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HIV-1 Infection - Pipeline Review, H2 2011

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HIV-1 Infection - Pipeline Review, H2 2011 Summary Global Markets Direct’s, 'HIV-1 Infection - Pipeline Review, H2 2011', provides an overview of the HIV-1 Infection therapeutic pipeline. This report provides information on the therapeutic development for HIV-1 Infection, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for HIV-1 Infection. 'HIV-1 Infection - Pipeline Review, H2 2011' is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - A snapshot of the global therapeutic scenario for HIV-1 Infection. - A review of the HIV-1 Infection products under development by companies and universities/research institutes based on information derived from company and industry-specific sources. - Coverage of products based on various stages of development ranging from discovery till registration stages. - A feature on pipeline projects on the basis of monotherapy and combined therapeutics. - Coverage of the HIV-1 Infection pipeline on the basis of route of administration and molecule type. - Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress. - Key discontinued pipeline projects. - Latest news and deals relating to the products. Reasons to buy - Identify and understand important and diverse types of therapeutics under development for HIV-1 Infection. - Identify emerging players with potentially strong product portfolio and design effective counter-strategies

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									HIV-1 Infection – Pipeline Review, H2 2011




                     HIV-1 Infection - Pipeline Review, H2 2011
                                                                                          Reference Code: GMDHC1351IDB

                                                                                          Publication Date: September 2011




HIV-1 Infection – Pipeline Review, H2 2011                                                                    GMDHC1351IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                 Page(1)
HIV-1 Infection – Pipeline Review, H2 2011



Ta b le o f Co n te n ts
Table of Contents                                                                                                     2
List of Tables                                                                                                        6
List of Figures                                                                                                       7
Introduction                                                                                                          8
     Global Markets Direct Report Coverage                                                                            8
HIV-1 Infection Overview                                                                                              9
Therapeutics Development                                                                                             10
     An Overview of Pipeline Products for HIV-1 Infection                                                            10
HIV-1 Infection Therapeutics under Development by Companies                                                          12
HIV-1 Infection Therapeutics under Investigation by Universities/Institutes                                          15
Late Stage Products                                                                                                  18
     Comparative Analysis                                                                                            18
Mid Clinical Stage Products                                                                                          19
     Comparative Analysis                                                                                            19
Early Clinical Stage Products                                                                                        20
     Comparative Analysis                                                                                            20
Discovery and Pre-Clinical Stage Products                                                                            21
     Comparative Analysis                                                                                            21
HIV-1 Infection Therapeutics - Products under Development by Companies                                               22
HIV-1 Infection Therapeutics - Products under Investigation by Universities/Institutes                               25
Companies Involved in HIV-1 Infection Therapeutics Development                                                       29
     Bristol-Myers Squibb Company                                                                                    29
     Johnson & Johnson                                                                                               29
     Boehringer Ingelheim GmbH                                                                                       30
     F. Hoffmann-La Roche Ltd.                                                                                       30
     Abbott Laboratories                                                                                             31
     GlaxoSmithKline plc                                                                                             31
     Merck & Co., Inc.                                                                                               32
     United Biomedical, Inc.                                                                                         32
     Biotron Limited                                                                                                 33
     Aphios Corporation                                                                                              33
     Japan Tobacco Inc.                                                                                              34
     Koronis Pharmaceuticals, Inc.                                                                                   34
     Ardea Biosciences, Inc.                                                                                         35
     ConjuChem Biotechnologies Inc.                                                                                  35
     Critical Outcome Technologies Inc.                                                                              36
     Nutri Pharma ASA                                                                                                36
     Vironova AB                                                                                                     37
     Argos Therapeutics, Inc.                                                                                        37
     Cytheris SA                                                                                                     38
     Heat Biologics, Inc.                                                                                            38
     Etubics Corporation                                                                                             39
     Tobira Therapeutics, Inc.                                                                                       39
     Tibotec Pharmaceuticals Ltd.                                                                                    40
     Kemin Industries, Inc.                                                                                          40
     ViiV Healthcare                                                                                                 41
     RFS Pharma, LLC                                                                                                 41


HIV-1 Infection – Pipeline Review, H2 2011                                                GMDHC1351IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                              Page(2)
HIV-1 Infection – Pipeline Review, H2 2011


HIV-1 Infection - Therapeutics Assessment                                                                               42
     Assessment by Monotherapy Products                                                                                 42
     Assessment by Combination Products                                                                                 43
     Assessment by Route of Administration                                                                              44
     Assessment by Molecule Type                                                                                        46
Late Stage Drug Profiles                                                                                                48
     Elvitegravir - Drug Profile                                                                                        48
          Product Description                                                                                           48
          Mechanism of Action                                                                                           48
          R&D Progress                                                                                                  48
     Edurant - Drug Profile                                                                                             50
          Product Description                                                                                           50
          Mechanism of Action                                                                                           50
          R&D Progress                                                                                                  50
     Emtricitabine + Tenofovir Disoproxil Fumarate + Ritonavir + Atazanavir - Drug Profile                              52
          Product Description                                                                                           52
          Mechanism of Action                                                                                           52
          R&D Progress                                                                                                  52
     Emtricitabine + Tenofovir Disoproxil Fumarate + Raltegravir - Drug Profile                                         53
          Product Description                                                                                           53
          Mechanism of Action                                                                                           53
          R&D Progress                                                                                                  53
     Emtricitabine + Tenofovir Disoproxil Fumarate + Darunavir + Ritonavir - Drug Profile                               54
          Product Description                                                                                           54
          Mechanism of Action                                                                                           54
          R&D Progress                                                                                                  54
     Isentress + Kaletra - Drug Profile                                                                                 55
          Product Description                                                                                           55
          Mechanism of Action                                                                                           55
          R&D Progress                                                                                                  55
     Zovirax - Drug Profile                                                                                             56
          Product Description                                                                                           56
          Mechanism of Action                                                                                           56
          R&D Progress                                                                                                  56
     Lopinavir + Ritonavir + Efavirenz - Drug Profile                                                                   57
          Product Description                                                                                           57
          Mechanism of Action                                                                                           57
          R&D Progress                                                                                                  57
     Lopinavir + Ritonavir + Zidovudine - Drug Profile                                                                  59
          Product Description                                                                                           59
          Mechanism of Action                                                                                           59
          R&D Progress                                                                                                  59
     Darunavir + Ritonavir - Drug Profile                                                                               60
          Product Description                                                                                           60
          Mechanism of Action                                                                                           60
          R&D Progress                                                                                                  60
     Isentress + Celsentri + Prezista + Norvir + Truvada - Drug Profile                                                 61
          Product Description                                                                                           61




HIV-1 Infection – Pipeline Review, H2 2011                                                   GMDHC1351IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(3)
HIV-1 Infection – Pipeline Review, H2 2011


          Mechanism of Action                                                                                        61
          R&D Progress                                                                                               61
     Viramune + Truvada - Drug Profile                                                                               62
          Product Description                                                                                        62
          Mechanism of Action                                                                                        62
          R&D Progress                                                                                               62
     Telzir + Norvir + Abacavir + Lamivudine - Drug Profile                                                          64
          Product Description                                                                                        64
          Mechanism of Action                                                                                        64
          R&D Progress                                                                                               64
     Atazanavir + Ritonavir + Abacavir + Lamivudine - Drug Profile                                                   66
          Product Description                                                                                        66
          Mechanism of Action                                                                                        66
          R&D Progress                                                                                               66
     Lopinavir + Ritonavir - Drug Profile                                                                            67
          Product Description                                                                                        67
          Mechanism of Action                                                                                        67
          R&D Progress                                                                                               67
     Tenofovir + Abacavir + Lamivudine - Drug Profile                                                                68
          Product Description                                                                                        68
          Mechanism of Action                                                                                        68
          R&D Progress                                                                                               68
     Lopinavir + Ritonavir + Lamivudine + Stavudine - Drug Profile                                                   69
          Product Description                                                                                        69
          Mechanism of Action                                                                                        69
          R&D Progress                                                                                               69
     Efavirenz + Lamivudine + Stavudine - Drug Profile                                                               71
          Product Description                                                                                        71
          Mechanism of Action                                                                                        71
          R&D Progress                                                                                               71
     Lopinavir + Ritonavir + Lamivudine + Tenofovir Disoproxil Fumarate - Drug Profile                               73
          Product Description                                                                                        73
          Mechanism of Action                                                                                        73
          R&D Progress                                                                                               73
     Invirase + Emtricitabine + Tenofavir + Ritonavir - Drug Profile                                                 75
          Product Description                                                                                        75
          Mechanism of Action                                                                                        75
          R&D Progress                                                                                               75
     Lamivudine + Tenofovir + Atazanavir + Ritonavir - Drug Profile                                                  77
          Product Description                                                                                        77
          Mechanism of Action                                                                                        77
          R&D Progress                                                                                               77
     572-Trii - Drug Profile                                                                                         79
          Product Description                                                                                        79
          Mechanism of Action                                                                                        79
          R&D Progress                                                                                               79
     Hepavax-Gene - Drug Profile                                                                                     80
          Product Description                                                                                        80




HIV-1 Infection – Pipeline Review, H2 2011                                                GMDHC1351IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                              Page(4)
HIV-1 Infection – Pipeline Review, H2 2011


          Mechanism of Action                                                                                                                   80
          R&D Progress                                                                                                                          80
HIV-1 Infection Therapeutics – Drug Profile Updates                                                                                             81
HIV-1 Infection Therapeutics - Discontinued Products                                                                                            84
     HIV-1 Infection - Featured News                                                                                                            85
          Sep 19, 2011: Gilead's Second Pivotal Phase III Clinical Study Of Quad Regimen Meets 48-Week Primary Objective                        85
          Aug 15, 2011: Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective In Pivotal Phase III Clinical Study
          102                                                                                                                                    86
          Aug 10, 2011: Gilead Sciences Receives FDA Approval For Complera For HIV-1 Infection In Treatment-Naïve Adults                        87
          Jul 20, 2011: Gilead Announces Encouraging Phase III Clinical Trial Results Of Elvitegravir                                           88
          Jul 19, 2011: Janssen Presents Phase III Safety And Efficacy Data Of EDURANT In HIV At International AIDS Society Conference          90
          Jul 18, 2011: Merck's ISENTRESS In Combination Therapy Demonstrated Efficacy In Phase II Study Extending To Nearly Five Years In
          Previously Untreated Adults With HIV-1                                                                                           91
          Jul 18, 2011: Bionor Pharma Presents Data From Phase IIb Study Of Vacc-4x At IAS Conference                                           93
          May 20, 2011: FDA Approves EDURANT (rilpivirine) For Use in Treatment-Naïve Adults with HIV-1                                         93
          Mar 23, 2011: Gilead's Phase III Clinical Trial Of Elvitegravir Meets 48-Week Primary Objective                                       94
          Mar 01, 2011: Cytheris Announces Results From Phase IIa Study Of CYT107                                                               95
Appendix                                                                                                                                        97
     Methodology                                                                                                                                97
          Coverage                                                                                                                              97
          Secondary Research                                                                                                                    97
          Primary Research                                                                                                                      97
          Expert Panel Validation                                                                                                               98
     Contact Us                                                                                                                                 98
     Disclaimer                                                                                                                                 98




HIV-1 Infection – Pipeline Review, H2 2011                                                              GMDHC1351IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                        Page(5)
HIV-1 Infection – Pipeline Review, H2 2011




Lis t o f Ta b le s
Number of Products Under Development for HIV-1 Infection, H2 2011                                                    10

Products under Development for HIV-1 Infection – Comparative Analysis, H2 2011                                       11

Number of Products under Development by Companies, H2 2011                                                           13

Number of Products under Development by Companies, H2 2011                                                           14

Number of Products under Investigation by Universities/Institutes, H2 2011                                           16

Number of Products under Investigation by Universities/Institutes, H2 2011                                           17

Comparative Analysis by Late Stage Development, H2 2011                                                              18

Comparative Analysis by Mid Clinical Stage Development, H2 2011                                                      19

Comparative Analysis by Early Clinical Stage Development, H2 2011                                                    20

Comparative Analysis by Discovery and Pre-Clinical Stage Development, H2 2011                                        21

Products under Development by Companies, H2 2011                                                                     22

Products under Development by Companies, H2 2011                                                                     23

Products under Development by Companies, H2 2011                                                                     24

Products under Investigation by Universities/Institutes, H2 2011        
								
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