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									Emergent BioSolutions Inc. – Product Pipeline Review
                    – H2 2011
                                                                                          Reference Code: GMDHC01713CDB

                                                                                                 Publication Date: NOV 2011




Emergent BioSolutions Inc. – Product Pipeline Review – H2 2011                              GMDHC01713CDB / Published NOV 2011

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




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 7
      List of Figures .................................................................................................................................................................................................... 9
Emergent BioSolutions Inc. Snapshot......................................................................................................................................................................10
      Emergent BioSolutions Inc. Overview................................................................................................................................................................10
      Key Information .................................................................................................................................................................................................10
      Key Facts ..........................................................................................................................................................................................................10
Emergent BioSolutions Inc. – Research and Development Overview ......................................................................................................................11
      Key Therapeutic Areas ......................................................................................................................................................................................11
Emergent BioSolutions Inc. – Pipeline Review.........................................................................................................................................................14
      Pipeline Products by Stage of Development ......................................................................................................................................................14
      Emergent BioSolutions Inc. – Pipeline Products Glance ....................................................................................................................................15
      Emergent BioSolutions Inc. – Late Stage Pipeline .............................................................................................................................................15
            Phase III Products/Combination Treatment Modalities ................................................................................................................................15
      Emergent BioSolutions Inc. Clinical Stage Pipeline Products ............................................................................................................................16
            Phase II Products/Combination Treatment Modalities .................................................................................................................................16
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................17
      Emergent BioSolutions Inc.–Early Stage Pipeline Products ...............................................................................................................................18
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................18
Emergent BioSolutions Inc. – Drug Profiles .............................................................................................................................................................20
      Anthrivig ............................................................................................................................................................................................................20
            Product Description ....................................................................................................................................................................................20
            Mechanism of Action...................................................................................................................................................................................20
            R&D Progress .............................................................................................................................................................................................20
      Anti-H5 MAb......................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
      AV7909 .............................................................................................................................................................................................................23
            Product Description ....................................................................................................................................................................................23
            Mechanism of Action...................................................................................................................................................................................23
            R&D Progress .............................................................................................................................................................................................23
      Chlamydia Vaccine ...........................................................................................................................................................................................24
            Product Description ....................................................................................................................................................................................24
            Mechanism of Action...................................................................................................................................................................................24
            R&D Progress .............................................................................................................................................................................................24
      dmPA7909 ........................................................................................................................................................................................................25
            Product Description ....................................................................................................................................................................................25
            Mechanism of Action...................................................................................................................................................................................25
            R&D Progress .............................................................................................................................................................................................25
      DRA161 ............................................................................................................................................................................................................26
            Product Description ....................................................................................................................................................................................26
            Mechanism of Action...................................................................................................................................................................................26
            R&D Progress .............................................................................................................................................................................................26
      DRA162 ............................................................................................................................................................................................................27
            Product Description ....................................................................................................................................................................................27




Emergent BioSolutions Inc. – Product Pipeline Review – H2 2011                                                                                              GMDHC01713CDB / Published NOV 2011

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



          Mechanism of Action...................................................................................................................................................................................27
          R&D Progress .............................................................................................................................................................................................27
    DRA187a ..........................................................................................................................................................................................................28
          Product Description ....................................................................................................................................................................................28
          Mechanism of Action...................................................................................................................................................................................28
          R&D Progress .............................................................................................................................................................................................28
    DRA187b ..........................................................................................................................................................................................................29
          Product Description ....................................................................................................................................................................................29
          Mechanism of Action...................................................................................................................................................................................29
          R&D Progress .............................................................................................................................................................................................29
    DRA209 ............................................................................................................................................................................................................30
          Product Description ....................................................................................................................................................................................30
          Mechanism of Action...................................................................................................................................................................................30
          R&D Progress .............................................................................................................................................................................................30
    DRACO Anti-CD3 SMIP ....................................................................................................................................................................................31
          Product Description ....................................................................................................................................................................................31
          Mechanism of Action...................................................................................................................................................................................31
          R&D Progress .............................................................................................................................................................................................31
    Hepatitis B Therapeutic Vaccine .......................................................................................................................................................................32
          Product Description ....................................................................................................................................................................................32
          Mechanism of Action...................................................................................................................................................................................32
          R&D Progress .............................................................................................................................................................................................32
    HuMax-CD4 ......................................................................................................................................................................................................33
          Product Description ....................................................................................................................................................................................33
          Mechanism of Action...................................................................................................................................................................................33
          R&D Progress .............................................................................................................................................................................................33
    MVA85A............................................................................................................................................................................................................35
          Product Description ....................................................................................................................................................................................35
          Mechanism of Action...................................................................................................................................................................................35
          R&D Progress .............................................................................................................................................................................................35
    MVAH5 .............................................................................................................................................................................................................38
          Product Description ....................................................................................................................................................................................38
          Mechanism of Action...................................................................................................................................................................................38
          R&D Progress .............................................................................................................................................................................................38
    PreviThrax ........................................................................................................................................................................................................39
          Product Description ....................................................................................................................................................................................39
          Mechanism of Action...................................................................................................................................................................................39
          R&D Progress .............................................................................................................................................................................................39
    rPA....................................................................................................................................................................................................................41
          Product Description ....................................................................................................................................................................................41
          Mechanism of Action...................................................................................................................................................................................41
          R&D Progress .............................................................................................................................................................................................41
    Thravixa ............................................................................................................................................................................................................42
          Product Description ....................................................................................................................................................................................42
          Mechanism of Action...................................................................................................................................................................................42
          R&D Progress .............................................................................................................................................................................................42
    TRU-016 ...........................................................................................................................................................................................................43
          Product Description ....................................................................................................................................................................................43




Emergent BioSolutions Inc. – Product Pipeline Review – H2 2011                                                                                             GMDHC01713CDB / Published NOV 2011

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



           Mechanism of Action...................................................................................................................................................................................43
           R&D Progress .............................................................................................................................................................................................43
     TRU-016 + Bendamustine .................................................................................................................................................................................44
           Product Description ....................................................................................................................................................................................44
           Mechanism of Action...................................................................................................................................................................................44
           R&D Progress .............................................................................................................................................................................................44
     Typhella ............................................................................................................................................................................................................46
           Product Description ....................................................................................................................................................................................46
           Mechanism of Action...................................................................................................................................................................................46
           R&D Progress .............................................................................................................................................................................................46
     X1 Scorpion Therapeutics .................................................................................................................................................................................48
           Product Description ....................................................................................................................................................................................48
           Mechanism of Action...................................................................................................................................................................................48
           R&D Progress .............................................................................................................................................................................................48
     X2 Scorpion Therapeutics .................................................................................................................................................................................49
           Product Description ....................................................................................................................................................................................49
           Mechanism of Action...................................................................................................................................................................................49
           R&D Progress .............................................................................................................................................................................................49
Emergent BioSolutions Inc. – Pipeline Analysis .......................................................................................................................................................50
     Emergent BioSolutions Inc. – Pipeline Products by Therapeutic Class ..............................................................................................................50
     Emergent BioSolutions Inc. - Pipeline Products By Target ................................................................................................................................52
     Emergent BioSolutions Inc. – Pipeline Products by Route of Administration ......................................................................................................54
     Emergent BioSolutions Inc. – Pipeline Products by Molecule Type ...................................................................................................................55
Emergent BioSolutions Inc. – Recent Pipeline Updates ..........................................................................................................................................56
Emergent BioSolutions Inc. - Dormant Projects .......................................................................................................................................................60
Emergent BioSolutions Inc. - Discontinued Pipeline Products ..................................................................................................................................61
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................61
           HuMax-CD4 ................................................................................................................................................................................................61
Emergent BioSolutions Inc. – Company Statement..................................................................................................................................................62
Emergent BioSolutions Inc. – Locations And Subsidiaries .......................................................................................................................................67
     Head Office .......................................................................................................................................................................................................67
     Other Locations & Subsidiaries .........................................................................................................................................................................67
Recent Developments .............................................................................................................................................................................................69
           Jul 31, 2008: Emergent BioSolutions Submits Proposal in Response to HHS RFP for Development and Procurement of a Recombinant
           Protective Antigen Anthrax Vaccine ............................................................................................................................................................69
           May 31, 2011: Emergent BioSolutions On Track To Complete Delivery Of 14.5 Million Doses Of BioThrax To US Government Ahead Of
           Schedule ....................................................................................................................................................................................................69
           Sep 30, 2009: NIAID To Fund Development Of Emergent BioSolutions' Advanced Anthrax Vaccine Candidate .........................................70
           Aug 30, 2005: Emergent Biosolutions' Typhoid Vaccine Achieves Positive Results In Phase II Clinical Study ............................................70
           Aug 29, 2006: U.S. Department Of Homeland Security Certifies BioThrax (Anthrax Vaccine Adsorbed) As An Approved Product For
           Homeland Security .....................................................................................................................................................................................71
           Apr 28, 2011: Oxford-Emergent Tuberculosis Consortium Vaccinates Last Infant In Phase IIb Clinical Trial ...............................................71
           Dec 27, 2010: Emergent BioSolutions Starts Phase I Clinical Trial For Anthrax Vaccine .............................................................................72
           Sep 27, 2007: Emergent BioSolutions Receives Development Contract from NIAID/BARDA to Fund Continued Development of Anthrax
           Therapeutic.................................................................................................................................................................................................72
           Mar 27, 2008: Trubion Initiates Phase I/II Study Of TRU-016 In CLL...........................................................................................................73
           Aug 26, 2011: Emergent BioSolutions Announces Publication Of Results Of Phase Ia Study On Adjuvanted BioThrax Anthrax Vaccine In
           Journal Vaccine ..........................................................................................................................................................................................73
           Aug 26, 2011: Emergent BioSolutions Completes Dosing In Phase Ib Anthrax Study .................................................................................74




Emergent BioSolutions Inc. – Product Pipeline Review – H2 2011                                                                                             GMDHC01713CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                               Page(4)
Emergent BioSolutions Inc. – Product Pipeline Review



         May 26, 2011: US Government Issues Request For Proposal For Supply Of 44.75 Million Doses Of Emergent's BioThrax Over Next Five
         Years ..........................................................................................................................................................................................................74
         Oct 25, 2004: TB Vaccine MVA85A Succeeds In Safety Trials....................................................................................................................74
         Feb 25, 2011: Delegates From European Parliament Express Support For Rapid Development Of New TB Vaccine MVA85A ..................75
         Jan 25, 2011: Emergent BioSolutions Initiates Phase Ib/II Study Of TRU-016 In Combination With Bendamustine For Chronic Lymphocytic
         Leukemia ....................................................................................................................................................................................................76
         Jun 24, 2010: Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments ....................................................76
         Jun 24, 2010: Emergent BioSolutions Completes Deliveries Of BioThrax To Allied Foreign Governments ..................................................77
         Jun 23, 2011: Emergent Receives Singapore Health Sciences Authority Approval For BioThrax ................................................................77
         Jun 23, 2008: Emergent BioSolutions And University of Oxford Form Joint Venture To Develop Advanced Tuberculosis Vaccine..............77
         Feb 23, 2007: Emergent BioSolutions Delivers Approximately 1 Million Doses of BioThrax Ahead of Schedule to U.S. Department of Health
         and Human Services for Strategic National Stockpile..................................................................................................................................78
         Apr 22, 2009: New TB Vaccine Candidate Enters Phase IIb Proof-of-Concept Trial In South Africa ............................................................79
         Apr 22, 2009: New TB Vaccine Candidate Enters Phase IIb Proof-of-Concept Trial in South Africa ............................................................80
         Nov 21, 2005: Emergent Biosolutions Starts Clinical Study Of Single-Dose Oral Typhoid Vaccine..............................................................80
         Mar 21, 2007: Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical
         Trial ...........................................................................................................................................................................................
								
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