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Hospira, Inc. – Product Pipeline Review – H2 2011 by GlobalMarketsDirect

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Hospira, Inc. – Product Pipeline Review – H2 2011 Summary Global Market Direct’s pharmaceuticals report, “Hospira, Inc. - Product Pipeline Review - H2 2011” provides data on the Hospira, Inc.’s research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects. This report is built using data and information sourced from Global Markets Direct’s proprietary databases, Hospira, Inc.’s corporate website, SEC filings, investor presentations and featured press releases, both from Hospira, Inc. and industry-specific third party sources, put together by Global Markets Direct’s team. Scope - Hospira, Inc. - Brief Hospira, Inc. overview including business description, key information and facts, and its locations and subsidiaries. - Review of current pipeline of Hospira, Inc. human therapeutic division. - Overview of pipeline therapeutics across various therapy areas. - Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe. - Product profiles for late stage and clinical stage products of Hospira, Inc. with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Hospira, Inc.’s pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products. Reasons to buy - Evaluate Hospira, Inc.’s strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Hospira, Inc. in its therapy areas of focus. - Identify new drug targets and therapeutic classes in the Hospira, Inc.’s R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas. - Exploit in-licensing opportunities by identifying windows of opportunity to fill por

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									       Hospira, Inc. – Product Pipeline Review – H2 2011

                                                                                          Reference Code: GMDHC01891CDB


                                                                                                 Publication Date: NOV 2011




Hospira, Inc. – Product Pipeline Review – H2 2011                                            GMDHC01891CDB/ Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Hospira, Inc. – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 5
      List of Figures .................................................................................................................................................................................................... 7
Hospira, Inc. Snapshot ............................................................................................................................................................................................. 8
      Hospira, Inc. Overview ....................................................................................................................................................................................... 8
      Key Information .................................................................................................................................................................................................. 8
      Key Facts ........................................................................................................................................................................................................... 8
Hospira, Inc. – Research and Development Overview .............................................................................................................................................. 9
      Key Therapeutic Areas ....................................................................................................................................................................................... 9
Hospira, Inc. – Pipeline Review ...............................................................................................................................................................................11
      Pipeline Products by Stage of Development ......................................................................................................................................................11
      Hospira, Inc. – Pipeline Products Glance ..........................................................................................................................................................12
      Hospira, Inc. – Late Stage Pipeline ...................................................................................................................................................................12
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................12
            Phase III Products/Combination Treatment Modalities ................................................................................................................................13
      Hospira, Inc. Clinical Stage Pipeline Products ...................................................................................................................................................14
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................14
Hospira, Inc. – Drug Profiles ....................................................................................................................................................................................15
      Biosimilar Erythropoietin....................................................................................................................................................................................15
            Product Description ....................................................................................................................................................................................15
            Mechanism of Action...................................................................................................................................................................................15
            R&D Progress .............................................................................................................................................................................................15
      Dyloject .............................................................................................................................................................................................................17
            Product Description ....................................................................................................................................................................................17
            Mechanism of Action...................................................................................................................................................................................17
            R&D Progress .............................................................................................................................................................................................17
      Ereska ..............................................................................................................................................................................................................18
            Product Description ....................................................................................................................................................................................18
            Mechanism of Action...................................................................................................................................................................................18
            R&D Progress .............................................................................................................................................................................................18
      POSIDUR .........................................................................................................................................................................................................19
            Product Description ....................................................................................................................................................................................19
            Mechanism of Action...................................................................................................................................................................................19
Hospira, Inc. – Pipeline Analysis..............................................................................................................................................................................20
      Hospira, Inc. – Pipeline Products by Therapeutic Class.....................................................................................................................................20
      Hospira, Inc. - Pipeline Products By Target .......................................................................................................................................................21
      Hospira, Inc. – Pipeline Products by Route of Administration ............................................................................................................................22
      Hospira, Inc. – Pipeline Products by Molecule Type ..........................................................................................................................................23
Hospira, Inc. – Recent Pipeline Updates.................................................................................................................................................................24
Hospira, Inc. - Dormant Projects ..............................................................................................................................................................................25
Hospira, Inc. - Discontinued Pipeline Products ........................................................................................................................................................26
      Discontinued Pipeline Product Profiles ..............................................................................................................................................................26
            Dexmedetomidine .......................................................................................................................................................................................26
            E21R ..........................................................................................................................................................................................................26
Hospira, Inc. – Company Statement ........................................................................................................................................................................27
Hospira, Inc. – Locations And Subsidiaries ..............................................................................................................................................................29




Hospira, Inc. – Product Pipeline Review – H2 2011                                                                                                              GMDHC01891CDB/ Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                                 Page(2)
Hospira, Inc. – Product Pipeline Review



     Head Office .......................................................................................................................................................................................................29
     Other Locations & Subsidiaries .........................................................................................................................................................................29
Hospira, Inc. - Key Manufacturing Facilities .............................................................................................................................................................31
Recent Developments .............................................................................................................................................................................................32
           Jul 31, 2007: Javelin Pharmaceuticals Initiates Phase 3 Breakthrough Cancer Pain Trial For Intranasal Ketamine .....................................32
           Oct 30, 2008: FDA Approves New Indication for Hospira's Precedex (Dexmedetomidine HCl) Injection .....................................................32
           Jun 29, 2009: Hospira Receives FDA Approval for Azithromycin for Injection .............................................................................................33
           Nov 27, 2006: Mayne Pharma Acquires Remaining Nipent Rights ..............................................................................................................33
           Oct 26, 2009: Hospira completes decentralized procedure for generic Docetaxel - full launch expected end 2010......................................34
           Sep 26, 2010: Hospira Receives Australian Approval For Nivestim .............................................................................................................34
           Jul 26, 2010: Hospira Begins Phase I U.S. Clinical Trial Of Biosimilar Erythropoietin In Renal Patients ......................................................34
           Jun 26, 1997: Neurex Announces FDA Panel Recommends Approval of CORLOPAM for Blood Pressure Control In The Hospital Setting 35
           Feb 24, 2004: SuperGen Acquires European Marketing Authorizations for Nipent from Pfizer ....................................................................36
           Jul 23, 2002: Vernalis PLC (Formerly Known As British Biotech PLC) And BresaGen Terminate E21R Development Agreement ..............36
           Apr 23, 1998: Biovail's Crystaal In-Licenses Canadian Rights to Corlopam From Neurex ...........................................................................37
           Aug 22, 2010: Hospira Japan Receives Approval for New Indication for 'Precedex IV 200ug' .....................................................................37
           Aug 22, 2010: Hospira Japan Receives Approval For New Indication For Precedex IV 200ug ....................................................................38
           Jun 22, 2010: Hospira Receives FDA Approval For Meropenem For Injection ............................................................................................38
           Apr 22, 2005: Orchid gets first ANDA approval ...........................................................................................................................................39
           Feb 22, 2010: Retacrit Received a Positive Opinion From the European Committee for Medicinal Products for Human Use (CHMP) for
           Subcutaneous (SC) use in Renal Anaemia .................................................................................................................................................39
           Oct 21, 2010: Hospira Launches Piperacillin And Tazobactam For Injection In US .....................................................................................39
           Sep 21, 2011: Orion Receives European Marketing Authorization For Dexdor ............................................................................................40
           Dec 20, 2000: British Biotech Announces Agreement With BresaGen To Develop And Commercialise Anti-Cancer Drug E21R ................40
           Dec 19, 2007: Hospira's Retacrit Receives Marketing Authorization in the EU ............................................................................................41
           Dec 19, 2007: STADA receives approval for Erythropoietin-zeta – market launch in Q1/2008.....................................................................41
           Oct 18, 2007: Hospira's Biosimilar Epoetin Retacrit Receives Positive Opinion Recommending EU Approval ............................................41
           Feb 17, 2010: Javelin Pharmaceuticals Receives FDA PDUFA Date For Dyloject NDA ..............................................................................41
           Nov 15, 2010: Hospira Launches Gemcitabine Hydrochloride For Injection ................................................................................................42
           Feb 15, 2001: Faulding Acquires FUDR Cancer Therapy Product From Roche ..........................................................................................42
           Dec 14, 2007: Javelin Pharmaceuticals Announces Successful Dyloject Pivotal US Phase 3 Trial Top-Line Results at New York City
           Analyst Day ................................................................................................................................................................................................43
           Oct 12, 2005: Phase IIb Study Data Demonstrate Rylomine Significantly Reduces Postsurgical Orthopedic Pain.......................................44
           Feb 11, 2010: Javelin Announces Top Line Phase III Results Of Ereska From Re-Examination Conducted By Third Party ........................44
           Jun 10, 2010: Hospira Receives Approval For Nivestim In Europe For Prevention Of Febrile Neutropenia Associated With Chemotherapy
           ...................................................................................................................................................................................................................45
           Jun 10, 2008: Enrolls First Patient In Pivotal Trial For PMI-150 ...................................................................................................................46
           Dec 09, 2005: Studies of Nipent in Combination Cancer Therapies for Treatment of Chronic Lymphocytic Leukemia and Graft-versus Host
           Disease (GVHD) Presented at American Society of Hematology Annual Meeting .......................................................................................46
           Mar 09, 2011: Hospira Announces US Approval Of Generic Docetaxel .......................................................................................................47
           Sep 06, 2011: Hospira Announces Positive Results From Phase I US Clinical Trial Of Biosimilar Erythropoietin In Renal Patients.............47
           Jun 06, 2010: SuperGen Completes Contract to Transition Wyeth Distribution of Nipent, Outside of the U.S..............................................48
           Mar 06, 2001: BresaGen Ltd Commences Patient Recruitment Into Phase II Trial Of E21R In Leukaemia .................................................48
           Dec 05, 2003: Orchid gets FDA nod for Cefazolin .......................................................................................................................................49
           Oct 05, 2011: Orion Introduces New Intensive Care Sedative Dexdor .........................................................................................................50
           Aug 05, 2011: Hospira Announces US Approval Of Solution Version Of Gemcitabine Injection ..................................................................51
           Feb 05, 1997: Neurex Initiates CORLOPAM Renal Program; Studies Focused on Beneficial Effect on the Kidney .....................................51
           Apr 03, 2007: Nipent Acquisition by Hospira is Complete ............................................................................................................................52
           Feb 03, 2011: Hospira Announces FDA Approval For Topotecan Injection .................................................................................................52




Hospira, Inc. – Product Pipeline Review – H2 2011                                                                                                               GMDHC01891CDB/ Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                                   Page(3)
Hospira, Inc. – Product Pipeline Review



           Dec 02, 2009: Javelin Pharmaceuticals Files New Drug Application Of Dyloject With FDA For Management Of Acute Moderate-To-Severe
           Pain ............................................................................................................................................................................................................52
           Jun 02, 2006: SuperGen Receives U.S. Patent For Nipent Pentostatin For Injection ..................................................................................53
           Feb 02, 2010: FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application For Formal Review ..................................................53
           Feb 02, 2009: Hospira's Precedex Phase IV Study Published in the Journal of The American Medical Association ....................................54
           Jul 01, 2005: Javelin Announces Acceptance Of Marketing Authorization Application (MAA) For European Regulatory Approval Of
           Dyloject.......................................................................................................................................................................................................55
           Mar 01, 2011: Hospira Receives Canadian Approval For Single-Vial Docetaxel ..........................................................................................55
Financial Deals Landscape......................................................................................................................................................................................57
     Hospira, Inc., Deals Summary ...........................................................................................................................................................................57
Hospira, Inc., Pharmaceuticals & Healthcare, Deal Details ......................................................................................................................................59
     Asset Transactions............................................................................................................................................................................................59
           Hospira Completes Acquisition Of Injectable Pharmaceuticals Business Of Orchid Chemicals & Pharmaceuticals .....................................59
           Hospira Acquires Worldwide Rights To Filgrastim From PLIVA ...................................................................................................................61
           Hospira Acquires EndoTool Business From MD Scientific...........................................................................................................................66
           Hospira Acquires Clayton Manufacturing Facility From Fresenius Kabi .......................................................................................................67
           Mayne Pharma Acquires M.V.I. And Aquasol From AAIPharma..................................................................................................................68
     Partnerships ......................................................................................................................................................................................................69
           Hospira Enters Into An Agreement With Smiths Medical .............................................................................................................................69
           Hospira Enters Into Agreement With University of Alabama at Birmingham ................................................................................................70
           Hospira Enters Into Co-Marketing Agreement With Celltrion .......................................................................................................................71
           StemCor Systems Enters Into An Agreement With Hospira ........................................................................................................................72
           Altea Therapeutics Enters Into An Agreement With Hospira .......................................................................................................................73
           Orexo Enters Into Co-Marketing Agreement With Hospira ..........................................................................................................................74
           Hospira Signs An Agreement With STADA .................................................................................................................................................75
           Hikma Pharmaceuticals
								
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