
                                                                                             inflammation
-                      ·ORALDRUGDELIVE         -                      -                      -                        -
                       RY
-                      ·INJECTABLES            -                      Anti-IL13              Interleukin-13 inhibitor antibodies
                                                                                             (an important growth
                                                                                             factor for malignant
                                                                                             Hodgkin's lymphoma
                                                                                             cells)

· Topigen              ·INHALATION             Dosage Strength(nitric -                      ·: nitric oxide-donating ·small molecule: nitric
Pharmaceuticals Inc.                           oxide-donating                                derivative of            oxide-donating
(North America)                                derivative of                                 budesonide               derivative of
                                               budesonide) : 0.6                                                      budesonide
                                               milligram ; Dosing
                                               Frequency: 2 per day
-   ·LiquidInhalers/Nebuliz Dosage Strengths :      -                   Contains two modified oligonucleotide
    ers                     0.25, 0.5 milligram ;                       phosphorothioate
                            Dosing Frequency: 1                         antisense
                            per day                                     oligonucleotides
                                                                        (ODNs), directed
                                                                        against human CCR3
                                                                        and the common beta
                                                                        chain (βc) of IL-
                                                                        3, IL-5, and GM-CSF
                                                                        receptors, thereby
                                                                        downregulating
                                                                        expression of CCR3
                                                                        and βc.



-   -                       -                       TRPA1 Antagonists   TRPA1 antagonist      -
-   ·ORALDRUGDELIVE   Dosage                  H1 (Histamine 1)      ·Nonnarcotic              ·small molecule:
    RY                Strength(carbetapenta Antagonists·Alpha       antitussive that has      carbetapentane
                      ne tannate) : 30        Adrenergic Agonists   atropine-like and         tannate·small
                      milligram Dosage                              anesthestic               molecule: pyrilamine
                      Strength(pyrilamine                           properties. Its cough     tannate·small
                      tannate) : 30 milligram                       suppressing activity is   molecule:
                      Dosage                                        due to its action on      phenylephrine tannate
                      Strength(phenylephrin                         the cough center of
                      e tannate) : 5                                the medulla.:
                      milligram ; Dosing                            carbetapentane
                      Frequency: 2 per day                          tannate·An
                                                                    antihistamine, H1
                                                                    receptor blocking
                                                                    agent belonging to the
                                                                    ethylenediamine class
                                                                    of antihistamines.:
                                                                    pyrilamine
                                                                    tannate·Alpha-agonist
                                                                    effects: phenylephrine
                                                                    tannate
-   ·ORALDRUGDELIVE   Dosage                  H1 (Histamine 1)      ·Nonnarcotic              ·small molecule:
    RY                Strength(carbetapenta Antagonists·Alpha       antitussive that has      carbetapentane
                      ne tannate) : 60        Adrenergic Agonists   atropine-like and         tannate·small
                      milligram Dosage                              anesthestic               molecule: pyrilamine
                      Strength(pyrilamine                           properties. Its cough     tannate·small
                      tannate) : 40 milligram                       suppressing activity is   molecule:
                      Dosage                                        due to its action on      phenylephrine tannate
                      Strength(phenylephrin                         the cough center of
                      e tannate) : 10                               the medulla.:
                      milligram ; Dosing                            carbetapentane
                      Frequency: 2 per day                          tannate·An
                                                                    antihistamine, H1
                                                                    receptor blocking
                                                                    agent belonging to the
                                                                    ethylenediamine class
                                                                    of antihistamines.:
                                                                    pyrilamine
                                                                    tannate·Alpha-agonist
                                                                    effects: phenylephrine
                                                                    tannate
-   ·DryPowderInhalers-   -   Corticosteroids     ·Corticosteroid with     ·small molecule:
    DPI                                           mainly glucocorticoid    budesonide
                                                  activity : budesonide




-   ·DryPowderInhalers-   -   Beta 2 Adrenergic   ·Selective long-acting   ·small molecule:
    DPI                       Agonists            (12 hours) ß2-           formoterol
                                                  adrenergic stimulant
                                                  (bronchodilator):
                                                  formoterol
-   ·DryPowderInhalers-   -   Corticosteroids     ·Corticosteroid with     ·small molecule:
    DPI                                           mainly glucocorticoid    beclomethasone
                                                  activity:                dipropionate
                                                  beclomethasone
                                                  dipropionate
-   ·Metered-          -   Corticosteroids   ·Corticosteroid with    ·small molecule:
    DoseInhalers-MDI                         mainly glucocorticoid fluticasone propionate
                                             activity. It has weak
                                             affinity for the
                                             progesterone
                                             receptor, and virtually
                                             no affinity for the
                                             mineralocorticoid,
                                             estrogen, or androgen
                                             receptors.: fluticasone
                                             propionate
· Laboratorios        ·OralOsmoticMR   Dosage                 Xanthines   ·Theophylline has two ·small molecule:
Phoenix (Argentina)                    Strength(theophylline)             distinct actions in the theophylline
                                       : 300 milligram ;                  airways of patients
                                       Dosing Frequency: 1                with reversible
                                       per day                            obstruction; smooth
                                                                          muscle relaxation
                                                                          (i.e., bronchodilation)
                                                                          and suppression of
                                                                          the response of the
                                                                          airways to stimuli

                                                                          : theophylline
-   ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·Brethine is a beta-     ·small molecule:
    ers                         Agonists            adrenergic receptor      terbutaline sulfate
                                                    agonist. In vitro and in
                                                    vivo pharmacologic
                                                    studies have
                                                    demonstrated that
                                                    terbutaline exerts a
                                                    preferential effect on
                                                    beta2-adrenergic
                                                    receptors.: terbutaline
                                                    sulfate
· Mitsubishi Tanabe   ·OralBarrierFilmTablet Dosage                  Xanthines   ·Theophylline has two ·small molecule:
Pharma Corporation    &Microcaps             Strengths(theophylline)             distinct actions in the theophylline
(Japan)                                      : 100, 200, 300, 450                airways of patients
                                             milligram ; Dosing                  with reversible
                                             Frequency: 127 for 2                obstruction; smooth
                                             days                                muscle relaxation
                                                                                 (i.e., bronchodilation)
                                                                                 and suppression of
                                                                                 the response of the
                                                                                 airways to stimuli

                                                                                 : theophylline
· Mitsubishi         ·OralBarrierFilmTablet Dosage                  Xanthines   ·Theophylline has two ·small molecule:
Pharmaceutical Corp. &Microcaps             Strengths(theophylline)             distinct actions in the theophylline
(Japan)                                      : 50, 75, 125, 200                 airways of patients
                                            milligram ; Dosing                  with reversible
                                            Frequency: 2-3 per                  obstruction; smooth
                                            day                                 muscle relaxation
                                                                                (i.e., bronchodilation)
                                                                                and suppression of
                                                                                the response of the
                                                                                airways to stimuli

                                                                                : theophylline
-                ·OralModifiedRel.(MR) Dosage                  Xanthines    ·Theophylline has two ·small molecule:
                                       Strengths(theophylline)              distinct actions in the theophylline
                                       : 300, 400, 450, 600                 airways of patients
                                       milligram                            with reversible
                                                                            obstruction; smooth
                                                                            muscle relaxation
                                                                            (i.e., bronchodilation)
                                                                            and suppression of
                                                                            the response of the
                                                                            airways to stimuli

                                                                            : theophylline




· Lavipharm SA   ·OralBarrierFilmTablet Dosage                  Xanthines   ·Theophylline has two ·small molecule:
                 &Microcaps             Strengths(theophylline)             distinct actions in the theophylline
                                        : 200, 300 milligram                airways of patients
                                                                            with reversible
                                                                            obstruction; smooth
                                                                            muscle relaxation
                                                                            (i.e., bronchodilation)
                                                                            and suppression of
                                                                            the response of the
                                                                            airways to stimuli

                                                                            : theophylline
-   ·OralBarrierFilmTablet Dosage                  Xanthines   ·Theophylline has two ·small molecule:
    &Microcaps             Strengths(theophylline)             distinct actions in the theophylline
                           : 200, 300 milligram                airways of patients
                                                               with reversible
                                                               obstruction; smooth
                                                               muscle relaxation
                                                               (i.e., bronchodilation)
                                                               and suppression of
                                                               the response of the
                                                               airways to stimuli

                                                               : theophylline
-   ·OralMatrixMR   Dosage                 Xanthines   ·Theophylline has two ·small molecule:
                    Strength(theophylline)             distinct actions in the theophylline
                    : 50 percent ; Dosing              airways of patients
                    Frequency: 2 per day               with reversible
                                                       obstruction; smooth
                                                       muscle relaxation
                                                       (i.e., bronchodilation)
                                                       and suppression of
                                                       the response of the
                                                       airways to stimuli

                                                       : theophylline
-   ·OralMatrixMR   Dosage                  Xanthines   ·Theophylline has two ·small molecule:
                    Strengths(theophylline)             distinct actions in the theophylline
                    : 50, 100, 200                      airways of patients
                    milligram ; Dosing                  with reversible
                    Frequency: 2 per day                obstruction; smooth
                                                        muscle relaxation
                                                        (i.e., bronchodilation)
                                                        and suppression of
                                                        the response of the
                                                        airways to stimuli

                                                        : theophylline
-   ·OralMatrixMR   Dosage                 Xanthines   ·Theophylline has two ·small molecule:
                    Strength(theophylline)             distinct actions in the theophylline
                    : 300 milligram                    airways of patients
                                                       with reversible
                                                       obstruction; smooth
                                                       muscle relaxation
                                                       (i.e., bronchodilation)
                                                       and suppression of
                                                       the response of the
                                                       airways to stimuli

                                                       : theophylline




-   ·OralMatrixMR   -                     Xanthines    ·Theophylline has two ·small molecule:
                                                       distinct actions in the theophylline
                                                       airways of patients
                                                       with reversible
                                                       obstruction; smooth
                                                       muscle relaxation
                                                       (i.e., bronchodilation)
                                                       and suppression of
                                                       the response of the
                                                       airways to stimuli

                                                       : theophylline
-   ·OralBarrierFilmTablet Dosage                  Xanthines   ·Theophylline has two ·small molecule:
    &Microcaps             Strengths(theophylline)             distinct actions in the theophylline
                           : 100, 125, 200, 300                airways of patients
                           milligram ; Dosing                  with reversible
                           Frequency: 2 per day                obstruction; smooth
                                                               muscle relaxation
                                                               (i.e., bronchodilation)
                                                               and suppression of
                                                               the response of the
                                                               airways to stimuli

                                                               : theophylline




-   ·OralModifiedRel.(MR) Dosage                  Xanthines    ·Theophylline has two ·small molecule:
                          Strengths(theophylline)              distinct actions in the theophylline
                          : 100, 200, 300, 450                 airways of patients
                          milligram ; Dosing                   with reversible
                          Frequency: 2 per day                 obstruction; smooth
                                                               muscle relaxation
                                                               (i.e., bronchodilation)
                                                               and suppression of
                                                               the response of the
                                                               airways to stimuli

                                                               : theophylline
-   ·Metered-          Dosage                 Mast Cell Stabilizers   ·Nedocromil sodium is ·small molecule:
    DoseInhalers-MDI   Strength(nedocromil                            a mast cell stabilizer nedocromil sodium
                       sodium) : 2 milligram                          and inhibits the
                       ; Dosing Frequency: 2-                         release of mediators
                       4 a day                                        from cells involved in
                                                                      hypersensitivity
                                                                      reactions. Decreased
                                                                      chemotaxis and
                                                                      decreased activation
                                                                      of eosinophils have
                                                                      been demonstrated. :
                                                                      nedocromil sodium
· King                 ·Metered-          Dosage                Mast Cell Stabilizers   ·Nedocromil sodium is ·small molecule:
Pharmaceuticals Inc.   DoseInhalers-MDI   Strength(nedocromil                           a mast cell stabilizer nedocromil sodium
(USA)                                     sodium) : 1.75                                and inhibits the
                                          milligram ; Dosing                            release of mediators
                                          Frequency: 4 a day                            from cells involved in
                                                                                        hypersensitivity
                                                                                        reactions. Decreased
                                                                                        chemotaxis and
                                                                                        decreased activation
                                                                                        of eosinophils have
                                                                                        been demonstrated. :
                                                                                        nedocromil sodium
-   ·LiquidInhalers/Nebuliz -   Corticosteroids   ·Corticosteroid with     ·small molecule:
    ers                                           mainly glucocorticoid    triamcinolone
                                                  activity, anti-          acetonide
                                                  inflammatory.:
                                                  triamcinolone
                                                  acetonide




-   ·PatchesDrug-in-        -   -                 ·Adrenergic beta2-       ·small molecule:
    Adhesive                                      agonist similar to       tulobuterol
                                                  albuterol: tulobuterol
-   ·PatchesDrug-in-        -   Beta 2 Adrenergic   ·Adrenergic beta2-       ·small molecule:
    Adhesive                    Agonists            agonist similar to       tulobuterol
                                                    albuterol: tulobuterol




-   ·Metered-               -   -                   -                        -
    DoseInhalers-
    MDI·LiquidInhalers/Ne
    bulizers
-   ·LiquidInhalers/Nebuliz -   -                   -                        small molecule
    ers


-   ·LiquidInhalers/Nebuliz -   -                   -                        -
    ers

-   ·LiquidInhalers/Nebuliz -   -                   -                        -
    ers
· Purdue Pharma     ·OralMatrixMR          Dosage                  Xanthines             ·Theophylline has two ·small molecule:
(USA)                                      Strengths(theophylline)                       distinct actions in the theophylline
                                           : 400, 600 milligram ;                        airways of patients
                                           Dosing Frequency: 1                           with reversible
                                           per day                                       obstruction; smooth
                                                                                         muscle relaxation
                                                                                         (i.e., bronchodilation)
                                                                                         and suppression of
                                                                                         the response of the
                                                                                         airways to stimuli

                                                                                         : theophylline




· AstraZeneca Plc   ·DrugNanoparticles,In Dosage                  Corticosteroids        ·Corticosteroid with    ·small molecule:
(World)             halation·LiquidInhalers Strengths(budesonide)                        mainly glucocorticoid   budesonide
                    /Nebulizers             : 0.135, 0.25                                activity : budesonide
                                            milligram ; Dosing
                                            Frequency: 2 per day




-                   -                      -                      alpha4beta1 (VLA-4)    VLA-4 (alpha 4 beta     small molecule
                                                                  Integrin Antagonists   1) antagonists
· Sandoz   ·DryPowderInhalers-   -   -   ·: undisclosed small   ·small molecule:
           DPI                           molecule·:             undisclosed small
                                         undisclosed small      molecule·small
                                         molecule               molecule: undisclosed
                                                                small molecule




· Sandoz   ·DryPowderInhalers-   -   -   -                      -
           DPI




-          ·DryPowderInhalers-   -   -   -                      small molecule
           DPI
-   -                     -   -   -                     vaccine


-   ·DryPowderInhalers-   -   -   ATP is known to affect small molecule
    DPI                           several cell types that
                                  play a critical
                                  mechanistic role in
                                  asthma. In particular,
                                  ATP exacerbates the
                                  immune reaction-
                                  induced release of
                                  histamine from human
                                  lung mast cells. We
                                  refer to the proposed
                                  drug that would block
                                  this action of ATP as
                                  Primastrene“  .



-   ·INHALATION           -   -   -                     small molecule
-   ·DryPowderInhalers-   -   -   -   -
    DPI
· GlaxoSmithKline Plc ·Metered-          Dosage                Beta 2 Adrenergic        ·Beta agonist:             ·small molecule:
(UK)                  DoseInhalers-MDI   Strength(albuterol) : Agonists·Corticosteroi   albuterol·Corticosteroi    albuterol·small
                                         0.1 milligram Dosage ds                        d with mainly              molecule:
                                         Strength(beclomethas                           glucocorticoid activity:   beclomethasone
                                         one dipropionate) :                            beclomethasone             dipropionate
                                         0.05 milligram ;                               dipropionate
                                         Dosing Frequency: 3-
                                         4 per day
-   ·DryPowderInhalers-   Dosage               Beta 2 Adrenergic        ·Albuterol sulfate, the    ·small molecule:
    DPI                   Strengths(albuterol  Agonists·Corticosteroi   racemic form of            albuterol sulfate·small
                          sulfate) : 0.2, 0.4  ds                       albuterol and a            molecule:
                          milligram Dosage                              relatively selective       beclomethasone
                          Strengths(beclometha                          beta 2 -adrenergic         dipropionate
                          sone dipropionate) :                          bronchodilator:
                          0.1, 0.2 milligram ;                          albuterol
                          Dosing Frequency: 3-                          sulfate·Corticosteroid
                          4 a day                                       with mainly
                                                                        glucocorticoid activity:
                                                                        beclomethasone
                                                                        dipropionate
-   ·DryPowderInhalers-   Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DPI                   Strength(albuterol) :   Agonists                                     albuterol
                          0.1 milligram
-   ·DryPowderInhalers-   Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DPI                   Strengths(albuterol    Agonists            racemic form of           albuterol sulfate
                          sulfate) : 0.2, 0.4                        albuterol and a
                          milligram ; Dosing                         relatively selective
                          Frequency: 1-4 a day                       beta 2 -adrenergic
                                                                     bronchodilator:
                                                                     albuterol sulfate
-   ·DryPowderInhalers-   Dosage                   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
    DPI                   Strength(albuterol       Agonists            racemic form of           albuterol sulfate
                          sulfate) : 0.2 milligram                     albuterol and a
                           ; Dosing Frequency:                         relatively selective
                          4 a day                                      beta 2 -adrenergic
                                                                       bronchodilator:
                                                                       albuterol sulfate
-   ·Metered-          Dosage                  Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI   Strength(albuterol) :   Agonists                                     albuterol
                       0.09 milligram ;
                       Dosing Frequency: 2-
                       4 per day
-                      ·Metered-              Dosage                  Beta 2 Adrenergic    ·Beta agonist: albuterol ·small molecule:
                       DoseInhalers-MDI       Strength(albuterol) :   Agonists                                      albuterol
                                              0.09 milligram




· GlaxoSmithKline Plc ·LiquidInhalers/Nebuliz Dosage                   Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
(USA)                 ers                     Strength(albuterol       Agonists            racemic form of           albuterol sulfate
                                              sulfate) : 2.5 milligram                     albuterol and a
                                               ; Dosing Frequency:                         relatively selective
                                              3-4 per day                                  beta 2 -adrenergic
                                                                                           bronchodilator:
                                                                                           albuterol sulfate
· Roxane Laboratories ·LiquidInhalers/Nebuliz Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
Inc. (USA)            ers                     Strengths(albuterol    Agonists            racemic form of           albuterol sulfate
                                              sulfate) : 2.5, 5                          albuterol and a
                                              milligram ; Dosing                         relatively selective
                                              Frequency: 4 per day                       beta 2 -adrenergic
                                                                                         bronchodilator:
                                                                                         albuterol sulfate




· GlaxoSmithKline Plc ·DryPowderInhalers-    Dosage                  Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
(USA)                 DPI                    Strengths(albuterol     Agonists            racemic form of           albuterol sulfate
                                             sulfate) : 0.2, 0.4                         albuterol and a
                                             milligram ; Dosing                          relatively selective
                                             Frequency: 1-4 a day                        beta 2 -adrenergic
                                                                                         bronchodilator:
                                                                                         albuterol sulfate
· GlaxoSmithKline Plc ·OralLiquidSolution   Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
(USA)                                       Strengths(albuterol    Agonists            racemic form of           albuterol sulfate
                                            sulfate) : 1, 2, 4                         albuterol and a
                                            milligram ; Dosing                         relatively selective
                                            Frequency: 3-4 a day                       beta 2 -adrenergic
                                                                                       bronchodilator:
                                                                                       albuterol sulfate
· GlaxoSmithKline Plc ·Metered-          Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
(UK)                  DoseInhalers-MDI   Strength(albuterol     Agonists            racemic form of           albuterol sulfate
                                         sulfate) : 0.12                            albuterol and a
                                         milligram ; Dosing                         relatively selective
                                         Frequency: 1-4 a day                       beta 2 -adrenergic
                                                                                    bronchodilator:
                                                                                    albuterol sulfate
-   ·NasalDelivery          Dosage                 Corticosteroids     ·Corticosteroid with    ·small molecule:
                            Strength(fluticasone                       mainly glucocorticoid fluticasone furoate
                            furoate) : 0.0275                          activity. It has weak
                            milligram ; Dosing                         affinity for the
                            Frequency: 1 per day                       progesterone
                                                                       receptor, and virtually
                                                                       no affinity for the
                                                                       mineralocorticoid,
                                                                       estrogen, or androgen
                                                                       receptors.: fluticasone
                                                                       furoate




-   ·LiquidInhalers/Nebuliz -                      Beta 2 Adrenergic   Beta 2 Adrenergic      small molecule
    ers                                            Agonists            Agonist
-   ·Metered-          -   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI       Agonists                                     albuterol




-   ·Metered-          -   Beta 2 Adrenergic   ·Beta agonist: albuterol ·small molecule:
    DoseInhalers-MDI       Agonists                                     albuterol
· GlaxoSmithKline Plc ·OralOsmoticMR   Dosage                 Beta 2 Adrenergic   ·Albuterol sulfate, the   ·small molecule:
(USA)                                  Strengths(albuterol    Agonists            racemic form of           albuterol sulfate
                                       sulfate) : 4, 8                            albuterol and a
                                       milligram ; Dosing                         relatively selective
                                       Frequency: 1 per day                       beta 2 -adrenergic
                                                                                  bronchodilator:
                                                                                  albuterol sulfate
-                    ·DryPowderInhalers-   -                      Beta 2 Adrenergic   ·Selective long-acting   ·small molecule:
                     DPI                                          Agonists            (12 hours) ß2-           formoterol
                                                                                      adrenergic stimulant
                                                                                      (bronchodilator):
                                                                                      formoterol
· Genentech Inc.     ·INJECTABLES          Dosage                 Anti-IgE            ·Inhibits the binding of ·antibodies:
(USA)· Novartis AG                         Strengths(omalizumab                       IgE to the high-affinity omalizumab
(ex-US,Japan)· PDL                         ) : 150, 375 milligram                     IgE receptor (FceRI)
Biopharma Inc.                             ; Dosing Frequency: 1-                     on the surface of mast
                                           2 per month                                cells and basophils.:
                                                                                      omalizumab
· Novartis AG   ·PrefillableSyringes/Ca -   Anti-IgE   ·Inhibits the binding of ·antibodies:
                rtridges                               IgE to the high-affinity omalizumab
                                                       IgE receptor (FceRI)
                                                       on the surface of mast
                                                       cells and basophils.:
                                                       omalizumab
-   ·Metered-          Dosage                  Beta 2 Adrenergic   ·A beta-agonist for the ·small molecule:
    DoseInhalers-MDI   Strength(levalbuterol   Agonists            treatment of reversible levalbuterol tartrate
                       tartrate) : 0.09                            bronchospasm.:
                       milligram ; Dosing                          levalbuterol tartrate
                       Frequency: 4-6 per
                       day
-   ·LiquidInhalers/Nebuliz -   Beta 2 Adrenergic   ·A beta-agonist for the ·small molecule:
    ers                         Agonists            treatment of reversible levalbuterol
                                                    bronchospasm.:          hydrochloride
                                                    levalbuterol
                                                    hydrochloride
· Cornerstone       ·ORALDRUGDELIVE   Dosage                 5-lipoxygenase   ·Active inhibitor of 5- ·small molecule:
Therapeutics Inc.   RY                Strength(zileuton) :   Inhibitors       lipoxygenase, the       zileuton
(USA)· DEY L.P.                       600 milligram ;                         enzyme that catalyzes
(USA)                                 Dosing Frequency: 4                     the formation of
                                      per day                                 leukotrienes from
                                                                              arachidonic acid.:
                                                                              zileuton
· Biogen Idec Inc.   ·INJECTABLES      Dosage                 Anti-IL-2R   ·An IL-2 receptor         ·antibodies:
(World)                                Strength(daclizumab)                antagonist that binds daclizumab
                                       : 1 milligram/kg ;                  with high-affinity to the
                                       Dosing Frequency: 1                 Tac subunit of the
                                       for 2 weeks                         high-affinity IL-2
                                                                           receptor complex and
                                                                           inhibits IL-2 binding. :
                                                                           daclizumab




· Alfresa Holdings   ·ORALDRUGDELIVE   Dosage Strength : 0.6 -             -                        -
Corp.                RY                percent
· Alfresa Holdings    ·ORALDRUGDELIVE         -                       H1 (Histamine 1)   ·Histamine H1             ·small molecule:
Corp.                 RY                                              Antagonists        antagonists :             mequitazine
                                                                                         mequitazine
· Alfresa Holdings    ·ORALDRUGDELIVE         -                       H1 (Histamine 1)   ·Histamine H1             ·small molecule:
Corp.                 RY                                              Antagonists        antagonists :             mequitazine
                                                                                         mequitazine
· Cornerstone         ·Cyclodextrins/Solubili Dosage                  5-lipoxygenase     ·Active inhibitor of 5-   ·small molecule:
Therapeutics Inc.     zers-Injectable         Strengths(zileuton) :   Inhibitors         lipoxygenase, the         zileuton
(World)                                       75, 150, 300, 600                          enzyme that catalyzes
                                              milligram                                  the formation of
                                                                                         leukotrienes from
                                                                                         arachidonic acid.:
                                                                                         zileuton




-                     -                       -                       -                  Dissociating           -
                                                                                         glucocorticoid
· AirPharma· Bespak   ·DryPowderInhalers-     -                       Surfactants        Protein-free synthetic ·small molecule:
                      DPI                                                                lung surfactant made pumactant
                                                                                         from naturally
                                                                                         occurring
                                                                                         phospholipids.···Lung
                                                                                         surfactant: pumactant
· Cornerstone       ·OralMatrixMR   Dosage                 5-lipoxygenase   ·Active inhibitor of 5- ·small molecule:
Therapeutics Inc.                   Strength(zileuton) :   Inhibitors       lipoxygenase, the       zileuton
(World)· DEY L.P.                   600 milligram ;                         enzyme that catalyzes
(USA)                               Dosing Frequency: 2                     the formation of
                                    a day                                   leukotrienes from
                                                                            arachidonic acid.:
                                                                            zileuton
-   ·LiquidInhalers/Nebuliz -   Surfactants       Based on the              peptide
    ers                                           proprietary peptide
                                                  KL4 (also known as
                                                  sinapultide) designed
                                                  to precisely mimic the
                                                  essential attributes of
                                                  human surfactant
                                                  protein B (SP-B).


-   ·INJECTABLES            -   Anti-YKL-40       anti YKL40 MAb            antibodies

-   ·ORALDRUGDELIVE         -           s
                                Bruton“Tyrosine         s
                                                  Bruton“ tyrosine          small molecule
    RY                          Kinase (BTK)      kinase inhibitor
                                Inhibitors

-   ·ORALDRUGDELIVE         -           s
                                Bruton“Tyrosine         s
                                                  Bruton“ tyrosine          small molecule
    RY                          Kinase (BTK)      kinase inhibitor.
                                Inhibitors

-   ·ORALDRUGDELIVE         -   -                 deCODE identified a       small molecule
    RY                                            promising compound
                                                  targeting the product
                                                  of an asthma gene
                                                  and developed by
                                                  another company for
                                                  use in a different
                                                  indication
· Cobra               ·INJECTABLES   ; Dosing Frequency: 2- H4 (Histamine 4)     Prevents activation of    protein
Biomanufacturing Plc.                4 per day              Antagonists          histamine receptors
                                                                                 including the H4
                                                                                 receptor




-                   ·INJECTABLES     -                     Elastase Inhibitors   ·A serine protease        ·protein: alpha-1
                                                                                 inhibitor (serpin). It    antitrypsin,
                                                                                 protects tissue from      recombinant human
                                                                                 enzymes from
                                                                                 inflammatory cells,
                                                                                 especially elastase. It
                                                                                 is present in human
                                                                                 blood at 1.5 - 3.5
                                                                                 gram/liter.

                                                                                 : alpha-1 antitrypsin,
                                                                                 recombinant human
· Genentech Inc.   ·INJECTABLES   -   Anti-CD134            Anti-OX40 ligand        antibodies
(World)· Roche                                              monoclonal antibody
                                                            blocks interaction of
                                                            OX40 (a TNF
                                                            superfamily receptor)
                                                            to its ligand
-                  -              -   Tryptase Inhibitors   ß-Tryptase inhibitors   -
PK Properties   Elimination Half Life Molecular Weight   Water Solubility   Excipient                How
                                                                                                     Supplied_Administer
                                                                                                     ed

-               -                    -                   -                  In Phase I trials, the   In Phase 2, doses of
                                                                            drug was delivered as    10, 15, and 20
                                                                            a vapor and as a dry     micrograms once
                                                                            powder trials            daily were studied.
                                                                                                     [18699]
-               -                    -                   -                  DPI formulation. Part -
                                                                            of Beyond Advair
                                                                            collaboration between
                                                                            Theravance and GSK.

-               -                    -                   -                  -                        -


-               -                    -                   -                  -                        An open-label, single
                                                                                                     dose study to
                                                                                                     investigate the safety,
                                                                                                     tolerability and
                                                                                                     pharmacokinetics of
                                                                                                     90mg of GW274150
                                                                                                     in adult and elderly
                                                                                                     RA subjects was
                                                                                                     completed. trials


-               -                    -                   -                  -                        -

-               -                    -                   -                  -                        -


-               -                    -                   -                  -                        -
-   -   -   -   -   Once daily inhaled
                    doses of GW870086X
                    administered via
                    DISKHALER trials

-   -   -   -   -   -


-   -   -   -   -   It is a once or
                    maximally twice daily
                    inhalation treatment

-   -   -   -   -   Once daily treatment


-   -   -   -   -   Phase II trial
                    : administered twice
                    daily
-   -   ·434.498: flunisolide   ·Practically Insoluble:   Each unit contains a     Supplied as a
                                flunisolide               0.24 % w/w solution of   pressurized lined
                                                          flunisolide              aluminum canister in
                                                          hemihydrate in 10:90     boxes of one.
                                                          w/w ethanol:1,1,1,2-     Adults (age 12 and
                                                          tetrafluoroethane        older): The
                                                          (HFA 134a).              recommended
                                                                                   starting dose is 160
                                                                                   mcg twice daily. The
                                                                                   maximum dose
                                                                                   should not exceed
                                                                                   320 mcg twice daily.

                                                                                   Children (age 6 to 11):
                                                                                   The recommended
                                                                                   starting dose is 80
                                                                                   mcg twice daily. The
                                                                                   maximum dose
                                                                                   should not exceed
                                                                                   160 mcg twice daily.




-   -   -                       -                         -                        -


-   -   -                       -                         -                        -
-   -   -   -   Compounds will be        -
                tested for delivery by
                the oral, intravenous
                or inhaled route of
                administration.
80% of microparticles -   -                    -                   PDDS microspheres      Once-a-day dosing
delivery to lung.                                                  of marketed small
Microparticles                                                     molecule. Inhalable
remained in the lung                                               powder in a sustained
for up to 24 hours and                                             release, microparticle
the drug was released                                              form delivered using
over a 12 to 24-hour                                               marketed DPI device.
period. Resperible                                                 Particles are 3.5 -4.5
fraction >25%.                                                     microns MMAD.
(Source: company                                                   Acusphere patent
website)                                                           WO2007070851
                                                                   describes use of
                                                                   fluticasone propionate
                                                                   as model drug
                                                                   delivered with
                                                                   Cyclohaler device.



-                     -   ·548.24: albuterol   ·Freely Soluble:    -                     -
                          sulfate              albuterol sulfate




-                     -   -                    -                   -                     -
-   -   -   -   Inhalation aerosol   maximum of one dose
                (undisclosed         per day, maximum of
                technology)          6 doses in 22 days
                                     trials.In Phase I trial,
                                     30 mg single dose
                                     arm; 20 mg multiple
                                     doses were
                                     administered. [56815]


-   -   -   -   Taifun inhaler       Phase I dosing:0.025
                                     mg to 5 mg. Phase II
                                     dosing: 5mg b.i.d.
-   -   ·266: pemirolast   ·Freely Soluble:       Excipients: Sucrose,   Available as dry syrup
        potassium          pemirolast potassium   sodium citrate         including 5 mg
                                                                         pemirolast potassium
                                                                         per gram. The usual
                                                                         child dosage for oral
                                                                         use is 0.2 mg/kg of
                                                                         pemirolast potassium
                                                                         for bronchial asthma,
                                                                         and 0.1 mg/kg or
                                                                         allergic rhinitis given
                                                                         twice a day after
                                                                         breakfast and at
                                                                         bedtime, dissolved in
                                                                         water before use.
-   -   ·266: pemirolast   ·Freely Soluble:       Excipients:Lactose,          Available as yellowish
        potassium          pemirolast potassium   partly pregelatinized        white, plain, round 5
                                                  starch,                      and 10 mg tablets.
                                                  hydroxypropylcellulose       The usual adult
                                                  , cellulose, silicic acid,   dosage for oral use is
                                                  magnesium stearate           10 mg of pemirolast
                                                                               potassium for
                                                                               bronchial asthma, and
                                                                               5 mg for allergic
                                                                               rhinitis given twice a
                                                                               day after breakfast
                                                                               and supper.




-   -   -                  -                      Tablet-based vaccine         -
-   -   -   -   -   Results from the
                    Phase 1 trial showed
                    that AM103 was safe
                    and well-tolerated at
                    doses up to 1,000 mg
                    per day. The systemic
                    exposure of AM103
                    increased linearly
                    from 50 mg to 1,000
                    mg. [27737]


-   -   -   -   -   -




-   -   -   -   -   -

-   -   -   -   -   -
-   -   -                 -            -                       -




-   -   -                 -            -                       Once-daily

-   -   ·440.5: APC 366   ·: APC 366   Dry powder inhaler      -
                                       formulation
-   -   -                 -            Captisol formulations   -
                                       delivered in AERX
                                       nebulizer




-   -   -                 -            -                       -

-   -   -                 -            -                       -




-   -   -                 -            -                       -


-   -   -                 -            -                       -


-   -   -                 -            -                       -

-   -   -                 -            -                       In phase I trial Avac
                                                               was administered
                                                               intranasally [43886].
-   -   -   -   -   -

-   -   -   -   -   -




-   -   -   -   -   -
-   -   -   -   -   -
-   -   -                   -               Decoy ODN              -
                                            Technology delivered
                                            with AKITA 2 nebulizer




-   -   ·458.275: AWD 12-   ·: AWD 12-281   -                      -
        281

-   -   -                   -               -                      -

-   -   -                   -               -                      -
-   -   -   -   -                      At phase 2 Asthma
                                       study patients
                                       received 50 mg, 400
                                       mg and 1000 mg
                                       AZD1981 tablet twice
                                       daily(trials). At phase
                                       2 COPD study
                                       patients received
                                       AZD1981 tablet twice
                                       daily for 4 weeks(trials)


-   -   -   -   -                      -

-   -   -   -   -                      -

-   -   -   -   -                      -


-   -   -   -   -                      -

-   -   -   -   -                      -
-   -   -   -   -                      -




-   -   -   -   -                      -

-   -   -   -   nasal spray solution   At phase 1 Allergic
                                       Rhinitis trials 30 or 60
                                       mg administered
                                       intranasally once
                                       weekly for one month.

-   -   -   -   -                      -
-   -   -                  -                         -                     -




-   -   ·343.21:           ·Practically Insoluble:   HFA MDI formulation   -
        triazolam·389.4:   triazolam·: reproterol
        reproterol




-   -   -                  -                         -                     -
ACCOLATE is rapidly -       ·575.683: zafirlukast   ·Practically Insoluble:   Inactive ingredients:    10 (unflavored) and
absorbed orally. It                                 zafirlukast               croscarmellose           20 mg white, round,
undergoes extensive                                                           sodium, lactose,         biconvex, film-coated
hepatic metabolism.                                                           magnesium stearate,      tablets.
Administration of                                                             microcrystalline         The recommended
zafirlukast with food                                                         cellulose, povidone,     dose in adults and
reduced the mean                                                              ydroxypropylmethylcell   children 12 years and
bioavailability by                                                            ulose, and titanium      older is 20 mg twice
approximately 40%.                                                            dioxide.                 daily.
Hydroxylated                                                                                           The recommended
metabolites of                                                                                         dose of in children 5
zafirlukast excreted in                                                                                through 11 years of
the feces are formed                                                                                   age is 10 mg twice
through the                                                                                            daily.
cytochrome P450 2C9
(CYP2C9) pathway.
Additional in vitro
studies utilizing
human liver
microsomes show
that zafirlukast inhibits
the cytochrome P450,
CYP3A4 and CYP2C9
isoenzymes at
concentrations close
to the clinically
achieved total plasma
concentrations. More
than 99% bound to
plasma proteins. Vd is
70 L, t1/2 is 10 h and
oral CL is 20 L/h.
Following a 3 mg         -   ·548.24: albuterol   ·Freely Soluble:    AccuNeb (albuterol        3 mL in unit-dose low-
dose of nebulized            sulfate              albuterol sulfate   sulfate) Inhalation       density polyethylene
albuterol in adults, the                                              Solution is supplied as   (LDPE) vials. Each
mean maximum                                                          a 3 mL, clear,            unit-dose LDPE is
albuterol plasma level                                                colorless, sterile,       protected in a foil
at 0.5 hours was 2.1                                                  preservative-free,        pouch, and each foil
ng/mL (range, 1.4 to                                                  aqueous solution in       pouch contains five
3.2 ng/mL). Most of                                                   two different strengths   unit-dose LDPE vials.
the absorbed dose                                                     (0.63 mg and 1.25         Each strength of
was recovered in                                                      mg) of albuterol          AccuNeb (albuterol
urine collected during                                                (equivalent to 0.75 mg    sulfate) Inhalation
the 24 hours after                                                    of albuterol sulfate or   Solution is available in
drug administration.                                                  1.5 mg of albuterol       a shelf carton
Following oral                                                        sulfate per 3 mL).        containing multiple foil
administration of 4 mg                                                                          pouches.
albuterol, t1/2 was 5-6                                                                         Administered 3 or 4
h.                                                                                              times daily


-                        -   ·548.24: albuterol   ·Freely Soluble:    -                         -
                             sulfate              albuterol sulfate
-   -   -                      -                      -                       -




-   -   ·500.57: fluticasone   ·Practically Insoluble: Mystic EHD nebulizer   -
        propionate             fluticasone propionate
flutacasone: BA is     -   ·500.57: fluticasone   ·Practically Insoluble:   Diskus DPI device.      Diskus100/50, 250/50
18%. First pass liver      propionate·603.7:      fluticasone               Inactive ingredients:   and 500/50 contain
metabolosim. Low           salmeterol xinafoate   propionate·Sparingly      lactose                 100mcg/50 mcg, 250
concentration in                                  Soluble: salmeterol                               mcg/50 mcg and 500
plasma. t1/2 is 5.33-                             xinafoate                                         mcg/50 mcg of
7.65 h.                                                                                             flutacasone/salmeterol
salmeterol: Tmax is                                                                                  respectively. Dosed
20 min with detectable                                                                              twice daily
levels within 5 min.
Low concentration in
plasma.
Peak plasma            -   ·500.57: fluticasone   ·Practically Insoluble:   Each unit contains a     Advair HFA is
concentrations of          propionate·603.7:      fluticasone               microcrystalline         available in three
fluticasone propionate     salmeterol xinafoate   propionate·Sparingly      suspension of            strengths, Advair HFA
were achieved in 0.33                             Soluble: salmeterol       fluticasone propionate   45/21, Advair HFA
to 1.5 hours and those                            xinafoate                 (micronized) and         115/21 and Advair
of salmeterol were                                                          salmeterol xinafoate     HFA 230/21. Each 12-
achieved in 5 to 10                                                         (micronized) in          gram canister of
minutes. Absolute                                                           propellant HFA-134a      Advair HFA provides
bioavailability of                                                          (1,1,1,2-                120 metered
fluticasone propionate                                                      tetrafluoroethane). It   inhalations. Dosed
from ADVAIR HFA in                                                          contains no other        twice daily. After
15 healthy subjects                                                         excipients.              priming, each
was 5.3%. Terminal                                                                                   actuation of the
half-life estimates of                                                                               inhaler delivers 50,
fluticasone propionate                                                                               125, or 250 mcg of
for ADVAIR HFA,                                                                                      fluticasone propionate
ADVAIR DISKUS, and                                                                                   and 25 mcg of
fluticasone propionate                                                                               salmeterol in 75 mg of
CFC inhalation                                                                                       suspension from the
aerosol were similar                                                                                 valve. Each actuation
and averaged 5.9                                                                                     delivers 45, 115, or
hours. No terminal                                                                                   230 mcg of
half-life estimates                                                                                  fluticasone propionate
were calculated for                                                                                  and 21 mcg of
salmeterol.                                                                                          salmeterol from the
                                                                                                     actuator.
-   -   ·433.96:             ·Freely Soluble:     AeRx nebulizer and   -
        hydroxychloroquine   hydroxychloroquine   APT's proprietary
        sulfate              sulfate              formulation (US
                                                  6,572,858 )




-   -   -                    -                    -                    -
-   -   ·: pitrakinra   ·: pitrakinra   Developed as an      In Phase II, 60 mg of
                                        inhaled dry powder   the drug was dosed
                                                             twice daily using an
                                                             undisclosed nebulizer
                                                             technology. [14378]
                                                             In Phase II trials, also
                                                             25 mgs s.c. once daily
                                                             for 28 days was
                                                             studied trials.In Phase
                                                             IIb study, a single 10
                                                             mg dose of Aerovant
                                                             inhalation powder was
                                                             administered.[44087].I
                                                             n Phase IIb trial,
                                                             Aerovant
                                                             administered at doses
                                                             1 mg, 3 mg or 10 mg
                                                             by inhalation twice
                                                             daily for 12 weeks.
                                                             [53068]
Total systemic BA is   -   ·434.498: flunisolide   ·Practically Insoluble:   AEROBID Inhaler is        Each activation
40%. t1/2 is 1.8 h.                                flunisolide               delivered in a metered-   delivers approximately
                                                                             dose aerosol system       250 mcg of flunisolide
                                                                             containing a              to the patient. One
                                                                             microcrystalline          AEROBID Inhaler
                                                                             suspension of             System is designed to
                                                                             flunisolide as the        deliver at least 100
                                                                             hemihydrate in            metered inhalations.
                                                                             propellants               Dose is two
                                                                             (trichloromonofluorom     inhalations twice daily.
                                                                             ethane,                   The maximum daily
                                                                             dichlorodifluoromethan    dose should not
                                                                             e and                     exceed 4 inhalations
                                                                             dichlorotetrafluoroetha   twice a day for a total
                                                                             ne) with sorbitan         daily dose of 2 mg.
                                                                             trioleate as a
                                                                             dispersing agent.
                                                                             AEROBID-M also
                                                                             contains menthol as a
                                                                             flavoring agent.
Aerodise salbutamol   -   ·239.213: albuterol   ·Sparingly Soluble:   -   -
was studied in a                                albuterol
single-centre,
investigator-blinded,
randomized, three-
way crossover design.
the trial enrolled
twenty-four patients
(non-smokers of
which 10 were males)
with at least a 12
month history of
moderate to severe
persistent asthma.
The Aerodose®
Inhaler was
approximately five
times as efficient as
the Pari LC Plus and
Evohaler in relative
lung delivery of
salbutamol in
moderate to severe
asthmatics. REF-1
-   -   ·430.53: budesonide   ·Practically Insoluble:   -   -
                              budesonide
-   -   ·412.38: ipratropium   ·: ipratropium bromide Inactive ingredients:   250 and 500
        bromide anhydrous      anhydrous              sodium chloride,        microgram
                                                      hydrochloric acid




-   -   -                      -                      -                       -
-                       -   ·180.16: theophylline   ·Slightly Soluble:    The product uses the   125, 250, 375, 500
                                                    theophylline          Company's              mg capsules
                                                                          Microcaps® and
                                                                          Diffucaps/Surecaps®
                                                                          tehnologies.




Readily absorbed        -   ·239.213: albuterol     ·Sparingly Soluble:   Each actuation         -
orally with Cmax                                    albuterol             contains 90 mcg
reached in 0.17 h.;                                                       albuterol and CFC
undergoes first-pass                                                      propellants.
metabolism in the
liver; the main
metabolite: an inactive
sulfate conjugate;
excreted unchanged
in the urine (28%) and
some in the faeces;
t1/2: 4 to 6 hours.
Albuterol (WHO          -   ·239.213: albuterol   ·Sparingly Soluble:   Microcrystalline         17 g canister for 200
designation is                                    albuterol             albuterol, CFC           inhalations
salbutamol) is readily                                                  propellants, and oleic
absorbed from the                                                       acid
gastrointestinal tract.
It is subject to first-
pass metabolism in
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate.
Approximately 72% of
the inhaled dose is
excreted within 24
hours in the urine, and
consists of 28% as
unchanged drug and
44% as metabolite.;
there is some
excretion in the
faeces.
Albuterol/Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
Because of its gradual -   ·548.24: albuterol   ·Freely Soluble:    Generic for Proventil   200 dose inhaler
absorption from the        sulfate              albuterol sulfate
bronchi, systemic
levels of albuterol
inhalation aerosol are
low after inhalation of
recommended doses.
Tmax is 2 - 4 hrs. The
urinary excretion
provided data
indicated that
albuterol has an
elimination half-life of
3.8 hours.
Approximately 72% of
the inhaled dose is
excreted within 24
hours in the urine, and
consists of 28% as
unchanged drug and
44% as metabolite.
Albuterol (WHO          -   ·239.213: albuterol   ·Sparingly Soluble:   Each actuation           Each canister
designation is                                    albuterol             contains 90 mcg          provides 200
salbutamol) is readily                                                  microcrystalline         inhalations.
absorbed from the                                                       albuterol, oleic acid,   Dosed as two
gastrointestinal tract.                                                 and CFC propellants      inhalations four times
It is subject to first-                                                                          daily
pass metabolism in
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate.
Approximately 72% of
the inhaled dose is
excreted within 24
hours in the urine, and
consists of 28% as
unchanged drug and
44% as metabolite.;
there is some
excretion in the
faeces.
Albuterol/Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
Albuterol (WHO          -   ·239.213: albuterol   ·Sparingly Soluble:   Mystic EHD nebulizer   -
designation is                                    albuterol
salbutamol) is readily
absorbed from the
gastrointestinal tract.
It is subject to first-
pass metabolism in
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate.
Approximately 72% of
the inhaled dose is
excreted within 24
hours in the urine, and
consists of 28% as
unchanged drug and
44% as metabolite.;
there is some
excretion in the
faeces.
Albuterol/Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
-   -   ·548.24: albuterol   ·Freely Soluble:    Generic for Proventil   -
        sulfate              albuterol sulfate   and Ventolin




-   -   ·548.24: albuterol   ·Freely Soluble:    Generic for Proventil   -
        sulfate              albuterol sulfate   and Ventolin
-   -   ·548.24: albuterol   ·Freely Soluble:    Generic for Proventil   Albuterol Sulfate
        sulfate              albuterol sulfate   and Ventolin            Inhalation Solution,
                                                                         0.042% is supplied as
                                                                         a prediluted 3 mL,
                                                                         clear, colorless,
                                                                         sterile, preservative-
                                                                         free, aqueous
                                                                         solution, containing
                                                                         1.25 mg of albuterol
                                                                         (equivalent to 1.5 mg
                                                                         albuterol sulfate in 3
                                                                         mL), in unit-dose
                                                                         lowdensity
                                                                         polyethylene (LDPE)
                                                                         vials. Each unit-dose
                                                                         LDPE vial is protected
                                                                         in a foil pouch.The
                                                                         usual starting dosage
                                                                         for patients 2 to 12
                                                                         years of age is 1.25
                                                                         mg of albuterol
                                                                         administered 3 or 4
                                                                         times daily by
                                                                         nebulization.
-   -   ·548.24: albuterol    ·Freely Soluble:       -   Standard 0.5%
        sulfate               albuterol sulfate          solution delivered with
                                                         Aria device. MMAD
                                                         approximately 3
                                                         microns. (AAPS 2006
                                                         poster)




-   -   -                     -                      -   -

-   -   ·285.77: epinastine   ·Soluble: epinastine   -   10 and 20 mg tablets.
        hydrochloride         hydrochloride




-   -   ·148000: eculizumab   ·: eculizumab          -   -
-   -   ·148000: eculizumab   ·: eculizumab   -   -
ALLEGRA is rapidly     -   ·538.13: fexofenadine ·Slightly Soluble:   Excipients:              30, 60, 120 and 180
absorbed into the          hydrochloride         fexofenadine         croscarmellose           mg tablets.
body following oral                              hydrochloride        sodium, magnesium        Adults and Children
administration, with                                                  stearate,                12 Years and Older:
Tmax at                                                               microcrystalline         The recommended
approximately 1-3                                                     cellulose, and           dose is 60 mg twice
hours post dose. The                                                  pregelatinized starch.   daily, or 180 mg once
single and multiple                                                   The aqueous tablet       daily. Children 6 to 11
dose                                                                  film coating is made     Years. The
pharmacokinetics of                                                   from hydroxypropyl       recommended dose is
fexofenadine are                                                      methylcellu-lose, iron   30 mg twice daily.
linear for oral doses                                                 oxide blends,
up to 120mg                                                           polyethylene glycol,
BID.Plasma protein                                                    povidone, silicone
binding is 60-70%.                                                    dioxide, and titanium
Fexofenadine                                                          dioxide.
undergoes negligible
metabolism (hepatic
or non-hepatic), as it
was the only major
compound identified
in urine and faeces of
animals and man. The
plasma concentration
profiles of
fexofenadine follow a
bi-exponential decline
with t1/2 of 11-15 h.
-   -   -                     -                  Aerosol formulation   -




-   -   ·512.333: sodium      ·Soluble: sodium   -                     -
        cromoglycate·389.4:   cromoglycate·:
        reproterol            reproterol
-   -   ·512.333: sodium      ·Soluble: sodium   The following not      Four times daily two
        cromoglycate·389.4:   cromoglycate·:     effective components   spraying impacts.
        reproterol            reproterol         are contained in the
                                                 medicine: Apafluran,
                                                 Dentomint pH
                                                 799959, Ethanol,
                                                 Macrogol-25-
                                                 glyceroltrioleat,
                                                 Saccharin sodium.
                                                 (translated from
                                                 German). CFC-free




-   -   -                     -                  Established active     -
                                                 pharmaceutical
                                                 ingredient delivered
                                                 with PADD inhaler
-   -   ·44324.5: alpha1-       ·: alpha1-proteinase   -   -
        proteinase inhibitor,   inhibitor, human
        human
3% of dose delivered -    ·520.59:         ·Freely Soluble:   3M MDI Metering          Each inhalation
intact to lungs with      metaproterenol   metaproterenol     Valves technology.       delivers 650 mcg
duration of effect 1.5    sulphate         sulphate           Inactive ingredients:    micronozed
to 2 hrs. The major                                           sorbitan trioleate and   metaproterenol.
metabolite,                                                   CFC propellants.         Available in 100 and
metaproterenol-3-0-                                                                    200 inhalation
sulfate, is produced in                                                                configurations.
the                                                                                    Single dose is two or
gastrointestinal tract.                                                                three inhalations. With
Alupent is not                                                                         repetitive dosing,
metabolized by                                                                         inhalation should
catechol-0-                                                                            usually not be
methyltransferase nor                                                                  repeated more often
have glucuronide                                                                       than about every three
conjugates been                                                                        to four hours. Total
isolated to date.                                                                      dosage per day
                                                                                       should not exceed 12
                                                                                       inhalations.
Absorption,             -   ·520.59:         ·Freely Soluble:   pH adjusted aqueous     10 mL or 30 mL
biotransformation and       metaproterenol   metaproterenol     solution containing     bottles. Dosed every
excretion studies           sulphate         sulphate           benzalkonium chloride   4 hours. Dose
following                                                       and edetate disodium    dependent on age.
administration by                                               as preservatives.
inhalation have not
been performed.
Following oral
administration of
tablet and solution, an
average of 40% of the
drug was excreted as
the unchanged drug
and its major
metabolite, a polar
conjugate,
metaproterenol-O-
sulfate.
-   -   ·520.59:         ·Freely Soluble:   Generic for Alupent.   -
        metaproterenol   metaproterenol
        sulphate         sulphate
-   -   ·520.59:         ·Freely Soluble:   Generic for Alupent   -
        metaproterenol   metaproterenol
        sulphate         sulphate
-   -   ·520.59:         ·Freely Soluble:   Generic for Alupent   -
        metaproterenol   metaproterenol
        sulphate         sulphate
The oral BA of both    -   ·540.69: ciclesonide   ·Practically Insoluble:   Clear and colourless   Once daily
ciclesonide and the                               ciclesonide               solution containing    solution.160 ug as
active metabolite is                                                        Norflurane (HFA-       starting dose and
negligible (                                                                134a) and Ethanol,     dose can be reduced
                                                                            anhydrous.             to 80 ug.




-                      -   ·540.69:               ·Practically Insoluble:   -                      -
                           ciclesonide·344.405:   ciclesonide·Slightly
                           formoterol             Soluble: formoterol




-                      -   -                      -                         -                      -

-                      -   ·414.6: ambroxol       ·Sparingly Soluble:       MPDDS: controlled      75 and 120 mg
                           hydrochloride          ambroxol                  release pellets in     capsules. Once daily
                                                  hydrochloride             capsules
Andolast was             -   ·333.314: andolast   ·: andolast   Formulated as dry   12 out-patients were
absorbed after                                                  powder for          treated with a single
inhalation and was                                              inhalation.         dose of andolast of 2,
available to the                                                                    4 and 8 mg by
systemic circulation.                                                               inhalation using the
Cmax values were                                                                    MIAT Monohaler
6.3, 10.9 and 30.5 ng                                                               device (Ref 1).
ml(-1) at the three
doses, respectively,
and occurred at 30,
52.5 and 30 min
(median t(max)). The
mean AUC(t) values
were 1852, 2889 and
7677 ng min ml(-1).
CL: 1141-1168
ml/min. Vd: 430-486
L. t1/2: 4.5-5 h. (REF
1- (Pubmed
id:11745909))

-                        -   -                    -             -                   -


-                        -   -                    -             -                   -




-                        -   -                    -             -                   -
-   -   ·182.17: mannitol   ·Freely Soluble:   Inhaled mannitol as a   Two FEV1 readings
                            mannitol           biomarker for airway    are taken at the
                                               inflammation            beginning of the test
                                                                       and the average is
                                                                       recorded as the
                                                                              s
                                                                       patient“ BASELINE
                                                                       FEV1. The patient will
                                                                       then be instructed to
                                                                       use a simple dry
                                                                       powder inhaler to
                                                                       inhale progressively
                                                                       higher doses of dry
                                                                       mannitol. After each
                                                                       step the patient waits
                                                                       for one minute and
                                                                       then performs two
                                                                       FEV1measurements.
                                                                       The test is stopped
                                                                       when a patient has a
                                                                       greater than 10 per
                                                                       cent drop in
                                                                       FEV1compared to
                                                                       their BASELINE
                                                                       FEV1. This is a
                                                                       positive test, which
                                                                       indicates the
                                                                       presence of active
                                                                       airway inflammation.
                                                                       On average, the
                                                                       procedure takes 10
                                                                       minutes plus recovery
                                                                       time for a positive test
                                                                       and 25 minutes for a
                                                                       negative test.
-   -   ·236.294: zileuton   ·Practically Insoluble:   -   Features offer the
                             zileuton                      opportunity to develop
                                                           a product candidate
                                                           with a reduced tablet
                                                           size or less frequent
                                                           dose administration
Absorption from the       -   ·521.04:         ·Practically Insoluble:   Each metered             The initial dose for
gastrointestinal tract is     beclomethasone   beclomethasone            actuation of 1.3 mg      patients with mild
slow and                      dipropionate     dipropionate              contains 50 mcg of       asthma is 200 to 400
bioavailability is low,                                                  drug and delivers 45     micrograms per day;
suggesting that most                                                     mcg of drug. For         this may be increased
of the absorbed drug                                                     other strengths of 100   to 800 micrograms
is metabolised during                                                    mcg and 250 mcg,         per day if required.
its first passage                                                        same ratios hold.
through the liver.                                                       Formulations contain
Since the dose of oral                                                   lactose monohydrate
beclometasone
dipropionate needed
to suppress plasma
cortisol is greater than
that required by
inhalation, this
suggests that the
portion absorbed from
the lungs is mainly
responsible for any
systemic effects.




-                         -   -                -                         -                        -
Cmax at steady state -   ·521.429:            ·Practically Insoluble:   TwistHaler DPI.         Each delivered dose
is 94 - 114 pcg/mL       mometasone furoate   mometasone furoate        Inactive ingredients:   contains 200 or 400
and the mean time to                                                    lactose anhydrous.      micrograms
peak levels ranged                                                                              mometasone furoate.
from approximately                                                                              Available in 14, 30, 60
1.0 to 2.5 hours.                                                                               multiple dose
Mometasone furoate                                                                              configurations. The
is primarily and                                                                                only approved dose
extensively                                                                                     for children 4 to 11 is
metabolized in the                                                                              110 mcg (1 puff)
liver of all species                                                                            administered once
investigated and                                                                                daily in the evening.
undergoes extensive
metabolism to multiple
metabolites. In-vitro
studies have
confirmed the primary
role of CYP 3A4 in the
metabolism of this
compound. The in
vitro protein binding
for mometasone
furoate was reported
to be 98 - 99% (in a
concentration range of
5 to 500 ng/ml). The
mean terminal t1/2is 5
h and the mean
steady-state Vd is 152
L.
10% delivered to         -   ·239.213: albuterol   ·Sparingly Soluble:   Clickhaler technology.     Each metered
airway. Readily                                    albuterol             95 mcg of drug in          actuation of 3 mg of
absorbed from GI                                                         lactose monohydrate        inhalation powder
tract but undergoes                                                      is delivered. Dose is 1-   contains 114
extensive first pass                                                     2 puffs three to four      micrograms of
metabolism. CL is                                                        times daily.               salbutamol sulphate
30L/hr. t1/2 is 3-7 hrs.                                                                            (95 micrograms
                                                                                                    salbutamol base) and
                                                                                                    delivers 110
                                                                                                    micrograms of
                                                                                                    salbutamol sulphate
                                                                                                    (90 micrograms of
                                                                                                    salbutamol base). er.

                                                                                                    The maximum
                                                                                                    recommended dose is
                                                                                                    two inhalations three
                                                                                                    or four times a day.
-   -   -   -   The inhaler             -
                incorporates a single
                increment dose
                counter which counts
                back from 199 doses,
                allowing the user to
                track each single dose
                taken. The device is
                also equipped with a
                special lever
                mechanism requiring
                50% less force to
                release a dose, this is
                especially important
                for the elderly and
                young children.



-   -   -   -   -                       -

-   -   -   -   As a part of the        -
                program, Eiffel
                Technologies supplies
                a re-engineered and
                modified asthma drug
                to Meridica for testing
                with their inhalation
                device.


-   -   -   -   -                       -

-   -   -   -   -                       -

-   -   -   -   Mycobacterium           -
                vaccae technology
-   -   -   -   -   -
-   -   ·238.25:                 ·Very Soluble:         -   -
        proxyphylline·201.695:   proxyphylline·Freely
        ephedrine                Soluble: ephedrine
        hydrochloride·232:       hydrochloride·Very
        phenobarbital            Slightly Soluble:
                                 phenobarbital
-   -   ·335.83: procaterol   ·Soluble: procaterol   -   60 mL bottle
        hydrochloride         hydrochloride              containing 25 mcg/5
                                                         mL procaterol HCl.
-   -   ·335.83: procaterol   ·Soluble: procaterol   -   25 and 50 mcg
        hydrochloride         hydrochloride              procaterol HCl
                                                         containing tablets.
-   -   ·430.38: ipratropium   ·Freely Soluble:      Drug in capsule         Dark olive/light olive
        bromide hydrate        ipratropium bromide   containing glucose as   opaque size 3 hard
                               hydrate               carroer. Delivered by   gelatin capsules.
                                                     Aeohaler device.        packaged in
                                                     Capsule shell:          PVC/Aluminium blister
                                                     Titanium dioxide        packs containing 30,
                                                     (E171), Indigo          50, 60, 90, 100, 120,
                                                     Carmine (E132), Iron    180, 240, 300 or 360
                                                     Oxide Yellow (E172),    AEROCAPS. 1
                                                     Iron Oxide Black        capsule three or four
                                                     (E172), Gelatin.        times daily. This dose
                                                                             may be doubled safely
                                                                             in patients who are
                                                                             less responsive. A
                                                                             total daily dose of 8
                                                                             capsules should not
                                                                             be exceeded.
Site specific action.  -   ·430.38: ipratropium   ·Freely Soluble:      3M MDI Metering         Each actuation meters
Drug is not readily        bromide hydrate        ipratropium bromide   Valves technology.      21 mcg of ipratropium
absorbed                                          hydrate               Inactive ingredients:   bromide from the
systemically. t1/2 is                                                   soya lectin and CFC     valve and delivers 18
about 2 hrs.                                                            propellants.            mcg of ipratropium
Ipratropium bromide is                                                                          bromide from the
minimally bound (0 to                                                                           mouthpiece. Each
9% in vitro) to plasma                                                                          14.7 gram canister
albumin and                                                                                     provides sufficient
1-acid                                                                                  medication for 200
glycoprotein.                                                                                   inhalations.
                                                                                                Dosed in two
                                                                                                inhalations, four times
                                                                                                daily
Following nebulization -   ·430.38: ipratropium   ·Freely Soluble:      Atrovent Inhalation        Atrovent®
of a 2 mg dose, a          bromide hydrate        ipratropium bromide   Solution is                (ipratropium bromide)
mean 7% of the dose                               hydrate               administered by oral       Inhalation Solution
was absorbed into the                                                   inhalation with the aid    Unit Dose Vial is
systemic circulation                                                    of a nebulizer. It         supplied as a 0.02%
either from the                                                         contains ipratropium       clear, colorless
surface of the lung or                                                  bromide 0.02%              solution containing 2.5
from the                                                                (anhydrous basis) in a     ml with 5 Unit Dose
gastrointestinal tract.                                                 sterile, isotonic saline   Vials per pouch, 5
t1/2 is 1.6 h (IV). The                                                 solution, pH adjusted      pouches per carton
volume of distribution                                                  to 3.4 (3 to 4) with       (NDC 0597-0080-62).
(Vβ) is 338 L (                                                    hydrochloric acid.         The usual dosage of
4.6 L/kg). The mean                                                                                Atrovent®
total clearance of the                                                                             (ipratropium bromide)
drug is determined to                                                                              Inhalation Solution is
be 2.3 L/min.                                                                                      500 mcg (1 Unit-Dose
Minimally (0 to 9% in                                                                              Vial) administered
vitro) bound to plasma                                                                             three to four times a
albumin and a1-acid                                                                                day by oral
glycoproteins. It is                                                                               nebulization, with
partially metabolized.                                                                             doses 6 to 8 hours
                                                                                                   apart.
-   -   -                       -                         -                    -




-   -   -                       -                         -                    -


-   -   -                       -                         -                    -

-   -   ·434.5: triamcinolone   ·Practically Insoluble:   HFA formulation in   -
        acetonide               triamcinolone             MDI device with
                                acetonide                 electronic dose
                                                          counter
Based upon             -   ·434.5: triamcinolone   ·Practically Insoluble:   Microcrystalline        Device delivers 200
intravenous dosing of      acetonide               triamcinolone             suspension of drug      micrograms from
triamcinolone                                      acetonide                 with                    valve and 75
acetonide phosphate                                                          dichlorofluoromethane   micrograms from
ester, t1/2 of                                                               propellant and          mouthpiece after
triamcinolone                                                                dehydrated alcohol      initial prime of two
acetonide is 88 min,                                                         1% w/w. each canister   actuations.
Vd is 1.42 L/kg (SD ±                                                        contains 60 mg of       Administered two
0.39) and CL is 0.65                                                         drug capable of         inhalations three to
L/h/kg (SD ± 0.13).                                                          delivering up to 240    four times daily or four
The overall mean                                                             actuations.             inhalations twice daily.
percent fraction bound
was approximately
68%. The metabolism
and excretion of
triamcinolone
acetonide were both
rapid and extensive.
Systemic absorption     -   ·521.04:         ·Practically Insoluble:   Modulite® technology      The usual starting
of unchanged                beclomethasone   beclomethasone            MDI CFC free              dose for 50
beclometasone               dipropionate     dipropionate              propellant/formulation    micrograms, 100
dipropionate (BDP)                                                     system based on the       micrograms & 200
occurs through the                                                     use of HFA                micrograms of BDP
lungs. There is                                                        propellants.Suspensio     Modulite is 200
negligible oral                                                        n contains excipients :   micrograms twice
absorption of the                                                      ethanol, glycerol,        daily.For 250
swallowed dose of                                                      norflurane                micrograms of BDP
unchanged                                                                                        Modulate the usual
BDP.When                                                                                         administration dosage
administered orally                                                                              is 1000 micrograms
the bioavailability of                                                                           daily, which may be
BDP is negligible but                                                                            increased to 2000
pre-systemic                                                                                     micrograms daily.For
conversion to B-17-                                                                              detailed information
MP results in 41% of                                                                             please see EU label.
the dose being
absorbed as B-17-
MP.The tissue
distribution at steady-
state for BDP is
moderate (20 L) but
more extensive for B-
17-MP (424 L).
Plasma protein
binding is moderately
high (87%).BDP is
cleared very rapidly
from the systemic
circulation, by
metabolism mediated
via esterase enzymes
that are found in most
-                       -   -   -   -                  inhalation solution
                                                       delivered by the
                                                       Respimat,
                                                       administered once
                                                       daily as doses 50 µg,
                                                       100 µg and 200 µg in
                                                       phase 2 trials
-                       -   -   -   -                  administered as
                                                       subcutaneously
-                       -   -   -   -                  inhalation solution
                                                       delivered once daily
                                                       as 5 and 10 mcg
                                                       doses by the
                                                       Respimat in phase 3
                                                       trials
-                       -   -   -   Hard Capsule for   administered as 30mg
                                    HandiHaler         twice daily in phase 2
                                                       trials
-                       -   -   -   -                  At phase 2 trials
                                                       patients received 0.1
                                                       mg/kg and 1.0 mg/kg
                                                       IV MEDI-563 on Study
                                                       Days 0 and 56.

It is orally active     -   -   -   -                  -
(~80% bioavailable)
and has
pharmacokinetics
optimised for once-a-
day dosing.
-                        -   -                      -                  -                      -




BA is 10%.               -   ·403.904: bambuterol   ·Freely Soluble:   Lactose monohydrate;   10 and 20 mg
Bambuterol is                hydrochloride          bambuterol         maize starch;          tablets.
metabolised in the                                  hydrochloride      povidone;              Once daily
liver and terbutaline is                                               microcrystalline       administration.
formed by both                                                         cellulose; magnesium
hydrolysis and                                                         stearate; water,
oxidation. After                                                       purified.
absorption from the
gut, about 2/3 of
terbutaline is first-
pass metabolised,
bambuterol escapes
this first-pass
metabolism. 40“0% 5
bound to plasma
proteins and t1/2 is
  1
9“7 h.

-                        -   -                      -                  Drug nanoparticles     -
                                                                       produced by
                                                                       Supercritical Fluid
                                                                       (SCF) technology to
                                                                       be tested with
                                                                       BattellePharma“ s
                                                                       MysticTM inhalation
                                                                       delivery technology
-                       -   ·521.04:         ·Practically Insoluble:   Oleic Acid,            Each inhalation
                            beclomethasone   beclomethasone            dichlorodifluoromethan delivers 50, 100, or
                            dipropionate     dipropionate              e, and                 250 mcg of drug.
                                                                       trichlorofluoromethane
                                                                       formualtion in Easi-
                                                                       breathe inhaler.




Readily absorbed in     -   ·521.04:         ·Practically Insoluble:   A mixture of 400       Double-foil disks
pulmonary tract             beclomethasone   beclomethasone            micrograms             comprising eight
(specific performance       dipropionate     dipropionate              beclomethasone         regularly spaced
data not available)                                                    dipropionate (as the   blisters each
                                                                       monohydrate) and       delivering a mixture of
                                                                       lactose, used in a     400 micrograms
                                                                       Diskhaler device.      beclomethasone
                                                                                              dipropionate (as the
                                                                                              monohydrate) and
                                                                                              lactose
Readily absorbed in     -   ·521.04:         ·Practically Insoluble:   EasyHaler DPI.        100 or 200 mcg/dose.
pulmonary tract             beclomethasone   beclomethasone            Lactose monohydrate
(specific performance       dipropionate     dipropionate
data not available)




-                       -   ·521.04:         ·Practically Insoluble:   -                     -
                            beclomethasone   beclomethasone
                            dipropionate     dipropionate
Readily absorbed in     -   ·521.04:         ·Practically Insoluble:   Oleic Acid,               50, 100 or 200
pulmonary tract             beclomethasone   beclomethasone            dichlorodifluoromethan    micrograms
(specific performance       dipropionate     dipropionate              e,                        Beclometasone
data not available)                                                    trichlorofluoromethane.   Dipropionate BP per
                                                                                                 actuation. Each
                                                                                                 canister delivers 80 or
                                                                                                 200 actuations.
                                                                                                 Adults (including the
                                                                                                 elderly): The usual
                                                                                                 starting dose is 200
                                                                                                 micrograms twice a
                                                                                                 day.
                                                                                                 Children: The usual
                                                                                                 starting dose is 100
                                                                                                 micrograms twice
                                                                                                 daily
Fenoterol               -   ·384.3: fenoterol      ·Soluble: fenoterol    Respimat nebulizer    Each single dose unit
hydrobromide:               hydrobromide·430.38:   hydrobromide·Freely    device. Excipients:   contains Fenoterol
Incompletely                ipratropium bromide    Soluble: ipratropium   Sodium chloride,      Hydrobromide Ph.Eur.
absorbed from the           hydrate                bromide hydrate        Hydrochloric acid,    1.25 mg and
gastrointestinal tract                                                    Purified water.       Ipratropium Bromide
and subject to                                                                                  Ph.Eur. 0.5 mg.
extensive first-pass                                                                            The recommended
metabolism by sulfate                                                                           dose for adults and
conjugation. The t1/2                                                                           children over 14 years
for total excretion is                                                                          is one vial (4 ml) to be
7.2 hours and                                                                                   nebulised immediately
absorption was                                                                                  upon presentation.
calculated to be                                                                                Repeat dosing may be
60%.                                                                                            given at the discretion
Ipratropium bromide:                                                                            of the treating
Poorly absorbed from                                                                            physician, up to a
the gastro-intestinal                                                                           maximum of 4 vials in
tract and slow to cross                                                                         24 hours.
mucous membranes
and the blood brain
barrier. Following
inhalation, uptake into
the plasma is minimal,
a peak blood
concentration is
attained 1½ to 3 hours
after inhalation (and
similarly for oral
administration).
Rapidly absorbed in    -     ·384.3: fenoterol   ·Soluble: fenoterol   Fenoterol solution in     0.625 and 0.25
GI tract with an             hydrobromide        hydrobromide          20 mL bottles             mg/mL vials, each mL
absorption level of                                                    contains preservatives    of aqueous solution
60%. Tmax is 2 h. t1/2                                                 (benzalkonium             contains 0.625 mg
is 6-7 h.                                                              chloride and edetate      and 0.25 mg fenoterol
                                                                       disodium) The 2 mL        HBr repectively.
                                                                       unit dose vial does not
                                                                       contain preservatives.
                                                                       Nonmedicinal
                                                                       ingredients:
                                                                       benzalkonium chloride
                                                                       and edetate disodium
                                                                       in an aqueous
                                                                       solution. Sodium:




Rapidly absorbed in      -   ·384.3: fenoterol   ·Soluble: fenoterol   Berotec (100 µg) and      Berotec (100 µg) and
GI tract. Tmax is 2 h.       hydrobromide        hydrobromide          Berotec forte (200 µg)    Berotec forte (200 µg).“
t1/2 is 6-7 h.                                                         are metered dose          The 100 ug cannister
                                                                       aerosol systems           contains 200 doses
                                                                       which contain a           and the 200ug
                                                                       suspension of             cannister(Forte)
                                                                       fenoterol HBr in          contains 100 doses.
                                                                       fluorocarbon              Non-CFC versions
                                                                       propellants               available in many
                                                                       (difluorodichlorometha    countries
                                                                       ne,
                                                                       monofluorotrichlorome
                                                                       thane,
                                                                       tetrafluorodichloroetha
                                                                       ne) with sorbitan
                                                                       trioleate as a
                                                                       dispersing agent.
-   -   -                      -                        CLICTM Lipids.          -




-   -   -                      -                        P20-MTS                 -
                                                        recombinant fusion
                                                        protein.




-   -   ·924.08: amphotericin ·Practically Insoluble:   BiOral cochleate        -
        B                     amphotericin B            technology. This is not
                                                        SinuNase.




-   -   ·: mepolizumab         ·: mepolizumab           -                       -
Brethine is variably    -   ·548.65: terbutaline   ·Soluble: terbutaline   Each milliliter of          1 mg/mL ampuls.
absorbed from the           sulfate                sulfate                 solution contains 1 mg      The usual
gastrointestinal tract.                                                    of terbutaline sulfate      subcutaneous dose of
Undergoes first-pass                                                       USP (0.82 mg of the         Brethine is 0.25 mg.
metabolism in the liver                                                    free base), sodium
and the gut wall.                                                          chloride for isotonicity,
About 60% excreted                                                         and hydrochloric acid
unchanged in the                                                           for adjustment to a
urine. CL is 311 (112)                                                     target pH of 4.
mL/min and t1/2 is 2.9
h.



Brethine is variably    -   ·548.65: terbutaline   ·Soluble: terbutaline   -                           2.5 and 5 mg tablets.
absorbed from the           sulfate                sulfate                                             The usual dose is 5
gastrointestinal tract.                                                                                milligrams taken at
It undergoes first-pass                                                                                approximately 6-hour
metabolism in the liver                                                                                intervals, 3 times per
and the gut wall.                                                                                      day during waking
About 60% excreted                                                                                     hours.
unchanged in the
urine. CL is 311 (112)
mL/min and t1/2 is
2.9 h.
Food reduces           -   ·548.65: terbutaline   ·Soluble: terbutaline   Terbutaline (0.25 mg),   0.25mg/dose. One or
bioavailability            sulfate                sulfate                 sorbitan trioleate,      two inhalations as
following oral dosing                                                     CFC 11,12, and 14.       required, with a short
(10% on average).                                                         For use with Bricanyl    interval between each
Fasting values of 14-                                                     Inhaler, Bricanyl        inhalation at 6 hourly
15% have been                                                             Spacer Inhaler and       intervals.
obtained. Vd is 114 L.                                                    Nebuhaler                Discontinued in US
Total body CL is 213                                                                               (0.2 mg/INH)
ml/min. Terminal t½ is
16-20 h.




Less than 10% of the -     ·548.65: terbutaline   ·Soluble: terbutaline   Breath actuated          One inhalation
dose is absorbed from      sulfate                sulfate                 metered dose powder      (0.5mg) as required.
the airways. The                                                          inhaler. Each dose       Not more than 4
remaining 90% is                                                          contains 0.5 mg          inhalations should be
swallowed but is                                                          terbutaline sulphate     required in any 24-
largely prevented from                                                    delivered using          hour period.
entering the systemic                                                     Turbohaler
circulation due to                                                        technology. Each
extensive first pass                                                      inhaler contains 100
metabolism.                                                               doses. No additives,
                                                                          lubricants, or
                                                                          preservatives added.


-                      -   ·354.4: seratrodast    ·: seratrodast          -                        40 and 80 mg tablets.
                                                                                                   Once daily.
-   -   ·430.53: budesonide   ·Practically Insoluble:   Auto-Jethaler   -
                              budesonide




-   -   ·430.53: budesonide   ·Practically Insoluble:   Jethaler DPI.   -
                              budesonide
-   -   ·430.53: budesonide   ·Practically Insoluble:   -   -
                              budesonide




-   -   ·430.53: budesonide   ·Practically Insoluble:   -   -
                              budesonide
-   -   ·430.53: budesonide   ·Practically Insoluble:   -                      -
                              budesonide




-   -   ·430.53: budesonide   ·Practically Insoluble:   A highly efficient      Supplied as a 120
                              budesonide                formulation involving a dose canister with 200
                                                        70%(in vitro) increase ug per puff.
                                                        of fine particles
                                                        compared to the
                                                        currently marketed
                                                        CFC-MDI. The
                                                        formulation includes
                                                        HFA227/134a
                                                        propellants,
                                                        budesonide,
                                                        surfactant and CO2.
                                                        Skyefine Technology
-   -   ·430.53: budesonide   ·Practically Insoluble:   Generic Pulmicort        0.25 mg/2 mL and 0.5
                              budesonide                Respules                 mg/2 mL indicated for
                                                                                 twice daily




-   -   ·430.53: budesonide   ·Practically Insoluble:   MMX matrix controlled    Cosmo is presently
                              budesonide                release delays           conducting two phase
                                                        absorption of drug for   III clinical trials, one in
                                                        colonic delivery         the Americas and one
                                                                                 in the EU. The US trial
                                                                                 is testing efficacy and
                                                                                 safety of new oral
                                                                                 Budesonide MMX“        9
                                                                                 mg and 6 mg
                                                                                 extended-release
                                                                                 tablet formulations
                                                                                 (CB-01-02) in patients
                                                                                 with mild or moderate,
                                                                                 active Ulcerative
                                                                                 Colitis.
Budesonide is rapidly -   ·430.53: budesonide   ·Practically Insoluble:   Modulite technology      0.2 mg drug dose per
and almost completely                           budesonide                uses HFA propellants actuation
absorbed following                                                        in a drug solution with
administration by                                                         optimized particle size.
mouth, but has poor
systemic availability
(about 10%) due to
extensive first-pass
metabolism in the
liver, mainly by the
cytochrome P450
isoenzyme CYP3A4.
The major
metabolites, 6-β-
hydroxybudesonide
and 16-α-
hydroxyprednisolone
have less than 1% of
the glucocorticoid
activity of unchanged
budesonide.
Budesonide is
reported to have a
terminal t1/2 of about
2- 4 h. (REF 1-
(Pubmed
id:11475468), REF 2-
(Pubmed
id:15355126) )
-   -   ·430.53: budesonide   ·Practically Insoluble:   Mystic EHD nebulizer   -
                              budesonide




-   -   ·430.53: budesonide   ·Practically Insoluble:   Powder-whirl           -
                              budesonide
Salbutamol is readily -   ·239.213: albuterol   ·Sparingly Soluble:   Inactive ingredients:   200 mcg salbutamol
absorbed from the                               albuterol             lactose monohydrate.    (albuterol) per dose.
gastrointestinal tract.                                                                       Dose not to exceed 4
It is subject to first-                                               Dose not to exceed 4    per day.
pass metabolism in                                                    per day
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate. Salbutamol
is rapidly excreted in
the urine as
metabolites and
unchanged drug;
there is some
excretion in the
faeces. Salbutamol
does not appear to be
metabolised in the
lung. The plasma t1/2
is 4 - 6 hrs. (REF 1-
(Pubmed id:5081599),
REF 2- (Pubmed
id:974663), REF 3-
(Pubmed id:17520),
REF 4- (Pubmed
id:3790406), REF 5-
(Pubmed id:2687008),
REF 6- (Pubmed
id:2598971), REF 7-
(Pubmed id:1457264),
REF 8- (Pubmed
id:1635728))
-   -   ·239.213: albuterol   ·Sparingly Soluble:   Inactive ingredients:   (salbutamol
                              albuterol             lactose monohydrate     inhalation powder 100
                                                                            and 200 mcg/dose




-   -   -                     -                     -                       At phase 1 study, 150
                                                                            mg and 300 mg
                                                                            subcutaneous
                                                                            administration
                                                                            compared with 150
                                                                            mg IV administration
                                                                            (trials). Phase 2
                                                                            dosing: 1 mg/kg CAT-
                                                                            354 on Day 0, 28, and
                                                                            56 5 mg/kg CAT-354
                                                                            on Day 0, 28, and 56
                                                                            10 mg/kg CAT-354 on
                                                                            Day 0, 28, and
                                                                            56(trials)
-   -   ·460.5: apremilast     ·: apremilast   -                  Phase 2 trials used
                                                                  doses varied between
                                                                  10, 20, 30, 40 mg
                                                                  tablets, once or twice
                                                                  a day.
                                                                  The pilot, open-label,
                                                                  single arm phase II
                                                                  study enrolled 19
                                                                  patients with 15
                                                                  patients having
                                                                  complete sets of
                                                                  evaluable biopsies
                                                                  and 17 patients
                                                                  evaluable for
                                                                  complete efficacy
                                                                  assessments. CC-
                                                                  10004 at 20mg was
                                                                  administered daily for
                                                                  29 days with an
                                                                  additional 28-day
                                                                  observational follow-
                                                                  up period to monitor
                                                                  safety [6764].

-   -   -                      -               -                  -


-   -   ·368.431: carmoterol   ·: carmoterol   Modulite HFA MDI   Phase 2 trials dosage;
                                                                  carmoterol 1.0
                                                                  μg, 2.0 μg,
                                                                  4.0 μg once a
                                                                  day, in the morning
-   -   ·368.431:             ·:                     -                        -
        carmoterol·430.53:    carmoterol·Practically
        budesonide            Insoluble: budesonide




-   -   -                     -                      Inhalation formulation   -


-   -   ·179.24: fudosteine   ·Freely Soluble:       Inactive ingredient:     It is supplied as white
                              fudosteine             Corn starch, talc,       film-coated tablet.
                                                     magnesium stearate,      Usually 400 mg as
                                                     hydroxypropylmethylce    fudosteine is orally
                                                     llulose,                 administered to adults
                                                     titanium oxide,          3 times a day after
                                                     macrogol                 meals.
-   -   -                     -                         A novel modified oral -
                                                        formulation (liquid,
                                                        extended release) of a
                                                        product used for the
                                                        treatment of asthma.

-   -   ·339.46: tofimilast   ·: tofimilast             -                     Dry powder formula
                                                                              for inhalation

-   -   ·392.464:             ·Practically Insoluble:   LVT derivative of     -
        betamethasone         betamethasone             betamethasone
-   -   ·360.5: prednisolone   ·Very Slightly Soluble: LVT derivative of   -
                               prednisolone            prednisolone




-   -   -                      -                       -                   Compound's
                                                                           pharmacokinetic
                                                                           properties allow once-
                                                                           a-day oral dosing.




-   -   -                      -                       -                   -

-   -   -                      -                       -                   -
-   -   ·360.5:               ·Very Slightly Soluble: -   Novel once-nightly
        prednisolone·263.4:   prednisolone·:              modified release co-
        nortriptyline         nortriptyline               formulation capsule
-   -   ·360.5:               ·Very Slightly Soluble: -   -
        prednisolone·263.4:   prednisolone·:
        nortriptyline         nortriptyline
-   -   ·: bromelains   ·: bromelains   -   -




-   -   -               -               -   CVT-6883, a
                                            selective, potent and
                                            orally available A2B-
                                            adenosine receptor
                                            antagonist, intended
                                            to treat asthma with
                                            once a day dosing
                                            [20373]
-   -   -   -   -   In a phase IIa pilot
                    study the 10 patients
                    received 6 weekly
                    injections of 300
                    μg CYT003-
                    QbG10 [9187]
-   -   -   -   -   Product is the
                    combination of 300µg
                    QbG10 with an
                    approved allergen
                    extract. In open-label,
                    single arm phase IIa
                    study, at the first two
                    weekly visits, the
                    allergen was injected
                    subcutaneously and
                    up-titrated. Thereafter,
                    at the next 4
                    weekly visits, allergen
                    was further up-
                    titrated, but now co-
                    administered
                    subcutaneously with
                    300 μg CYT005-
                    AllQbG10. Finally, at
                    an additional two
                    biweekly visits, 300
                    μg CYT005-
                    AllQbG10 were
                    coadministered
                    with the highest
                    targeted allergen dose
                    [20410]
Well absorbed orally   -   ·441.5: deflazacort   ·Practically Insoluble:   1mg and 30mg            1, 6 and 30 mg
and immediately                                  deflazacort               tablets:                tablets. For acute
converted by plasma                                                        Microcrystalline        disorders, up to 120
esterases to the                                                           cellulose, lactose,     mg/day deflazacort
pharmacologically                                                          maize starch and        may need to be given
active metabolite (D                                                       magnesium stearate.     initially. Maintenance
21OH), which                                                               6mg tablets:            doses in most
achieves peak plasma                                                       Microcrystalline        conditions are within
concentrations in 1.5                                                      cellulose, lactose,     the range 3 - 18
to 2 hours.                                                                sucrose, maize starch   mg/day.
Metabolism of D 21-                                                        and magnesium
OH is extensive. 40%                                                       stearate.
protein-bound. t1/2 is
1.1-1.9 h.


When Captisol-         -   ·430.53: budesonide   ·Practically Insoluble:   Contain 2-10%           The solution is
Enabled Budesonide                               budesonide                Captisol. Doses of      nebulized with a
Solution is                                                                60, 120 and 240         modified Pari e-flow
administered,                                                              microgram per 0.5 mL    nebulizer.
budesonide is                                                              delivered in Pahse I.
delivered to the lung                                                      US2007197487
and subsequently
absorbed into the
blood stream for rapid
clearance of Captisol
and budesonide.
Dose proportinalty has
been shown.
Scintographic images
have shown better
distribution of the
captisol solution vs.
Pulmicort Respules.
-   -   -   -   -   -




-   -   -   -   -   -
-   -   -   -   -   -




-   -   -   -   -   -

-   -   -   -   -   -
Protein binding is 40%. -   ·283.33: oxtriphylline   ·Freely Soluble:          Inactive ingredients:     400 mg and 600 mg
                                                     oxtriphylline             carnauba wax,             extended release
                                                                               hydrogenated              tablets. One 400 or
                                                                               soybean oil,              600 mg tablet every
                                                                               magnesium stearate        12 hours.
                                                                               and sugar; coating:
                                                                               candelilla wax,
                                                                               hydroxypropyl
                                                                               cellulose, opaseal,
                                                                               opaspray pink and talc.




-                       -   ·283.33: choline         ·: choline theophylline   -                         400 mg and 600 mg
                            theophylline                                                                 sustained release
                                                                                                         tablets.

-                       -   ·540.69: ciclesonide     ·Practically Insoluble:   -                         -
                                                     ciclesonide
-   -   ·50708.2: cintredekin   ·: cintredekin   -   -
        besudotox               besudotox
-                       -   -                -                         Nanosteroids are a       -
                                                                       drug delivery system
                                                                       in which steroids are
                                                                       inserted into a
                                                                       polylactic acid particle
                                                                       with a width of only
                                                                       150 nanometres.

Readily absorbed in     -   ·521.04:         ·Practically Insoluble:   Pulvinal technology.     100, 200, 400 mcg
pulmonary tract             beclomethasone   beclomethasone            Inactive ingredients:    beclomethasone
(specific performance       dipropionate     dipropionate              lactose monohydrate,     dipropionate. Dosed
data not available)                                                    magnesium stearate.      two to four times daily
Ipratropium bromide is -   ·430.38: ipratropium   ·Freely Soluble:      Combivent Inhalation      Two inhalations four
not readily absorbed       bromide                ipratropium bromide   Aerosol contains a        times a day.
into the systemic          hydrate·548.24:        hydrate·Freely        microcrystalline          Combivent®
circulation either from    albuterol sulfate      Soluble: albuterol    suspension of             Inhalation Aerosol is
the surface of the lung                           sulfate               ipratropium bromide       supplied as a metered-
or from the                                                             and albuterol             dose inhaler with a
gastrointestinal tract.                                                 sulfate in a              white mouthpiece
t1/2 is 2 h. Minimally                                                  pressurized metered-      which has a clear,
bound (0 to 9% in                                                       dose aerosol unit for     colorless sleeve and
vitro) to plasma                                                        oral inhalation           an orange protective
albumin and α1-                                                    administration. The       cap.
acid glycoprotein. It is                                                200 inhalation unit has
partially                                                               a net weight of 14.7
metabolized to                                                          grams. Each actuation
inactive ester                                                          meters 21 mcg of
hydrolysis products.                                                    ipratropium bromide
The mean terminal                                                       and 120 mcg of
t1/2 of albuterol is 3.9                                                albuterol sulfate from
hours with a mean CL                                                    the valve and delivers
of 439 mL/min/1.73                                                      18 mcg of ipratropium
m2. It crosses blood-                                                   bromide and 103 mcg
brain barrier.                                                          of albuterol sulfate
                                                                        (equivalent to 90 mcg
                                                                        albuterol base) from
                                                                        the mouthpiece. The
                                                                        excipients are
                                                                        dichlorodifluoromethan
                                                                        e,
                                                                        dichlorotetrafluoroetha
                                                                        ne, and
                                                                        trichloromonofluorome
                                                                        thane as propellants
                                                                        and soya lecithin.
-   -   ·344.405: formoterol   ·Slightly Soluble:   Formoterol 12µg and     -
                               formoterol           24µg delivered by a
                                                    new inhalation device
                                                    (Concept1) (source:
                                                    clinicaltrials.gov
                                                    NCT00443482)

-   -   ·275.8: levalbuterol   ·Freely Soluble:     -                       -
        hydrochloride          levalbuterol
                               hydrochloride
-   -   ·234.34: lidocaine   ·Practically Insoluble:   PARI's eFlow           -
                             lidocaine                 electronic nebulizer
                                                       (Ventaira's Mystic was
                                                       also studied)
Poorly absorbed from   -   ·512.33: cromolyn   ·Soluble: cromolyn   -   5 mg/dose
GI tract but readily       sodium              sodium
absorbed in lung.
-   -   ·512.33: cromolyn   ·Soluble: cromolyn   Utilizes one of the   -
        sodium              sodium               Company's
                                                 proprietary
                                                 biodegradable drug
                                                 delivery platforms
-   -   ·468.4: cromolyn        ·Soluble: cromolyn   Mystic EHD nebulizer   -




-   -   -                       -                    -                      -

-   -   -                       -                    -                      -

-   -   -                       -                    -                      -

-   -   -                       -                    -                      -




-   -   ·403.211: roflumilast   ·: roflumilast       -                      In the RECORD study
                                                                            patients were treated
                                                                            for 24 weeks with
                                                                            either placebo or
                                                                            250µg or 500 µg
                                                                            Roflumilast. Once
                                                                            daily. [11395]
-   -   ·180.16: theophylline   ·Slightly Soluble:   Diffutab based.          100, 200, 350 mg
                                theophylline         Excipients: HPMC         once a day tablets
                                                     and shellac, calcium
                                                     phosphate dibasic,
                                                     calcium phosphate
                                                     tribasic, magnesium
                                                     stearate, precipitated
                                                     silica. (translated from
                                                     Italian)




-   -   -                       -                    -                       -
When a single dose of -   ·282.73: ozagrel   ·Soluble: ozagrel   Each white film-         For oral use, the usual
200 mg is orally          hydrochloride      hydrochloride       coated tablets 100 mg    adult dosage is 400
administered to                                                  and 200 mg               mg of ozagrel
healthy adults, the                                              DOMENAN Tablets          hydrochloride (four
plasma concentration                                             contains 100 mg and      100 mg tablets or two
reaches its peak in                                              200 mg of ozagrel        200 mg tablets) in two
about 1.3                                                        hydrochloride. For 100   divided doses (after
hours. Its                                                       mg tablet Lactose,       breakfast and before
concentration is                                                 Microcrystalline         bed-time). The
approximately 1.9                                                cellulose,               dosage
μg/mL. The                                                  Hydroxypropyl            may be adjusted
plasma half-life is                                              cellulose,Magnesium      according to the
approximately 1.45                                               stearate, Macrogol,             s
                                                                                          patient“ age and
hours. 74.6% of the                                              Polyoxyethylene          symptoms
dose administered is                                             polyoxypropylene
excreted into the urine                                          glycol, for 200 mg
within 48 hours after                                            tablet Lactose,
administration, and                                              Microcrystalline
the majority of it is                                            cellulose,
excreted within 8                                                Hydroxypropyl
hours after                                                      cellulose,
administration. The                                              Magnesium
principal metabolites                                            stearate,
in the plasma                                                    Hydroxypropylmethylc
and urine are the beta-                                          ellulose,
oxide form of the                                                Polyoxyethylene
propenoic acid portion                                           polyoxypropylene
and its reduced form.                                            glycol are inactive
Some of these and                                                ingredients.
the unchanged drug
are excreted into the
urine as glucuronic
acid conjugates
-   -   -   -   -                    -




-   -   -   -   Undisclosed fixed    -
                dose comination in
                DuoHaler device
-   -   -   -   Undisclosed fixed    -
                dose comination in
                DuoHaler device
-   -   -   -   -                    -




-   -   -   -   -                    -
-   -   -                      -                      -   -




-   -   ·: undisclosed small   ·: undisclosed small   -   once daily
        molecule·:             molecule·:
        undisclosed small      undisclosed small
        molecule               molecule
-   -   -   -   -                         Oral treatment




-   -   -   -   As part of the            -
                program, Eiffel
                Technologies supplies
                a reengineered and
                modified asthma drug
                to Oriel for testing with
                their inhalation device.
poorly absorbed from -    ·512.33: cromolyn   ·Soluble: cromolyn   Eligen technology   -
the gastrointestinal      sodium              sodium
tract, with a reported
bioavailability of only
1%. The elimination
half-life has been
reported to be about
20 to 60 minutes after
intravenous
administration, but the
elimination half-life
following oral
administration or
inhalation is longer,
being stated to be
about 80 minutes.
-   -   ·183.204: epinephrine ·Very Slightly Soluble: Epinephrine Mist is     Delivers 0.22 mg
                              epinephrine             generic and National    epinephrine per
                                                      Brand Equivalent        inhalation.
                                                      (NBE) product to        Epinephrine Mist
                                                      Primatene Mist®.        products are available
                                                      Inactive ingredients:   in a ½ fl oz (15mL) Kit
                                                      alcohol 34%, ascorbic   (with mouthpiece),
                                                      acid, fluorocarbons     and ½ fl oz (15mL)
                                                      (propellant),           refill (without
                                                      hydrochloric acid,      mouthpiece).
                                                      nitric acid, water.
-   -   ·180.16: theophylline   ·Slightly Soluble:   Euphyllin Retard® is a   It is supplied as light
                                theophylline         delayed release          blue, convex, oblong,
                                                     formulation of           scored, film coated
                                                     anhydrous theophylline   tablets.
                                                                              Adults: Generally, one
                                                                              tablet taken twice a
                                                                              day (every 10-12
                                                                              hours) after meals,
                                                                              preferably with some
                                                                              water. Depending
                                                                              upon the effect
                                                                              achieved and in
                                                                              severe cases one
                                                                              tablet can be
                                                                              administered 3 times
                                                                              a day (at intervals of 8
                                                                              hours, or half tablets
                                                                              can be added to the
                                                                              dosage. As a general
                                                                              guideline the average
                                                                              daily dosage can be
                                                                              given as 10-14 mg/kg
                                                                              body mass/day.
-   -   ·180.16: theophylline   ·Slightly Soluble:   -                      Once daily
                                theophylline                                intravenous
                                                                            administration




-   -   -                       -                    Alchemia's proprietary -
                                                     VAST“  drug discovery
                                                     technology with
                                                     Euroscreen's
                                                     expertise in GPCR
                                                     screening
-                       -   -   -   -   -




Results of Phase I      -   -   -   -   -
have shown that
FAR404 is a safe, non-
toxic and well-
tolerated bio-available
compound with no
side effects in healthy
human volunteers.


-                       -   -   -   -   -
-   -   ·521.04:              ·Practically Insoluble:   Fixed dose            -
        beclomethasone        beclomethasone            combination product
        dipropionate·804.9:   dipropionate·Slightly     using Modulite HFA
        formoterol fumarate   Soluble: formoterol       MDI technology
                              fumarate




-   -   -                     -                         -                     -
Oral BA is less than -   ·500.57: fluticasone   ·Practically Insoluble: Each double foil         50, 100, 250 and 500
1%. Systemic BA from     propionate             fluticasone propionate rotadisk contains 4       mcg flutacasone
inhalation averaged                                                     blisters with 50, 100,   propionate blended
13.5%                                                                   250 and 500 mcg          with lactose to a
                                                                        flutacasone              weight of 25 mg.
                                                                        propionate blended       Administered twice
                                                                        with lactose to a        daily.
                                                                        weight of 25 mg.
                                                                        Contents are inhaled
                                                                        twice daily using
                                                                        DiskHaler.




-                    -   ·402.484:              ·Practically Insoluble:   NonSpil(TM) liquid    5 mg/5 mL and 15
                         prednisolone acetate   prednisolone acetate      drug delivery system, mg/5 mL prednisolone
                                                                          taste masking formula solution
                                                                          has a cherry flavor.
Oral BA                  -   ·500.57: fluticasone   ·Practically Insoluble: Pressurized, metered-    44, 110 and 220 mcg
                             propionate             fluticasone propionate dose aerosol units        inhalation aerosols.
                                                                            intended for oral        Twice daily
                                                                            inhalation only. Each    administration.
                                                                            unit contains a
                                                                            microcrystalline
                                                                            suspension of
                                                                            fluticasone propionate
                                                                            (micronized) in CFC
                                                                            propellants It
                                                                            contains no other
                                                                            excipients.



Oral BA is less than     -   ·500.57: fluticasone   ·Practically Insoluble: Specially designed       Flovent diskus 0.05,
1%. Systemic BA from         propionate             fluticasone propionate plastic devices           0.1, 0.25 mg.
inhalation averaged                                                         containing a double      Administered twice
18%. First pass                                                             foil blister. Each       daily.
metabolism. Vd is 4.2                                                       blister contains 50,
L/kg. Plasma protein                                                        100, 250 mcg of drug
binding is 91%. Total                                                       blended with lactose
CL is 0.066 L/h. t1/2 is                                                    to a weight of 12.5
7.8 hrs.                                                                    mg. Contents are
                                                                            inhaled twice daily
                                                                            using DISKUS device.
                                                                             50 mcg inhaler
                                                                            supplied with a dose
                                                                            counter.
Fluticasone             -   ·500.57: fluticasone   ·Practically Insoluble: Pressurised             44 micrograms, 110
propionate is poorly        propionate             fluticasone propionate inhalation,              micrograms, and 220
absorbed from the                                                          suspensions,            micrograms inhalers
gastrointestinal tract                                                     delivering either 44,   dosed twice daily
and undergoes                                                              110 or 220
extensive first-pass                                                       micrograms of
metabolism; oral                                                           fluticasone per
bioavailability is                                                         actuation,
reported to be only                                                        respectively.
about 1%. In healthy                                                       HFA 134a propellant.
subjects the mean                                                          44 mcg dose is
systemic BA of                                                             available with a dose
Flixotide Evohaler is                                                      counter.
28.6%. In patients
with asthma the
mean systemic
absolute BA was
reduced by 62%.
Systemic absorption
occurs mainly through
the lungs and has
been shown to be
linearly related to
dose over the dose
range 500 to 2000
micrograms.
Absorption is initially
rapid then prolonged
and the remainder of
the dose may be
swallowed.
-   -   ·290.415: fluasterone   ·: fluasterone         -                        -




-   -   ·500.57: fluticasone    ·Practically Insoluble: Miat-Haler, multidose   -
        propionate              fluticasone propionate DPI.
-                    -   ·344.405:              ·Slightly Soluble:       HFA based MDI            -
                         formoterol·500.57:     formoterol·Practically   formulation of fixed
                         fluticasone propionate Insoluble: fluticasone   dose formoterol and
                                                propionate               fluticasone. Product
                                                                         includes a dose
                                                                         counter.




Cmax of 92 pg/mL is -    ·804.9: formoterol     ·Slightly Soluble:       Foradil Aerolizer is a   Individual capsules
reached within 5         fumarate               formoterol fumarate      single-dose dry          packaged in foil
minutes of dosing.                                                       powder inhaler. Each     blisters. Taken twice
Binding to plasma                                                        capsule contains 12      daily (morning and
proteins is 61%-64%.                                                     mcg of formoterol and    evening)
Four cytochrome                                                          25 mg of lactose for
P450 isozymes                                                            use with Aerolizer
(CYP2D6, CYP2C19,                                                        inhaler. (US6488027).
CYP2C9 and
CYP2A6) are
involved in the
metabolism. t1/2 is 10
hrs.
-   -   ·804.9: formoterol   ·Slightly Soluble:    AirMax DPI   -
        fumarate             formoterol fumarate
Inhaled formoterol is   -   ·804.9: formoterol   ·Slightly Soluble:    Certihaler is a novel,     FORADIL®
rapidly absorbed. It is     fumarate             formoterol fumarate   breath-activated multi-    CERTIHALER®
largely metabolised by                                                 dose dry powder            contains a powder
glucuronidation and O-                                                 inhaler technology         formulation of
demethylation, with                                                    developed by               formoterol fumarate
about 10% being                                                        SkyePharma.                intended for oral
excreted as                                                            Contains 60 doses.         inhalation only. Each
unchanged drug. The                                                    The device provides        actuation of FORADIL
terminal t1/2 is                                                       patients confirmation      CERTIHALER
estimated to be 8 hrs.                                                 that the full dose has     delivers approximately
Onset of action in 1-3                                                 been administered.         8.5 mcg of formoterol
minutes with 12 hours                                                  Embodies two               fumarate from the
of bronchodilation.                                                    proprietary                mouthpiece (based on
                                                                       SkyePharma                 in vitro testing at 60
                                                                       technologies, the          L/min for 2 sec),
                                                                       SKYEHALER breath-          corresponding to a
                                                                       actuated multi-dose        metered dose of 10
                                                                       dry powder inhaler         mcg of formoterol
                                                                       device and                 fumarate. Twice daily
                                                                       SKYEPROTECT, a             administration
                                                                       powder formulation
                                                                       that protects the drug
                                                                       from atmospheric
                                                                       moisture to ensure
                                                                       product stability and
                                                                       dose-to-dose
                                                                       reproducibility. Foradil
                                                                       currently marketed as
                                                                       a single dose DPI.
                                                                       Excipients: Lactose
                                                                       monohydrate (which
                                                                       contains trace levels
                                                                       of milk proteins) and
                                                                       magnesium stearate.
Inhaled formoterol is   -   ·344.405: formoterol   ·Slightly Soluble:    NOVOLIZER         6 and 12 microgram
rapidly absorbed. It is                            formoterol            technology        doses
largely metabolised by
glucuronidation and O-
demethylation, with
about 10% being
excreted as
unchanged drug. The
terminal elimination
t1/2 is estimated to be
8 hrs.


-                       -   ·804.9: formoterol     ·Slightly Soluble:    Skyeprotect HFA   -
                            fumarate               formoterol fumarate   formulation
Inhaled formoterol is   -   ·804.9: formoterol     ·Slightly Soluble:    Modulite HFA MDI   each actuation
rapidly absorbed and        fumarate               formoterol fumarate                      provides 12
metabolised by                                                                              microgram drug
glucuronidation and O-
demethylation, with
about 10% being
excreted as
unchanged drug. The
terminal t1/2 after
inhalation is estimated
to be 8 h.




-                       -   ·804.9: formoterol     ·Slightly Soluble:    Powderwhirl        -
                            fumarate               formoterol fumarate




-                       -   ·344.405: formoterol   ·Slightly Soluble:    -                  -
                                                   formoterol
Preliminary           -   ·521.04:              ·Practically Insoluble:   NEXT DPI   Phase II trials daily
pharmacokinetic and       beclomethasone        beclomethasone                       dosages are 400/24
pharmacodynamic           dipropionate·804.9:   dipropionate·Slightly                µg and 100/6 µg
investigations with       formoterol fumarate   Soluble: formoterol
Foster® DPI have                                fumarate
been completed.
(source: company
website)
-   -   ·430.53: budesonide   ·Practically Insoluble:   Miat-Haler, multidose    -
                              budesonide                DPI




-   -   -                     -                         -                        -


-   -   ·516.3: oglemilast    ·: oglemilast             Phase II studies utilize -
                                                        a once-daily-dosing
                                                        regimen.

-   -   -                     -                         -                        -




-   -   -                     -                         Pulmonary delivery       -


-   -   ·137.136: MABA        ·Slightly Soluble:        Undisclosed inhalation Once daily
                              MABA                      technology (DPI or
                                                        MDI)
-   -   ·425.4: darotropium   ·: darotropium bromide Novel dry powder       The long duration of
        bromide                                      inhaler (Source:       action of GSK233705
                                                     clinicaltrials.gov     when administered via
                                                     NCT00783003)           inhalation in animal
                                                                            models supports the
                                                                            potential for use as a
                                                                            once-daily
                                                                            bronchodilator for
                                                                            chronic obstructive
                                                                            pulmonary disease.
                                                                            trials


-   -   -                     -                         -                   -


-   -   ·538.6: fluticasone   ·Practically Insoluble:   DPI assumed to be   In Phase II study
        furoate               fluticasone furoate       Diskus inhaler      started October 2008,
                                                                            GW685698X is being
                                                                            dosed 200mcg once
                                                                            daily or 100mcg twice
                                                                            daily.
                                                                            (clinicaltrials.gov,
                                                                            NCT00766090).In
                                                                            Phase 2b trial, a
                                                                            range of eight doses
                                                                            (25 ? 800 mcg)of
                                                                            GW685698X was
                                                                            administered.[51771]
-   -   ·538.6: fluticasone   ·Practically Insoluble:   GW642444M and          In separate phase 2b
        furoate               fluticasone furoate       GW685698X will be      studies assessing
                                                        simultaneously co-     efficacy and safety of
                                                        administered from a          s
                                                                               GSK“ inhaled
                                                        single device trials   corticosteroid (ICS)
                                                                               fluticasone furoate
                                                                               (FF or GW685698)
                                                                               eight doses (25 “ 800
                                                                               mcg) in over 1,800
                                                                               patients with mild,
                                                                               moderate and severe
                                                                               asthma were treated
                                                                               [51747].




-   -   -                     -                         -                      -
-   -   -                      -                     -                      -


-   -   ·430.38: ipratropium   ·Freely Soluble:      Generic for Atrovent   250 mcg/mL. Supplied
        bromide hydrate        ipratropium bromide                          as a 20 mL clear
                               hydrate                                      colorless solution
                                                                            containing 0.025%
                                                                            ipratropium bromide in
                                                                            isotonic solution
                                                                            preserved with
                                                                            benzalkonium chloride
                                                                            0.025% and disodium
                                                                            edetate 0.05% in an
                                                                            amber glass bottle
                                                                            with screw cap.
-   -   ·430.38: ipratropium   ·Freely Soluble:      Ipratropium nebules.   1 or 2 mL of clear
        bromide hydrate        ipratropium bromide   Generic for Atrovent   colorless solution
                               hydrate                                      containing 0.025%
                                                                            ipratropium bromide in
                                                                            isotonic solution,
                                                                            presented in plastic
                                                                            single use vial. Each
                                                                            vial contains,
                                                                            respectively, a total of
                                                                            250 or 500 mcg
                                                                            ipratropium bromide.
-   -   ·548.24: albuterol   ·Freely Soluble:    Generic for Ventolin   5 mg/mL in bottles of
        sulfate              albuterol sulfate   Resp. Solution         10 mL.




-   -   ·548.24: albuterol   ·Freely Soluble:    Generic for Ventolin   2.5 or 5 mg solution
        sulfate              albuterol sulfate   Nebules                supplied in 2.5 mL
                                                                        translucent nebules.




-   -   -                    -                   -                      -
-   -   ·430.53: budesonide   ·Practically Insoluble:   -   -
                              budesonide
Budesonide is rapidly -   ·430.53: budesonide   ·Practically Insoluble:   Equivalent to   100 mcg drug twice
and almost completely                           budesonide                Turbohaler      daily.
absorbed following
administration by
mouth, but has poor
systemic availability
(about 10%) due to
extensive first-pass
metabolism in the
liver, mainly by the
cytochrome P450
isoenzyme CYP3A4.
The major
metabolites, 6-β-
hydroxybudesonide
and 16-α-
hydroxyprednisolone
have less than 1% of
the glucocorticoid
activity of unchanged
budesonide. t1/2 is 2 -
4 hrs. (REF 1-
(Pubmed
id:11475468), REF 2-
(Pubmed
id:15355126))
-   -   ·430.53:              ·Practically Insoluble:   -   -
        budesonide·344.405:   budesonide·Slightly
        formoterol            Soluble: formoterol
-   -   ·398.335:              ·Soluble:              -   -
        glycopyrrolate bromide glycopyrrolate bromide




-   -   -                      -                      -   -
-   -   -                      -                      -                      -




-   -   ·: undisclosed small   ·: undisclosed small   HFA formulation of a   -
        molecule·:             molecule·:             corticosteroid and a
        undisclosed small      undisclosed small      beta-2-agonist.
        molecule               molecule
-   -   -   -   -   -




-   -   -   -   -   -
After a single          -   ·227.73: tulobuterol   ·Practically Insoluble:   Each HOKUNALIN          HOKUNALIN Tapes
transdermal                                        tulobuterol               Tapes 0.5mg, 1 mg       are drug-in-adhesive
application                                                                  and 2 mg contains 0,5   patches containing
of 2mg via patch for                                                         mg , 1 mg and 2 mg      0.5, 1 and 2 mg
24hrs to healthy                                                             of tulobuterol          tulobuterol for
adults, are                                                                  respectively.           transdermal delivery
Cmax(ng/mL): 1.35                                                            Polyisobutylene,        to be worn before
Tmax(hr): 11.8 AUC0-                                                         Polybutene, Alicyclic   use.
∞(ng・h                                                          saturated hydrocarbon   It is attached on the
r/mL): 27.8                                                                  resin are excipients.   skin of chest, back or
T1/2(hr):5.9. A single                                                                               upper arm once a
transdermal                                                                                          day. For adults,
application of                                                                                       HOKUNALIN Tape
tulobuterol for 24hrs                                                                                2mg (2mg of
to pediatric patients                                                                                tulobuterol) is applied.
with bronchial asthma                                                                                For children from 6
was performed with a                                                                                 months to less than 3
1mg patch for patients                                                                               years of age,
4 to 9 years of age                                                                                  HOKUNALIN Tape
(weight 18.0 to                                                                                      0.5mg (0.5mg of
26.5kg) and 2mg                                                                                      tulobuterol) is applied.
patch for patients 9 to                                                                              For children from 3 to
13 years of age                                                                                      less than 9 years of
(weight 33.0 to                                                                                      age, HOKUNALIN
41.7kg)                                                                                              Tape 1mg (1mg of
respectively.After one                                                                               tulobuterol) is applied.
tulobuterol patch                                                                                    For children of 9 years
(4mg) was applied to                                                                                 of age and older,
the skin of healthy                                                                                  HOKUNALIN Tape
adults for 24hrs, the                                                                                2mg (2mg of
unchanged                                                                                            tulobuterol) is applied.
compound,
3-hydroxy compound,
4-hydroxy compound,
-                       -   -                      -                         -                       -
-   -   -   -   -   -


-   -   -   -   -   -


-   -   -   -   -   -


-   -   -   -   -   -


-   -   -   -   -   -




-   -   -   -   -   -
-   -   ·50708.2: cintredekin   ·: cintredekin   IL13-PE38QQR is a          IL13-PE38QQR is
        besudotox               besudotox        targeted molecule          administered directly
                                                 composed of two            to brain tumors
                                                 parts: a tumor-            through positive-
                                                 targeting molecule         pressure convection-
                                                 (IL13) and a cytotoxic     enhanced delivery.
                                                 agent (PE38). IL13         The anticancer agent
                                                 receptors are found        is delivered
                                                 on malignant glioma        continuously by
                                                 cells, but not to any      infusion (0.25 ug/mL
                                                 measurable degree, if      or 0.5 ug/mL) infused
                                                 at all, on healthy brain   over 96 hours.
                                                 cells. Cintredekin
                                                 besudotox is designed
                                                 to bind to IL13
                                                 receptors on the
                                                 tumor.




-   -   -                       -                -                          -

-   -   -                       -                -                          -
-   -   ·145400:             ·: anrukinzumab         -   -
        anrukinzumab

-   -   ·309.4: nadolol      ·Slightly Soluble:      -   -
                             nadolol




-   -   ·499.65: suplatast   ·: suplatast tosilate   -   50 and 100 mg
        tosilate                                         capsules
-   -   ·499.65: suplatast    ·: suplatast tosilate   -   5% dry syrup
        tosilate




-   -   -                     -                       -   Phase IIb dosing: 20
                                                          mg once daily [5070].




-   -   -                     -                       -   -




-   -   ·1304.52: icatibant   ·Soluble: icatibant     -   -




-   -   -                     -                       -   -
-   -   ·430.53: budesonide   ·Practically Insoluble:   -                  administered as
                              budesonide                                   doses of 400mcg




-   -   -                     -                         Nektar pulmonary   -
                                                        delivery system
-   -   ·548.24: albuterol    ·Freely Soluble:          -                  -
        sulfate               albuterol sulfate




-   -   -                     -                         -                  -
This drug is a product -   ·512.33: cromolyn   ·Soluble: cromolyn   Inactive ingredient:   20 mg/ml metered-
in which the inactive      sodium              sodium               Povidone               dose spray type
ingredients of                                                      Macrogol 600           aerosol unit.
chlorofluorocarbon                                                  1,1,1,2,3,3,3,-        Inhale a dose of two
group (specific fron),                                              heptafluoropropane     sprays (2 mg as
etc. contained in                                                   (HFA-227)              sodium
INTAL                                                                                      cromoglicate)
Aerosol are altered.                                                                       four times daily
After a dose of two                                                                        (morning, noon,
sprays (2 mg as                                                                            evening and at
sodium                                                                                     bedtime).
cromoglicate) of this                                                                      When the symptoms
product and INTAL                                                                          have been alleviated,
Aerosol inhaled                                                                            the dosage should
in 35 healthy adults by                                                                    be reduced to two to
cross-over method,                                                                         three times daily
maximum plasma                                                                             under careful
concentrations were                                                                        observation
3.15 ng/mL at 0.33                                                                                       s
                                                                                           of the patient“ clinical
hours and 3.20                                                                             condition.
ng/mL
at 0.20 hours,
respestively. In 11
healthy adults inhaled
the
above dose of this
product and INTAL
Aerosol, urinary
excretion
rates up to 24 hours
after the inhalation
were 6.83% and
5.61% of the
administered dose,
One capsule of this     -   ·512.33: cromolyn   ·Soluble: cromolyn   -   20 mg light orange
product (20 mg as           sodium              sodium                   transparent/colorless
sodium                                                                   transparent, hard
cromoglicate)                                                            capsules.
with an inhaling                                                         Bronchial asthma:
instrument for the                                                       The product should be
exclusive use of                                                         inhaled in a dose of 1
this product                                                             capsule
(Spinhaler) and one                                                      (20 mg as sodium
ampoule of INTAL                                                         cromoglicate), 3 to 4
Nebuliser                                                                times daily
Solution (20 mg as                                                       (morning, noon and
sodium                                                                   before sleeping, or
cromoglicate/2 mL)                                                       morning,
with                                                                     noon, evening and
an electromotive                                                         before sleeping) with
nebulizer were                                                           an inhaling
administered to 10                                                       instrument for the
healthy                                                                  exclusive use of this
adults, respectively by                                                  product.
cross-over method.                                                       When the symptoms
The urinary excretion                                                    have been alleviated,
rates up to 24 hours                                                     the dosage
after inhalation were                                                    should be reduced to
7.92%                                                                    2 to 3 capsules daily
and 4.83% of                                                             under
administered dose,                                                       careful observation of
respectively.3) The                                                                  s
                                                                         the patient“ clinical
difference                                                               condition.
of the results was                                                       Allergic rhinitis: The
considered to be due                                                     product should be
to difference                                                            inhaled to each nasal
of inhalation method.                                                    cavity in
In 4 healthy                                                             a dose of 1 capsule
-   -   ·512.33: cromolyn   ·Soluble: cromolyn   HFA based MDI   -
        sodium              sodium
Poorly absorbed from   -   ·512.33: cromolyn   ·Soluble: cromolyn   Inactive ingredients:   Each dose contains 5
GI tract but readily       sodium              sodium               sorbitan trioleate,     mg cromolyn sodium.
absorbed in lung. 8%                                                macrogal 600, CFC       Each 8.1 g canister
of delivered dose is                                                propellants.            delivers at least 112
absorbed in lung.                                                                           metered inhalations
                                                                                            (56 doses); each 14.2
                                                                                            g canister delivers at
                                                                                            least 200 metered
                                                                                            inhalations (100
                                                                                            doses). Two
                                                                                            inhalations, four times
                                                                                            daily
After administration by -   ·512.33: cromolyn   ·Soluble: cromolyn   Clear, colorless (or     Each 2 mL ampule
inhalation,                 sodium              sodium               very pale), sterile      contains 20 mg
approximately 8% of                                                  solution for             cromolyn sodium,
the total cromolyn                                                   nebulization. Contains   USP, in purified water.
sodium dose                                                          1% w/w active and        Dose four times daily.
administered is                                                      purified water.
absorbed and rapidly
excreted unchanged,
approximately equally
divided between urine
and bile.
-   -   ·512.33: cromolyn   ·Soluble: cromolyn   Generic for Intal       2 mL vials containing
        sodium              sodium               inhalation Solutions.   20 mg drug
                                                 Drug in purified water.
-   -   ·512.33: cromolyn   ·Soluble: cromolyn   Generic for Intal      10 mg/mL
        sodium              sodium               inhalation Solutions
Poorly absorbed from   -   ·512.33: cromolyn   ·Soluble: cromolyn   20 mg of micronized       Sodium Cromoglicate
GI tract but readily       sodium              sodium               cromyln sodium in         20.0 mg. The normal
absorbed in lung. 8%                                                hard gelatin capsule      dose is one Spincap
of delivered dose is                                                for use in Spinhaler or   four times daily
absorbed in lung.                                                   other capsule based
                                                                    DPI device.
-   -   ·512.33: cromolyn   ·Soluble: cromolyn   Inactive ingredients:   Each dose contains
        sodium              sodium               povidone, macrogal      5mg cromolyn
                                                 600, heptafluro         sodium. Two
                                                 propane non-CFC         inhalations, four times
                                                 propellant.             daily.
-   -   ·430.38: ipratropium   ·Freely Soluble:      -   -
        bromide hydrate        ipratropium bromide
                               hydrate
small amount of          -   ·430.38: ipratropium   ·Freely Soluble:      -   250 micrograms/ ml,
ipratropium enters the       bromide hydrate        ipratropium bromide       500 micrograms /
systemic circulation, if                            hydrate                   2ml.
some ipratropium is
swallowed, it is poorly                                                       20 or 40 micrograms
absorbed from GI                                                              three or four times
tract.                                                                        daily is the usual UK
                                                                              dose and it may be up
                                                                              to 80 micrograms as a
                                                                              single dose. The daily
                                                                              dose should not
                                                                              exceed 216
                                                                              micrograms (12
                                                                              inhalations). In
                                                                              children aged 6 to 12
                                                                              years the usual dose
                                                                              is 20 or 40
                                                                              micrograms three
                                                                              times daily, and below
                                                                              6 years the usual
                                                                              dose is 20
                                                                              micrograms three
                                                                              times daily.
-   -   ·512.333: sodium   ·Soluble: sodium   -   1% isotonic solution
        cromoglycate       cromoglycate




-   -   -                  -                  -   -

-   -   -                  -                  -   -
-   -   ·530.7: tipelukast   ·: tipelukast   -   In the phase II/III
                                                 interstitial cystitis trial,
                                                 patients were given
                                                 500mg MN-001 once
                                                 or twice a day for 8
                                                 weeks [15029].

                                                 In the Phase III
                                                 Asthma trial patients
                                                 were to receive
                                                 placebo or MN-001
                                                 (750 mg BID, 500 mg
                                                 TID) for 12 weeks.
-   -   ·: undisclosed small   ·: undisclosed small   ICS/LABA               -
        molecule·:             molecule·:             Combination
        undisclosed small      undisclosed small
        molecule               molecule




-   -   -                      -                      ICS molecule in Aero   -
                                                      Device MDI
-   -   -                      -                      -                      -


-   -   -                      -                      -                      -
-   -   -                     -                        -   -

-   -   ·955.1: bedoradrine   ·: bedoradrine sulfate   -   In the Phase Ib clinical
        sulfate                                            trial volunteers
                                                           received a single-
                                                           dose intravenous
                                                           infusion regimen of
                                                           MN-221, consisting of
                                                           two consecutive
                                                           rounds of a 15-minute
                                                           priming and a 105-
                                                           minute maintenance
                                                           infusion to deliver 294
                                                           micrograms of MN-
                                                           221 over four hours.
                                                           [23946]
                                                           The Phase IIa study
                                                           for treatment of status
                                                           asthmaticus achieved
                                                           statistical significance
                                                           in its primary endpoint
                                                           of mean change in
                                                           FEV1 (forced
                                                           expiratory volume in 1
                                                           second) from baseline
                                                           at 15 minutes (the end
                                                           of the infusion) at
                                                           doses of 10, 16, 30
                                                           and 60
                                                           micrograms/min of
                                                           MN-221 (p less than
                                                           or equal to 0.0006).
                                                           [26230]
                                                           In Phase II trial, MN-
                                                           221 administered 16
                                                           micrograms/min for
-   -   -                    -                       -                     -




-   -   ·230.31: ibudilast   ·Very Slightly Soluble: -                     10 mg capsules.
                             ibudilast                                     Asthma: 10 mg twice
                                                                           daily. Cerebrovascular
                                                                           disorders: 10 mg
                                                                           three times daily.




-   -   -                    -                       -                     -

-   -   -                    -                       -                     -

-   -   -                    -                       -                     -

-   -   -                    -                       -                     -

-   -   -                    -                       Almirall intends to    Once daily
                                                     further develop this
                                                     compound with the
                                                     same proprietary
                                                     inhaler device used
                                                     for aclidinium bromide
                                                     (Genuair device).
                                                     [35230]
-   -   -                    -                       -                     -
-   -   -   -   -   Supplied as 0.25
                    gram tablets

-   -   -   -   -   -
         has
Lodotra“ been           -   ·358.431: prednisone   ·Very Slightly Soluble: Geoclock formulation. 1 mg, 2 mg, and 5 mg
designed so that                                   prednisone                         is
                                                                            Lodotra“ comprised tablets
maximum plasma                                                             of an active core
levels are reached six                                                     containing
hours after intake.                                                        prednisone, which is
This enables a patient                                                     encapsulated by an
to swallow the tablet                                                      inactive porous shell.
at 10pm before going                                                       The inactive shell acts
to sleep, with the dose                                                    as a barrier between
of prednisone not                                                                        s
                                                                           the product“ active
being released until                                                       core and a patient“ s
2am, reaching                                                              gastrointestinal fluids.
maximum plasma                                                             Following ingestion of
levels at 4am which is                                                              ,
                                                                           Lodotra“water in the
regarded as the                                                            digestive tract diffuses
optimal timing to                                                          through the shell to
relieve the stiffness                                                      the active core which
and pain on waking.                                                        expands, leading to a
                                                                           weakening and
                                                                           breakage of the shell
                                                                           allowing a release of
                                                                           prednisone from the
                                                                           core tablet. This
                                                                           proprietary technology
                                                                           is able to define the
                                                                           period of delay
                                                                           between ingestion and
                                                                           dissolution of the
                                                                           active core by the
                                                                                  s
                                                                           patient“
                                                                           gastrointestinal fluids.
                                                                           In the case of Lodotra“  ,
                                                                           this period is
                                                                           approximately four
-                       -   -                      -                       -                          -
In the randomized,      -   ·466.95: loteprednol   ·: loteprednol   -   In a single-center,
double-blind (except        etabonate              etabonate            double-blind, placebo-
for fluticasone                                                         controlled, parallel-
propionate ), parallel-                                                 group trial 165
group study (n =                                                        subjects with SAR to
8/group), all subjects                                                  grass pollen received
received for 14 days                                                    daily single doses of
once daily in the                                                       either 100, 200, 400
morning two puffs of                                                    μg LE nasal
the following nasal                                                     spray, or placebo for
spray formulations                                                      14 days [REF 1 -
into each nostril: LE                                                   (Pubmed
0.1% (400                                                               id:15679722)] .
microg/day), LE 0.2%
(800 microg/day), FP
0.05% (200
microg/day), and
placebo. All
formulations were
rapidly absorbed
(t(max) less than 1 h).
The rather short mean
terminal half-lives of
2.2 +/- 1.5 hours and
1.8 +/- 1.0 hours for
LE 400 microg and LE
800 microg,
respectively, and 4.2
+/- 1.8 hours for the
200-microg FP
treatment explained
the lack of any
accumulation. Mean
peak concentrations
-   -   ·466.95: loteprednol   ·: loteprednol   Novolizer   -
        etabonate              etabonate
It is absorbed rapidly -   ·254.25: diphylline   ·Freely Soluble:   Magnesium stearate,   200 mg and 400 mg
in therapeutically                               diphylline         microcrystalline      tablets dosed every 6
active form and in                                                  cellulose.            hours
healthy volunteers
reaches a mean peak
plasma concentration
of 17.1 mcg/mL in
approximately 45
minutes following a
single oral dose of
1000 mg of LUFYLLIN.
In a Phase I, single-       -   ·: lumiliximab   ·: lumiliximab   Idec's Primatized®      -
dose, dose-escalating                                             antibody technology
clinical trial for allergic
asthma, Cohorts of 3
to 6 patients received
single IV infusions of
either placebo or
IDEC-152 (0.05, 0.25,
1.0, 4.0, 10.0, or 15.0
mg/kg) and Cmax and
AUC of IDEC-152
found to be
proportional to the
dose administered for
the dose range 4.0 to
15.0 mg/kg and t1/2
of the IDEC-152
antibody increased
from 2 to 10 days with
increasing doses. [Ref
1- (Pubmed
id:13679816)]




-                           -   -                -                -                       -




-                           -   -                -                Eiffel SCF technology   -
-   -   ·430.53:              ·Practically Insoluble:   Eiffel ASES SCF          Phase II trial
        budesonide·344.405:   budesonide·Slightly       particle technology to   evaluated two doses
        formoterol            Soluble: formoterol       manufacture              of MAP0005, 104/5.4
                                                        steroid/beta agonist     mcg and 312/16.2
                                                        combinations. Patent     mcg of
                                                        describes                budesonide/formoterol.
                                                        formoterol/budesonide,   [34683]
                                                         salmeterol
                                                        xinafoate/fluticasone
                                                        propionate, formoterol
                                                        fumarate/fluticasone
                                                        propionate, and
                                                        salmeterol xinafoate
                                                        /budesonide as
                                                        potential
                                                        combinations. The
                                                        drugs are combined at
                                                        micron or submicron
                                                        level rather than
                                                        separate particles
                                                        which can improve
                                                        dose efficiency and
                                                        consistency.




-   -   -                     -                         -                        -
-                         -   -   -   -   In Phase II trials
                                          escalating multiple SC
                                          doses (0.3 mg/kg, 1
                                          mg/kg, 3 mg/kg) of
                                          MEDI-528 were
                                          administred. In Phase
                                          IIA trials MEDI-528
                                          was administred as a
                                          Subcutaneous
                                          injection twice weekly
                                          for 4 weeks (total of 8
                                          doses) at Day 0
                                          through Day 24. In
                                          another Phase IIA
                                          trials the patients
                                          received MEDI-528
                                          (9.0 mg/kg) as a
                                          single IV infusion. In
                                          Phase II trials patients
                                          received single IV
                                          dose of MEDI-528.




Studies in three          -   -   -   -   In the Phase 2a trial,
species demonstrate                       600 mg of MEM 1414
high oral bioavailability                 was administered.
with a safety profile,
that is significantly
superior to other PDE-
4 inhibitors.
-   -   ·335.83: procaterol   ·Soluble: procaterol   Dehydrated ethanol,   Each gram of
        hydrochloride         hydrochloride          oleic acid, and       MEPTIN Air 10
                                                     1,1,1,2,3,3,3-        μg contains 143
                                                     heptafluoropropane    μg of
                                                     (HFA-227) are used    procaterol
                                                     as inactive           hydrochloride, and a
                                                     ingredients.          single puff delivers 10
                                                                           μg
                                                                           of the active
                                                                           ingredient. Each
                                                                           container contains 5
                                                                           mL of
                                                                           the drug suspension
                                                                           and provides about
                                                                           100 puffs.
                                                                           MEPTIN Air 10
                                                                           μg is delivered
                                                                           as a mist, when
                                                                           shaken
                                                                           well and sprayed
                                                                           through anadapter.
                                                                           The usual adult dose
                                                                           is 20 μg (2
                                                                           puffs) of procaterol
                                                                           hydrochloride. For
                                                                           children the amount
                                                                           should be reduced to
                                                                           10 μg (1 puff) of
                                                                           procaterol
                                                                           hydrochloride.
When MEPTIN              -   ·335.83: procaterol   ·Soluble: procaterol   Inactive                 MEPTIN Drysyrup
Drysyrup 0.005%              hydrochloride         hydrochloride          ingredients: sucrose,    0.005% is a white
were administered                                                         ascorbic acid,           odorless powder or
orally to 44 healthy                                                      anhydrous citric acid,   granules with a sweet
male subjects at                                                          and light anhydrous      taste.
single doses of 100                                                       silicic acid.
μg/subject (The                                                                               The usual adult dose
approved dose for a                                                                                is 50 μg of
single administration                                                                              procaterol
of                                                                                                 hydrochloride (1 g
MEPTIN Drysyrup                                                                                    of MEPTIN Drysyrup
0.005% for adults is                                                                               0.005%) once daily (at
50 μg), Cmax                                                                                  bedtime) or
(pg/mL): 298±111;                                                                                  twice daily (in the
tmax (hr): 1.3±0.7; t1/2“                                                                          morning and at
(hr): 4.2±1.7;                                                                                     bedtime) by the oral
AUC13hr (pg.hr/mL):                                                                                route.
1207±338.“                                                                                         MEPTIN Drysyrup
                                                                                                   0.005% is prepared
When MEPTIN                                                                                        into a solution at the
Tablets were                                                                                       time of use.
administered orally at                                                                             The dose for children
single                                                                                             6 years of age or older
doses of 50 and 100                                                                                is 25 μg of
μg/subject as                                                                                 procaterol
procaterol                                                                                         hydrochloride (0.5 g of
hydrochloride, 9.93%                                                                               MEPTIN Drysyrup
and 11.65% of the                                                                                  0.005%) once daily (at
dose wasexcreted into                                                                              bedtime) or twice daily
the urine within 24                                                                                (in the
hours                                                                                              morning and at
postdosing,respectivel                                                                             bedtime) by the oral
y.                                                                                                 route.
When MEPTIN             -   ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients: D-   MEPTIN Granules are
Tablets were                hydrochloride         hydrochloride          mannitol, purified         white odorless
administered orally to                                                   sucrose, corn starch,      granules with a sweet
6 healthy male                                                           crystalline cellulose,     taste. Each gram of
subjects at single                                                       and anhydrous citric       MEPTIN Granules
doses of 50 and 100                                                      acid.                      contains 100 μg
μg/subject as                                                                                  of
procaterol                                                                                          procaterol
hydrochloride (The                                                                                  hydrochloride.
approved dose for a
single oral                                                                                         The usual adult dose
administration                                                                                      is 50 μg of
of MEPTIN Tablets for                                                                               procaterol
adults is 50 μg.),                                                                             hydrochloride (0.5
Cmax: 97 pg/mL, 226                                                                                 g of MEPTIN
pg/mL;                                                                                              Granules) once daily
Tmax: 1.1 hr, 1.5 hr;                                                                               (at bedtime) or twice
t1/2: not determined,                                                                               daily
3.6 hr, respectively.                                                                               (in the morning and at
                                                                                                    bed time) by the oral
When MEPTIN                                                                                         route.
Tablets were                                                                                        The dose for children
administered orally at                                                                              6 years of age or older
single                                                                                              is 25 μg of
doses of 50 and 100                                                                                 procaterol
μg/subject as                                                                                  hydrochloride (0.25 g
procaterol                                                                                          of MEPTIN
hydrochloride, 9.93%                                                                                Granules)
and 11.65% of the                                                                                   once daily (at
dose were                                                                                           bedtime) or twice daily
excreted into the urine                                                                             (in the morning
within 24 hours                                                                                     and at bedtime) by the
postdosing,                                                                                         oral route.
respectively.                                                                                       The dose for children
When MEPTIN             -   ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients:     100 μg of
Inhalation Solution         hydrochloride         hydrochloride          Anhydrous citric acid,    procaterol
was administered by                                                      sodium hydroxide (pH      hydrochloride/mL.
inhalation to 6 healthy                                                  adjuster), purified       Clear, colorless
male subjects as 4                                                       water. Additionally, 30   liquids. They have no
doses (40 μg                                                        mL/bottle includes        odor.
per                                                                      benzalkonium              The usual adult dose
subject as procaterol                                                    chloride solution.        is 30-50 μg of
hydrochloride), a peak                                                                             procaterol
plasma                                                                                             hydrochloride
concentration of 128                                                                               (0.3-0.5 mL of
pg/mL was attained at                                                                              MEPTIN Inhalation
15 min post-dosing,                                                                                Solution) via a
followed by a gradual                                                                              nebulizer
decline.                                                                                           with deep breathing.
                                                                                                   For children, the
When MEPTIN Air                                                                                    amount should be
was administered by                                                                                reduced to 10-30
inhalation as 4                                                                                    μg of procaterol
doses (40 μg                                                                                  hydrochloride (0.1-0.3
per subject as                                                                                     mL of
procaterol                                                                                         the drug).
hydrochloride),
14.36% of the dose
was excreted in the
urine within 24
hours post-dosing.

The enzyme is mainly
CYP3A4.

(The approved dose
for a single
administration of
-   -   ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients:   MEPTIN Kid Air 5
        hydrochloride         hydrochloride          Dehydrated ethanol,     μg is delivered
                                                     oleic acid, and         as a mist, when
                                                     1,1,1,2,3,3,3-          shaken
                                                     heptafluoropropane      well and sprayed
                                                     (HFA-227).              through an adapter.
                                                                             Each gram of
                                                                             MEPTIN Kid Air 5
                                                                             μg contains 143
                                                                             μg of
                                                                             procaterol
                                                                             hydrochloride, and a
                                                                             single puff delivers 5
                                                                             μg of
                                                                             the active ingredient.
                                                                             Each container
                                                                             contains 2.5 mL of
                                                                             the drug suspension
                                                                             and provides about
                                                                             100 puffs.

                                                                             The usual adult dose
                                                                             is 20 μg (4
                                                                             puffs) of procaterol
                                                                             hydrochloride. For
                                                                             children the amount
                                                                             should be reduced to
                                                                             10 μg (2 puffs)
                                                                             of procaterol
                                                                             hydrochloride.
When MEPTIN Syrup -      ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients:    MEPTIN Syrup is a
was administered         hydrochloride         hydrochloride          Ethyl                    colorless, clear,
orally to 44 healthy                                                  parahydroxybenzoate,     slightly viscous liquid.
male subjects at a                                                    butyl                    It has an orange odor
single dose of 100                                                    parahydroxybenzoate,     and sweet taste.
μg/ subject (The                                                                          pH: 3.5 - 4.5.
approved dose for a                                                   sodium benzoate,         Each mL of MEPTIN
single administration                                                 flavor, purified         Syrup contains 5
of MEPTIN Syrup for                                                   sucrose, ethanol,        μg of procaterol
adults is 50 μg)                                                 anhydrous citric acid,   hydrochloride.
as procaterol                                                         sodium citrate, and      The usual adult
hydrochloride in a                                                    purified water.          dosage is 50 μg
fasting condition,                                                                             of procaterol
Cmax (pg/mL): 263 ±                                                                            hydrochloride
104; tmax                                                                                      (10 mL of MEPTIN
(hr): 1.3 ± 0.7; t1/2                                                                          Syrup) once daily (at
(hr): 4.1 ± 1.8;                                                                               bed time) or twice
AUC13hr                                                                                        daily (in the morning
(pg.hr/mL): 1151 ±                                                                             and at bed time) by
288.                                                                                           the oral route.
                                                                                               The dose for children
When MEPTIN                                                                                    6 years of age or older
Tablets were                                                                                   is 25 μg of
administered orally at                                                                         procaterol
single                                                                                         hydrochloride (5 mL of
doses of 50 and 100                                                                            MEPTIN Syrup) once
μg/subject as                                                                             daily
procaterol                                                                                     (at bed time) or twice
hydrochloride,                                                                                 daily (in the morning
9.93% and 11.65% of                                                                            and at bed time) by
the dose were                                                                                  the oral route.
excreted into the                                                                              The dose for children
urine                                                                                          younger than 6 years
within 24 hours                                                                                of age is 1.25
When MEPTIN            -   ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients:   MEPTIN Tablets are
Tablets were               hydrochloride         hydrochloride          D-mannitol, corn        white compressed
administered orally to                                                  starch, crystalline     tablets scored on one
6 healthy male                                                          cellulose,              side. Each MEPTIN
subjects as single                                                      hydroxypropylmethylce   Tablets contains 50
doses of 50 or 100                                                      llulose,                μg of procaterol
μg/subject as                                                      and magnesium           hydrochloride.
procaterol                                                              stearate.
hydrochloride (The                                                                              The usual adult dose
approved dose for a                                                                             of MEPTIN Tablets is
single oral                                                                                     50 μg of
administration of                                                                               procaterol
MEPTIN Tablets for                                                                              hydrochloride (one
adults is 50 μg),                                                                          tablet) once daily (at
Cmax: 97 pg/mL, 226                                                                             bedtime) or twice
pg/mL; Tmax: 1.1 hr,                                                                            daily (in the morning
1.5 hr; t1/2: not                                                                               and at bedtime) by the
determined, 3.6 hr,                                                                             oral route.
respectively.

When MEPTIN
Tablets were
administered orally at
single
doses of 50 and 100
μg/subject as
procaterol
hydrochloride,
9.93% and 11.65% of
the dose were
excreted into the
urine
within 24 hours
postdosing,
When MEPTIN              -   ·335.83: procaterol   ·Soluble: procaterol   Inactive ingredients:   MEPTIN-Mini Tablets
Tablets were                 hydrochloride         hydrochloride          D-mannitol, corn        are white compressed
administered orally to                                                    starch, crystalline     tablets scored on one
6 healthy male                                                            cellulose,              side. Each MEPTIN-
subjects at single                                                        hydroxypropylmethylce   Mini Tablet contains
doses of 50 and 100                                                       llulose, and            25 μg of
μg/subject as                                                        magnesium stearate.     procaterol
procaterol                                                                                        hydrochloride.
hydrochloride (The
approved dose for a                                                                               The usual adult dose
single oral                                                                                       of MEPTIN Mini
administration of                                                                                 Tablet is 50 μg
MEPTIN Tablets for                                                                                of
adults is 50 μg.),                                                                           procaterol
Cmax: 97 pg/mL, 226                                                                               hydrochloride (two
pg/mL; Tmax: 1.1 hr,                                                                              tablets) once daily (at
1.5 hr; t1/2: not                                                                                 bedtime)
determined, 3.6 hr,                                                                               or twice daily (in the
respectively. When                                                                                morning and at
MEPTIN Tablets were                                                                               bedtime) by the oral
administered orally at                                                                            route.
single doses of 50                                                                                The dose for children
and 100                                                                                           6 years of age or older
μg/subject as                                                                                is 25 μg (one
procaterol                                                                                        tablet) once daily (at
hydrochloride, 9.93%                                                                              bedtime) or twice daily
and 11.65% of the                                                                                 (in the morning and at
dose were excreted                                                                                bedtime) by the oral
into the urine within 24                                                                          route.
hours postdosing,
respectively. The
enzyme is mainly
CYP3A4.
-   -   ·358.843: etoricoxib   ·Practically Insoluble:   -                      Phase 2 Asthma trial
                               etoricoxib                                       dosage was 5mg po
                                                                                qd.trials
                                                                                Phase 2
                                                                                Atherosclerosis and
                                                                                COPD trial dosage
                                                                                was 100mg. trials
-   -   -                      -                         -                      -




-   -   -                      -                         -                      -


-   -   ·530.7: tipelukast     ·: tipelukast             -                      -


-   -   -                      -                         -                      -


-   -   -                      -                         Aerosol formulation or -
                                                         nebulizable powder




-   -   -                      -                         -                      -
Low systemic             -   ·300.353: pirbuterol   ·Freely Soluble:     MAXAIR                    200 mcg/inh. Each
concentration. t1/2 is       acetate                pirbuterol acetate   AUTOHALER is a            14.0 g canister
2 hrs.                                                                   pressurized metered-      provides 400
                                                                         dose aerosol unit for     inhalations and each
                                                                         oral inhalation. It       2.8 g canister
                                                                         provides a fine-          provides 80
                                                                         particle suspension of    inhalations.
                                                                         pirbuterol acetate in     The usual dose for
                                                                         the propellant mixture    adults and children 12
                                                                         of trichioro-             years and older is two
                                                                         monofluoromethane         inhalations (400 mcg)
                                                                         and                       repeated every 4-6
                                                                         dichlorodifluoromethan    hours. A total daily
                                                                         e, with sorbitan          dose of 12 inhalations
                                                                         trioleate. Each           should not be
                                                                         actuation delivers 253    exceeded.
                                                                         mcg of drug from the
                                                                         valve and 200 mcg of
                                                                         drug from the
                                                                         mouthpiece. The unit
                                                                         is breath-actuated
                                                                         such that the
                                                                         medication is
                                                                         delivered
                                                                         automatically during
                                                                         inspiration without the
                                                                         need for the patient to
                                                                         coordinate actuation
                                                                         with inspiration.
-   -   ·335.83: procaterol   ·Soluble: procaterol   Clickhaler technology   The usual adult dose
        hydrochloride         hydrochloride                                  is 20 μg (2
                                                                             puffs) of procaterol
                                                                             hydrochloride. For
                                                                             children the amount
                                                                             should be reduced to
                                                                             10 μg (1 puff) of
                                                                             procaterol
                                                                             hydrochloride.




-   -   -                     -                      Combinations            -
                                                     delivered in Miat-
                                                     Haler, multidose DPI
-   -   -                     -                      -                       -
-   -   ·430.53: budesonide   ·Practically Insoluble:   AirMax DPI   -
                              budesonide
-   -   ·521.429:          ·Practically Insoluble:   Mometasone              -
        mometasone         mometasone                Furoate/Formoterol
        furoate·344.405:   furoate·Slightly          Fumarate 200/10mcg
        formoterol         Soluble: formoterol       or 400/10 mcg BID
                                                     delivered by
                                                     pressurized metered-
                                                     dose Inhaler (source:
                                                     clinical trials.gov).
                                                     Product combines
                                                     Novartis“  Foradil®
                                                     (formoterol fumarate),
                                                     a selective, long-
                                                     acting beta2-agonist,
                                                     with Schering-Plough“ s
                                                     Asmanex®
                                                     (mometasone
                                                     furoate), an inhaled
                                                     corticosteroid.
-   -   ·608.18: montelukast   ·Freely Soluble:     -   Phase 3; Intravenous
        sodium                 montelukast sodium       single administration
                                                        trials
-   -   ·110.044: sodium   ·Very Soluble: sodium Inhalation into the     -
        pyruvate           pyruvate              lung by a nebulizer.
                                                 Sodium Pyruvate in
                                                 0.9% sodium chloride
                                                 solution in phase 2
                                                 trial (trials)




-   -   -                  -                     A proprietary           -
                                                 nebulized formulation
                                                 of s-nitrosoglutathione
                                                 [31530]

-   -   -                  -                     3 day patch             -
-   -   ·227.73: tulobuterol   ·Practically Insoluble:   1 day patch         -
                               tulobuterol




-   -   -                      -                         NexACT in           -
                                                         transdermal patch
-   -   -                      -                         Nasal drops         -


-   -   -                      -                         Tablets             In Phase II trials
                                                                             patients were given 4
                                                                             mg and/or 8 mg NM-
                                                                             702 twice a day (BID)
-   -   -   -   -   Once daily
                    administration
When NEOPHYLLIN -          ·420.4: aminophylline   ·Freely Soluble:   Inactive ingredients:   250 mg in 10 mL
Injection 250 mg was                               aminophylline      Ethylenediamine         ampules.
intravenous                                                                                   Administered
drip-infused to 6                                                                             intravenously once to
healthy adult                                                                                 twice daily. If
volunteers                                                                                    necessary, it
(nonsmokers)                                                                                  should be
at a single dose of two                                                                       administrated by
ampulesnote) (400mg                                                                           intravenous drip-
of                                                                                            infusion
theophylline) for 30
min, the peak plasma
theophylline
concentration reached
immediately after
administration,
and was theophylline
disappeared from the
plasma
with a half-life of 9.51
hr. The half-life of
elimination
from the plasma
tended to be shorter
in smokers than in
non-smokers. The
area under the
plasma
concentration
time-curve for
smokers was
significantly as
compared
to non-smokers (p<
When NEOPHYLLIN -        ·420.4: aminophylline   ·Freely Soluble:   Each gram of white to     Each gram of white to
Powder was                                       aminophylline      pale yellow granules      pale yellow granules
administered orally                                                 or powder contains 1      or powder contains 1
to 8 healthy adult                                                  g of aminophylline, JP.   g of aminophylline,
male volunteers at                                                                            JP. The usual adult
100 mg of                                                                                     dosage for oral use is
aminophylline four                                                                            300 to 400 mg of
times a day every 6 hr                                                                        aminophylline daily in
(400                                                                                          three to four divided
mg/day) for 13                                                                                doses.
consecutive times, the                                                                                      s
                                                                                              The children“ dosage
plasma theophylline                                                                           for oral use is 2-4
concentration                                                                                 mg/kg of
increased gradually                                                                           aminophylline three to
for 2 days and                                                                                four times daily.
reached an almost
steady-state on the
third day after
administration (after
48 hr). Range of
effective blood
concentration: 8-
20&#956;g/mL in
adults
Main cytochrome
P450 subfamily
involved in
metabolism:
CYP1A2.
When NEOPHYLLIN -        ·420.4: aminophylline   ·Freely Soluble:   Inactive ingredients:    100 mg white plain
Tablets 100 mg was                               aminophylline      carmellose calcium,      tablet. The usual adult
administered                                                        calcium stearate, corn   dosage is 3 to 4
orally to 7 healthy                                                 starch,                  tablets (300 to 400 mg
adult male volunteers                                               hydroxypropylcellulose   of aminophylline) daily
at 100                                                               and povidone K30.       in three to four divided
mg of aminophylline                                                                          doses. The children“  s
four times a day every                                                                       dosage is 2-4 mg/kg
6 hr (400                                                                                    of aminophylline three
mg/day) for 13                                                                               to four times daily.
consecutive times, the
plasma theophylline
concentration
increased gradually
for 2 days and
reached an almost
steady-state on the
third day after
administration (after
48 hr). Range of
effective blood
concentration: 8-
20&#956;g/mL in
adults
Main cytochrome
P450 subfamily
involved in
metabolism:
CYP1A2.
-   -   ·965.025: nepadutant   ·: nepadutant    -   -




-   -   -                      -                -   -




-   -   ·: neutrazumab         ·: neutrazumab   -   -
Among 10 healthy        -   ·14400: lysozyme   ·Soluble: lysozyme   Inactive ingredients: D- Each 1 g of white fine
adult male volunteers,      hydrochloride      hydrochloride        mannitol                 granules contains 200
five received a 90mg                                                                         mg (potency) of
tablet of NEUZYM                                                                             lysozyme
after fasting overnight                                                                      hydrochloride,
and five served as the                                                                       administered three
control and received                                                                         times daily.
no treatment. Upon
measuring the serum
lysozyme
concentration over
time by the two-site
enzyme immunoassay
for the subjects who
received NEUZYM,
the lysozyme
concentration peaked
at 1,700pg/mL within
1h and decreased to a
non-detectable level
by 48h.
Among 10 healthy        -   ·14400: lysozyme   ·Soluble: lysozyme   Inactive ingredients:   Each 1 g of white
adult male volunteers,      hydrochloride      hydrochloride        corn starch, povidone   granules contains 100
five received a 90mg                                                K30 and D-mannitol      mg (potency) of
tablet of NEUZYM                                                                            lysozyme
after fasting overnight                                                                     hydrochloride,
and five served as the                                                                      administered three
control and received                                                                        times daily.
no treatment. Upon
measuring the serum
lysozyme
concentration over
time by the two-site
enzyme immunoassay
for the subjects who
received NEUZYM,
the lysozyme
concentration peaked
at 1,700pg/mL within
1h and decreased to a
non-detectable level
by 48h.
Among 10 healthy        -   ·14400: lysozyme   ·Soluble: lysozyme   Inactive ingredients:    30 and 90 mg white,
adult male volunteers,      hydrochloride      hydrochloride        calcium stearate,        plain tablets,
five received a 90mg                                                hydroxypropylcellulose   administered three
tablet of NEUZYM                                                     and D-mannitol          times daily.
after fasting overnight
and five served as
the control and
received no
treatment.
Upon measuring the
serum lysozyme
concentration over
time
by the two-site
enzyme immunoassay
for the subjects who
received
NEUZYM, the
lysozyme
concentration peaked
at
1,700pg/mL within 1h
and decreased to a
non-detectable level
by 48h.
-   -   -                     -                         -                       -




-   -   -                     -                         -                       -




-   -   ·430.53: budesonide   ·Practically Insoluble:   Novolizer technology.   One metered dose
                              budesonide                200 µg and 400 µg       contains 200
                                                        budesonide. Inactive    micrograms of
                                                        ingredients: lactose    budesonide. Adults:
                                                        monohydrate             Initial recommended
                                                                                dose: 200 - 400 mcg
                                                                                once or twice daily;
                                                                                max. recommended
                                                                                dose: 800 mcg twice
                                                                                daily. Children: Initial
                                                                                recommended dose:
                                                                                200 mcg twice or 200 -
                                                                                 400 mcg once daily;
                                                                                max. recommended
                                                                                dose: 400 mcg twice
                                                                                daily
Rapidly and            -   ·180.16: theophylline   ·Slightly Soluble:   Excipients: Lactose    175 and 250 mg
completely absorbed                                theophylline         Ph Eur, Cellulose      prolonged release
after oral                                                              Acetate Phthalate Ph   tablets. 1 to 2 tablets
administration in                                                       Eur, Magnesium         twice daily.
solution or immediate-                                                  Stearate Ph Eur
release solid oral
dosage form.
Undergoes extensive
hepatic metabolism.
CL: 0.65 mL/kg/min.
t1/2: 8.7 h. 40%
bound to plasma
proteins. In adults,
about 10% of a dose
of theophylline is
excreted unchanged
in the urine. Vd: 0.45
L/kg (range 0.3-0.7
L/kg).


-                      -   -                       -                    -                      Once daily.

-                      -   -                       -                    -                      -


-                      -   -                       -                    -                      In Phase II, patients
                                                                                               are given OX914 in
                                                                                               doses of 15 or 50 mg
                                                                                               for two weeks. [42449]

-                      -   -                       -                    -                      -
-   -   -   -   Program contains non- -
                steroid anti-
                inflammatory
                substances that have
                shown favorable
                effects in preclinical
                asthma models.
-   -   -   -   -                     -




-   -   -   -   -                     -
-   -   -   -   -                       In Phase II Clinical
                                        Trials, patients with
                                        seasonal allergic
                                        rhinitis will be treated
                                        with a placebo or
                                        OX914 in dosages of
                                        15 or 50 mg for two
                                        weeks in a double-
                                        blind, three-way
                                        cross-over study.
                                        company report
                                        page:5


-   -   -   -   MicroAir nebulizer to   -
                deliver marketed
                nebulizer solutions
When ONON® was          -   ·490.51: pranlukast   ·Practically Insoluble:   Each ONON®             White - yellowish
administered orally to      hydrate               pranlukast hydrate        Capsules contains      white opaque hard
5 healthy adults after                                                      112.5 mg of            112.5 mg
meals at a single dose                                                      Pranlukast hydrate     capsules.The usual
of 225 mg, the plasma                                                       and Macrogol 4000,     adult dosage for oral
concentration reached                                                       magnesium stearate,    use is 450 mg of
a maximum of 642                                                            lactose hydrate        pranlukast hydrate (4
ng/mL about 5 hours                                                         (Capsules containing   capsules) daily in two
after administration                                                        gelatin, macrogol      divided doses after
and decreased with a                                                        4000, sodium lauryl    each meal
half-life of about 1.2                                                      sulfate and titanium   in the morning and
hours.Pranlukast                                                            oxide) as inactive     evening.
hydrate was mainly                                                          ingredients.
metabolized by a
hepatic
drug-metabolizing
enzyme cytochrome
P450 (CYP3A4).
Urinary and fecal
excretions were
0.24% and 98.9%,
respectively.The
protein binding rate to
human serum was
99.7 -
99.8%.(Reference:
Japan Label)
When ONON® Dry          -   ·490.51: pranlukast   ·Practically Insoluble:   Each gram of             White to light yellow
Syrup was                   hydrate               pranlukast hydrate        ONON® Dry Syrup          granules,100 mg dry
administered orally to                                                      10% contains 100 mg      syrup. The usual
6 healthy adults after                                                      Pranlukast hydrate       childhood dosage for
meals at a single dose                                                      and Corn starch,         oral use is 7 mg/kg of
of 2.25g (containing                                                        Hydroxypropylcellulose   pranlukast hydrate (70
225 mg of pranlukast                                                        , sucrose as inactive    mg/kg of dry syrup)
hydrate), the plasma                                                        ingredients.             daily in 2 divided
concentration reached                                                                                doses after each meal
a maximum of 859                                                                                     in the morning and
ng/mL about 5 hours                                                                                  evening, preparing a
after administration                                                                                 suspension each time.
and decreased with a                                                                                 The dosage may be
half-life of about 1.5                                                                               adjusted according to
hours. AUC was                                                                                       the patient's age and
3,487                                                                                                symptoms. The
ng&#8901;hr/mL.Pranl                                                                                 maximum daily dose
ukast hydrate was                                                                                    is 10 mg/kg of
mainly metabolized by                                                                                pranlukast hydrate
a hepatic drug-                                                                                      (100 mg/kg of dry
metabolizing enzyme                                                                                  syrup). It should not
cytochrome P450                                                                                      exceed the usual
(CYP3A4). Urinary                                                                                    adult daily dose of 450
and fecal excretion                                                                                  mg/day of pranlukast
were 0.24% and                                                                                       hydrate (4.5 g/day of
98.9%,                                                                                               dry syrup).
respectively.The
protein-binding rate to
human serum was
99.7 -
99.8%.(Reference:
Japan Label)


-                       -   -                     -                         Sterile, topical product -
Well absorbed.       -   ·484.39: prednisolone ·Freely Soluble:      Taste masked, oral    Oral solution
Solution produces        sodium phosphate      prednisolone sodium   liquid solution       containing 20.2 mg
14% higher Cmax and                            phosphate             containing alcohol,   (15 mg free base)
20% faster Tmax than                                                 fructose, glycerin,   drug in 5 mL. Dosing
tablets.                                                             monoammonium          ranges from 5 mg - 60
                                                                     glycyrrhizinate,      mg of free base per
                                                                     povidone, sodium      day. Doses vary
                                                                     benzoate, sorbitol,   between subjects and
                                                                     and grape flavor.     need to be
                                                                                           individualized.
Prednisolone is       -   ·484.39: prednisolone ·Freely Soluble:      Grape flavored tablet     White, flat faced,
rapidly and well          sodium phosphate      prednisolone sodium   containing citric acid,   beveled 13.4 mg, 20.2
absorbed from the GI                            phosphate             colloidal silicon         mg, and 40.3 mg
tract following oral                                                  dioxide, grape flavor,    (equivalent to 10 mg,
administration. Under                                                 hypromellose,             15 mg, and 30 mg
fasted conditions,                                                    magnesium stearate,       prednisolone base)
Orapred ODT is                                                        mannitol,                 tablets in blisters
bioequivalent to                                                      methacrylate              containing 48 tablets
Orapred Solution                                                      copolymer,                per carton. Each card
                                                                      microcrstalline           contains 6 tablets.
                                                                      cellulose, sodium         Doses are
                                                                      bicarbonate,              individualized with
                                                                      sucralose and             initial dose of 10-60
                                                                      sucrose. Orapred          mg daily. Up to 200
                                                                      ODT is taste-masked,      mg per day may be
                                                                      and non-refrigerated      used in treatment of
                                                                      formulation of            exacerbations of
                                                                      prednisolone.             multiple sclerosis.
                                                                                                The standard regimen
                                                                                                for treatment of
                                                                                                nephrotic syndrome in
                                                                                                pediatric patients is 60
                                                                                                mg/m2 in three
                                                                                                divided doses for four
                                                                                                weeks followed by 40
                                                                                                mg/m2of a single
                                                                                                dose alternate day for
                                                                                                four weeks
-                     -   ·540.69: ciclesonide   ·Practically Insoluble:   HFA formulation,        -
                                                 ciclesonide               generic for Alvesco
                                                                           HFA




-                     -   -                      -                         -                       -




Rapidly absorbed with -   ·804.9: formoterol     ·Slightly Soluble:        Delivers 9 mcg or 4.5   9 micrograms
Tmax is 15 min. 28-       fumarate               formoterol fumarate       mcg of drug. Inactive   formoterol fumarate
49% of drug is                                                             ingredients: lactose    dihydrate. Dosed 1or
delivered to lung.                                                         monohydrate             2 actuations once or
Total systemic BA is                                                                               twice daily.
61%. Plasma protein
binding is 50%. t1/2 is
8 hrs (estimated).




-                     -   -                      -                         -                       -




-                     -   -                      -                         -                       Phase 1 trial: Oral,
                                                                                                   two doses 12 hours
                                                                                                   apart trials
-   -   -                     -               -                     In a Phase 2a study
                                                                    of Single Oral Doses
                                                                    of PF-04191834 to
                                                                    determine the
                                                                    bronchodilatory
                                                                    effects of PF-
                                                                    04191834 compared
                                                                    with zileuton in
                                                                    patients with asthma,
                                                                    single dose 30, 100
                                                                    and 2000 mg PF-
                                                                    04191834 will be
                                                                    administered trials.


-   -   -                     -               -                     -

-   -   -                     -               -                     -


-   -   ·745.25: giripladib   ·: giripladib   Capsule formulation   In the upcoming
                                                                    Phase II osteoarthritis
                                                                    trial, subjects will be
                                                                    randomized to 1 of 6
                                                                    treatment groups:
                                                                    PLA-695 50 mg, 200
                                                                    mg, or 400 mg QD,
                                                                    PLA-695 200 mg BID,
                                                                    placebo, or naproxen
                                                                    500 mg BID.



-   -   -                     -               -                     -
The systemic levels of -   ·548.24: albuterol   ·Freely Soluble:    Bespak MDI Metering     Cannister containing
albuterol are low after    sulfate              albuterol sulfate   Valve technology.       200 doses. 0.108 mg
inhalation of                                                       Microcrystalline        (0.09 mg base) per
recommended                                                         suspension of drug in   inhalation. Dosed two
doses.                                                              ethanol and HFA 134a.   inhalations every 4-6
Cmax and systemic                                                                           hours
exposure (AUCinf)
values are
approximately 4,100
pg/mL and 28,426
   h
pg“r/mL, respectively
compared to
approximately 3,900
pg/mL and 28,395
   h
pg“r/mL,“
respectively following
the same dose of an
active HFA-134a
albuterol inhaler
comparator. The
terminal plasma t1/2
of albuterol delivered
by ProAir HFA
Inhalation Aerosol
was approximately 6
hrs. The primary
enzyme responsible
for the metabolism of
albuterol in humans is
SULTIA3
(sulfotransferase). (R)-
albuterol is
preferentially
metabolized in the
-   -   -   -   -                      -




-   -   -   -   -                      In phase 2 psoriasis
                                       trials 10 mg capsules
                                       given orally,in phase 2
                                       asthma trials 30 mg
                                       capsules given once
                                       daily,in COPD phase
                                       2 trials 1mg,10mg
                                       capsules given 3
                                       times daily.


-   -   -   -   -                      -


-   -   -   -   PW3101 was a           -
                reformulation of a
                branded product that
                is marketed for oral
                asthma.
-   -   -   -   -                      -




-   -   -   -   -                      -
-                      -   -                     -                  New version of          -
                                                                    PXS25, called PXS64
                                                                    delivers PXS25 more
                                                                    effectively to the site
                                                                    of action when
                                                                    administered orally

-                      -   -                     -                  -                       -
-                      -   -                     -                  -                       -




Aminophylline          -   ·456: aminophylline   ·Freely Soluble:   Excipients:              225 mg matrix tablet.
(theophylline) is well     dihydrate             aminophylline      Hydroxyethylcellulose,
absorbed and at least                            dihydrate          Povidone [K25],
60% may be bound to                                                 Cetostearyl alcohol,
plasma proteins. The                                                Purified talc,
main urinary                                                        Magnesium stearate,
metabolites are 1,3                                                 Hypromellose (E464),
dimethyl uric acid and                                              Macrogol 400,
3-methylxanthine.                                                   Industrial methylated
About 10% is                                                        spirit, Titanium dioxide
excreted unchanged.                                                 (E171), Iron oxide
                                                                    (E172)
Aminophylline          -   ·456: aminophylline   ·Freely Soluble:   Excipients:              350 mg matrix tablet.
(theophylline) is well     dihydrate             aminophylline      Hydroxyethylcellulose,
absorbed and at least                            dihydrate          Povidone [K25],
60% may be bound to                                                 Cetostearyl alcohol,
plasma proteins. The                                                Purified talc,
main urinary                                                        Magnesium stearate,
metabolites are 1,3                                                 Hypromellose (E464),
dimethyl uric acid and                                              Macrogol 400,
3-methylxanthine.                                                   Industrial methylated
About 10% is                                                        spirit, Titanium dioxide
excreted unchanged.                                                 (E171), Iron oxide
                                                                    (E172)
Aminophylline          -   ·456: aminophylline   ·Freely Soluble:   -   100 mg controlled
(theophylline) is well     dihydrate             aminophylline          release tablets
absorbed from                                    dihydrate
PHYLLOCONTIN
CONTINUS tablets
and at least 60% may
be bound to plasma
proteins. The main
urinary metabolites
are 1,3 dimethyl uric
acid and 3-
methylxanthine. About
10% is excreted
unchanged.




-                      -   -                     -                  -   -




-                      -   -                     -                  -   -
Preclinical studies       -   ·381.4: pleconaril   ·: pleconaril   -   Given as an oral
have demonstrated                                                      solution (2-5 mg/kg,
that the bioavailability                                               also 200 and 400 mg
of pleconaril in a solid-                                              doses) to reduce food
dose form is                                                           effect in clinical
increased                                                              studies. In some
approximately                                                          clinical studies
sevenfold in the                                                       pleconaril 400 mg 3
presence of food                                                       times/day for 5-7 days
compared to under                                                      given within 24-36
fasting conditions.                                                    hours of symptom
Inadults at 2.86 mg/k                                                  onset decreases the
dose CL/F = 0.34 ±                                                     duration and severity
0.12 liters/kg and                                                     of the common cold
VSS/F = 3.2 ± 2.0
liters/kg, the mean
elimination half-life of
pleconaril is 5.7 h. Its
oral bioavailability is
approximately 70%
when administered in
a fed state. (REF 1-
(Pubmed id:9756781))
-   -   ·1355.38:        ·Sparingly Soluble:   1.8 cm cherry flavored 3.3 mg lozenges
        cyanocobalamin   cyanocobalamin        lozenge                administered under
                                                                      the tongue twice daily
                                                                      2-3 weeks prior to
                                                                      allergy season and an
                                                                      additional three weeks
                                                                      into the allergy
                                                                      season. (website and
                                                                      EP1128835)
-   -   ·548.24: albuterol    ·Freely Soluble:          -   -
        sulfate               albuterol sulfate




-   -   ·430.53: budesonide   ·Practically Insoluble:   -   -
                              budesonide
-   -   ·512.333: sodium   ·Soluble: sodium   -   -
        cromoglycate       cromoglycate
-   -   ·183.204: epinephrine ·Very Slightly Soluble: Inactive ingredients:     Delivers 0.22 mg
                              epinephrine             ascorbic acid,            epinephrine per
                                                      dehydrated alcohol        inhalation. Available
                                                      (34%),                    in: 1/2 fl oz (15 mL)
                                                      dichlorodifluoromethan    with mouthpiece
                                                      e (CFC 12),               (actuator), 1/2 fl oz
                                                      dichlorotetrafluoroetha   (15 mL) refill and 3/4 fl
                                                      ne (CFC 114),             oz (22.5 mL) refill.
                                                      hydrochloric acid,
                                                      nitric acid, purified
                                                      water
-   -   ·548.24: albuterol   ·Freely Soluble:    Breath actuated       -
        sulfate              albuterol sulfate   inhalation based on
                                                 Easi-breathe
                                                 technology.
Bioavailability is about -   ·425.5: ketotifen   ·Sparingly Soluble:   -   1 mg tablets
50% due to a first-          fumarate            ketotifen fumarate
pass effect of about
50% in the liver and
its bioavailability is not
influenced by food
intake. Maximal
plasma concentration
reaches within 2-4
hours. Plasma protein
binding is 75%.
Ketotifen is eliminated
biphasically with a
short half-life of 3 - 5
hours and a longer
one of 21 hours.
About 60 % - 70 % of
the administered dose
is excreted as
metabolites and 1 %
is excreted
unchanged in the
urine.
-   -   -                    -                   -                      -




-   -   ·548.24: albuterol   ·Freely Soluble:    CFC-MDI. Replaced      -
        sulfate              albuterol sulfate   with HFA formulation
Salbutamol is readily -   ·548.24: albuterol   ·Freely Soluble:    3M MDI Metering          Each actuation
absorbed from the GI      sulfate              albuterol sulfate   Valvesand HFA-MDI        delivers 120 mcg of
tract. It is subject to                                            Ethanol Formulations     microcrystallized drug.
first-pass metabolism                                              technologies. Inactive   Each canister
in the liver and                                                   components: ethanol,     provides 200
possibly in the gut                                                oleic acid and non-      inhalations.
wall; the main                                                     CFC propellant.          Dosed in two
metabolite is an                                                                            inhalations every 4-6
inactive sulfate                                                                            hrs.
conjugate. Salbutamol
is rapidly excreted in
the urine as
metabolites and
unchanged drug;
there is some
excretion in the
faeces. Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
the proportion
inadvertently
swallowed. It has
been suggested that
the majority of an
inhaled dose is
-                       -   ·430.53: budesonide   ·Practically Insoluble:   SkyePharma will use      -
                                                  budesonide                HFA as propellant to
                                                                            replace CFC's in the
                                                                            currently marketed
                                                                            MDIs. Product
                                                                            developed for
                                                                            territories outside of
                                                                            the US.




The metabolism of       -   ·430.53: budesonide   ·Practically Insoluble:   Busedonide (200          200 mcg/dose. Dosed
budesonide is                                     budesonide                mcg/dose), sorbitam      twice daily.
primarily mediated by                                                       trioleate, CFC 11, 12,   Can be used with
CYP3A4, one of the                                                          114.                     Nebuhaler and
cytochrome p450                                                                                      Nebuchamber.
enzymes. Systemic
availability after
inhalation is 70%. t1/2
is 2 hrs.
Tmax is 10-30 min      -   ·430.53: budesonide   ·Practically Insoluble:   Pulmicort Respules is    0.5 mg and 1 mg
and Cmax is 2.6                                  budesonide                a sterile suspension     nebuliser suspension,
nmol/L, BA is 6%.                                                          for inhalation via jet   Budesonide 0.25
Extensive first pass                                                       nebulizer and contains   mg/ml and 0. 5 mg/ml
liver metabolism.                                                          micronized               respectively.
Terminal t1/2 is 2.3                                                       budesonide (0.25 mg      Administered usually
hrs and CL is 0.5                                                          and 0.5 mg per 2 mL),       2
                                                                                                    1 “ mg twice daily.
L/min.                                                                     disodium edetate,
                                                                           sodium chloride,
                                                                           sodium citrate, citric
                                                                           acid, polysorbate 80,
                                                                           and water for
                                                                           injection.
                                                                           Pari-LC-Jet plus
                                                                           Nebulizer/Pari master
                                                                           compressor system
                                                                           technology.


-                      -   ·430.53: budesonide   ·Practically Insoluble:   Generic for Pulmicort    0.25 mg/2 mL and 0.5
                                                 budesonide                Respules                 mg/2 mL indicated for
                                                                                                    twice daily
Tmax is 1-2 hrs and     -   ·430.53: budesonide    ·Practically Insoluble:   Micronized             100 mcg and 400 mcg
34% of dose                                        budesonide                budesonide (200        strengths. Dosed
deposited in lungs. BA                                                       mcg/dose) delivered    twice daily.
is 39%. Extensive first                                                      using Turbuhaler
pass liver metabolism.                                                       technology.
t1/2 is 2-3 hrs.




-                       -   ·239.213: albuterol    ·Sparingly Soluble:       PulmoSphere“  particle -
                                                   albuterol                 processing technology




-                       -   ·392.49: indacaterol   ·: indacaterol            SkyeHaler and          Once daily
                                                                             SkyeProtect.           administration. Phase
                                                                                                    III trial studies 75,
                                                                                                    150, 300 & 600 µg o.d
                                                                                                    via SDDPI trials

-                       -   -                      -                         -                      -
-                       -   -                      -                         -                      -
-   -   -   -   -   -
-   -   ·392.49:               ·:                        Indacaterol in Fixed   -
        indacaterol·521.429:   indacaterol·Practically   Combination With
        mometasone furoate     Insoluble:                Mometasone Furoate
                               mometasone furoate        Delivered Via a
                                                         MDDPI (Twisthaler).
                                                         (Source:
                                                         clinicaltrials/gov,
                                                         NCT00556673)
-   -   ·521.04:         ·Practically Insoluble:   Propellant HFA-134a   50 nad 100 mcg per
        beclomethasone   beclomethasone            (Norflurane) and      actuation inhalers.
        dipropionate     dipropionate              ethanol.              Daily doses of 100 to
                                                                         800 mcg in divided
                                                                         doses.




-   -   ·521.04:         ·Practically Insoluble:   Propellant HFA-134a   Qvar 50 and 100
        beclomethasone   beclomethasone            (Norflurane) and      deliver 50 mcg and
        dipropionate     dipropionate              ethanol.              100 mcg from the
                                                                         actuator respectively.
                                                                         Dosed twice daily.
-                      -   ·521.04:         ·Practically Insoluble:   Propellant HFA-134a    50 mcg and 100 mcg
                           beclomethasone   beclomethasone            (Norflurane) and       per actuation inhalers.
                           dipropionate     dipropionate              ethanol anhydrous in    Dosed at 100-800
                                                                      Easi-breathe device    mcg per day in two
                                                                                             divided doses.




Tmax is 30 min.        -   ·521.04:         ·Practically Insoluble:   Each unit contains a   Qvar 40 and 80
Three major                beclomethasone   beclomethasone            solution of drug in    deliver 40 mcg and 80
metabolites are            dipropionate     dipropionate              ethanol and HFA-       mcg from the actuator
formed via                                                            134a non-CFC           respectively. Each
cytochrome P450 3A                                                    propellant.            dose is approx. 50
catalyzed                                                                                    mcL.
biotransformation.                                                                           Dosed twice daily.
The mean t1/2 of 17-
BMP is 2.8 hrs.
-   -   -   -   -                      In Phase 1 trial,
                                       patients will be
                                       randomized to receive
                                       placebo or R1671, at
                                       a starting dose of
                                       0.0015mg, by
                                       intravenous infusion;
                                       this dose will be
                                       escalated in
                                       subsequent groups of
                                       patients after a
                                       satisfactory
                                       assessment of the
                                       data from the previous
                                       dose. The anticipated
                                       time on study
                                       treatment is

-   -   -   -   Small molecules to be Phase 1 trial: Inhaled,
                delivered in          two doses 4 hours
                undisclosed DPI       apart
                device
After 100 mg IV         -   ·641.4: valategrast   ·: valategrast      -   -
infusion of                 hydrochloride         hydrochloride
RO0270608 (active
metabolite of R411) ,
CL (mean +/-
standard deviation)
was 19.4 +/- 7.1 L/h,
and the Vd was 93.1
+/- 36.1 L. [Ref 1 -
(Pubmed
id:15545307)]
-                       -   -                     -                   -   -




-                       -   ·548.24: albuterol    ·Freely Soluble:    -   administered as single
                            sulfate               albuterol sulfate       dose dry powder in a
                                                                          novel inhaler
The blood tranilast     -   ·327.33: tranilast   ·Practically Insoluble:   Inactive ingredients:   Light yellow dry syrup.
concentration peaked                             tranilast                 Sucrose, D-Mannitol,    The usual dosage in
2                                                                          Microcrystalline        children is 0.1 g/kg (5
hours after                                                                cellulose, Carmellose   mg/kg of tranilast)
administration, and                                                        sodium,                 daily in three divided
was below one-tenth                                                        Hydroxypropyl           doses in suspensions
of the maximal blood                                                       cellulose
concentration after 24
hours. The half-life of
the blood
concentration was
about 5 hours. The
urinary excretion ratio
during the first 96
hours was
37.7%, and 28.8%
was excreted within
24 hours. 100 mg oral
administration, C max
(&#956;g/mL) is 12.6,
AUC (&#956;g hr/mL)
is 114.4.
The blood tranilast     -   ·327.33: tranilast   ·Practically Insoluble:   Inactive ingredients:   0.5 and 1 g light
concentration peaked                             tranilast                 Lactose, D-Mannitol,    yellow fine granule.
2                                                                          Hydroxypropyl           The usual adult
hours after                                                                cellulose, Talc         dosage is one gram
administration, and                                                                                (100 mg of tranilast)
was below one-tenth                                                                                three times daily. The
of the maximal blood                                                                               usual dosage in
concentration after 24                                                                             children is 0.05 g/kg
hours. The half-life of                                                                            (5 mg /kg of tranilast)
the blood                                                                                          daily in three divided
concentration was                                                                                  doses.
about 5 hours. The
urinary excretion ratio
during the first 96
hours was
37.7%, and 28.8%
was excreted within
24 hours. 100 mg oral
administration, C
max
(&#956;g/mL) is 12.6,
AUC (&#956;g hr/mL)
is 114.4.




-                       -   -                    -                         -                       -
-   -   -                -                       -                         -




-   -   ·183.204:        ·Very Slightly Soluble: Inhalation solution for   2.25% inhalation
        racepinephrine   racepinephrine          use in aerosol            solution. If
                                                 bronchodilator therapy    administered via
                                                 employing hand-bulb       hand-bulb nebulizer,
                                                 nebulizer or oxygen       racepinephrine
                                                 aerosolization.           inhalation solution
                                                 Inactive ingredients:     does not require
                                                 Benzoic Acid,             dilution; however, if
                                                 Chlorobutanol,            administered via jet
                                                 Potassium                 nebulizer, it should be
                                                 Metabisulfite,            diluted to a
                                                 Propylene Glycol,         volume of 3 to 5 mL
                                                 Sodium Chloride,          with sterile 0.9%
                                                 Sodium Metabisulfite,     sodium chloride
                                                 Water for Injection       solution. For use in
                                                                           hand-bulb nebulizer: 1
                                                                           to 3 inhalations not
                                                                           more
                                                                           often than every 3
                                                                           hours. For use in a jet
                                                                           nebulizer:
                                                                           Administered for
                                                                           fifteen minutes every
                                                                           three to four hours.
-   -   ·: reslizumab          ·: reslizumab   -   Reslizumab 1 mg/kg,
                                                   2 mg/kg, 3 mg/kg
                                                   were studied in the
                                                   Phase 2-3 trials. IV
                                                   administration once
                                                   monthly.Phase 2-3
                                                   trials




-   -   ·485.401: etiprednol   ·: etiprednol   -   -
        dicloacetate           dicloacetate


-   -   -                      -               -   -
Ipratoprium bromide is -   ·430.38: ipratropium   ·Freely Soluble:      Oral inhalation       The recommended
a quaternary               bromide hydrate        ipratropium bromide   solution via a        dose is 0.4 to 2ml
ammonium compound                                 hydrate               nebuliser.            solution (100-500
which is poorly                                                         1ml or 2ml plastic    micrograms) up to
absorbed from the                                                       ampoules containing   four times daily.
gastro-intestinal tract,                                                0.25mg/ml of
and is slow to cross                                                    Ipratropium Bromide
mucous membranes                                                        Ph.Eur. Sodium
and the blood/brain                                                     Chloride, Diluted
barrier. Following,                                                     Phosphoric Acid,
inhalation, uptake into                                                 Purified Water
the plasma is minimal,
a peak blood
concentration is
obtained 1½ to 3
hours after inhalation.
Excretion is chiefly via
the kidneys.




-                      -   -                      -                     AeroEclipse Nebulizer 10 mg, 50 mg, 100
                                                                                              mg, or 200 mg
                                                                                              nebulizer charge
-   -   ·327.33: tranilast   ·Practically Insoluble:   -   100 mg tablets. Three
                             tranilast                     times daily.




-   -   ·355.4: repirinast   ·: repirinast             -   10% granules




-   -   ·355.4: repirinast   ·: repirinast             -   150 mg tablets.
-   -   ·: S-5751              ·: S-5751            -                  -


-   -   -                      -                    -                  -

-   -   -                      -                    -                  -

-   -   -                      -                    -                  -

-   -   -                      -                    -                  -

-   -   ·20025.1: interferon   ·: interferon beta   inhaled IFN-beta   -
        beta




-   -   ·20025.1: interferon   ·: interferon beta   inhaled IFN-beta   -
        beta




-   -   -                      -                    -                  -
-   -   -                      -                    -                  -

-   -   -                      -                    -                  -
-   -   -                      -                    -                  -
-   -   -                      -                    -                        -




-   -   ·20025.1: interferon   ·: interferon beta   An IFN&#946;             -
        beta                                        formulation suitable
                                                    for inhalation through
                                                    an appropriate
                                                    aerosol delivery
                                                    system




-   -   -                      -                    Barrier function protein -




-   -   -                      -                    -                        -




-   -   -                      -                    -                        -


-   -   -                      -                    Undisclosed device.      Once a day
                                                    Possibly SunHaler.
Salbutamol is readily      -   ·239.213: albuterol   ·Sparingly Soluble:   Delivers 100 mcg       Dosed 1-2 puffs up to
absorbed from the                                    albuterol             drug in alcohol. HFA   4 times daily
gastro-intestinal tract.                                                   used as propellant.
It is subject to                                                           200 doses per unit.
first pass metabolism                                                      List of Excipients:
in the liver. The                                                          Ethanol, anhydrous
plasma t1/2 has been                                                       Norflurane (Propellant
estimated to range                                                         HFA-134a)
from about 2 - 7 hrs.                                                      Salamol Easi-Breathe
                                                                           CFC-Free Inhaler
                                                                           contains a new
                                                                           propellant (HFA-
                                                                           134a)
                                                                           and does not contain
                                                                           any
                                                                           chlorofluorocarbon
                                                                           (CFC) propellants.


-                          -   ·239.213: albuterol   ·Sparingly Soluble:   EasiBreathe with       100 microgram dose
                                                     albuterol             CFC's
-   -   ·239.213: albuterol   ·Sparingly Soluble:   3M MDI Metering          Metered dose inhaler
                              albuterol             Valves technology.
                                                    HFA 134-A
                                                    formulation in an
                                                    improved Autohaler
                                                    device for easy use.




-   -   ·239.213: albuterol   ·Sparingly Soluble:   -                        -
                              albuterol




-   -   ·239.213: albuterol   ·Sparingly Soluble:   Phares lipid based       -
                              albuterol             HFA formulation that
                                                    is stable for 2 years.
Readily absorbed        -   ·239.213: albuterol   ·Sparingly Soluble:   -                    The usual dose for an
from the                                          albuterol                                  adult is 2.5 or 5 mg up
gastrointestinal tract.                                                                      to 4 times a day.
T1/2: 4-6 hours. It is
subject to first-pass
metabolism in the liver
and possibly in the gut
wall.




Lung deposition is     -    ·239.213: albuterol   ·Sparingly Soluble:   TAIFUN® DPI          200 doses per unit.
24% of metered dose                               albuterol             technology. 50 and   Dose up to 4 times
with high inhalation                                                    100 mcg salbutamol   daily.
rate and 10% with a                                                     and lactose.
low rate. Peak serum
of Taifun are 20-90%
greater than Ventolin
comparator.
Undergoes extensive
first pass metabolism.
t1/2 is 3-7 hrs.
After 50 mg, 100 mg, -    ·323.3: senicapoc      ·: senicapoc              -   Once-daily dosing
and 150 mg given to
different patient
groups, overall mean
t1/2 was determined
to be 12.8 days. Mean
peak plasma
concentrations rose
between the 50- and
100-mg dose levels
but plateaued at 150
mg (59.1, 108.7, and
109.1 ng/ml,
respectively). The rate
of absorption,
however, appeared to
be delayed at doses
greater than 100 mg.
[Ref 1- (Pubmed
id:17064199)]




-                     -   ·540.69: ciclesonide   ·Practically Insoluble:   -   -
                                                 ciclesonide
Salmeterol produces -     ·603.7: salmeterol     ·Sparingly Soluble:      25 micrograms of         25/50, 25/125 and
12 hrs of                 xinafoate·500.57:      salmeterol               salmeterol (as           25/250 mcg/actuation.
bronchodilation.          fluticasone propionate xinafoate·Practically    salmeterol xinafoate)    Dosed as two
Salmeterol acts locally                          Insoluble: fluticasone   and 50, 125 or 250       inhalations twice daily.
in the lung therefore                            propionate               micrograms of
plasma levels are                                                         fluticasone propionate
low                                                                       (delivered from the
The absolute BA of                                                        valve). This is
inhaled fluticasone                                                       equivalent to 21
propionate in healthy                                                     micrograms of
subjects varies                                                           salmeterol and 44
between                                                                   micrograms, 110
approximately 10-30%                                                      micrograms and 220
of the nominal dose                                                       micrograms of
depending on the                                                          fluticasone propionate
inhalation device                                                         delivered from the
used. Plasma protein                                                      actuator (delivered
binding is 91%.                                                           dose). Excipients:
Terminal t1/2 is about                                                    Norflurane (HFA
8 hrs. The main                                                           134a).
pathway is
metabolism to an
inactive carboxylic
acid metabolite, by the
cytochrome P450
enzyme CYP3A4.
Salmeterol acts locally -   ·603.7: salmeterol   ·Sparingly Soluble:    Disks comprising four    One blister (50
in the lung, therefore      xinafoate            salmeterol xinafoate   regularly spaced         micrograms) twice
plasma levels are not                                                   double-foil blisters     daily, increasing to
predictive of                                                           each delivering a        two blisters (2 x 50
therapeutic effect. In                                                  mixture of 50            micrograms) twice
addition there are only                                                 micrograms               daily if required.
limited data available                                                  salmeterol (as
on the                                                                  xinafoate) and lactose
pharmacokinetics of                                                     used in a Diskhaler
salmeterol because of                                                   device.
the technical difficulty
of assaying the drug
in plasma because of
the very low plasma
concentrations
(approximately 200
pg/ml or less)
achieved after inhaled
dosing. After regular
dosing with salmeterol
xinafoate, xinafoic
acid can be detected
in the systemic
circulation, reaching
steady state
concentrations of
approximately 100
ng/ml. These
concentrations are up
to 1000-fold lower
than steady state
levels observed in
toxicity studies. These
concentrations in long
Cmax of 167 pg/mL is -      ·603.7: salmeterol   ·Sparingly Soluble:    DISKUS device            Teal green unit
reached at 20 min.          xinafoate            salmeterol xinafoate   technology.Specially     containing 60 blisters.
Plasma protein                                                          designed plastic         Each blister contains
binding is 96%. Drug                                                    devices containing a     50 mcg of drug
detected in plasma in                                                   double foil blister.     blended with lactose
5-45 minutes. t1/2 is                                                   Each blister contains    to a weight of 12.5
5.5 hrs.                                                                50 mcg of drug           mg.
                                                                        blended with lactose      The drug product is
                                                                        to a weight of 12.5      packaged within a teal
                                                                        mg.                      green, plastic-coated,
                                                                                                 moisture-protective
                                                                                                 foil pouch. Contents
                                                                                                 are inhaled twice daily.


Salmeterol acts locally -   ·603.7: salmeterol   ·Sparingly Soluble:    Pressurised inhalation   White to off white
in the lung therefore       xinafoate            salmeterol xinafoate   suspension.              suspension sealed in
plasma levels are not                                                   Norflurane (HFA          an aluminium canister
an indication of                                                        134a), a                 in a green actuator.
therapeutic effects. In                                                 hydrofluoroalkane        One metered dose
addition there are only                                                 (non-                    (ex-valve) contains 25
limited data available                                                  chlorofluorocarbon)      micrograms
on the                                                                  propellant               salmeterol (as
pharmacokinetics of                                                                              xinafoate). This is
salmeterol because of                                                                            equivalent to a
the technical difficulty                                                                         delivered dose (ex-
of assaying the active                                                                           actuator) of 21
substance in plasma                                                                              micrograms
due to the low plasma                                                                            salmeterol (as
concentrations at                                                                                xinafoate). Two
therapeutic doses                                                                                actuations of 25
(approximately 200                                                                               micrograms
picogram/ml or less)                                                                             salmeterol twice daily.
achieved after inhaled
dosing.
Salmeterol acts locally -   ·603.7: salmeterol   ·Sparingly Soluble:    A pressurized,              Inhalation Aerosol is
in the lung. Binding of     xinafoate            salmeterol xinafoate   metered-dose aerosol        supplied in 13-g
salmeterol to human                                                     unit for oral inhalation.   canisters containing
plasma proteins                                                         It contains a               120 metered
averages 96%.                                                           microcrystalline            actuations in boxes of
Salmeterol base is                                                      suspension of               1. Each actuation
extensively                                                             salmeterol xinafoate        delivers 25 mcg of
metabolized by                                                          in a mixture of 2           salmeterol base (as
hydroxylation, with                                                     chlorofluorocarbon          salmeterol xinafoate)
subsequent                                                              propellants                 from the valve and 21
elimination                                                             (trichlorofluoromethan      mcg of salmeterol
predominantly in the                                                    e and                       base (as salmeterol
feces. The terminal                                                     dichlorodifluoromethan      xinafoate) from the
elimination t1/2 is                                                     e) with soya lecithin.      actuator. Each
about 5.5 hrs.                                                          36.25 mcg of                canister is supplied
                                                                        salmeterol xinafoate is     with a green plastic
                                                                        equivalent to 25 mcg        actuator. Twice daily
                                                                        of salmeterol base.         administration.
                                                                        Each actuation
                                                                        delivers 25 mcg of
                                                                        salmeterol base (as
                                                                        salmeterol xinafoate)
                                                                        from the valve and 21
                                                                        mcg of salmeterol
                                                                        base (as salmeterol
                                                                        xinafoate) from the
                                                                        actuator. Each 6.5-g
                                                                        canister provides 60
                                                                        inhalations and each
                                                                        13-g canister provides
                                                                        120 inhalations
Following              -   ·146943: golimumab   ·: golimumab   SIMPONI does not          SIMPONI must be
subcutaneous (SC)                                              contain preservatives.    refrigerated at 2ºC to
administration of                                              The solution is clear     8ºC (36ºF to 46ºF)
SIMPONI to healthy                                             to slightly opalescent,   and protected from
subjects and patients                                          colorless to light        light.. Each single
with active R.A, T max                                         yellow with a pH of       dose SmartJect
ranged from 2 to 6                                             approximately 5.5.        autoinjector contains
days and Cmax                                                  SIMPONI is provided       a prefilled glass
approximately 2.5                                              in one strength: 50 mg    syringe (27 gauge ½
g/mL. Following a                                              of the golimumab          inch) providing 50 mg
single IV                                                      antibody in 0.5 mL of     of SIMPONI per 0.5
administration ovèr                                            solution. Each 0.5 mL     mL of solution. Each
the same dose range                                            of SIMPONI contains       single dose prefilled
in patients with                                               50 mg of the              glass syringe (27
activeRA, mean                                                 golimumab antibody,       gauge ½ inch)
systemic clearance of                                          0.44 mg of L-histidine    contains 50 mg of
SIMPONI was                                                    and L-histidine           SIMPONI per 0.5 mL
estimated to be 4.9 to                                         monohydrochloride         of solution. The
6.7 mL/day/kg, and                                             monohydrate, 20.5         SIMPONI dose
mean volume of                                                 mg of sorbitol, 0.08      regimen is 50 mg
distrbution Vd ranged                                          mg of polysorbate 80,     administered by
from 58 to 126                                                 and Water for             subcutaneous (SC)
mL/kg.                                                         Injection.                injection once a
Median terminal half-                                                                    month. For patients
life values were                                                                         with rheumatoid
estimated to be                                                                          arthrtis (RA),
approximately 2                                                                          SIMPONI should be
weeks inhealthy                                                                          given in combination
subjects and                                                                             with methotrexate and
patients with active                                                                     for patients with
RA,PsA or AS. By                                                                         psoriatic arthrtis (PsA)
cross-study                                                                              or ankylosing
comparisons of mean                                                                      spondylitis (AS),
AUCinfvalues                                                                             SIMPONI
Rapidly absorbed        -   ·608.18: montelukast   ·Freely Soluble:     Inactive ingredients:    4 mg (oval) and 5 mg
orally. Tmax is 2 - 2.5     sodium                 montelukast sodium   mannitol,                (round), pink,
h in the fasted state.                                                  microcrystalline         biconvex-shaped
The mean oral BA is                                                     cellulose,               chewable tablets.
73% in the fasted                                                       hydroxypropyl            The dosage for
state versus 63%                                                        cellulose, red ferric    pediatric patients 6 to
when administered                                                       oxide, croscarmellose    14 years of age is one
with a standard meal                                                    sodium, cherry flavor,   5-mg chewable tablet
in the morning.                                                         aspartame and            daily.
Extensively                                                             magnesium stearate.      The dosage for
metabolized in the                                                                               pediatric patients 2 to
liver. 99% bound to                                                                              5 years of age is one
plasma proteins. Vd is                                                                           4-mg chewable tablet
8 - 11L. t1/2 is 2.7 -                                                                           daily
5.5 h.
                                                                                                 In Japan,
                                                                                                 recommended
                                                                                                 dosage for pediatric
                                                                                                 patients aged 6 years
                                                                                                 or older is 5 mg as
                                                                                                 montelukast orally
                                                                                                 administered once
                                                                                                 daily
                                                                                                 before sleep.
Montelukast is rapidly -   ·608.18: montelukast   ·Freely Soluble:     Inactive ingredients:   SINGULAIR Oral
absorbed following         sodium                 montelukast sodium   mannitol,               Granules are supplied
oral administration.                                                   hydroxypropyl           as 4 mg white
The 4-mg oral granule                                                  cellulose, and          granules with 500 mg
formulation is                                                         magnesium stearate      net weight. Once daily
bioequivalent to the 4-                                                                        administration
mg chewable tablet
when administered to
adults in the fasted
state. A high fat meal
in the morning
did not affect the AUC
of montelukast oral
granules; however,
the meal decreased
Cmax by 35% and
prolonged Tmax from
2.3 ± 1.0 hours to 6.4
± 2.9 hours.
Montelukast is more
than 99% bound to
plasma proteins. The
steady state Vd
averages 8 to 11
liters. Cytochromes
P450 3A4 and 2C9
are involved in the
metabolism.The
plasma clearance of
montelukast averages
45 mL/min. Following
an oral dose of
radiolabeled
montelukast, 86% of
Rapidly absorbed         -   ·608.18: montelukast   ·Freely Soluble:     Inactive ingredients:   beige, rounded
orally. Oral BA: 64%.        sodium                 montelukast sodium   microcrystalline        square-shaped, film-
After administration of                                                  cellulose, lactose      coated 10-mg
the 10-mg film-coated                                                    monohydrate,            Singulair tablet
tablet to fasted adults,                                                 croscarmellose          contains 10.4 mg
Cmax is achieved in 3                                                    sodium, hydroxypropyl   montelukast sodium,
to 4 hours (Tmax).                                                       cellulose, and          which is the molar
99% bound to plasma                                                      magnesium stearate.     equivalent to 10.0 mg
proteins. Vd: 8 to 11                                                    The film coating        of free acid.
liters. Extensively                                                      consists of:            The dosage for
metabolized in the                                                       hydroxypropyl           adolescents and
liver. t1/2: 2.7 to 5.5                                                  methylcellulose,        adults 15 years of age
hours. The mean oral                                                     hydroxypropyl           and older is one 10
BA is 73% in the                                                         cellulose, titanium     mg tablet daily.
fasted state versus                                                      dioxide, red iron       In clinical studies, a
63% when                                                                 oxide, yellow iron      single tablet of
administered with a                                                      oxide, and carnauba     SINGULAIR 10 mg
standard meal in the                                                     wax.                    prevented EIB when
morning.                                                                                         taken two hours
                                                                                                 before exercise
                                                                                                 [19670].

-                        -   -                      -                    Sirna is currently      -
                                                                         developing siRNAs
                                                                         formulated to provide
                                                                         a long duration of
                                                                         activity after local
                                                                         administration to the
                                                                         lungs.
-   -   ·298.3: amlexanox   ·: amlexanox   -   25 and 50 mg tablets.
                                               Three times daily.
Following inhalation of -   ·490.4: tiotropium  ·Sparingly Soluble:   Inactive ingredients:    2.5 microgram
the solution by young       bromide monohydrate tiotropium bromide    Benzalkonium             tiotropium per puff (2
healthy volunteers,                             monohydrate           chloride; disodium       puffs comprise one
urinary excretion data                                                edetate; water,          medicinal dose) and is
suggest that                                                          purified; Hydrochloric   equivalent to 3.124
approximately 33% of                                                  acid 3.6 % (for pH       microgram tiotropium
the inhaled dose                                                      adjustment)              bromide
reach the systemic                                                                             monohydrate. The
circulation. At steady                                                                         recommended dose
state, tiotropium                                                                              for adults is 5
bromide plasma levels                                                                          microgram tiotropium
in COPD patients at                                                                            given as two puffs
peak were 10.5-11.7                                                                            from the Respimat
pg/ml when measured                                                                            inhaler once daily, at
10 minutes after                                                                               the same time of the
administration of a 5                                                                          day. The
microgram dose                                                                                 recommended dose
delivered by the                                                                               should not be
Respimat inhaler and                                                                           exceeded.
decreased rapidly in a
multi-compartmental
manner. Steady state
trough plasma
concentrations were
1.49-1.68 pg/ml. Food
is not expected to
influence the
absorption of this
quaternary
ammonium
compound.The drug is
bound by 72% to
plasma proteins.
Tiotropium is excreted
Tiotropium bromide is -   ·490.4: tiotropium  ·Sparingly Soluble:   SPIRIVA HandiHaler       SPIRIVA capsules,
absorbed from the         bromide monohydrate tiotropium bromide    consists of a capsule    contain 18 mcg
lung, with a systemic                         monohydrate           dosage form              tiotropium, are light
BA of about 20%                                                     containing a dry         green. The
reported. It is about                                               powder formulation of    recommended
72% bound to plasma                                                 SPIRIVA (tiotropium      dosage of SPIRIVA
proteins. Tiotropium is                                             bromide) intended for    HandiHaler is the
excreted largely                                                    oral inhalation only     inhalation of the
unchanged in the                                                    with the HandiHaler      contents of one
urine, although it may                                              inhalation device.       SPIRIVA capsule,
undergo some                                                        Each light green, hard   once-daily
metabolism by non-                                                  gelatin capsule
enzymatic cleavage                                                  contains 18 mcg
and by the                                                          tiotropium (equivalent
cytochrome P450                                                     to 22.5 mcg tiotropium
isoenzymes CYP2D6                                                   bromide
and CYP3A4.                                                         monohydrate) blended
Tiotropium shows a                                                  with lactose
Vd of 32 L/kg                                                       monohydrate as the
indicating that the                                                 carrier.
drug binds
extensively
to tissues. The
terminal t1/2 is 5 - 6
days and total CL is
880 mL/min
-   -   ·313.7: clenbuterol   ·Soluble: clenbuterol   -   10 and 20 mcg
        hydrochloride         hydrochloride               tablets. 20-40 mcg
                                                          twice daily.
Orally inhaled          -   ·430.53:              ·Practically Insoluble:   Each 10.2 g             Administered twice
budesonide is rapidly       budesonide·840.9:     budesonide·Slightly       Symbicort 80/4.5 or     daily. The inhaler
absorbed in the lung        formoterol fumarate   Soluble: formoterol       160/4.5 cannister is    should be primed
and peak                    dihydrate             fumarate dihydrate        formulated with HFA     before using for the
concentrations are                                                          227 propelled           first time by releasing
reached within 20                                                           pressurized metered     two test sprays. In
minutes. Orally                                                             dose inhaler            cases where the
inhaled formoterol is                                                       containing 120          inhaler has not been
rapidly absorbed in                                                         actuations. After       used in seven days or
the lung and peak                                                           priming, each           when it has been
concentrations are                                                          actaution delivers      dropped, prime the
reached within 5-10                                                         91/5.1 micrograms or    inhaler again by
minutes.                                                                    181/5.1 micrograms      shaking well for 5
                                                                            from the valve and      seconds and
                                                                            either 80/4.5 or        releasing 2 test sprays
                                                                            160/4.5 micrograms      into the air.
                                                                            from the actuator.
                                                                            The formulation
                                                                            contains micronized
                                                                            drugs, povidone K-25,
                                                                            and polyethylene
                                                                            glycol 1000
Budesonide is rapidly -   ·430.53:              ·Practically Insoluble:   Turbuhaler DPI device 100/6 Turbohaler:
and almost completely     budesonide·344.405:   budesonide·Slightly       with lactose          Each delivered dose
absorbed orally.          formoterol            Soluble: formoterol       formulation           contains: budesonide
Extensive first-pass                                                                            80 mcg/inhalation and
metabolism in the                                                                               formoterol fumarate
liver. t1/2 is 2.5 h.                                                                           dihydrate 4.5
Liver metabolism.                                                                               mcg/inhalation. 200/6
The binding of                                                                                  Turbohaler: Each
formoterol to human                                                                             delivered dose
plasma proteins in                                                                              contains: budesonide
vitro is 61%-64% at                                                                             160 mcg/inhalation
concentrations from                                                                             and formoterol
0.1 to 100 ng/mL.                                                                               fumarate dihydrate
Binding to human                                                                                4.5 mcg/inhalation.
serum albumin in vitro                                                                          400/12 Turbohaler:
is 31%-38% over a                                                                               Each delivered dose
range of 5 to 500                                                                               contains: budesonide
ng/m. Vd is 3 lt/kg.                                                                            320 mcg/inhalation
Inhaled formoterol is                                                                           and formoterol
rapidly absorbed. t1/2                                                                          fumarate dihydrate 9
is 8 hours. and CL is                                                                           mcg/inhalation.
1.2 lt/h/kg. Hepatic                                                                            Asthma
metabolism.                                                                                     Adults(18 years and
                                                                                                older):
                                                                                                80/4.5 and 160/4.5
                                                                                                mcg/inhalation:Usual
                                                                                                          2
                                                                                                dose is 1“ inhalations
                                                                                                twice daily. Maximum
                                                                                                dose is 4 inhalations
                                                                                                twice daily.
                                                                                                320/9
                                                                                                mcg/inhalation:Usual
                                                                                                dose is 1 inhalation
                                                                                                twice daily. Maximum
-   -   -   -   -   -




-   -   -   -   -   -




-   -   -   -   -   -




-   -   -   -   -   -
-   -   -                        -                        -                -




-   -   ·862.91: bimosiamose ·: bimosiamose               -                In a Phase II study,
                                                                           the dosage was 70
                                                                           mg of Bimosiamose
                                                                           twice a day. [27616]
-   -   -                        -                        -                -

-   -   -                        -                        -                -

-   -   -                        -                        Captisol based   -
                                                          formulation




-   -   -                        -                        -                -

-   -   -                        -                        -                -




-   -   ·: nitric oxide-donating ·: nitric oxide-donating -                600 micrograms
        derivative of            derivative of                             dosed in Phase II
        budesonide               budesonide                                [1307]
-   -   -   -   Undisclosed nebulizer 250 micrgrams and
                                      500 micrograms once
                                      a day over a 14-day
                                      period being studied
                                      in Phase II [17654]




-   -   -   -   -                    -
-   -   ·333.469:               ·: carbetapentane       TUSSI-12D is an             5 mL (one
        carbetapentane          tannate·: pyrilamine    antitussive/antihistami     teaspoonful) of the
        tannate·1995.98:        tannate·Sparingly       ne/nasal                    blue-colored, grape-
        pyrilamine              Soluble:                decongestant                flavored suspension
        tannate·1867.99:        phenylephrine tannate   combination available       containing
        phenylephrine tannate                           for oral administration     Carbetapentane
                                                        as a Suspension.            Tannate 30 mg,
                                                        Other ingredients:          Pyrilamine Tannate 30
                                                        benzoic acid, FD&C          mg, Phenylephrine
                                                        Blue No. 1, FD&C            Tannate 5 mg. 5 to 10
                                                        Red No. 3, FD&C Red         mL (1 to 2
                                                        No. 40, FD&C Yellow         teaspoonfuls) for
                                                        No. 5 (see                  children over six years
                                                        Precautions), flavors       of age and 2.5 to 5
                                                        (natural and artificial),   mL (1/2 to 1
                                                        glycerin, kaolin,           teaspoonful) for
                                                        magnesium aluminum          children two to six
                                                        silicate,                   years of age. The
                                                        methylparaben,              recommended dose
                                                        pectin, purified water,     should be
                                                        saccharin sodium,           administered every 12
                                                        sucrose.                    hours.
-   -   ·333.469:               ·: carbetapentane       TUSSI-12D is an           Pink-colored, capsule-
        carbetapentane          tannate·: pyrilamine    antitussive/antihistami   shaped tablet
        tannate·1995.98:        tannate·Sparingly       ne/nasal                  containing
        pyrilamine              Soluble:                decongestant              Carbetapentane
        tannate·1867.99:        phenylephrine tannate   combination available     Tannate 60 mg,
        phenylephrine tannate                           for oral administration   Pyrilamine Tannate 40
                                                        as Tablets. Other         mg, Phenylephrine
                                                        ingredients: corn         Tannate 10 mg. 1 or 2
                                                        starch, dibasic           tablets for adults and
                                                        calcium phosphate,        children 12 years of
                                                        FD&C Blue No. 1,          age and older and 1/2
                                                        FD&C Red No. 40,          or 1 tablet for children
                                                        magnesium stearate,       6 to 11 years. The
                                                        methylcellulose,          recomended dose
                                                        polygalacturonic          should be
                                                        acid,                     administered every 12
                                                        povidone, silicon         hours.
                                                        dioxide, talc.
-   -   ·430.53: budesonide    ·Practically Insoluble:   Taifun DPI              -
                               budesonide




-   -   ·344.405: formoterol   ·Slightly Soluble:        Taifun DPI              -
                               formoterol




-   -   ·521.04:               ·Practically Insoluble:   Miat-Haler, multidose   -
        beclomethasone         beclomethasone            DPI.
        dipropionate           dipropionate
-   -   ·500.57: fluticasone   ·Practically Insoluble: Tempo pMDI   -
        propionate             fluticasone propionate
Theophylline is rapidly -   ·180.16: theophylline   ·Slightly Soluble:   Uses Osmodex            300mg plus once
and completely                                      theophylline         Osmotic tablet          daily. Boxes of 15 and
absorbed from liquid                                                     technology. Each        30 coated extended-
preparations,                                                            extended-release        release tablets as
capsules, and                                                            tablet as SOL           osmotic release
uncoated tablets; the                                                    (Osmotic Release        system
rate, but not the                                                        System)
extent, of absorption                                                    contains:Theophylline
is decreased by food,                                                    (as monoethalomine),
and food may also                                                        300 mg; anhydrous
affect theophylline                                                      theophylline, 100 mg
clearance.
Theophylline is
approximately 40%
bound to plasma
proteins. Theophylline
is metabolised in the
liver to 1,3-
dimethyluric acid, 1-
methyluric acid (via
the intermediate 1-
methylxanthine), and
3-methylxanthine.
-   -   ·548.65: terbutaline   ·Soluble: terbutaline   Mystic EHD nebulizer   -
        sulfate                sulfate
(Japan label) for 200 -    ·180.16: theophylline   ·Slightly Soluble:   (Japan label) Inactive   100, 200, 300 mg,
mg; Cmax                                           theophylline         ingredient: (100 mg):    and 450 mg extended
(&#956;g/mL) is 3.0 ±                                                   Sucrose, corn starch,    release tablets. The
0.5, tmax (h) is 7.2 ±                                                  lactose, magnesium       usual adult dosage is
1.6,                                                                    stearate, acacia,        200 mg of
AUC0&#8594;&#8734;                                                      cellulose acetate        theophylline (2
                                                                        phthalate,               tablets) twice daily.
(&#956;g&#65381;h/m                                                     talc, sodium lauryl      The usual children
L) is 53.9 ± 10.8. After                                                sulfate, gryceryl        dosage is 100 - 200
9 times at 12-hour                                                      stearate,                mg (1-2 tablets) twice
intervals oral                                                          white beeswax,           daily. 400 mg of
administration of two                                                   cetanol, myristyl        theophylline (2
THEODUR Tablets                                                         alcohol, diethyl         tablets) may be orally
100 mg, healthy non-                                                    phthalate (200 mg):      administered to adult
eldery, Cmax                                                            Sucrose, corn starch,    patients with bronchial
(&#956;g/mL) is 8.7 ±                                                   lactose, magnesium       asthma once daily at
2.2, tmax (h) is 3.9 ±                                                  stearate, cellulose      bedtime.
1.4,                                                                    acetate phthalate,
AUC96&#8594;108                                                         hydroxypropylmethylce
(&#956;g&#65381;h/m                                                     llulose, gryceryl
L) is 93.1 ± 25.5,                                                      stearate, white
healthy elderly adults,                                                 beeswax, cetanol,
Cmax (&#956;g/mL)                                                       myristyl alcohol,
is 10.3 ± 2.3, tmax (h)                                                 diethyl phthalate
is 4.8 ± 1.7,
AUC96&#8594;108
(&#956;g&#65381;h/m
L) is 111.6 ± 24.7.
Metabolized mainly in
the liver. Metabolites
in urine were identified
to be 1, 3-dimethyluric
acid, 1-methyluric
acid, and 3-
In two-separate single- -   ·180.16: theophylline   ·Slightly Soluble:   Microencapsulated        50 mg, 75 mg, 125
dose studies utilizing                              theophylline         beads consisting of      mg, or 200 mg
different subjects, the                                                  ethylcellulose,          capsules. The entire
following BA variables                                                   hydroxypropylcellulose   contents of a Theo-
were observed. Theo-                                                     , povidone, and          Dur Sprinkle capsule
Dur Sprinkle                                                             sucrose                  are intended to be
administered in a 500-                                                                            sprinkled on a small
mg dose as pellets on                                                                             amount of soft food
applesauce to 6                                                                                   immediately prior to
healthy adults                                                                                    ingestion, or it may be
produced Cmax of                                                                                  swallowed whole.
9.03 ± 2.59 mcg/ml at                                                                             Administered 2-3
8.67 ± 1.03 hours                                                                                 times daily.
following
administration.
Administration of two
lots of Theo-Dur
Sprinkle as intact
capsules in a 600-mg
dose to 6 healthy
adults produced
Cmax of 9.08 ±1.30
mcg/ml and 7.60 ±
0.95 mcg/ml at 8.33 ±
1.50 and 8.67 ± 3.01
hours after
administration,
respectively. In these
studies, Theo-Dur
Sprinkle exhibited
complete
bioavailability when
compared with an
immediate release
Approximately 90% of -     ·180.16: theophylline   ·Slightly Soluble:   Generic for TheoDur   300 mg, 400 mg, 450
the dose is                                        theophylline                               mg, 600 mg tablets
metabolized in the
liver. The total body
CL is 0.016-0.06
L/h/kg, t1/2 is 6.1-12.8
h and the apparent Vd
is 0.3-0.7 L/kg.




-                      -   ·180.16: theophylline   ·Slightly Soluble:   Generic for Theodur   200 and 300 mg
                                                   theophylline                               sustained release
                                                                                              tablets.
Theophylline is        -   ·180.16: theophylline   ·Slightly Soluble:   Sustained release   200 mg and 300 mg
approximately 40%                                  theophylline         capsules            sustained release
bound to plasma                                                                             capsules
proteins. Theophylline
is metabolised in the
liver to 1,3-
dimethyluric acid, 1-
methyluric acid (via
the intermediate 1-
methylxanthine), and
3-methylxanthine.
THEOLONG Tablets -        ·180.16: theophylline   ·Slightly Soluble:   Inactive ingredients:     Each 1 g of white,
were administered to                              theophylline         light anhydrous silicic   sustained-release
seven patients with                                                    acid, hydrogenated        granules contains 500
asthma at a dose of                                                    oil, talc, povidone K30   mg of theophylline.
200 mg of                                                              and hydrated silicon      The usual adult
theophylline twice                                                     dioxide                   dosage for oral use is
daily for three days to                                                                          0.4 g of theophylline
achieve a steady state                                                                           twice daily
in the theophylline
blood concentration.
The blood
theophylline
concentration was
determined 12 hr after
the final
administration. The
mean blood
concentration (Cave)
was 10.16
&#956;g/mL. Cmax:
12.58 &#956;g/mL,
Tmax: 4.9 hr.
Theophylline is little
affected by the first-
pass effect but is
metabolized in the
liver and is almost
completely excreted in
the urine
THEOLONG Tablets -         ·180.16: theophylline   ·Slightly Soluble:   Inactive ingredients:     50, 100 and 200 mg
were administered to                               theophylline         ethylcellulose,           white, speckled
seven patients with                                                     croscarmellose            sustained-release
asthma at a dose of                                                     sodium, light             tablets. The usual
200 mg of                                                               anhydrous silicic acid,   adult dosage for oral
theophylline twice                                                      microcrystalline          use is 200 mg of
daily for three days to                                                 cellulose,                theophylline
achieve a steady state                                                  hydrogenated oil,         twice daily.
in the theophylline                                                     calcium stearate, talc,
blood concentration.                                                    corn starch, lactose,
The blood                                                               hydroxypropylcellulose
theophylline                                                             and hydrated silicon
concentration was                                                       dioxide.
determined
12 hr after the final
administration. The
mean blood
concentration (Cave)
was 10.16
&#956;g/mL.
Cmax: 12.58
&#956;g/mL, Tmax:
4.9 hr. Theophylline is
little affected by the
first-pass effect but is
metabolized in the
liver and is almost
completely excreted in
the urine
-   -   ·180.16: theophylline   ·Slightly Soluble:   -                   -
                                theophylline




-   -   ·180.16: theophylline   ·Slightly Soluble:   12 hour sustained   -
                                theophylline         release tablets
The total body CL is    -   ·180.16: theophylline   ·Slightly Soluble:   -   100 mg, 125 mg, 200
0.27-1.03 ml/kg/min                                 theophylline             mg, 300 mg capsules
and t1/2 is 6.1-12.8                                                         administered twice a
hrs. The apparent Vd                                                         day.
of theophylline is
approximately 0.3-0.7
L/kg.




-                       -   ·180.16: theophylline   ·Slightly Soluble:   -   100 mg, 200 mg, 300
                                                    theophylline             mg and 450 mg tablets
After inhalation of       -   ·415.3: nedocromil   ·Soluble: nedocromil   Pressurized inhalation   The initial dose is 4
nedocromil sodium (in         sodium               sodium                 suspension. HFA          mg (2 actuations) four
common with other                                                         based MDI containing     times daily. Once
drugs inhaled using                                                       1,1,1,2,3,3,3 -          control of symptoms
an MDI) a small                                                           heptafluoropropane       has been achieved it
fraction (generally                                                       (HFA-227), povidone      may be possible to
10%) reaches the                                                          K30, polyethylene        reduce the dose to a
lungs, while a major                                                      glycol (PEG) 600,        maintenance dose of
portion of the dose is                                                    levomenthol              4mg (2 actuations)
deposited in the                                                                                   twice daily. The
mouth or oropharynx                                                                                aluminium can is fitted
and swallowed. The                                                                                 with a metering valve
oral absorption of                                                                                 which delivers
nedocromil sodium                                                                                  actuations each
from the                                                                                           containing 2 mg of
gastrointestinal tract is                                                                          nedocromil sodium.
low, being                                                                                         Each canister
approximately 2% of                                                                                contains 112
an orally administered                                                                             actuations. Tilade
dose. Hence,                                                                                       CFC-Free Inhaler:
nedocromil sodium                                                                                  The cartoned pack
measured in plasma                                                                                 consists of an aerosol
following inhalation is                                                                            canister and two
considered to                                                                                      plastic adaptors with
represent mainly the                                                                               dustcaps
drug absorbed by the
airways. After
inhalation, plasma
concentrations of
nedocromil sodium
reach a maximum
within one hour post-
dosing and decline
with a half-life of 1-2
Absolute BA is 8% for -   ·415.3: nedocromil   ·Soluble: nedocromil   Tilade Inhaler is a       16.2 gram container
single and 17% for        sodium               sodium                 pressurized metered-      with at least 104
multiple doses. t1/2 is                                               dose aerosol              inhalations. Dosed 2
3.3 hrs. 89% bound to                                                 suspension for            inhalations four times
plasma proteins.                                                      inhalation containing     a day
                                                                      micronized
                                                                      nedocromil sodium
                                                                      and sorbitan trioleate,
                                                                      as well as
                                                                      dichlorotetrafluoroetha
                                                                      ne and
                                                                      dichlorodifluoromethan
                                                                      e as propellants. Each
                                                                      Tilade canister
                                                                      contains 210 mg
                                                                      nedocromil sodium.
                                                                      Each actuation meters
                                                                      2.00 mg nedocromil
                                                                      sodium from the valve
                                                                      and delivers 1.75 mg
                                                                      nedocromil sodium
                                                                      from the mouthpiece.
                                                                      Each 16.2 g canister
                                                                      provides at least 104
                                                                      metered actuations.
-   -   ·434.5: triamcinolone   ·Practically Insoluble:   Mystic EHD nebulizer   -
        acetonide               triamcinolone
                                acetonide




-   -   ·227.73: tulobuterol    ·Practically Insoluble:   -                      -
                                tulobuterol
-   -   ·227.73: tulobuterol   ·Practically Insoluble:   LTS Drug In          -
                               tulobuterol               Adhesives technology




-   -   -                      -                         Captisol solubilizer     -
                                                         with undisclosed
                                                         corticosteroid

-   -   -                      -                         Mystic inhaler and       -
                                                         formulation of long
                                                         acting broncho-dilator
                                                         and steroid
-   -   -                      -                         Mystic                   -


-   -   -                      -                         Mystic                   -
Rapidly and            -   ·180.16: theophylline   ·Slightly Soluble:        Inactive Ingredients:     400 (round) and 600
completely absorbed                                theophylline              cetostearyl alcohol,      mg (rectangular,
after oral                                                                   hydroxyethyl cellulose,   concave) white,
administration in                                                            magnesium stearate,       opaque plastic
solution or immediate-                                                       povidone and talc.        controlled release
release solid oral                                                                                     tablets. Once daily
dosage form.                                                                                           administration.
Undergoes extensive
hepatic metabolism.
CL: 0.65 mL/kg/min.
t1/2: 8.7 h. 40%
bound to plasma
proteins. In adults,
about 10% of a dose
of theophylline is
excreted unchanged
in the urine. Vd: 0.45
L/kg (range 0.3-0.7
L/kg).


-                      -   ·430.53: budesonide     ·Practically Insoluble:   NanoCrystal               In Phase III, patients
                                                   budesonide                formulation for           are randomized to
                                                                             nebulization              either 0.25mg UDB,
                                                                                                       0.135mg UDB or
                                                                                                       placebo given twice a
                                                                                                       day over a 12-week
                                                                                                       treatment period.
                                                                                                       [30743]




-                      -   -                       -                         -                         -
-   -   ·: undisclosed small   ·: undisclosed small   Generic combination -
        molecule·:             molecule·:             formulation delivered
        undisclosed small      undisclosed small      with Gyrohaler device.
        molecule               molecule




-   -   -                      -                      VR632 is being        -
                                                      developed as a
                                                      generic combination
                                                      product using the
                                                      GyroHaler® DPI
-   -   -                      -                      Believed to be       -
                                                      GyroHaler device due
                                                      to local delivery
-   -   -   -   -   -


-   -   -   -   -   -




-   -   -   -   -   -
-   -   -   -   Collaboration to to     -
                develop a dry powder
                inhaler as a
                Boehringer Ingelheim
                branded device, to
                deliver a range of
                proprietary respiratory
                products of
                Boehringer Ingelheim,
                mainly for the
                treatment of asthma
                and chronic
                obstructive pulmonary
                disease.
Salbutamol:            -   ·239.213:           ·Sparingly Soluble:     Ventide Inhaler is a      Adults: 2 inhalations 3
Salbutamol does not        albuterol·521.04:   albuterol·Practically   pressurised metered-      or 4 times daily.
appear to be               beclomethasone      Insoluble:              dose inhaler delivering   Children: 1-2
metabolised in the         dipropionate        beclomethasone          100 micrograms            inhalations 2, 3 or 4
lung, therefore its                            dipropionate            Salbutamol BP and 50      times daily.
ultimate metabolism                                                    micrograms
and excretion                                                          Beclomethasone
following inhalation                                                   Dipropionate BP per
depends upon the                                                       actuation.
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
the proportion
inadvertently
swallowed. It has
been suggested that
the majority of an
inhaled dose is
swallowed and
absorbed from the
gut. The plasma t1/2
of salbutamol has
been estimated to
range from 4 - 6 hrs.
(REF 1- (Pubmed
id:5081599), REF 2-
(Pubmed id:974663),
REF 3- (Pubmed
id:17520), REF 4-
(Pubmed id:3790406),
REF 5- (Pubmed
id:2687008), REF 6-
(Pubmed id:2598971),
Salbutamol                -   ·548.24: albuterol   ·Freely Soluble:      200 micrograms          One ventide rotacap
administered                  sulfate·521.04:      albuterol             microfine Salbutamol    containing 400
intravenously has a           beclomethasone       sulfate·Practically   (as sulphate) and 100   micrograms
half-life of 4 to 6 hours     dipropionate         Insoluble:            micrograms microfine    salbutamol (as
and is cleared partly                              beclomethasone        Beclomethasone          sulphate) and 200
renally and partly by                              dipropionate          Dipropionate per        micrograms
metabolism to the                                                        capsule or 400          beclomethasone
inactive 4' - 0-sulphate                                                 micrograms microfine    dipropionate three or
(phenolic sulphate)                                                      Salbutamol (as          four times a day. The
which is also excreted                                                   sulphate) and 200       maximum dose is one
primarily in the urine.                                                  micrograms microfine    ventide rotacap four
The faeces are a                                                         Beclomethasone          times a day.
minor route of                                                           Dipropionate per
excretion. The                                                           capsule. For use with
majority of a dose of                                                    Rotohaler device
salbutamol given
intravenously, orally or
by inhalation is
excreted within 72
hours. Salbutamol is
bound to plasma
proteins to the extent
of 10%.
After administration by
the inhaled route
between 10 and 20%
of the dose reaches
the lower airways.
Beclomethasone
dipropionate: When
administered via
inhalation (via
metered dose inhaler)
there is extensive
Salbutamol (albuterol) -   ·239.213: albuterol   ·Sparingly Soluble:   Novolizer technology.   -
sulfate provides short-                          albuterol             100 mcg salbutamol
acting (4-6 hour)                                                      (120 mcg as sulfate)
bronchodilatation with                                                 and lactose
a fast onset (within 5                                                 monohydrate
minutes) in reversible
airways obstruction.
Salbutamol is readily
absorbed from the
gastrointestinal tract.
It is subject to first-
pass metabolism in
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate. Salbutamol
is rapidly excreted in
the urine as
metabolites and
unchanged drug;
there is some
excretion in the
faeces. Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
Salbutamol               -   ·548.24: albuterol   ·Freely Soluble:    Ventodisks contain    Carton containing 14
administered                 sulfate              albuterol sulfate   200mcg or 400 mcg     disks plus a diskhaler.
intravenously has a                                                   salbutamol sulphate   200 micrograms or
t1/2 of 4 - 6 hrs and is                                              with lactose BP For   400 micrograms may
cleared partly renally                                                use with Diskhaler    be administered as a
and partly by                                                         device.               single dose.
metabolism to the                                                                           The maximum dose is
inactive 4'-O-Sulphate                                                                      400 micrograms four
(Phenolic Sulphate)                                                                         times daily.
which is also excreted
primarily in the urine.
The faeces are a
minor route of
excretion. The
majority of a dose of
Salbutamol given
intravenously, orally or
by inhalation is
excreted within 72
hours.Salbutamol is
readily absorbed from
the gastrointestinal
tract. It is subject to
first-pass metabolism
in the liver and
possibly in the gut
wall; the main
metabolite is an
inactive sulfate
conjugate.
Salbutamol                -   ·548.24: albuterol   ·Freely Soluble:    Ventolin Accuhaler is      Ventolin Accuhaler is
administered                  sulfate              albuterol sulfate   a plastic inhaler          a plastic inhaler
intravenously has a                                                    device containing a        device containing a
half-life of 4 to 6 hours                                              foil strip with 60         foil strip with 60
and is cleared partly                                                  regularly spaced           regularly spaced
renally, and partly by                                                 blisters each              blisters each
metabolism to the                                                      containing a mixture       containing a mixture
inactive 4'-O-sulphate                                                 of 200 micrograms of       of 200 micrograms of
(phenolic sulphate)                                                    microfine salbutamol       microfine salbutamol
which is also excreted                                                 (as sulphate) and          (as sulphate) and
primarily in the urine.                                                larger particle lactose.   larger particle lactose.
The faeces are a                                                                                  200 micrograms as a
minor route of                                                                                    single dose. Dose four
excretion. After                                                                                  times daily.
administration by the
inhaled route between
10 and 20% of the
dose reaches the
lower airways. The
remainder is retained
in the delivery system
or is deposited in the
oropharynx from
where it is swallowed.
The fraction deposited
in the airways is
absorbed into the
pulmonary tissues
and circulation, but is
not metabolised by
the lung. On reaching
the systemic
circulation it becomes
accessible to hepatic
Albuterol (WHO          -   ·239.213: albuterol   ·Sparingly Soluble:   Each actuation           Each canister
designation is                                    albuterol             contains 90 mcg          provides 200
salbutamol) is readily                                                  microcrystalline         inhalations.
absorbed from the                                                       albuterol, oleic acid,   Dosed as two
gastrointestinal tract.                                                 and CFC propellants.     inhalations four times
It is subject to first-                                                                          daily
pass metabolism in
the liver and possibly
in the gut wall; the
main metabolite is an
inactive sulfate
conjugate.
Approximately 72% of
the inhaled dose is
excreted within 24
hours in the urine, and
consists of 28% as
unchanged drug and
44% as metabolite.;
there is some
excretion in the
faeces.
Albuterol/Salbutamol
does not appear to be
metabolised in the
lung, therefore its
ultimate metabolism
and excretion
following inhalation
depends upon the
delivery method used,
which determines the
proportion of inhaled
salbutamol relative to
-                      -   ·239.213: albuterol   ·Sparingly Soluble:   CFC MDI, generic for      100 mcg per
                                                 albuterol             Ventolin CFC              actuation, 90 mcg
                                                                                                 delivered. Canister
                                                                                                 containing 200 doses




Cmax of 1.4 - 3.2      -   ·548.24: albuterol    ·Freely Soluble:      Aqueous, colorless to     0.5% is supplied in
ng/mL occurs at 0.5        sulfate               albuterol sulfate     light yellow solution,    amber glass bottles of
hrs. Less than 20% of                                                  pH 3.5, providing         20 mL. 2.5 mg of
dose absorbed. Short-                                                  5mg/ml of albuterol       albuterol administered
acting (4-6 hour)                                                      sulphate. Inactive        three to four times
bronchodilatation with                                                 ingredients:              daily.
a fast onset (within 5                                                 benzyalkonium
minutes) in reversible                                                 chloride preservative,
airways obstruction.                                                   sulfuric acid to adjust
t/1/2 is 4-6 hrs (IV)                                                  to pH 3.5., purified
                                                                       water
                                                                       Dosed every 4-6
                                                                       hours via or
                                                                       continuously nebulizer
Cmax of 1.4 - 3.2       -   ·548.24: albuterol   ·Freely Soluble:    Plastic ampoule          2.5mg to 5mg
ng/mL occurs at 0.5         sulfate              albuterol sulfate   containing 2.5 ml of a   salbutamol should be
hours. t/1/2 is 4-6 hrs                                              sterile 0.1% or 0.2%     administered up to
(IV). is bound to                                                    w/v solution of          four times a day.
plasma proteins to the                                               salbutamol (as
extent of 10%.                                                       Salbutamol Sulphate
                                                                     BP) in normal saline
                                                                     and sulfuric acid to
                                                                     adjust pH.
                                                                     Dosed up to 4 times
                                                                     daily via nebulizer


Salbutamol (albuterol) -    ·548.24: albuterol   ·Freely Soluble:    200mcg microfine        Dosed up to four
sulfate provides short-     sulfate              albuterol sulfate   salbutamol (as          times daily.
acting (4-6 hour)                                                    sulphate) in each light
bronchodilatation with                                               blue capsule, marked
a fast onset (within 5                                               Ventolin 200 or 400
minutes) in reversible                                               mcg microfine
airways obstruction.                                                 salbutamol (as
Undergoes extensive                                                  sulphate) in each light
first pass metabolism.                                               blue capsule, marked
                                                                     Ventolin 200. Inactive
                                                                     ingredients: lactose
                                                                     Delivered using
                                                                     Rotohaler device.
-   -   ·548.24: albuterol   ·Freely Soluble:    Sodium citrate, Citric   150 mL or 2000 mL
        sulfate              albuterol sulfate   acid monohydrate,        amber glass bottle.
                                                 Hydroxypropyl
                                                 methylcellulose,         Adults
                                                 Sodium benzoate,         The minimum starting
                                                 Saccharin sodium,        dose is 2mg three
                                                 Sodium chloride,         times a day given as
                                                 Orange flavour IFF       5ml syrup. The usual
                                                 17.42.8187, Purified     effective dose is 4mg
                                                 water                    (10ml syrup) three or
                                                                          four times a day,
                                                                          which may be
                                                                          increased to a
                                                                          maximum of 8mg
                                                                          (20ml syrup) three or
                                                                          four times a day if
                                                                          adequate
                                                                          bronchodilatation is
                                                                          not obtained.

                                                                          Elderly
                                                                          In elderly patients or
                                                                          in those known to be
                                                                          unusually sensitive to
                                                                          beta-adrenergic
                                                                          stimulant drugs, it is
                                                                          advisable to initiate
                                                                          treatment with the
                                                                          minimum starting
                                                                          dose.

                                                                          Children
                                                                          2 - 6 years: the
                                                                          minimum starting
Tmax= is 52 hrs        -   ·548.24: albuterol   ·Freely Soluble:    Each actuation          Dosed as two
(longer than CFC           sulfate              albuterol sulfate   contains 120 mcg        inhalations repeated
propellant=0.17 hrs),                                               microcrystalline        every4-6 hrs.
t1/2 is 4.6 hrs.                                                    albuterol sulfate (90
Undergoes extensive                                                 mcg base) and HFA-
first pass metabolism.                                              134a non CFC
                                                                    propellant. Device is
                                                                    available with dose
                                                                    counter.
-   -   ·538.6: fluticasone   ·Practically Insoluble:   It is an aqueous        0.0275 mg dosed
        furoate               fluticasone furoate       suspension of           once daily
                                                        micronized fluticasone
                                                        furoate for topical
                                                        administration to the
                                                        nasal mucosa by
                                                        means of a metering
                                                        (50 microliters),
                                                        atomizing spray
                                                        pump. After initial
                                                        priming, each
                                                        actuation delivers 27.5
                                                        mcg of fluticasone
                                                        furoate in a volume of
                                                        50 microliters of nasal
                                                        spray suspension. It
                                                        also contains 0.015%
                                                        w/w benzalkonium
                                                        chloride, dextrose
                                                        anhydrous, edetate
                                                        disodium,
                                                        microcrystalline
                                                        cellulose and
                                                        carboxymethylcellulos
                                                        e sodium,
                                                        polysorbate 80, and
                                                        purified water.




-   -   -                     -                         Modified Pari e-flow   -
-   -   ·239.213: albuterol   ·Sparingly Soluble:   -   -
                              albuterol




-   -   ·239.213: albuterol   ·Sparingly Soluble:   -   -
                              albuterol
Salbutamol is readily -    ·548.24: albuterol   ·Freely Soluble:    OROS technology.           Controlled Release
absorbed from the          sulfate              albuterol sulfate   Each Volmax®               Tablets. Salbutamol
gastrointestinal tract.                                             Extended-Release           Sulphate BP 4.82mg
It is subject to first-                                             Tablet for oral            equivalent to
pass metabolism in                                                  administration             Salbutamol 4mg per
the liver and possibly                                              contains 4 mg or 8 mg      tablet. Salbutamol
in the gut wall; the                                                of albuterol as 4.8 mg     Sulphate BP 9.64mg
main metabolite is an                                               or 9.6 mg,                 equivalent to
inactive sulfate                                                    respectively, of           Salbutamol 8mg per
conjugate. BA is                                                    albuterol sulfate in a     tablet.
about 50%.                                                          nondeformable
Salbutamol                                                          cellulosic material that
administered                                                        serves as the rate-
intravenously has a                                                 controlling membrane.
t1/2 of 4 - 6 hrs and is                                            Each tablet also
cleared partly renally                                              contains the inactive
and partly by                                                       ingredients cellulose
metabolism.                                                         acetate,
                                                                    croscarmellose
                                                                    sodium, FD&C Blue
                                                                    No. 1 (4 mg tablet
                                                                    only), hydroxypropyl
                                                                    cellulose (8 mg tablet
                                                                    only), hydroxypropyl
                                                                    methylcellulose,
                                                                    magnesium stearate,
                                                                    povidone, silica,
                                                                    sodium chloride, and
                                                                    titanium dioxide.
-                       -   ·344.405: formoterol   ·Slightly Soluble:   -                         -
                                                   formoterol




After SC                -   ·149000: omalizumab    ·: omalizumab        A 150 mg vial             75 mg/vial and 150
administration,                                                         contains 202.5 mg of      mg/vial lyophilized
Omalizumab is                                                           Omalizumab, 145.5         powder for SC
absorbed with an                                                        mg sucrose, 2.8 mg L-     administration.
average absolute BA                                                     histidine hydrochloride   150 to 375 mg is
of 62%. Following a                                                     monohydrate, 1.8 mg       administered SC
single SC dose in                                                       L-histidine, and 0.5      every 2 or 4 weeks.
adult and adolescent                                                    mg polysorbate 20,
patients with asthma,                                                   and is designed to
Omalizumab was                                                          deliver 150 mg of
absorbed slowly,                                                        Omalizumab in 1.2
reaching peak serum                                                     mL after reconstitution
concentrations after                                                    with 1.4 mL SWFI,
an average of 7-8                                                       USP.
days. Vd (SC): 78 ±
32 mL/kg. t1/2: 26
days, CL: 2.4 ± 1.1
mL/kg/day.
-   -   ·149000: omalizumab   ·: omalizumab   -   -
There is some          -   ·628.7: levalbuterol   ·Freely Soluble:        Levalbuterol tartrate is   Aerosol for adults and
systemic absorption of     tartrate               levalbuterol tartrate   the generic name for       children 4 years of
inhaled                                                                   (R)-albuterol tartrate     age and older is 2
levosalbutamol. It                                                        in the United States.      inhalations (90 mcg)
appears to be                                                             XOPENEX HFA                repeated every 4 to 6
stereochemically                                                          Inhalation Aerosol is a    hours; in some
stable in vivo and not                                                    pressurized metered-       patients, 1 inhalation
metabolised to S(+)-                                                      dose aerosol inhaler       every 4 hours may be
salbutamol. After a                                                       (MDI), which               sufficientXOPENEX
single dose                                                               produces an aerosol        HFA (levalbuterol
levosalbutamol has a                                                      for oral inhalation. It    tartrate) Inhalation
half-life of 3.3 hours                                                    contains a suspension      Aerosol is supplied as
                                                                          of micronized              a pressurized
                                                                          levalbuterol tartrate,     aluminum canister in
                                                                          propellant HFA-134a        a box (NDC 63402-
                                                                          (1,1,1,2-                  510-01). The canister
                                                                          tetrafluoroethane),        is labeled with a net
                                                                          Dehydrated Alcohol         weight of 15 g and
                                                                          USP, and Oleic Acid        contains 200 metered
                                                                          NF.                        actuations (or
                                                                                                     inhalations). Each
                                                                                                     canister is supplied
                                                                                                     with a blue plastic
                                                                                                     actuator (or
                                                                                                     mouthpiece), a red
                                                                                                     mouthpiece cap, and
                                                                                                             s
                                                                                                     patient“ instructions.
-   -   ·275.8: levalbuterol   ·Freely Soluble:   Generic Xopenex   -
        hydrochloride          levalbuterol
                               hydrochloride
Zileuton is rapidly      -   ·236.294: zileuton   ·Practically Insoluble:   Inactive Ingredients:    600 mg white to off
absorbed upon oral                                zileuton                  crospovidone,            white, ovaloid, film-
administration with a                                                       hydroxypropyl            coated tablets. (300
mean time to peak                                                           cellulose,               mg dosage strength
plasma concentration                                                        hypromellose,            discontinued). The
(Tmax) of 1.7 hours                                                         magnesium stearate,      recommended
and a mean                                                                  microcrystalline         dosage is one 600-mg
peak level (Cmax) of                                                        cellulose,               tablet four times a day
4.98 &#956;g/mL. The                                                        pregelatinized starch,   for a total daily dose
absolute bioavailability                                                    propylene glycol,        of 2400 mg.
of ZYFLO is unknown.                                                        sodium starch
Systemic exposure                                                           glycolate, talc, and
(mean AUC) following                                                        titanium dioxide.
600 mg
ZYFLO administration
is 19.2
&#956;g.hr/mL.
Plasma
concentrations of
zileuton are
proportional to dose,
and steady-state
levels are
predictable from
single-dose
pharmacokinetic data.
Administration of
ZYFLO with food
resulted in a small but
statistically
significant
increase (27%) in
zileuton Cmax without
significant changes in
t1/2: 11-38 days. CL:   -   ·142612: daclizumab   ·: daclizumab   Each milimeter          25 mg/5mL
15 mL/hour                                                        contains, as inactive   concentrate for IV
                                                                  ingredients, 3.6 mg     administration.
                                                                  sodium phosphate        The recommended
                                                                  monobasic               dose for ZENAPAX is
                                                                  monohydrate, 11 mg      1.0 mg/kg. Based on
                                                                  sodium phosphate        the clinical trials, the
                                                                  dibasic heptahydrate,   standard course of
                                                                  4.6 mg sodium           ZENAPAX therapy is
                                                                  chloride, 0.2 mg        five doses. The first
                                                                  polysorbate 80 and      dose should be given
                                                                  may contain             no more than 24
                                                                  hydrochloric acid or    hours before
                                                                  sodium hydroxide to     transplantation. The
                                                                  adjust the pH to 6.9.   four remaining doses
                                                                                          should be given at
                                                                                          intervals of 14 days. In
                                                                                          the Phase 2 trial of
                                                                                          daclizumab in
                                                                                          combination with
                                                                                          Interferon-&#946; (the
                                                                                          CHOICE study) in
                                                                                          patients with active
                                                                                          relapsing multiple
                                                                                          sclerosis, the study
                                                                                          patients who received
                                                                                          daclizumab 2 mg/kg
                                                                                          subcutaneously every
                                                                                          two weeks showed a
                                                                                          statistically significant
                                                                                          72% reduction in the
                                                                                          number of new or
                                                                                          enlarged gadolinium-
                                                                                          enhancing lesions
-                       -   -                     -               -                       -
-   -   ·322.47: mequitazine   ·: mequitazine            -   -


-   -   ·322.47: mequitazine   ·: mequitazine            -   -


-   -   ·236.294: zileuton     ·Practically Insoluble:   -   Patients enrolled in
                               zileuton                      the Phase I/II trial
                                                             were randomized into
                                                             four escalating dose
                                                             groups (75 mg, 150
                                                             mg, 300 mg, and 600
                                                             mg), each receiving
                                                             one infusion of either
                                                             zileuton IV or placebo.
                                                             [8208]




-   -   -                      -                         -   -

-   -   ·: pumactant           ·: pumactant              -   -
A three-way crossover -    ·236.294: zileuton   ·Practically Insoluble:   ZYFLO CR (zileuton)       Adults and children 12
study was conducted                             zileuton                  extended-release          years of age and
in healthy male and                                                       tablets                   older: The
female subjects                                                           for oral administration   recommended dose
(n=24) with a mean                                                        are triple-layer          of ZYFLO CR is two
age of 35 (range 19-                                                      tablets                   600 mg extended-
56) following multiple                                                    comprised of an           release tablets twice
doses of 1200 mg (2 x                                                     immediate-release         daily, within one hour
600 mg) ZYFLO CR                                                          layer, a middle           after morning and
tablets administered                                                      (barrier) layer, and a    evening meals, for a
every 12 hours under                                                      extended-release          total daily dose of
fasted and fed                                                            layer. ZYFLO CR           2400 mg.
conditions, and 600                                                       tablets are oblong,
mg zileuton                                                               film-coated tablets
immediate-release                                                         with one red layer
tablets every 6 hours                                                     between two white
under fed conditions                                                      layers, debossed on
until steady state                                                                       C .
                                                                          one side with “T2“
zileuton levels were                                                      Each tablet contains
achieved. Food                                                            600 mg of zileuton
increased AUC and                                                         and the following
Cmin of ZYFLO CR                                                          inactive ingredients:
by 43%                                                                    crospovidone, ferric
and 170%,                                                                 oxide, glyceryl
respectively, but had                                                     behenate,
no effect on Cmax.                                                        hydroxypropyl
Therefore, ZYFLO CR                                                       cellulose,
is recommended to be                                                      hypromellose,
administered with                                                         magnesium stearate,
food. At steady state,                                                    mannitol,
relative bioavailability                                                  microcrystalline
of ZYFLO CR to                                                            cellulose, povidone,
zileuton                                                                  pregelatinized starch,
immediate-release                                                         propylene glycol,
-   -   -   -   -   -




-   -   -   -   -   -

-   -   -   -   -   -




-   -   -   -   -   -




-   -   -   -   -   -
-   -   -                         -                         rEV131 is smaller          In the Phase II post-
                                                            than therapeutic anti-     cataract eye
                                                            histamine receptor         inflammation trial,
                                                            antibodies and its         rEV131, dosed twice a
                                                            compact structure          day, will be compared
                                                            gives good                 with prednisolone,
                                                            bioavailablity by a        dosed four times a
                                                            number of routes           day over a two week
                                                            including: injected,       period [12378].
                                                            inhaled,
                                                            intraperitoneal, topical
                                                            (ocular and nasal).
                                                            The molecule is
                                                            thermo-stable and can
                                                            be stored in solution
                                                            for more than 18
                                                            months at room
                                                            temperature without
                                                            significant loss of
                                                            activity.

-   -   ·: alpha-1 antitrypsin,   ·: alpha-1 antitrypsin,   -                          -
        recombinant human         recombinant human
-   -   -   -   -   -




-   -   -   -   -   -
DDS Technologies   Physical Chemical   DDS Technology        Approval _
                   Properties          Owner                 Exclusivity
                                                                           1
                                                                           2
-                  -                   Theravance Inc.       -




                                                                           3
-                  -                   GlaxoSmithKline Plc   -




                                                                           4
-                  -                   GlaxoSmithKline Plc   -

                                                                           5
-                  -                   -                     -




                                                                           6
-                  -                   GlaxoSmithKline Plc   -
                                                                           7
-                  -                   -                     -

                                                                           8
-                  -                   GlaxoSmithKline Plc   -

                                                                           9
-   -   GlaxoSmithKline Plc   -




                                  10
-   -   -                     -

                                  11
-   -   -                     -


                                  12
-   -   -                     -

                                  13
-   -   Argenta Discovery     -

                                  14
-   ·USP 29 (Flunisolide) 3M Health Care   Year of US Approval:
    White to creamy-                       2006-01-27
    white, crystalline                     Earliest US Market
    powder. Melts at                       Exclusivity: 2009-01-
    about 245 , with                       27
    decomposition.
    Practically insoluble in
    water; soluble in
    acetone; sparingly
    soluble in chloroform;
    slightly soluble in
    methanol.
    The octanol: water
    partition coefficient is
    2.17 at neutral pH.:
    flunisolide




                                                                   15
-   -                    -                 -

                                                                   16
-   -                    -                 -

                                                                   17
-   -   -   -




                18
PDDS“         -                      Acusphere Inc.    -




                                                           19
AIR Inhaler   ·USP 29 (Albuterol      Alkermes, Inc.   -
              Sulfate) White or
              practically white
              powder. Freely
              soluble in water;
              slightly soluble in
              alcohol, in chloroform,
              and in ether.
              pKa=9.14. Solubility:
              24.5% w/v at pH 7.:
              albuterol sulfate
                                                           20
AIR Inhaler   -                      Alkermes, Inc.    -
                                                           21
-             -   Altair Therapeutics Inc. -




                                               22
TAIFUN® DPI   -   Akela Pharma Inc.        -




                                               23
-   ·Pemirolast potassium -   Year of Japan
    occurs as an              Approval: 1992-08-01
    odorless, bitter, light
    yellow crystalline
    powder. It is freely
    soluble in water,
    slightly soluble in
    methanol and ethanol,
    and practically
    insoluble in ether.:
    pemirolast potassium




                                                     24
-   ·Pemirolast potassium -            Year of Japan
    occurs as an                       Approval: 1991-03-01
    odorless, bitter, light
    yellow crystalline
    powder. It is freely
    soluble in water,
    slightly soluble in
    methanol and ethanol,
    and practically
    insoluble in ether.:
    pemirolast potassium




                                                              25
-   -                     ALK-Abello   -
                                                              26
-   -   -   -




                27
-   -   -   -




                28
-   -   -   -
                29
-   -   -   -




                30
-                -            -                      -




                                                         31
-                -            -                      -
                                                         32
-                ·: APC 366   Celera Corp.           -
                                                         33
    ·
AERx“CAPTISOL®   -            Aradigm Corp.          -




                                                         34
-                -            -                      -
                                                         35
-                -            ISIS Pharmaceuticals   -
                              Inc.

                                                         36
-                -            -                      -

                                                         37
-                -            -                      -

                                                         38
-                -            A-Viral                -
                                                         39
-                -            Genesis Research &     -
                              Development Corp.
                                                         40
-   -   Pfizer Inc.   -
                          41
-   -   Pfizer Inc.   -




                          42
-   -   -             -   43
-   -   -   -




                44
Decoy ODN            -               Activaero GmbH   -
Technology· AKITA® 2




                                                          45
-                    ·: AWD 12-281   elbion NV        -

                                                          46
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                                                          47
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                                                          48
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                49
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                50
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                52
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                55
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                57
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                                                59
-   ·USP 29 (Triazolam)    Sanofi-Aventis   -
    White to off-white,
    practically odorless,
    crystalline powder.
    Soluble in chloroform;
    slightly soluble in
    alcohol; practically
    insoluble in ether and
    in water.: triazolam·:
    reproterol




                                                60
-   -                      -                -

                                                61
-   ·A fine white to pale     -   Year of US Approval:
    yellow amorphous              1996-09-26
    powder, is practically        Earliest US Market
    insoluble in water. It is     Exclusivity: 2010-01-
    slightly soluble in           01
    methanol and freely           Earliest Patent
    soluble in                    Exclusivity: 2010-09-
    tetrahydrofuran,              26
    dimethylsulfoxide, and        Year of EU Approval:
    acetone.                      2000-06-01
    : zafirlukast




                                                          62
-   ·USP 29 (Albuterol      DEY L.P.               Year of US Approval:
    Sulfate) White or                              2001-04-30
    practically white                              Earliest US Market
    powder. Freely                                 Exclusivity: 2021-01-
    soluble in water;                              01
    slightly soluble in                            Earliest Patent
    alcohol, in chloroform,                        Exclusivity: 2021-12-
    and in ether.                                  28
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate




                                                                           63
-   ·USP 29 (Albuterol      Watson                 Year of US Approval:
    Sulfate) White or       Pharmaceuticals Inc.   2007-09-25
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate
                                                                           64
-         -                       -           -




                                                  65
Mystic“   ·(EP5.0) White or        Ventaira   -
          almost white powder.
          Practically insoluble in
          water, sparingly
          soluble in methylene
          chloride, slightly
          soluble in alcohol.:
          fluticasone propionate




                                                  66
Diskus/AccuHaler   ·(EP5.0) White or        GlaxoSmithKline Plc   Year of US Approval:
                   almost white powder.                           2000-08-24
                   Practically insoluble in                       Earliest US Market
                   water, sparingly                               Exclusivity: 2011-04-
                   soluble in methylene                           30
                   chloride, slightly                             Earliest Patent
                   soluble in alcohol.:                           Exclusivity: 2008-02-
                   fluticasone                                    12
                   propionate·A white to                          Year of EU Approval:
                   off-white powder. It is                        1999-02-01
                   freely soluble in                              Year of Japan
                   methanol; slightly                             Approval: 2007-04-18
                   soluble in ethanol,
                   chloroform, and
                   isopropanol; and
                   sparingly soluble in
                   water.

                   : salmeterol xinafoate
                                                                                          67
-   ·(EP5.0) White or        GlaxoSmithKline Plc   Year of US Approval:
    almost white powder.                           2006-06-08
    Practically insoluble in                       Earliest US Market
    water, sparingly                               Exclusivity: 2009-06-
    soluble in methylene                           08
    chloride, slightly                             Earliest Patent
    soluble in alcohol.:                           Exclusivity: 2008-02-
    fluticasone                                    12
    propionate·A white to
    off-white powder. It is
    freely soluble in
    methanol; slightly
    soluble in ethanol,
    chloroform, and
    isopropanol; and
    sparingly soluble in
    water.

    : salmeterol xinafoate




                                                                           68
AERx“   ·USP 29                  Aradigm Corp.   -
        (Hydroxychloroquine
        Sulfate) White or
        practically white,
        crystalline powder. Is
        odorless, and has a
        bitter taste. Its
        solutions have a pH of
        about 4.5. Exists in
        two forms, the usual
        form melting at about
        240 and the other
        form melting at about
        198 . Freely soluble in
        water; practically
        insoluble in alcohol, in
        chloroform, and in
        ether.:
        hydroxychloroquine
        sulfate

                                                     69
-       -                      -                 -




                                                     70
-   ·: pitrakinra   Aerovance, Inc.   -




                                          71
3M MDI Metering   ·USP 29 (Flunisolide) 3M Health Care   Year of US Approval:
Valves            White to creamy-                       1984-08-17
                  white, crystalline                     Earliest US Market
                  powder. Melts at                       Exclusivity: 2007-01-
                  about 245 , with                       01
                  decomposition.                         Earliest Patent
                  Practically insoluble in               Exclusivity: 2007-06-
                  water; soluble in                      12
                  acetone; sparingly
                  soluble in chloroform;
                  slightly soluble in
                  methanol.
                  The octanol: water
                  partition coefficient is
                  2.17 at neutral pH.:
                  flunisolide




                                                                                 72
AeroDose“   ·USP 29 (Albuterol)      Nektar Therapeutics   -
            White, crystalline
            powder. Soluble in
            alcohol, sparingly
            soluble in water. Melts
            at about 156 oC. n-
            Octanol/Water
            Partition Coefficient is
            1.7 x 10 -3 at pH 7.
            pKa=9.14. : albuterol




                                                               73
Aeroneb® Pro   ·Budesonide is a         Nektar Therapeutics   -
               white to off-white,
               odorless powder that
               is practically insoluble
               in water and in
               heptane, sparingly
               soluble in ethanol, and
               freely soluble in
               chloroform. Its
               partition coefficient
               between octanol and
               water at pH 5 is 1.6 x
               10.3 : budesonide

                                                                  74
-           ·: ipratropium bromide Arrow                  -
            anhydrous              Pharmaceuticals Ltd.




                                                              75
AeroCell“   -                     AerovectRx Corp.        -
                                                              76
Microcaps®·           ·USP 29                  Eurand N.V.   -
Diffucaps/Surecaps®   (Theophylline) White,
                      odorless, crystalline
                      powder, having a
                      bitter taste. Is stable
                      in air. Slightly soluble
                      in water, but more
                      soluble in hot water;
                      freely soluble in
                      solutions of alkali
                      hydroxides and in
                      ammonia; sparingly
                      soluble in
                      alcohol, in chloroform,
                      and in ether.:
                      theophylline

                                                                 77
-                     ·USP 29 (Albuterol)      GenPharm      -
                      White, crystalline
                      powder. Soluble in
                      alcohol, sparingly
                      soluble in water. Melts
                      at about 156 oC. n-
                      Octanol/Water
                      Partition Coefficient is
                      1.7 x 10 -3 at pH 7.
                      pKa=9.14. : albuterol



                                                                 78
-   ·USP 29 (Albuterol)      Teva Pharmaceutical   Year of US Approval:
    White, crystalline       Industries Ltd.       1995-12-28
    powder. Soluble in
    alcohol, sparingly
    soluble in water. Melts
    at about 156 oC. n-
    Octanol/Water
    Partition Coefficient is
    1.7 x 10 -3 at pH 7.
    pKa=9.14. : albuterol




                                                                          79
-   ·USP 29 (Albuterol      Martec                -
    Sulfate) White or       Pharmaceutical Inc.
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate




                                                      80
-   ·USP 29 (Albuterol)      Barr Pharmaceuticals   Year of US Approval:
    White, crystalline       Inc.                   1996
    powder. Soluble in
    alcohol, sparingly
    soluble in water. Melts
    at about 156 oC. n-
    Octanol/Water
    Partition Coefficient is
    1.7 x 10 -3 at pH 7.
    pKa=9.14. : albuterol




                                                                           81
Mystic“   ·USP 29 (Albuterol)      Ventaira   -
          White, crystalline
          powder. Soluble in
          alcohol, sparingly
          soluble in water. Melts
          at about 156 oC. n-
          Octanol/Water
          Partition Coefficient is
          1.7 x 10 -3 at pH 7.
          pKa=9.14. : albuterol




                                                  82
-   ·USP 29 (Albuterol      DEY L.P.         Year of US Approval:
    Sulfate) White or                        1992-02-21
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate
                                                                    83
-   ·USP 29 (Albuterol      Wockhardt Ltd.   Year of US Approval:
    Sulfate) White or                        1999-11-22
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate
                                                                    84
-   ·USP 29 (Albuterol      Nephron               Year of US Approval:
    Sulfate) White or       Pharmaceuticals Corp. 1997-09-17
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate




                                                                         85
Aria   ·USP 29 (Albuterol      Chrysalis      -
       Sulfate) White or       Technologies
       practically white
       powder. Freely
       soluble in water;
       slightly soluble in
       alcohol, in chloroform,
       and in ether.
       pKa=9.14. Solubility:
       24.5% w/v at pH 7.:
       albuterol sulfate
                                                  86
-      -                      -               -
                                                  87
-      ·Water solubility 38 -                 -
       mg/mL (Sigma Aldrich
       catalog): epinastine
       hydrochloride
                                                  88
-      ·: eculizumab          -               -




                                                  89
-   ·: eculizumab   Alexion                -
                    Pharmaceuticals Inc.




                                               90
-   ·Fexofenadine          -   Year of US Approval:
    hydrochloride is a         2000-02-25
    white to off-white         Earliest US Market
    crystalline powder. It     Exclusivity: 2006-11-
    is freely soluble in       12
    methanol and ethanol,      Earliest Patent
    slightly soluble in        Exclusivity: 2012-05-
    chloroform and water,      11
    and insoluble in
    hexane.
    Fexofenadine
    hydrochloride is a
    racemate and exists
    as a zwitterion in
    aqueous media at
    physiological pH.:
    fexofenadine
    hydrochloride




                                                       91
-            -                      Allergica   -




                                                    92
Novolizer®   ·A white, odourless,   Almirall    -
             hygroscopic,
             crystalline powder.
             Soluble in water;
             insoluble in alcohol
             and in chloroform.:
             sodium
             cromoglycate·:
             reproterol




                                                    93
-          ·A white, odourless,   Meda AB           -
           hygroscopic,
           crystalline powder.
           Soluble in water;
           insoluble in alcohol
           and in chloroform.:
           sodium
           cromoglycate·:
           reproterol




                                                        94
PADD DPI   -                      Britannia         -
                                  Pharmaceuticals

                                                        95
-   ·: alpha1-proteinase   -   -
    inhibitor, human




                                   96
3M MDI Metering   ·USP 29                  3M Health Care   Year of US Approval:
Valves            (Metaproterenol                           1973-07-31
                  Sulfate) White to off-
                  white, crystalline
                  powder. Freely
                  soluble in water.:
                  metaproterenol
                  sulphate




                                                                                   97
-   ·USP 29                  Boehringer Ingelheim   Year of US Approval:
    (Metaproterenol                                 1983-06-30
    Sulfate) White to off-
    white, crystalline
    powder. Freely
    soluble in water.:
    metaproterenol
    sulphate




                                                                           98
-   ·USP 29                  DEY L.P.   Year of US Approval:
    (Metaproterenol                     1987-08-17
    Sulfate) White to off-
    white, crystalline
    powder. Freely
    soluble in water.:
    metaproterenol
    sulphate




                                                               99
-   ·USP 29                  Wockhardt Ltd.   Year of US Approval:
    (Metaproterenol                           2002-05-30
    Sulfate) White to off-
    white, crystalline
    powder. Freely
    soluble in water.:
    metaproterenol
    sulphate




                                                                     100
-   ·USP 29                  Nephron               Year of US Approval:
    (Metaproterenol          Pharmaceuticals Corp. 1988-07-14
    Sulfate) White to off-
    white, crystalline
    powder. Freely
    soluble in water.:
    metaproterenol
    sulphate




                                                                          101
3M MDI Metering         ·Ciclesonide is a white 3M Health Care         Market Launch Date
Valves· HFA-MDI         to yellow-white                                US: 2008-09-08Year
Ethanol Formulations·   powder, practically                            of US Approval: 2008-
AEROCOUNT               insoluble in water and                         01-15
                        freely                                         Year of EU Approval:
                        soluble in ethanol and                         2004-04-16
                        acetone: ciclesonide                           Year of Japan
                                                                       Approval: 2007-04-18
                                                                                               102
-                       ·Ciclesonide is a white Nycomed                -
                        to yellow-white
                        powder, practically
                        insoluble in water and
                        freely
                        soluble in ethanol and
                        acetone:
                        ciclesonide·White to
                        yellow crystal slightly
                        soluble in water.:
                        formoterol
                                                                                               103
-                       -                      -                       -
                                                                                               104
MPDDS                   ·(EP5.0) White or        Themis Laboratories   -
                        yellowish crystalline    Private Ltd.
                        powder. Sparingly
                        soluble in water,
                        soluble in methanol,
                        practically insoluble in
                        methylene chloride.:
                        ambroxol
                        hydrochloride
                                                                                               105
-   ·: andolast   Rottapharm   -




                                   106
-   -             -            -

                                   107
-   -             -            -


                                   108
-   -             -            -
                                   109
-   ·USP 29 (Mannitol)       Pharmaxis Ltd.   -
    White, crystalline
    powder or free-flowing
    granules. Is odorless
    and has a sweet
    taste. Freely soluble in
    water; soluble in
    alkaline solutions;
    slightly soluble in
    pyridine; very slightly
    soluble in alcohol;
    practically insoluble:
    mannitol




                                                  110
-   ·USP 29 (Zileuton)       -   -
    White to off-white
    powder.
    It is a racemic mixture
    (50:50) of R(+) and S(-
    ) enantiomers.
    Zileuton is a
    practically odorless,
    white, crystalline
    powder that is soluble
    in methanol and
    ethanol, slightly
    soluble in acetonitrile,
    and practically
    insoluble in water and
    hexane.: zileuton


                                     111
Clickhaler   ·(EP5.0) A white or      Vectura Group Plc   -
             almost white,
             crystalline powder,
             practically insoluble in
             water, freely soluble in
             acetone, sparingly
             soluble in alcohol.
             It melts at about 210
             °C, with
             decomposition.:
             beclomethasone
             dipropionate




                                                              112
-            -                      -                     -
                                                              113
TwistHaler   ·USP 29                Schering-Plough Corp.   Year of US Approval:
             (Mometasone                                    2005-03-30
             Furoate) White to off-                         Earliest US Market
             white powder. Melts at                         Exclusivity: 2008-03-
             about 220, with                                30
             decomposition.                                 Earliest Patent
             Soluble in acetone                             Exclusivity: 2012-06-
             and in methylene                               25
             chloride.:
             mometasone furoate




                                                                                    114
Clickhaler   ·USP 29 (Albuterol)      Vectura Group Plc   Year of EU Approval:
             White, crystalline                           1997-05-09
             powder. Soluble in
             alcohol, sparingly
             soluble in water. Melts
             at about 156 oC. n-
             Octanol/Water
             Partition Coefficient is
             1.7 x 10 -3 at pH 7.
             pKa=9.14. : albuterol




                                                                                 115
Asmair® /Assist        -   Bang and Olufsen     -
Actuated Inhaler(TM)       Medicom AS




                                                    116
Clickhaler             -   Vectura Group Plc    -
                                                    117
Eiffel SCF            -    Telesso Technologies -
Technology· Xcelovair




                                                    118
-                      -   -                    -
                                                    119
-                      -   -                    -
                                                    120
-                      -   -                    -
                                                    121
-   -   -   -




                122
-   ·(EP5.0) A white,       -   -
    crystalline powder,
    very soluble in water,
    soluble in alcohol.
    Melting point: 134 °C
    to 136 °C.:
    proxyphylline·(EP5.0)
    White, crystalline
    powder or colourless
    crystals. Freely
    soluble in water,
    soluble in alcohol. mp:
    about 219 °C.:
    ephedrine
    hydrochloride·USP 29
    (Phenobarbital) White,
    odorless, glistening,
    small crystals, or
    white, crystalline
    powder, which may
    exhibit polymorphism.
    Is stable in air. Its
    saturated solution has
    a pH of about 5. Very
    slightly soluble in
    water; soluble in
    alcohol, in ether, and
    in solutions of fixed
    alkali hydroxides and
    carbonates; sparingly
    soluble in chloroform.:
    phenobarbital

                                    123
-   ·Procaterol              -   -
    hydrochloride occurs
    as white to pale yellow-
    white crystals or
    crystalline powder. It
    is soluble in water,
    formic acid and
    methanol, slightly
    soluble in ethanol
    (95), and practically
    insoluble in diethyl
    ether. The pH of its
    aqueous solution
    (1&#8594;100) is 4.0-
    5.0. It
    gradually changes in
    color when exposed
    to light. Its aqueous
    solution (1&#8594;20)
    shows no optical
    rotation: procaterol
    hydrochloride


                                     124
-   ·Procaterol              -   -
    hydrochloride occurs
    as white to pale yellow-
    white crystals or
    crystalline powder. It
    is soluble in water,
    formic acid and
    methanol, slightly
    soluble in ethanol
    (95), and practically
    insoluble in diethyl
    ether. The pH of its
    aqueous solution
    (1&#8594;100) is 4.0-
    5.0. It
    gradually changes in
    color when exposed
    to light. Its aqueous
    solution (1&#8594;20)
    shows no optical
    rotation: procaterol
    hydrochloride


                                     125
AeroHaler   ·White to off-white      Boehringer Ingelheim   Year of EU Approval:
            crystalline substance,                          2006-01-13
            freely soluble in water
            and lower alcohols. It
            is a quaternary
            ammonium compound
            and thus exists in an
            ionized state in
            aqueous solutions. It
            is relatively insoluble
            in non-polar media..
            The pH of a 1%
            solution in water is 5.0
            to 7.5. : ipratropium
            bromide hydrate




                                                                                   126
3M MDI Metering   ·White to off-white      3M Health Care   Year of US Approval:
Valves            crystalline substance,                    1986-12-29
                  freely soluble in water                   Earliest US Market
                  and lower alcohols. It                    Exclusivity: 2007-11-
                  is a quaternary                           17
                  ammonium compound                         Earliest Patent
                  and thus exists in an                     Exclusivity: 2009-11-
                  ionized state in                          28
                  aqueous solutions. It
                  is relatively insoluble
                  in non-polar media..
                  The pH of a 1%
                  solution in water is 5.0
                  to 7.5. : ipratropium
                  bromide hydrate




                                                                                    127
-   ·White to off-white      Boehringer Ingelheim   Year of US Approval:
    crystalline substance,                          1993
    freely soluble in water                         Year of EU Approval:
    and lower alcohols. It                          2003-03-01
    is a quaternary
    ammonium compound
    and thus exists in an
    ionized state in
    aqueous solutions. It
    is relatively insoluble
    in non-polar media..
    The pH of a 1%
    solution in water is 5.0
    to 7.5. : ipratropium
    bromide hydrate




                                                                           128
-   -                       -                 -




                                                  129
-   -                       -                 -

                                                  130
-   -                       -                 -
                                                  131
-   ·USP 29                  Sanofi-Aventis   -
    (Triamcinolone
    Acetonide) White to
    cream-colored,
    crystalline powder,
    having not more than
    a slight odor.
    Practically insoluble in
    water; sparingly
    soluble in dehydrated
    alcohol, in chloroform,
    and in methanol.:
    triamcinolone
    acetonide

                                                  132
-   ·USP 29                  Abbott Laboratories   Year of US Approval:
    (Triamcinolone           Inc.                  1982-04-23
    Acetonide) White to
    cream-colored,
    crystalline powder,
    having not more than
    a slight odor.
    Practically insoluble in
    water; sparingly
    soluble in dehydrated
    alcohol, in chloroform,
    and in methanol.:
    triamcinolone
    acetonide




                                                                          133
Modulite® technology   ·(EP5.0) A white or      Chiesi Farmaceutici   Year of EU Approval:
                       almost white,            SpA                   2006-06-29
                       crystalline powder,
                       practically insoluble in
                       water, freely soluble in
                       acetone, sparingly
                       soluble in alcohol.
                       It melts at about 210
                       °C, with
                       decomposition.:
                       beclomethasone
                       dipropionate




                                                                                             134
Respimat     -   Boehringer Ingelheim   -




                                            135
-            -   -                      -
                                            136
Respimat     -   Boehringer Ingelheim   -




                                            137
HandiHaler   -   Boehringer Ingelheim   -

                                            138
-            -   -                      -




                                            139
-            -   -                      -




                                            140
-                     -                        -          -


                                                              141
-                     ·(EP5.0) A white or      -          -
                      almost white,
                      crystalline powder,
                      freely soluble in water,
                      soluble in alcohol. It
                      shows polymorphism.:
                      bambuterol
                      hydrochloride




                                                              142
Eiffel SCF            -                        Ventaira   -
Technology· Mystic“




                                                              143
Easi-Breathe   ·(EP5.0) A white or      Teva Pharmaceutical   Year of EU Approval:
               almost white,            Industries Ltd.       2000-09-28
               crystalline powder,
               practically insoluble in
               water, freely soluble in
               acetone, sparingly
               soluble in alcohol.
               It melts at about 210
               °C, with
               decomposition.:
               beclomethasone
               dipropionate

                                                                                     144
Diskhaler      ·(EP5.0) A white or      GlaxoSmithKline Plc   Year of EU Approval:
               almost white,                                  2003-03-14
               crystalline powder,
               practically insoluble in
               water, freely soluble in
               acetone, sparingly
               soluble in alcohol.
               It melts at about 210
               °C, with
               decomposition.:
               beclomethasone
               dipropionate

                                                                                     145
EasyHaler    ·(EP5.0) A white or      Orion Corp.           -
             almost white,
             crystalline powder,
             practically insoluble in
             water, freely soluble in
             acetone, sparingly
             soluble in alcohol.
             It melts at about 210
             °C, with
             decomposition.:
             beclomethasone
             dipropionate

                                                                146
CycloHaler   ·(EP5.0) A white or      Teva Pharmaceutical   -
             almost white,            Industries Ltd.
             crystalline powder,
             practically insoluble in
             water, freely soluble in
             acetone, sparingly
             soluble in alcohol.
             It melts at about 210
             °C, with
             decomposition.:
             beclomethasone
             dipropionate

                                                                147
-   ·(EP5.0) A white or      Orion Corp.   Year of EU Approval:
    almost white,                          1999-03-04
    crystalline powder,
    practically insoluble in
    water, freely soluble in
    acetone, sparingly
    soluble in alcohol.
    It melts at about 210
    °C, with
    decomposition.:
    beclomethasone
    dipropionate




                                                                  148
Respimat   · A 4% solution in       Boehringer Ingelheim   Year of EU Approval:
           water has a pH of 4.2                           1993-06-09
           to 5.2. Protect from
           light.
           (EP5.0) White,
           crystalline powder.
           Soluble in water and
           in alcohol.: fenoterol
           hydrobromide·White
           to off-white crystalline
           substance, freely
           soluble in water and
           lower alcohols. It is a
           quaternary
           ammonium compound
           and thus exists in an
           ionized state in
           aqueous solutions. It
           is relatively insoluble
           in non-polar media..
           The pH of a 1%
           solution in water is 5.0
           to 7.5. : ipratropium
           bromide hydrate




                                                                                  149
-   · A 4% solution in       Boehringer Ingelheim   -
    water has a pH of 4.2
    to 5.2. Protect from
    light.
    (EP5.0) White,
    crystalline powder.
    Soluble in water and
    in alcohol.: fenoterol
    hydrobromide




                                                        150
-   · A 4% solution in       Boehringer Ingelheim   -
    water has a pH of 4.2
    to 5.2. Protect from
    light.
    (EP5.0) White,
    crystalline powder.
    Soluble in water and
    in alcohol.: fenoterol
    hydrobromide




                                                        151
    Lipids
CLIC“        -                      Inovio BioMedical        -
                                    Corp.




                                                                 152
-            -                      -                        -




                                                                 153
Bioral       ·USP 29                  BioDelivery Sciences   -
             (Amphotericin B)         International Inc.
             Yellow to orange
             powder; odorless or
             practically so.
             Insoluble in water, in
             anhydrous alcohol, in
             ether, in benzene, and
             in toluene; soluble in
             dimethylformamide, in
             dimethyl sulfoxide,
             and in propylene
             glycol; slightly soluble
             in methanol.:
             amphotericin B


                                                                 154
-            ·: mepolizumab         -                        -

                                                                 155
-   ·USP 29 (Terbutaline -    Year of US Approval:
    Sulfate) White to gray-   1981
    white, crystalline
    powder. Is odorless or
    has a faint odor of
    acetic acid. Soluble in
    water and in 0.1 N
    hydrochloric acid;
    slightly soluble in
    methanol; insoluble in
    chloroform.:
    terbutaline sulfate

                                                     156
-   ·USP 29 (Terbutaline -    Year of US Approval:
    Sulfate) White to gray-   1976
    white, crystalline
    powder. Is odorless or
    has a faint odor of
    acetic acid. Soluble in
    water and in 0.1 N
    hydrochloric acid;
    slightly soluble in
    methanol; insoluble in
    chloroform.:
    terbutaline sulfate

                                                     157
-            ·USP 29 (Terbutaline AstraZeneca Plc   Year of US Approval:
             Sulfate) White to gray-                1985-03-19
             white, crystalline                     Year of EU Approval:
             powder. Is odorless or                 2002-06-04
             has a faint odor of
             acetic acid. Soluble in
             water and in 0.1 N
             hydrochloric acid;
             slightly soluble in
             methanol; insoluble in
             chloroform.:
             terbutaline sulfate

                                                                           158
Turbuhaler   ·USP 29 (Terbutaline AstraZeneca Plc   Year of US Approval:
             Sulfate) White to gray-                1985-03-19
             white, crystalline                     Year of EU Approval:
             powder. Is odorless or                 2002-06-04
             has a faint odor of
             acetic acid. Soluble in
             water and in 0.1 N
             hydrochloric acid;
             slightly soluble in
             methanol; insoluble in
             chloroform.:
             terbutaline sulfate

                                                                           159
-            ·: seratrodast       -                 -




                                                                           160
Auto-Jethaler®   ·Budesonide is a         Pulmotec   Year of EU Approval:
                 white to off-white,                 2005
                 odorless powder that
                 is practically insoluble
                 in water and in
                 heptane, sparingly
                 soluble in ethanol, and
                 freely soluble in
                 chloroform. Its
                 partition coefficient
                 between octanol and
                 water at pH 5 is 1.6 x
                 10.3 : budesonide

                                                                            161
Jethaler®        ·Budesonide is a         Pulmotec   -
                 white to off-white,
                 odorless powder that
                 is practically insoluble
                 in water and in
                 heptane, sparingly
                 soluble in ethanol, and
                 freely soluble in
                 chloroform. Its
                 partition coefficient
                 between octanol and
                 water at pH 5 is 1.6 x
                 10.3 : budesonide

                                                                            162
Airmax/Spriomax   ·Budesonide is a         Teva Pharmaceutical   -
                  white to off-white,      Industries Ltd.
                  odorless powder that
                  is practically insoluble
                  in water and in
                  heptane, sparingly
                  soluble in ethanol, and
                  freely soluble in
                  chloroform. Its
                  partition coefficient
                  between octanol and
                  water at pH 5 is 1.6 x
                  10.3 : budesonide

                                                                                        163
Clickhaler        ·Budesonide is a         Vectura Group Plc     Year of EU Approval:
                  white to off-white,                            2005
                  odorless powder that
                  is practically insoluble
                  in water and in
                  heptane, sparingly
                  soluble in ethanol, and
                  freely soluble in
                  chloroform. Its
                  partition coefficient
                  between octanol and
                  water at pH 5 is 1.6 x
                  10.3 : budesonide

                                                                                        164
CycloHaler   ·Budesonide is a         Teva Pharmaceutical   -
             white to off-white,      Industries Ltd.
             odorless powder that
             is practically insoluble
             in water and in
             heptane, sparingly
             soluble in ethanol, and
             freely soluble in
             chloroform. Its
             partition coefficient
             between octanol and
             water at pH 5 is 1.6 x
             10.3 : budesonide

                                                                165
SkyeFine     ·Budesonide is a         SkyePharma Plc        -
             white to off-white,
             odorless powder that
             is practically insoluble
             in water and in
             heptane, sparingly
             soluble in ethanol, and
             freely soluble in
             chloroform. Its
             partition coefficient
             between octanol and
             water at pH 5 is 1.6 x
             10.3 : budesonide

                                                                166
-     ·Budesonide is a         Teva Pharmaceutical   Market Launch Date
      white to off-white,      Industries Ltd.       US: 2008-11-19Year
      odorless powder that                           of US Approval: 2008-
      is practically insoluble                       11-19
      in water and in
      heptane, sparingly
      soluble in ethanol, and
      freely soluble in
      chloroform. Its
      partition coefficient
      between octanol and
      water at pH 5 is 1.6 x
      10.3 : budesonide

                                                                             167
MMX   ·Budesonide is a         Cosmo                 -
      white to off-white,      Pharmaceuticals
      odorless powder that S.p.A.
      is practically insoluble
      in water and in
      heptane, sparingly
      soluble in ethanol, and
      freely soluble in
      chloroform. Its
      partition coefficient
      between octanol and
      water at pH 5 is 1.6 x
      10.3 : budesonide



                                                                             168
Modulite® technology   ·Budesonide is a         Chiesi Farmaceutici   Year of EU Approval:
                       white to off-white,      SpA                   2003
                       odorless powder that
                       is practically insoluble
                       in water and in
                       heptane, sparingly
                       soluble in ethanol, and
                       freely soluble in
                       chloroform. Its
                       partition coefficient
                       between octanol and
                       water at pH 5 is 1.6 x
                       10.3 : budesonide




                                                                                             169
Mystic“       ·Budesonide is a         Ventaira           -
              white to off-white,
              odorless powder that
              is practically insoluble
              in water and in
              heptane, sparingly
              soluble in ethanol, and
              freely soluble in
              chloroform. Its
              partition coefficient
              between octanol and
              water at pH 5 is 1.6 x
              10.3 : budesonide

                                                              170
PowderWhirl   ·Budesonide is a         Direct-Haler A/S   -
              white to off-white,
              odorless powder that
              is practically insoluble
              in water and in
              heptane, sparingly
              soluble in ethanol, and
              freely soluble in
              chloroform. Its
              partition coefficient
              between octanol and
              water at pH 5 is 1.6 x
              10.3 : budesonide

                                                              171
Pulvinal   ·USP 29 (Albuterol)      Chiesi Farmaceutici   Year of EU Approval:
           White, crystalline       SpA                   2001
           powder. Soluble in
           alcohol, sparingly
           soluble in water. Melts
           at about 156 oC. n-
           Octanol/Water
           Partition Coefficient is
           1.7 x 10 -3 at pH 7.
           pKa=9.14. : albuterol




                                                                                 172
-   ·USP 29 (Albuterol)      Orion Corp.   -
    White, crystalline
    powder. Soluble in
    alcohol, sparingly
    soluble in water. Melts
    at about 156 oC. n-
    Octanol/Water
    Partition Coefficient is
    1.7 x 10 -3 at pH 7.
    pKa=9.14. : albuterol
                                               173
-   -                       -              -




                                               174
-                      ·: apremilast   -                     -




                                                                 175
-                      -               -                     -

                                                                 176
Modulite® technology   ·: carmoterol   Chiesi Farmaceutici   -
                                       SpA




                                                                 177
-   ·:                        Chiesi Farmaceutici   -
    carmoterol·Budesonid SpA
    e is a white to off-
    white, odorless
    powder that is
    practically insoluble in
    water and in heptane,
    sparingly soluble in
    ethanol, and freely
    soluble in chloroform.
    Its partition coefficient
    between octanol and
    water at pH 5 is 1.6 x
    10.3 : budesonide

                                                                           178
-   -                       -                       -

                                                                           179
-   ·Fudosteine is white to -                       Year of Japan
    pale yellow white                               Approval: 2001-12-01
    crystal                                         Market Launch Date
    or crystalline powder.                          Japan: 2001-12-01
    It is very soluble in
    formic
    acid, freely soluble in
    water, slightly soluble
    4 Mitsubishi Pharma
    Corporation in acetic
    acid (100), very
    slightly soluble in
    ethanol (95) and
    practically insoluble in
    diethylether.:
    fudosteine

                                                                           180
Collegium Liquid   -                     Collegium             -
Modified Release                         Pharmaceuticals




                                                                   181
-                  ·: tofimilast         Pfizer Inc.           -

                                                                   182
Lipid Vector       ·USP 29                 Clavis Pharma ASA   -
Technology (LVT)   (Betamethasone)
                   White to practically
                   white, odorless,
                   crystalline powder.
                   Melts at about 240 ,
                   with some
                   decomposition.
                   Insoluble in water;
                   sparingly soluble in
                   acetone, in alcohol, in
                   dioxane, and in
                   methanol; very slightly
                   soluble in chloroform
                   and in ether.:
                   betamethasone

                                                                   183
Lipid Vector       ·USP 29                 Clavis Pharma ASA   -
Technology (LVT)   (Prednisolone) White
                   to practically white,
                   odorless, crystalline
                   powder. Melts at
                   about 235, with some
                   decomposition. Very
                   slightly soluble in
                   water; soluble in
                   methanol
                   and in dioxane;
                   sparingly soluble in
                   acetone and in
                   alcohol; slightly
                   soluble in
                   chloroform.
                   (EP5.0) It shows
                   polymorphism.:
                   prednisolone

                                                                   184
-                  -                       -                   -




                                                                   185
-                  -                       -                   -
                                                                   186
-                  -                       -                   -

                                                                   187
-   ·USP 29                 CombinatoRx Inc.   -
    (Prednisolone) White
    to practically white,
    odorless, crystalline
    powder. Melts at
    about 235, with some
    decomposition. Very
    slightly soluble in
    water; soluble in
    methanol
    and in dioxane;
    sparingly soluble in
    acetone and in
    alcohol; slightly
    soluble in
    chloroform.
    (EP5.0) It shows
    polymorphism.:
    prednisolone·:
    nortriptyline




                                                   188
-   ·USP 29                 -   -
    (Prednisolone) White
    to practically white,
    odorless, crystalline
    powder. Melts at
    about 235, with some
    decomposition. Very
    slightly soluble in
    water; soluble in
    methanol
    and in dioxane;
    sparingly soluble in
    acetone and in
    alcohol; slightly
    soluble in
    chloroform.
    (EP5.0) It shows
    polymorphism.:
    prednisolone·:
    nortriptyline




                                    189
-   ·Bromelain is a        -   -
    mixture of sulfur-
    containing protein-
    digesting
    enzymes“  called
    proteolytic enzymes or
               a
    proteases“nd several
    other substances in
    smaller quantities.
    The two main
    enzymes are: stem
    bromelain and fruit
    bromelain: bromelains


                                   190
-   -                      -   -




                                   191
-   -   -   -




                192
-   -   -   -




                193
-                  ·: deflazacort          -                       Year of EU Approval:
                                                                   2008-08-06




                                                                                          194
CAPTISOL®· eFlow   ·Budesonide is a         CyDex                  -
                   white to off-white,      Pharmaceuticals, Inc
                   odorless powder that
                   is practically insoluble
                   in water and in
                   heptane, sparingly
                   soluble in ethanol, and
                   freely soluble in
                   chloroform. Its
                   partition coefficient
                   between octanol and
                   water at pH 5 is 1.6 x
                   10.3 : budesonide




                                                                                          195
-   -   -   -




                196
-   -   -   -

                197
-   -   -   -




                198
-   -   -   -
                199
-   -   -   -

                200
-   ·USP 29                 Pfizer Inc.       Year of US Approval:
    (Oxtriphylline) White,                    1983-05-24
    crystalline powder,
    having an amine-like
    odor. A solution (1 in
    100) has a pH of
    about 10.3. Freely
    soluble in water and in
    alcohol; very slightly
    soluble in chloroform.:
    oxtriphylline




                                                                     201
-   ·: choline theophylline   Galenica S.A.   -


                                                                     202
-   ·Ciclesonide is a white Nycomed           -
    to yellow-white
    powder, practically
    insoluble in water and
    freely
    soluble in ethanol and
    acetone: ciclesonide
                                                                     203
-   ·: cintredekin   NeoPharm Inc.   -
    besudotox




                                         204
LTT PLA         -                       LTT Bio-Pharma Co      -
Nanoparticles                           Ltd




                                                                                      205
Pulvinal        ·(EP5.0) A white or      Chiesi Farmaceutici   Year of EU Approval:
                almost white,            SpA                   2006-06-29
                crystalline powder,
                practically insoluble in
                water, freely soluble in
                acetone, sparingly
                soluble in alcohol.
                It melts at about 210
                °C, with
                decomposition.:
                beclomethasone
                dipropionate

                                                                                      206
-   ·White to off-white      Boehringer Ingelheim   Year of US Approval:
    crystalline substance,                          1996-10-24
    freely soluble in water                         Earliest US Market
    and lower alcohols. It                          Exclusivity: 2015-01-
    is a quaternary                                 01
    ammonium compound                               Earliest Patent
    and thus exists in an                           Exclusivity: 2015-06-
    ionized state in                                09
    aqueous solutions. It                           Year of EU Approval:
    is relatively insoluble                         1994-03-22
    in non-polar media..
    The pH of a 1%
    solution in water is 5.0
    to 7.5. : ipratropium
    bromide hydrate·USP
    29 (Albuterol Sulfate)
    White or practically
    white powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate




                                                                            207
-            ·White to yellow           Novartis AG   -
             crystal slightly soluble
             in water.: formoterol




                                                          208
Contramid®   ·Levosalbutamol, the Labopharm Inc.      -
             R(-)-enantiomer of
             salbutamol. It is a
             white to off-white,
             crystalline solid, with a
             melting point of
             approximately 187° C
             and solubility of
             approximately 180
             mg/mL in water.
             Levalbuterol is the (R)-
             enantiomer of the
             drug substance
             racemic albuterol.

             : levalbuterol
             hydrochloride
                                                          209
eFlow   ·USP 29 (Lidocaine)      Pari Pharma GmbH   -
        White or slightly
        yellow, crystalline
        powder. Has a
        characteristic odor
        and is stable in air.
        Practically insoluble in
        water; very soluble in
        alcohol and in
        chloroform; freely
        soluble in benzene
        and in ether.
        Dissolves in oils.
        (EP5.0) Melting point:
        66 °C to 70 °C,
        determined without
        previous drying.:
        lidocaine




                                                        210
Easi-Breathe   ·Cromolyn Sodium:        Teva Pharmaceutical   -
               White, odorless,         Industries Ltd.
               crystalline powder. Is
               tasteless at first, with
               a slightly bitter after
               taste. Is hygroscopic.
               Soluble in water;
               insoluble in alcohol
               and in chloroform.
               (Cromolyn Sodium for
               Inhalation) White to
               creamy white,
               odorless, hygroscopic,
               and very finely divided
               powder.: cromolyn
               sodium




                                                                  211
-   ·Cromolyn Sodium:        Durect Corporation   -
    White, odorless,
    crystalline powder. Is
    tasteless at first, with
    a slightly bitter after
    taste. Is hygroscopic.
    Soluble in water;
    insoluble in alcohol
    and in chloroform.
    (Cromolyn Sodium for
    Inhalation) White to
    creamy white,
    odorless, hygroscopic,
    and very finely divided
    powder.: cromolyn
    sodium




                                                      212
Mystic“   ·Cromolyn sodium is a Ventaira            -
          water soluble,
          odorless, white,
          hydrated crystalline
          powder. It is tasteless
          at first, but leaves a
          slightly bitter
          aftertaste.: cromolyn
                                                        213
-         -                     -                   -
                                                        214
-         -                     -                   -
                                                        215
-         -                     Dr. Reddys          -
                                Laboratories Ltd.       216
-         -                     -                   -




                                                        217
-         ·: roflumilast        -                   -




                                                        218
Diffutab®   ·USP 29                  Eurand N.V.   -
            (Theophylline) White,
            odorless, crystalline
            powder, having a
            bitter taste. Is stable
            in air. Slightly soluble
            in water, but more
            soluble in hot water;
            freely soluble in
            solutions of alkali
            hydroxides and in
            ammonia; sparingly
            soluble in
            alcohol, in chloroform,
            and in ether.:
            theophylline

                                                       219
-           -                      -               -




                                                       220
-   ·Ozagrel                 -   Year of Japan
    hydrochloride occurs         Approval: 1992-06-01
    as in the form of white
    crystals or a
    crystalline powder. It
    is odorless but has an
    acidic and bitter taste.
    It is freely soluble in
    methanol, soluble in
    water, sparingly
    soluble in ethanol
    (95), and practically
    insoluble in acetone or
    diethyl ether.: ozagrel
    hydrochloride




                                                        221
-                      -   -                     -




                                                     222
DuoHaler(C200)         -   Vectura Group Plc     -

                                                     223
DuoHaler(C200)         -   Vectura Group Plc     -

                                                     224
Modulite® technology   -   Chiesi Farmaceutici   -
                           SpA




                                                     225
-                      -   Enanta                -
                           Pharmaceuticals




                                                     226
-   -                      Enanta                  -
                           Pharmaceuticals




                                                       227
-   ·This entery is used    Epigenesis             -
    as a place holder in    Pharmaceuticals Inc.
    the database for NCE
    or undisclosed small
    molecules. It is
    required to be used in
    some cases (e.g.
    combination products)
    in order for charts and
    statistics to function
    properly.: undisclosed
    small molecule·This
    entery is used as a
    place holder in the
    database for NCE or
    undisclosed small
    molecules. It is
    required to be used in
    some cases (e.g.
    combination products)
    in order for charts and
    statistics to function
    properly.: undisclosed
    small molecule



                                                       228
-                     -   -                    -




                                                   229
Eiffel SCF            -   Telesso Technologies -
Technology· Oriel DPI




                                                   230
Eligen&#8482   ·Cromolyn Sodium:        Emisphere            -
               White, odorless,         Technologies, Inc.
               crystalline powder. Is
               tasteless at first, with
               a slightly bitter after
               taste. Is hygroscopic.
               Soluble in water;
               insoluble in alcohol
               and in chloroform.
               (Cromolyn Sodium for
               Inhalation) White to
               creamy white,
               odorless, hygroscopic,
               and very finely divided
               powder.: cromolyn
               sodium




                                                                 231
-   ·USP 29                  Amphastar            Year of US Approval:
    (Epinephrine) White to Pharmaceuticals Inc.   1984-05-23
    practically white,
    odorless,
    microcrystalline
    powder or granules,
    gradually darkening
    on exposure to light
    and air. With acids, it
    forms salts that are
    readily soluble in
    water, and the base
    may be
    recovered by the
    addition of ammonia
    water or alkali
    carbonates. Its
    solutions are alkaline
    to litmus. Very slightly
    soluble in water and in
    alcohol; insoluble in
    ether, in chloroform,
    and in fixed and
    volatile oils.
    (Epinephrine
    Injection) Practically
    colorless, slightly acid
    liquid. Gradually turns
    dark on exposure to
    light and air.
    (Epinephrine
    Inhalation Solution)
    Practically colorless,
    slightly acid liquid.                                                232
-   ·USP 29                  Nycomed   -
    (Theophylline) White,
    odorless, crystalline
    powder, having a
    bitter taste. Is stable
    in air. Slightly soluble
    in water, but more
    soluble in hot water;
    freely soluble in
    solutions of alkali
    hydroxides and in
    ammonia; sparingly
    soluble in
    alcohol, in chloroform,
    and in ether.:
    theophylline




                                           233
-   ·USP 29                  -   -
    (Theophylline) White,
    odorless, crystalline
    powder, having a
    bitter taste. Is stable
    in air. Slightly soluble
    in water, but more
    soluble in hot water;
    freely soluble in
    solutions of alkali
    hydroxides and in
    ammonia; sparingly
    soluble in
    alcohol, in chloroform,
    and in ether.:
    theophylline

                                     234
-   -                        -   -




                                     235
-   -   -   -




                236
-   -   -   -




                237
-   -   -   -




                238
Modulite® technology   ·(EP5.0) A white or      Chiesi Farmaceutici   Year of EU Approval:
                       almost white,            SpA                   2006
                       crystalline powder,
                       practically insoluble in
                       water, freely soluble in
                       acetone, sparingly
                       soluble in alcohol.
                       It melts at about 210
                       °C, with
                       decomposition.:
                       beclomethasone
                       dipropionate· A white
                       or almost white or
                       slightly yellow powder.
                       Slightly soluble in
                       water and in isopropyl
                       alcohol; practically
                       insoluble in
                       acetonitrile; soluble in
                       methyl alcohol. A
                       0.1% solution in water
                       has a pH of 5.5 to 6.5.
                       Protect from light.:
                       formoterol fumarate



                                                                                             239
-                      -                       -                      -




                                                                                             240
Diskhaler   ·(EP5.0) White or        GlaxoSmithKline Plc   Year of EU Approval:
            almost white powder.                           1993-02-25
            Practically insoluble in
            water, sparingly
            soluble in methylene
            chloride, slightly
            soluble in alcohol.:
            fluticasone propionate




                                                                                  241
-           ·USP 29                  Taro Pharmaceutical   Year of US Approval:
            (Prednisolone            Industries Ltd.       2008-01-22
            Acetate) White to
            practically white,
            odorless, crystalline
            powder. Melts at
            about 235, with some
            decomposition.
            Practically insoluble in
            water; slightly soluble
            in
            acetone, in alcohol,
            and in chloroform.:
            prednisolone acetate

                                                                                  242
-                  ·(EP5.0) White or        GlaxoSmithKline Plc   Year of US Approval:
                   almost white powder.                           1996-03-27
                   Practically insoluble in
                   water, sparingly
                   soluble in methylene
                   chloride, slightly
                   soluble in alcohol.:
                   fluticasone propionate




                                                                                          243
Diskus/AccuHaler   ·(EP5.0) White or        GlaxoSmithKline Plc   Year of US Approval:
                   almost white powder.                           2000-09-29
                   Practically insoluble in                       Earliest US Market
                   water, sparingly                               Exclusivity: 2011-01-
                   soluble in methylene                           01
                   chloride, slightly                             Earliest Patent
                   soluble in alcohol.:                           Exclusivity: 2011-03-
                   fluticasone propionate                         01




                                                                                          244
-   ·(EP5.0) White or        GlaxoSmithKline Plc   Year of US Approval:
    almost white powder.                           2004-05-14
    Practically insoluble in                       Earliest US Market
    water, sparingly                               Exclusivity: 2009-02-
    soluble in methylene                           28
    chloride, slightly                             Earliest Patent
    soluble in alcohol.:                           Exclusivity: 2012-12-
    fluticasone propionate                         04
                                                   Year of EU Approval:
                                                   2000-06-27




                                                                           245
-            ·: fluasterone          -           -




                                                     246
Miat-Haler   ·(EP5.0) White or        Miat Spa   -
             almost white powder.
             Practically insoluble in
             water, sparingly
             soluble in methylene
             chloride, slightly
             soluble in alcohol.:
             fluticasone propionate




                                                     247
Skyepharma HFA        ·White to yellow           SkyePharma Plc   Company Estimated
Formulations· SkyeDry crystal slightly soluble                    Launch Date: 2010-01-
                      in water.:                                  01
                      formoterol·(EP5.0)
                      White or almost white
                      powder. Practically
                      insoluble in water,
                      sparingly soluble in
                      methylene chloride,
                      slightly soluble in
                      alcohol.: fluticasone
                      propionate




                                                                                          248
-                       · A white or almost      Novartis AG      Year of US Approval:
                        white or slightly yellow                  2001-02-16
                        powder. Slightly                          Earliest US Market
                        soluble in water and in                   Exclusivity: 2006-02-
                        isopropyl alcohol;                        16
                        practically insoluble in                  Earliest Patent
                        acetonitrile; soluble in                  Exclusivity: 2019-03-
                        methyl alcohol. A                         08
                        0.1% solution in water                    Year of EU Approval:
                        has a pH of 5.5 to 6.5.                   2003-03-20
                        Protect from light.:
                        formoterol fumarate


                                                                                          249
Airmax/Spriomax   · A white or almost      Teva Pharmaceutical   -
                  white or slightly yellow Industries Ltd.
                  powder. Slightly
                  soluble in water and in
                  isopropyl alcohol;
                  practically insoluble in
                  acetonitrile; soluble in
                  methyl alcohol. A
                  0.1% solution in water
                  has a pH of 5.5 to 6.5.
                  Protect from light.:
                  formoterol fumarate


                                                                     250
SkyeHaler DPI·   · A white or almost      SkyePharma Plc   Year of US Approval:
SkyeProtect“     white or slightly yellow                  2006-12-15
                 powder. Slightly                          Earliest US Market
                 soluble in water and in                   Exclusivity: 2009-12-
                 isopropyl alcohol;                        15
                 practically insoluble in                  Year of EU Approval:
                 acetonitrile; soluble in                  2004
                 methyl alcohol. A
                 0.1% solution in water
                 has a pH of 5.5 to 6.5.
                 Protect from light.:
                 formoterol fumarate




                                                                                   251
Novolizer®     ·White to yellow           Almirall       -
               crystal slightly soluble
               in water.: formoterol




                                                             252
SkyeProtect“   · A white or almost      SkyePharma Plc   -
               white or slightly yellow
               powder. Slightly
               soluble in water and in
               isopropyl alcohol;
               practically insoluble in
               acetonitrile; soluble in
               methyl alcohol. A
               0.1% solution in water
               has a pH of 5.5 to 6.5.
               Protect from light.:
               formoterol fumarate


                                                             253
Modulite® technology   · A white or almost      Chiesi Farmaceutici   Year of EU Approval:
                       white or slightly yellow SpA                   2004
                       powder. Slightly
                       soluble in water and in
                       isopropyl alcohol;
                       practically insoluble in
                       acetonitrile; soluble in
                       methyl alcohol. A
                       0.1% solution in water
                       has a pH of 5.5 to 6.5.
                       Protect from light.:
                       formoterol fumarate


                                                                                             254
PowderWhirl            · A white or almost      Direct-Haler A/S      -
                       white or slightly yellow
                       powder. Slightly
                       soluble in water and in
                       isopropyl alcohol;
                       practically insoluble in
                       acetonitrile; soluble in
                       methyl alcohol. A
                       0.1% solution in water
                       has a pH of 5.5 to 6.5.
                       Protect from light.:
                       formoterol fumarate


                                                                                             255
-                      ·White to yellow           Miat Spa            -
                       crystal slightly soluble
                       in water.: formoterol

                                                                                             256
NEXT DPI   ·(EP5.0) A white or      Chiesi Farmaceutici   -
           almost white,            SpA
           crystalline powder,
           practically insoluble in
           water, freely soluble in
           acetone, sparingly
           soluble in alcohol.
           It melts at about 210
           °C, with
           decomposition.:
           beclomethasone
           dipropionate· A white
           or almost white or
           slightly yellow powder.
           Slightly soluble in
           water and in isopropyl
           alcohol; practically
           insoluble in
           acetonitrile; soluble in
           methyl alcohol. A
           0.1% solution in water
           has a pH of 5.5 to 6.5.
           Protect from light.:
           formoterol fumarate



                                                              257
Miat-Haler   ·Budesonide is a         Miat Spa             -
             white to off-white,
             odorless powder that
             is practically insoluble
             in water and in
             heptane, sparingly
             soluble in ethanol, and
             freely soluble in
             chloroform. Its
             partition coefficient
             between octanol and
             water at pH 5 is 1.6 x
             10.3 : budesonide

                                                               258
-            -                       -                     -

                                                               259
-            ·: oglemilast           -                     -


                                                               260
-            -                       -                     -




                                                               261
-            -                       GlaxoSmithKline Plc   -

                                                               262
-            ·It has a beige solid   Theravance Inc.       -
             appearance.: MABA



                                                               263
-                  ·: darotropium bromide GlaxoSmithKline Plc    -




                                                                     264
-                  -                      Theravance Inc.        -

                                                                     265
Diskus/AccuHaler   ·Fluticasone furoate is GlaxoSmithKline Plc   -
                   a white powder with a
                   molecular weight of
                   538.6, and the
                   empirical
                   formula is
                   C27H29F3O6S. It is
                   practically insoluble in
                   water.: fluticasone
                   furoate




                                                                     266
-   ·Fluticasone furoate is GlaxoSmithKline Plc   -
    a white powder with a
    molecular weight of
    538.6, and the
    empirical
    formula is
    C27H29F3O6S. It is
    practically insoluble in
    water.: fluticasone
    furoate




                                                      267
-   -                      -                      -




                                                      268
-   -                     -             -

                                            269
-   ·White to off-white      GenPharm   -
    crystalline substance,
    freely soluble in water
    and lower alcohols. It
    is a quaternary
    ammonium compound
    and thus exists in an
    ionized state in
    aqueous solutions. It
    is relatively insoluble
    in non-polar media..
    The pH of a 1%
    solution in water is 5.0
    to 7.5. : ipratropium
    bromide hydrate




                                            270
-   ·White to off-white      GenPharm   -
    crystalline substance,
    freely soluble in water
    and lower alcohols. It
    is a quaternary
    ammonium compound
    and thus exists in an
    ionized state in
    aqueous solutions. It
    is relatively insoluble
    in non-polar media..
    The pH of a 1%
    solution in water is 5.0
    to 7.5. : ipratropium
    bromide hydrate




                                            271
-   ·USP 29 (Albuterol      GenPharm   -
    Sulfate) White or
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate
                                           272
-   ·USP 29 (Albuterol      GenPharm   -
    Sulfate) White or
    practically white
    powder. Freely
    soluble in water;
    slightly soluble in
    alcohol, in chloroform,
    and in ether.
    pKa=9.14. Solubility:
    24.5% w/v at pH 7.:
    albuterol sulfate
                                           273
-   -                    -             -

                                           274
-   ·Budesonide is a         Apotex   Year of US Approval:
    white to off-white,               2009-03-30
    odorless powder that
    is practically insoluble
    in water and in
    heptane, sparingly
    soluble in ethanol, and
    freely soluble in
    chloroform. Its
    partition coefficient
    between octanol and
    water at pH 5 is 1.6 x
    10.3 : budesonide

                                                             275
-   ·Budesonide is a         Orion Corp.   -
    white to off-white,
    odorless powder that
    is practically insoluble
    in water and in
    heptane, sparingly
    soluble in ethanol, and
    freely soluble in
    chloroform. Its
    partition coefficient
    between octanol and
    water at pH 5 is 1.6 x
    10.3 : budesonide




                                               276
EasyHaler   ·Budesonide is a         Orion Corp.   -
            white to off-white,
            odorless powder that
            is practically insoluble
            in water and in
            heptane, sparingly
            soluble in ethanol, and
            freely soluble in
            chloroform. Its
            partition coefficient
            between octanol and
            water at pH 5 is 1.6 x
            10.3 :
            budesonide·White to
            yellow crystal slightly
            soluble in water.:
            formoterol

                                                       277
Novolizer®   ·USP 29                 Almirall         -
             (Glycopyrrolate)
             White, odorless,
             crystalline powder.
             Soluble in water and
             in alcohol; practically
             insoluble in
             chloroform and in
             ether. Unlike atropine,
             glycopyrrolate is
             completely ionized at
             physiological pH
             values. The partition
             coefficient of
             glycopyrrolate in a n-
             octanol/water system
             is 0.304 (log10 P= -
             1.52) at ambient room
             temperature (24°C).:
             glycopyrrolate bromide




                                                          278
-            -                       Genentech Inc.   -




                                                          279
-           -                       -           -




                                                    280
Inyx MDIs   ·This entery is used    Inyx Inc.   -
            as a place holder in
            the database for NCE
            or undisclosed small
            molecules. It is
            required to be used in
            some cases (e.g.
            combination products)
            in order for charts and
            statistics to function
            properly.: undisclosed
            small molecule·This
            entery is used as a
            place holder in the
            database for NCE or
            undisclosed small
            molecules. It is
            required to be used in
            some cases (e.g.
            combination products)
            in order for charts and
            statistics to function
            properly.: undisclosed
            small molecule



                                                    281
-   -   -   -


                282
-   -   -   -

                283
-   ·Tulobuterol occurs as Nitto Denko Corp.   Year of Japan
    white crystals or                          Approval: 1998-12-01
    crystalline powder. It
    is odorless. It is very
    soluble in methanol,
    freely soluble in
    ethanol (95), acetic
    acid (100),
    diethylether or
    isopropylether,
    sparingly soluble in
    hexane and practically
    insoluble in water. It
    has no optical
    rotation: tulobuterol




                                                                      284
-   -                     -                    -

                                                                      285
-   -   -   -

                286
-   -   -   -

                287
-   -   -   -

                288
-   -   -   -

                289
-   -   -   -




                290
-   -   -   -




                291
NeoPharm Tumor   ·: cintredekin   NeoPharm Inc.   -
Targeting        besudotox




                                                      292
-                -                -               -
                                                      293
-                -                -               -
                                                      294
-   ·: anrukinzumab         -                 -

                                                  295
-   ·USP 29 (Nadolol)       Inverseon, Inc.   -
    White to off-white,
    practically odorless,
    crystalline powder.
    Freely soluble in
    alcohol and in
    methanol; soluble in
    water at pH 2; slightly
    soluble in chloroform,
    in methylene chloride,
    in isopropyl alcohol,
    and in water (between
    pH 7 and pH 10);
    insoluble in acetone,
    in benzene, in ether,
    in hexane, and in
    trichloroethane.:
    nadolol


                                                  296
-   ·