Bayer AG – Product Pipeline Review – H2 2011

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					            Bayer AG – Product Pipeline Review – H2 2011
                                                                                          Reference Code: GMDHC01665CDB

                                                                                                 Publication Date: NOV 2011




Bayer AG – Product Pipeline Review – H2 2011                                                GMDHC01665CDB / Published NOV 2011

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




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables.....................................................................................................................................................................................................16
      List of Figures ...................................................................................................................................................................................................22
Bayer AG Snapshot .................................................................................................................................................................................................23
      Bayer AG Overview...........................................................................................................................................................................................23
      Key Information .................................................................................................................................................................................................23
      Key Facts ..........................................................................................................................................................................................................23
Bayer AG – Research and Development Overview..................................................................................................................................................24
      Key Therapeutic Areas ......................................................................................................................................................................................24
Bayer AG – Pipeline Review....................................................................................................................................................................................29
      Pipeline Products by Stage of Development ......................................................................................................................................................29
      Pipeline Products – Monotherapy .....................................................................................................................................................................30
      Pipeline Products – Combination Treatment Modalities .....................................................................................................................................31
Bayer AG – Pipeline Products Glance .....................................................................................................................................................................32
      Bayer AG – Late Stage Pipeline ........................................................................................................................................................................32
            Phase III Products/Combination Treatment Modalities ................................................................................................................................32
      Bayer AG Clinical Stage Pipeline Products........................................................................................................................................................34
            Phase II Products/Combination Treatment Modalities .................................................................................................................................34
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................37
      Bayer AG–Early Stage Pipeline Products ..........................................................................................................................................................38
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................38
Bayer AG – Drug Profiles ........................................................................................................................................................................................39
      Adenosine A1 Agonist .......................................................................................................................................................................................39
            Product Description ....................................................................................................................................................................................39
            Mechanism of Action...................................................................................................................................................................................39
            R&D Progress .............................................................................................................................................................................................39
      Alemtuzumab + Fludarabine Phosphate ............................................................................................................................................................40
            Product Description ....................................................................................................................................................................................40
            Mechanism of Action...................................................................................................................................................................................40
            R&D Progress .............................................................................................................................................................................................40
      Alpharadin.........................................................................................................................................................................................................41
            Product Description ....................................................................................................................................................................................41
            Mechanism of Action...................................................................................................................................................................................41
            R&D Progress .............................................................................................................................................................................................41
      Angeliq low-low .................................................................................................................................................................................................43
            Product Description ....................................................................................................................................................................................43
            Mechanism of Action...................................................................................................................................................................................43
            R&D Progress .............................................................................................................................................................................................43
      Autologous FL Vaccine .....................................................................................................................................................................................44
            Product Description ....................................................................................................................................................................................44
            Mechanism of Action...................................................................................................................................................................................44
            R&D Progress .............................................................................................................................................................................................44
      Bay 50-4798......................................................................................................................................................................................................45
            Product Description ....................................................................................................................................................................................45
            Mechanism of Action...................................................................................................................................................................................45
            R&D Progress .............................................................................................................................................................................................45




Bayer AG – Product Pipeline Review – H2 2011                                                                                                               GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



    BAY 60-4552.....................................................................................................................................................................................................46
         Product Description ....................................................................................................................................................................................46
         Mechanism of Action...................................................................................................................................................................................46
         R&D Progress .............................................................................................................................................................................................46
    BAY 81-8781.....................................................................................................................................................................................................47
         Product Description ....................................................................................................................................................................................47
         Mechanism of Action...................................................................................................................................................................................47
         R&D Progress .............................................................................................................................................................................................47
    BAY 86-6150.....................................................................................................................................................................................................48
         Product Description ....................................................................................................................................................................................48
         Mechanism of Action...................................................................................................................................................................................48
         R&D Progress .............................................................................................................................................................................................48
    BAY 86-9766.....................................................................................................................................................................................................49
         Product Description ....................................................................................................................................................................................49
         Mechanism of Action...................................................................................................................................................................................49
         R&D Progress .............................................................................................................................................................................................49
    BAY60-4552 + Vardenafil ..................................................................................................................................................................................50
         Product Description ....................................................................................................................................................................................50
         Mechanism of Action...................................................................................................................................................................................50
         R&D Progress .............................................................................................................................................................................................50
    BAY63-2521......................................................................................................................................................................................................51
         Product Description ....................................................................................................................................................................................51
         Mechanism of Action...................................................................................................................................................................................51
         R&D Progress .............................................................................................................................................................................................51
    BAY79-4620......................................................................................................................................................................................................52
         Product Description ....................................................................................................................................................................................52
         Mechanism of Action...................................................................................................................................................................................52
         R&D Progress .............................................................................................................................................................................................52
    BAY80-6946......................................................................................................................................................................................................53
         Product Description ....................................................................................................................................................................................53
         Mechanism of Action...................................................................................................................................................................................53
         R&D Progress .............................................................................................................................................................................................53
    BAY86-5302 + Cisplatin ....................................................................................................................................................................................54
         Product Description ....................................................................................................................................................................................54
         Mechanism of Action...................................................................................................................................................................................54
         R&D Progress .............................................................................................................................................................................................54
    BAY86-9766 + Gemcitabine ..............................................................................................................................................................................55
         Product Description ....................................................................................................................................................................................55
         Mechanism of Action...................................................................................................................................................................................55
         R&D Progress .............................................................................................................................................................................................55
    BAY86-9766 + Sorafenib...................................................................................................................................................................................56
         Product Description ....................................................................................................................................................................................56
         Mechanism of Action...................................................................................................................................................................................56
         R&D Progress .............................................................................................................................................................................................56
    BAY87-2243......................................................................................................................................................................................................57
         Product Description ....................................................................................................................................................................................57
         Mechanism of Action...................................................................................................................................................................................57
         R&D Progress .............................................................................................................................................................................................57




Bayer AG – Product Pipeline Review – H2 2011                                                                                                          GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



    BAY94-9027......................................................................................................................................................................................................58
          Product Description ....................................................................................................................................................................................58
          Mechanism of Action...................................................................................................................................................................................58
          R&D Progress .............................................................................................................................................................................................58
    BAY98-7111 + Diphenhydramine ......................................................................................................................................................................60
          Product Description ....................................................................................................................................................................................60
          Mechanism of Action...................................................................................................................................................................................60
          R&D Progress .............................................................................................................................................................................................60
    Bifonazol Spray .................................................................................................................................................................................................61
          Product Description ....................................................................................................................................................................................61
          Mechanism of Action...................................................................................................................................................................................61
          R&D Progress .............................................................................................................................................................................................61
    Capadenoson....................................................................................................................................................................................................62
          Product Description ....................................................................................................................................................................................62
          Mechanism of Action...................................................................................................................................................................................62
          R&D Progress .............................................................................................................................................................................................62
    Cinaciguat .........................................................................................................................................................................................................63
          Product Description ....................................................................................................................................................................................63
          Mechanism of Action...................................................................................................................................................................................63
          R&D Progress .............................................................................................................................................................................................63
    Cipro .................................................................................................................................................................................................................64
          Product Description ....................................................................................................................................................................................64
          Mechanism of Action...................................................................................................................................................................................64
          R&D Progress .............................................................................................................................................................................................64
    Dehydroepiandrosterone + BAY86-5314 ...........................................................................................................................................................66
          Product Description ....................................................................................................................................................................................66
          Mechanism of Action...................................................................................................................................................................................66
          R&D Progress .............................................................................................................................................................................................66
    Drospirenone + Ethinylestradiol + Methyltetrahydrofolate ..................................................................................................................................67
          Product Description ....................................................................................................................................................................................67
          Mechanism of Action...................................................................................................................................................................................67
          R&D Progress .............................................................................................................................................................................................67
    E2 + DRSP .......................................................................................................................................................................................................68
          Product Description ....................................................................................................................................................................................68
          Mechanism of Action...................................................................................................................................................................................68
          R&D Progress .............................................................................................................................................................................................68
    Elastase Inhibitor...............................................................................................................................................................................................70
          Product Description ....................................................................................................................................................................................70
          Mechanism of Action...................................................................................................................................................................................70
          R&D Progress .............................................................................................................................................................................................70
    FC Patch Low ...................................................................................................................................................................................................71
          Product Description ....................................................................................................................................................................................71
          Mechanism of Action...................................................................................................................................................................................71
          R&D Progress .............................................................................................................................................................................................71
    Florbetaben .......................................................................................................................................................................................................72
          Product Description ....................................................................................................................................................................................72
          Mechanism of Action...................................................................................................................................................................................72
          R&D Progress .............................................................................................................................................................................................72




Bayer AG – Product Pipeline Review – H2 2011                                                                                                               GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



    Fludarabine + Rituximab ...................................................................................................................................................................................73
          Product Description ....................................................................................................................................................................................73
          Mechanism of Action...................................................................................................................................................................................73
          R&D Progress .............................................................................................................................................................................................73
    Idiotype Vaccine................................................................................................................................................................................................74
          Product Description ....................................................................................................................................................................................74
          Mechanism of Action...................................................................................................................................................................................74
          R&D Progress .............................................................................................................................................................................................74
    Kogenate PF .....................................................................................................................................................................................................75
          Product Description ....................................................................................................................................................................................75
          Mechanism of Action...................................................................................................................................................................................75
          R&D Progress .............................................................................................................................................................................................75
    L19-SIP .............................................................................................................................................................................................................76
          Product Description ....................................................................................................................................................................................76
          Mechanism of Action...................................................................................................................................................................................76
          R&D Progress .............................................................................................................................................................................................76
    Mapracorat ........................................................................................................................................................................................................77
          Product Description ....................................................................................................................................................................................77
          Mechanism of Action...................................................................................................................................................................................77
          R&D Progress .............................................................................................................................................................................................77
    MN Immunoconjugate .......................................................................................................................................................................................78
          Product Description ....................................................................................................................................................................................78
          R&D Progress .............................................................................................................................................................................................78
    Modified FOLFOX6 + Nexavar ..........................................................................................................................................................................79
          Product Description ....................................................................................................................................................................................79
          Mechanism of Action...................................................................................................................................................................................79
          R&D Progress .............................................................................................................................................................................................79
    Nexavar + Paclitaxel + Carboplatin + Bevacizumab .........................................................................................................................................80
          Product Description ....................................................................................................................................................................................80
          Mechanism of Action...................................................................................................................................................................................80
          R&D Progress .............................................................................................................................................................................................81
    Nexavar + Doxorubicin ......................................................................................................................................................................................82
          Product Description ....................................................................................................................................................................................82
          Mechanism of Action...................................................................................................................................................................................82
          R&D Progress .............................................................................................................................................................................................82
    Nexavar + Paclitaxel + Carboplatin ...................................................................................................................................................................83
          Product Description ....................................................................................................................................................................................83
          Mechanism of Action...................................................................................................................................................................................83
          R&D Progress .............................................................................................................................................................................................83
    PI3K Inhibitor ....................................................................................................................................................................................................85
          Product Description ....................................................................................................................................................................................85
          Mechanism of Action...................................................................................................................................................................................85
          R&D Progress .............................................................................................................................................................................................85
    PTK787/ ZK 222584..........................................................................................................................................................................................86
          Product Description ....................................................................................................................................................................................86
          Mechanism of Action...................................................................................................................................................................................86
          R&D Progress .............................................................................................................................................................................................86
    RDEA 436 .........................................................................................................................................................................................................87




Bayer AG – Product Pipeline Review – H2 2011                                                                                                              GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



           Product Description ....................................................................................................................................................................................87
           Mechanism of Action...................................................................................................................................................................................87
           R&D Progress .............................................................................................................................................................................................87
     Regorafenib ......................................................................................................................................................................................................88
           Product Description ....................................................................................................................................................................................88
           Mechanism of Action...................................................................................................................................................................................88
           R&D Progress .............................................................................................................................................................................................88
     Regorafenib + Cisplatin + Pemetrexed ..............................................................................................................................................................90
           Product Description ....................................................................................................................................................................................90
           Mechanism of Action...................................................................................................................................................................................90
           R&D Progress .............................................................................................................................................................................................90
     Regorafenib + FOLFIRI .....................................................................................................................................................................................91
           Product Description ....................................................................................................................................................................................91
           Mechanism of Action...................................................................................................................................................................................91
           R&D Progress .............................................................................................................................................................................................91
     Regorafenib + FOLFOX6 ..................................................................................................................................................................................92
           Product Description ....................................................................................................................................................................................92
           Mechanism of Action...................................................................................................................................................................................92
           R&D Progress .............................................................................................................................................................................................92
     Sagopilone + Acetyl-L-Carnitine + Prednisone ..................................................................................................................................................94
           Product Description ....................................................................................................................................................................................94
           Mechanism of Action...................................................................................................................................................................................94
           R&D Progress .............................................................................................................................................................................................94
     YAZ-Flex ...........................................................................................................................................................................................................96
           Product Description ....................................................................................................................................................................................96
           Mechanism of Action...................................................................................................................................................................................96
           R&D Progress .............................................................................................................................................................................................96
     ZK-Epothilone + Carboplatin .............................................................................................................................................................................98
           Product Description ....................................................................................................................................................................................98
           Mechanism of Action...................................................................................................................................................................................98
           R&D Progress .............................................................................................................................................................................................98
     ZK-Epothilone + Prednisone .............................................................................................................................................................................99
           Product Description ....................................................................................................................................................................................99
           Mechanism of Action...................................................................................................................................................................................99
           R&D Progress .............................................................................................................................................................................................99
Bayer AG – Pipeline Analysis ................................................................................................................................................................................100
     Bayer AG – Pipeline Products by Therapeutic Class .......................................................................................................................................100
     Bayer AG - Pipeline Products By Target..........................................................................................................................................................102
     Bayer AG – Pipeline Products by Route of Administration ...............................................................................................................................104
     Bayer AG – Pipeline Products by Molecule Type.............................................................................................................................................105
Bayer AG – Recent Pipeline Updates ...................................................................................................................................................................106
Bayer AG - Dormant Projects ................................................................................................................................................................................114
Bayer AG - Discontinued Pipeline Products ...........................................................................................................................................................115
     Discontinued Pipeline Product Profiles ............................................................................................................................................................115
           Spheramine ..............................................................................................................................................................................................115
           BAY 79-4980 ............................................................................................................................................................................................115
           Sagopilone................................................................................................................................................................................................116
Bayer AG – Company Statement...........................................................................................................................................................................117




Bayer AG – Product Pipeline Review – H2 2011                                                                                                              GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



Bayer AG – Locations And Subsidiaries ................................................................................................................................................................119
     Head Office .....................................................................................................................................................................................................119
     Other Locations & Subsidiaries .......................................................................................................................................................................119
Recent Developments ...........................................................................................................................................................................................122
           Oct 31, 2008: Bayer And Onyx's New Analyses Confirm Nexavar's Efficacy And Safety In Multiple Patient Subsets With Liver Cancer ...122
           Oct 31, 2007: European Approval Submission By Bayer HealthCare For Rivaroxaban .............................................................................122
           Aug 31, 2010: J&JPRD Reports Data From Phase III Study Of Rivaroxaban For Prevention Of Recurrent Venous Thromboembolism ....123
           Aug 31, 2010: TALENT Study Shows: Starting With A Combination Of Adalat Gits And Pritor/Kinzal Achieves Earlier Blood Pressure
           Control Than Initiating Monotherapy With Either Combination Component ...............................................................................................124
           Jul 31, 2008: Rivaroxaban Submitted For Approval In The US. .................................................................................................................125
           Nov 30, 2005: Schering Announces Start Of Three Phase II Clinical Trials With Anti-Cancer Compound ZK-EPO ...................................125
           Oct 30, 1998: First Approval of Cerivastatin 0.4mg Strength in Mexico .....................................................................................................126
           Sep 30, 2009: Onyx And Bayer Announces Phase 2 Results Of Nexavar In Combination With Paclitaxel For Treatment Of Advanced
           Breast Cancer...........................................................................................................................................................................................126
           Sep 30, 2009: Results Reported for Exploratory Phase II Trial of Nexavar in Combination with Chemotherapeutic Agent Paclitaxel for
           Treatment of Advanced Breast Cancer Preliminary results require further analysis and interpretation .....................................................127
           Aug 30, 2009: Patient Enrollment Over For Major Phase III Study On Rivaroxaban(ROCKET AF) ...........................................................128
           Jul 30, 2009: Transave Enters Into Research Agreement With NIH To Study ARIKACE In Nontuberculous Mycobacteria. .......................128
           May 30, 2008: Pivotal Phase III Clinical Trial Results Of Rivaroxaban Developed By Bayer Corporation And Johnson & Johnson ...........129
           Mar 30, 2006: Bayer Pharmaceuticals Corporation And Onyx Pharmaceuticals, Inc. Receives Approval For Nexavar In Switzerland .......129
           Sep 29, 2011: Phase III Study Of Bayer’s Rivaroxaban In Patients With Acute Coronary Syndrome Meets Primary Efficacy Endpoint .....130
           Sep 29, 2008: Bayer Broadens Its Manufacturing Basis For Biopharmaceuticals In Tobacco Plants .........................................................130
           Nov 28, 2005: Schering AG and Siemens Medical Solutions to jointly explore novel Computer Tomography technology ..........................131
           Jul 28, 2008: Bayer HealthCare Pharmaceuticals And Onyx Pharmaceuticals, Inc. Receives Approval For Nexavar In China ..................131
           Jun 28, 2008: Titan Pharmaceuticals And Bayer Announce Spheramine Initial Phase IIb Results ............................................................132
           May 28, 2009: Phase III Trial Started to Evaluate Combination Therapy of Nexavar and Tarceva in Patients with Liver Cancer ...............133
           May 28, 2009: Phase III Trial Started To Evaluate Combination Therapy Of Nexavar And Tarceva In Patients With Liver Cancer. ...........133
           May 28, 2009: U.S. FDA Issues Complete Response Letter For Rivaroxaban (Xarelto). ...........................................................................134
           Jan 28, 2010: Bayer Initiates Phase I Trial Of Personalized Vaccine From Tobacco Plants ......................................................................134
           Jan 28, 2010: Bayer Starts Clinical Phase I Study With Personalized Vaccine From Tobacco Plants .......................................................135
           Jan 28, 2010: Bayer Starts Phase I Study With Personalized Non-Hodgkin’s Lymphoma Vaccine From Tobacco Plants .........................136
           Dec 27, 1995: U.S. Food and Drug Administration Clears Femstat 3 For Marketing..................................................................................137
           Jun 27, 2007: Bayer And Onyx Submits Supplemental New Drug Application For Nexavar To Treat Liver Cancer ...................................137
           Jun 27, 1997: Baycol Cleared For Marketing By U.S F.D.A.......................................................................................................................138
           Apr 27, 2009: Phase III Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint
           Study stopped based on interim analysis ..................................................................................................................................................138
           Oct 26, 2011: Bayer Announces Phase III Trial Of Regorafenib In Metastatic Colorectal Cancer Meets Primary Endpoint Of Improving
           Overall Survival.........................................................................................................................................................................................139
           Oct 26, 2005: Ortho-McNeil Pharmaceutical And Bayer AG To Co-Develop Bayer AG 's Xarelto..............................................................140
           Mar 26, 1996: Procter-Syntex Announces Availability Of Femstat 3 ..........................................................................................................141
           Jan 26, 2006: Bayer Clinical Trials on Trasylol Not Consistent with New England Journal of Medicine (NEJM) Study ..............................141
           Oct 25, 2007: Bayer Issues Additional Guidance to Physicians on Trasylol ...............................................................................................142
           Jul 25, 2011: Bayer's Xarelto Meets Primary Endpoint In Phase III Atrial Fibrillation Study .......................................................................142
           Jan 25, 2010: Bayer Discontinues Phase II Clinical Trial Of BAY79-4980 Following Interim Analysis........................................................144
           Jan 25, 2007: Bayer discontinues Trasylol clinical trial program in non-CABG indications.........................................................................144
           Oct 24, 2007: Ardea Biosciences, Inc. Presents Initial Data On MEK inhibitor, RDEA119 At The 2007 AACR-NCI-EORTC Conference On
           Molecular Targets And Cancer Therapeutics ............................................................................................................................................144
           Sep 24, 2011: Bayer Reports Positive Phase III Data Of Alpharadin In Castration-Resistant Prostate Cancer And Symptomatic Bone
           Metastases ...............................................................................................................................................................................................145
           Jul 24, 2006: European Commission Approves Marketing Authorization For Nexavar To Treat Advanced Kidney Cancer ........................146




Bayer AG – Product Pipeline Review – H2 2011                                                                                                             GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



         Feb 24, 2011: Bayer And Onyx Begin Enrollment In Phase III Trial Of Nexavar In Combination With Chemotherapy Agent Capecitabine For
         Patients With Advanced Breast Cancer ....................................................................................................................................................147
         Nov 23, 2006: Betaferon Approved in Australia for Earliest Stages of Multiple Sclerosis. ..........................................................................148
         Oct 23, 2009: Bayer and Onyx Initiate Phase III Trial of Nexavar in Patients with Non-Responsive Thyroid Cancer..................................148
         Sep 23, 2011: Bayer HealthCare’s Xarelto Recommended For Approval In Prevention Of AF Related Stroke And Treatment Of Deep Vein
         Thrombosis In EU .....................................................................................................................................................................................149
         Sep 23, 2010: Bayer Launches Betaferon For Treatment Of Multiple Sclerosis In China...........................................................................150
         Sep 23, 2010: Bayer launches Betaferon in China ....................................................................................................................................150
         Sep 23, 2009: Nexavar in Combination with Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival First
         presentation of results at joint ECCO-ESMO congress in Berlin, Germany ...............................................................................................151
         Aug 23, 2011: FDA Grants Fast Track Designation To Bayer’s Alpharadin For Castration Resistant Prostate Cancer In Patients With Bone
         Metastases ...............................................................................................................................................................................................151
         May 23, 2011: Bayer Healthcare Launches Next Generation Of Aspirin For Pain Relief............................................................................152
         May 23, 2009: Bayer Schering Pharma To Present Data on Oncology Development Compound BAY 73-4506 ........................................153
         May 23, 2006: Schering AG Announces Initiation Of Two New Phase II Trials With Sagopilone (ZK-EPO) In U.S. ...................................153
         Sep 22, 2009: Bayer’s Regorafenib Shows Promise In Renal Cancer, May Fuel Onyx Dispute ................................................................154
         Sep 22, 2009: New Phase II Data Presented At Ecco 15 - 34Th Esmo Congress Reinforces Exciting Potential Of Algeta'S Alpharadin As A
         New Treatment For Bone Metastases In Cancer Patients .........................................................................................................................155
         Jul 22, 2009: Nexavar in Combination with Chemotherapy Shown To Extend Progression-Free Survival in Patients with Advanced Breast
         Cancer Statistically Significant Results Reported from a Phase II Study Combining Two Oral Cancer Therapies.....................................156
         Oct 21, 2011: New Data Confirms Benefits Of Early And First Line Treatment With Betaferon In Multiple Sclerosis .................................156
         Sep 21, 2011: Health Canada Provides Update On Trasylol .....................................................................................................................158
         Sep 21, 2006: FDA Advisory Committee Strongly Endorses Use of Trasylol in CABG Surgery Patients ...................................................159
         Aug 21, 2008: Bayer And Onyx Begin Enrollment In Storm Trial Studying Nexavar As Adjuvant Therapy For Patients With Liver Cancer 159
         Jun 21, 2010: New erectile dysfunction treatment Staxyn approved in the U.S. ........................................................................................160
         May 21, 2010: Bayer Announces Results Of Phase III Clinical Trial Of Gadobutrol ...................................................................................160
         Apr 21, 2009: Transave Completes Patient Enrollment In Phase II Study Of Arikace. ...............................................................................161
         Feb 21, 2008: Algeta Receives IND Approval For Alpharadin To Initiate Clinical Development In The USA ..............................................161
         Dec 20, 2005: CuraGen And Bayer Update Agreement For The Development Of BAY 76-7171 (Formerly CT052) ..................................162
         Dec 20, 2005: FDA Approves Nexavar For Treatment Of Patients With Advanced Kidney Cancer ...........................................................162
         May 20, 2010: Bayer And Onyx Announce Presentation Of Nexavar Data At 46th American Society Of Clinical Oncology Annual Meeting
         .................................................................................................................................................................................................................163
         May 20, 2009: Bayer And Onyx Receives Approval For Nexavar In Japan For The Treatment Of Advanced Liver Cancer .......................164
         May 20, 2009: Nexavar Approved in Japan for the Treatment of Advanced Liver Cancer .........................................................................165
         May 20, 2008: Ardea Biosciences Presents Preclinical Data On RDEA119 Demonstrating Favorable Anti-Inflammatory Profile For Potential
         Use In Ulcerative Colitis ............................................................................................................................................................................166
         Mar 20, 2009: Ardea Biosciences To Present Preclinical Data On RDEA119 At The American Association For Cancer Research 100th
         Annual Meeting .........................................................................................................................................................................................167
         Nov 19, 2009: Bayer Healthcare To Appeal The Decision By NICE To Deny NHS Funding For Nexavar(sorafenib). ................................167
         Oct 19, 2009: Transave Completes Successful Phase II Clinical Program for ARIKACE ...........................................................................168
         Aug 19, 2009: New Levitra formulation submitted for registration in the EU ..............................................................................................168
         Jun 19, 2007: Bayer And Onyx Submits New European Marketing Authorization Application To EMEA For Nexavar To Treat Liver Cancer
         .................................................................................................................................................................................................................169
         May 19, 2011: Ardea Announces Data On MEK Inhibitor BAY 86-9766 (RDEA119) To Be Presented At ASCO 2011 Annual Meeting ....169
         May 19, 2009: Bayer Schering Pharma Presents Positive Phase II Study With Riociguat .........................................................................170
         May 19, 2008: Amikacin Inhale Shows Promising Results In Phase II Study.............................................................................................170
         Mar 19, 2007: Avid Announces Results Of AV-1 Molecular Imaging Agent For Alzheimer's Disease Presented At AD/PD Meeting ..........171
         Aug 18, 2005: Bayer To Commence Late-stage Trials On BAY 59-7939...................................................................................................172
         May 18, 2011: Bayer And Onyx Pharmaceuticals Announce Presentation Of Nexavar Data At ASCO 2011 Annual Meeting....................172
         May 18, 2011: Bayer And Onyx Report Positive Phase IIb Trial Results Of Nexavar Plus Chemotherapy In Advanced Breast Cancer .....173
         May 18, 2010: Bayer Presents New Riociguat Phase II Data ....................................................................................................................174
         Nov 17, 2000: Bayer Signs Hemophilia Gene Therapy Deal with Avigen ..................................................................................................175



Bayer AG – Product Pipeline Review – H2 2011                                                                                                               GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



         Jun 17, 2008: Bayer HealthCare Cinaciguat Safely Improves Cardiopulmonary Haemodynamics In Acute Decompensated Heart Failure
         .................................................................................................................................................................................................................175
         May 17, 2011: Bayer Presents Positive Data From Phase II Study Of Ciprofloxacin DPI In Patients With Non-Cystic Fibrosis Bronchiectasis
         At ATS Annual Meeting.............................................................................................................................................................................176
         May 17, 2005: Schering AG Announces Phase 1 Results Of ZK-EPO In Treating Solid Tumors ..............................................................176
         Mar 17, 2003: Betaseron (Interferon Beta-1b) Gains Expanded FDA Labeling Approval for Treating Relapsing Forms of Multiple Sclerosis.
         .................................................................................................................................................................................................................177
         Oct 16, 2008: Ardea Biosciences Initiates A Phase 1/2 Study Of RDEA119, Its Lead MEK Inhibitor, In Combination With Nexavar
         (sorafenib) In Patients With Advanced Cancer ..........................................................................................................................................177
         Sep 16, 2008: Bayer’s Xarelto Approved In Canada. ................................................................................................................................178
         Sep 16, 1996: Bayer And Roche To Enter In An OTC Joint Venture .........................................................................................................179
         Aug 16, 2001: Avigen Begins Testing of Its Liver Delivery of Hemophilia B Gene Therapy .......................................................................179
         Jun 16, 2008: Bayer Will Use Tobacco Plants To Produce Medicines For Development Of Candidate From The New Plant For Non-
         Hodgkin’s Lymphoma ...............................................................................................................................................................................180
         Nov 15, 2010: Johnson & Johnson Announces Pivotal Phase III Study Results Of Rivaroxaban For Reduction Of Stroke In Atrial Fibrillation
         Patients ....................................................................................................................................................................................................181
         Sep 15, 2006: AstraZeneca And Schering AG Form Strategic Alliance To Develop Novel SERD Breast Cancer Drug .............................182
         May 15, 2009: Bayer And Onyx Announce Nexavar Data Presentations At 45th American Society Of Clinical Oncology Annual Meeting 182
         Mar 15, 2011: Bayer Receives FDA Approval For Gadobutrol Injection For MRI Of Central Nervous System ...........................................183
         Sep 14, 2011: MorphoSys Announces Clinical Milestone In Cancer Antibody Program With Bayer HealthCare Pharmaceuticals .............183
         Jul 14, 2010: New Variant to rFVIIa-BAY 86-6150 Shows Good Early Results in Patients With Complicated Haemophilia .......................184
         Jun 14, 2011: ImmunoGen Earns Milestone With BAY 94-9343 IND Submission .....................................................................................184
         Jun 14, 2010: Bayer And Onyx Report Phase III Data Of Nexavar In Advanced NSCLC...........................................................................185
         Apr 14, 2011: Bayer’s Rivaroxaban Submitted for Approval in Japan ........................................................................................................186
         Oct 13, 2003: Betaseron Gains FDA Approval for Pre-Filled Diluent Syringe. .........................................................................................186
         Sep 13, 2011: Bayer And Onyx Announce Presentation Of New Nexavar Data At 2011 ECCO-ESMO Congress.....................................186
         Sep 13, 2011: Bayer To Present New Data On Alpharadin's Pivotal Phase III Study At 2011 ECCO-ESMO Congress .............................187
         Sep 13, 2011: Bayer To Present New Data On Regorafenib At 2011 ECCO-ESMO Congress .................................................................188
         Jun 13, 2006: Nexavar Receives Fast Track Designation From FDA For Metastatic Liver Cancer ............................................................189
         Nov 12, 2008: Phase II Trial Of Experimental Anti Coagulant Reports Safety And Outcomes Data Of Rivaroxaban. ................................189
         Sep 12, 2007: FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol .............................................190
         Sep 12, 2005: Bayer And Onyx Announce European Marketing Submission For Sorafenib ......................................................................190
         Aug 12, 2008: Algeta Begins First US Clinical Trial Of Alpharadin In Men With Advanced Bone Metastasis .............................................191
         Jun 12, 2009: Bayer Completes First Global Phase II Study Of BAY 94-9172 In Alzheimer’s Disease Imaging.........................................191
         Mar 12, 2010: Bayer Starts Phase III Study To Evaluate Efficacy And Safety Of Gadovist In Magnetic Resonance Mammography..........192
         Dec 11, 2009: Algeta Initiates Phase III Clinical Study Of Alpharadin For The Treatment Of Bone Metastases .........................................193
         Dec 11, 2009: Bayer HealthCare Pharmaceuticals And Onyx Pharmaceuticals, Inc. Announces A Collaborative Phase 2 Trials Results Of
         Nexavar At The 32nd Annual San Antonio Breast Cancer Symposium (SABCS) ......................................................................................193
         Nov 11, 2010: Ardea To Present Data On RDEA119 At EORTC-NCI-AACR Symposium On Molecular Targets And Cancer Therapeutics
         .................................................................................................................................................................................................................194
         Sep 11, 2008: Ardea Biosciences To Present Data On Lead MEK inhibitor, RDEA119, At EORTC-NCI-AACR Symposium .....................194
         Jun 11, 2010: Bayer Reports Phase II Results Of Riociguat In Treatment Of Pulmonary Hypertension .....................................................194
         Jun 11, 2008: Maxygen Receives The Necessary Approvals In The United Kingdom To Initiate A First-In-Human Phase I Trial Of MAXY-
         VII In Hemophilia Patients. ........................................................................................................................................................................196
         May 11, 2000: Bayer Sues Generics Firms Over Adalat CC .....................................................................................................................196
         Apr 11, 2005: Bayer Initiates Phase III Clinical Study of Trasylol Therapy During Primary Total Hip Replacement Surgery ......................196
         Dec 10, 2010: Bayer Submits Marketing Authorization Application For New Oral Contraceptive Regimen In EU ......................................197
         Dec 10, 2009: Bayer Schering Pharma Completes The First Phase II Trial Study Of Riociguat (BAY 63-2521) For The Treatment Of
         Interstitial Lung Disease (PH-ILD) .............................................................................................................................................................197
         Nov 10, 2008: Bayer's Xarelto Phase II Study Results In Patients With Acute Coronary Syndrome. .........................................................198
         Aug 10, 2011: Bayer Announces Publication Of Results Of Landmark ROCKET AF Study In New England Journal Of Medicine .............198
         May 10, 2011: Bayer Receives FDA Fast Track Designation For Regorafenib For Treatment Of Gastrointestinal Stromal Tumors ...........200



Bayer AG – Product Pipeline Review – H2 2011                                                                                                               GMDHC01665CDB / Published NOV 2011

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Bayer AG – Product Pipeline Review



         Mar 10, 2008: Bayer to launch world’s first pre-filled cartridges for MRI contrast media ............................................................................200
         Jan 10, 2011: Bayer Initiates Phase III Trial Of Regorafenib In Gastrointestinal Stromal Tumors ..............................................................201
         Nov 09, 2004: Berlex Inc. Announces Preclinical Trial Results Of Lipoxin For Crohn's Disease ................................................................201
         Nov 09, 2004: Trasylol (aprotinin injection) Reduced Bleeding in Patients Receiving Anti-Platelet Therapy Prior to Coronary Artery Bypass
         Graft Surgery. ...........................................................................................................................................................................................202
         Sep 09, 2011: FDA Advisory Committee Recommends Approval Of Bayer’s Xarelto ................................................................................202
         Sep 09, 2008: Ardea Biosciences ToPresent Data On RDEA119 At American College Of Gastroenterology Annual Scientific Meeting....203
         Jun 09, 2004: Low Dose Menostar Approved In U.S. For Osteoporosis Prevention ..................................................................................204
         Feb 09, 2009: Bayer Schering Pharma Receives Approval To Initiate Phase III Program For Riociguat For Investigational Pulmonary
         Hypertension Therapy...............................................................................................................................................................................204
         Oct 08, 2010: Algeta And Bayer To Present Analysis From Alpharadin Clinical Program At 35Th ESMO Congress .................................205
         Sep 08, 2011: AHA's Perspective On FDA Committee Decision On Rivaroxaban .....................................................................................205
         Aug 08, 2001: Bayer Announced Withdrawal Of Baycol/Lipobay...............................................................................................................206
         Jul 08, 2010: Bayer HealthCare To Present Phase I Clinical Data On BAY 86-6150 For Treatment Of Hemophilia A Or Hemophilia B At
         WHF Congress .........................................................................................................................................................................................206
         Jul 08, 2007: Phase III Clinical Trial Results Of Rivaroxaban To Treat Vein Thrombosis and Pulmonary Embolism.................................206
         Mar 08, 2005: Bayer And Onyx Initiates Phase III Clinical Trial Of Nexavar In Patients With Advanced Primary Liver Cancer ..................207
         Feb 08, 2006: Bayer and Global Regulatory Authorities Evaluating Published Reports on Trasylol ...........................................................208
         Nov 07, 2007: BRIGHT Results Show Less Pain and Higher Patient Satisfaction with Betaseron than with Rebif ....................................208
         Oct 07, 2011: Phase III Study Of Bayer’s Rivaroxaban In Patients With Acute Coronary Syndrome Accepted For Presentation As Late
         Breaker At AHA Scientific Sessions 2011 .................................................................................................................................................209
         Oct 07, 2010: Bayer And Onyx Announce Nexavar Data Presentations At 35th European Society For Medical Oncology Congress ........209
         Oct 07, 2008: Ardea Biosciences Presents Preclinical Anti-Inflammatory Data On Its Lead MEK Inhibitor, RDEA119, At The ACG 2008
         Annual Meeting .........................................................................................................................................................................................210
         Jun 07, 2006: Betaferon Approved in Europe as a First-Line Treatment for the Earliest Stages of Multiple Sclerosis. ..............................210
         May 07, 2010: Bayer Schering Pharma Initiates Phase III Trial Of Regorafenib In Metastatic Colorectal Cancer ......................................211
         Mar 07, 2003: Levitra Approved for the Treatment of Erectile Dysfunction by European Commission .......................................................211
         Oct 06, 2008: Bayer Initiates Phase III Clinical Trial Of Riociguat..............................................................................................................212
         Sep 06, 2011: FDA Panel To Review NDA Of Bayer's Rivaroxaban .........................................................................................................212
         Sep 06, 2010: Bayer Receives European Approval For LEVITRA 10mg Orodispersible Tablet For Treatment Of Erectile Dysfunction .....213
         Jul 06, 2009: Bayer HealthCare Launches Xarelto In China . ....................................................................................................................214
         Jun 06, 2011: Bayer's Alpharadin Significantly Improves Overall Survival In Phase III Trial In Patients With Castration-Resistant Prostate
         Cancer ......................................................................................................................................................................................................214
         Jan 06, 2004: Bayer Wins Legal Dispute With The European Commission In Appeal Court......................................................................215
         Nov 05, 2007: Bayer Temporarily Suspends Global Trasylol Marketing ....................................................................................................215
         May 05, 2009: Bayer Starts Phase III Studies With Innovative Low-dose Contraceptive Patch. ................................................................216
         Apr 05, 2011: J&JPRD Announces Results From MAGELLAN Phase III Trial ...........................................................................................216
         Jan 05, 2011: Algeta Completes Phase III Trial Enrollment For Alpharadin In Bone Metastasis ................................................................217
         Jan 05, 2011: J&J Submits Complete Response Letter To FDA For Rivaroxaban For Prevention Of Deep Vein Thrombosis And Pulmonary
         Embolism ..................................................................................................................................................................................................218
         Jan 05, 2011: J&J Submits NDA To FDA For Rivaroxaban For Prevention Of Stroke In Patients With Atrial Fibrillation ............................218
         Aug 04, 2010: Bayer’s Rivaroxaban Meets Primary Endpoint In Long-Term Phase III EINSTEIN-DVT Study ...........................................218
         Jul 04, 2008: Bayer And Titan Pharmaceuticals Discontinue The Spheramine Cell Therapy .....................................................................220
         Feb 04, 2011: Bayer Wins FDA Orphan Drug Designation For Regorafenib For Treatment Of Gastrointestinal Stromal Tumors ..............220
         Feb 04, 2010: New Single Dose Study Shows: Generic Nifedipine Not Bioequivalent To Adalat Gits........................................................221
         Feb 04, 2010: Progenics Presents Novel Multiplex PI3-Kinase Inhibitors At American Association For Cancer Research Conference On
         Protein Translation And Cancer ...............
				
DOCUMENT INFO
Description: Bayer AG – Product Pipeline Review – H2 2011 Summary Global Market Direct’s pharmaceuticals report, “Bayer AG - Product Pipeline Review - H2 2011” provides data on the Bayer AG’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, Bayer AG’s corporate website, SEC filings, investor presentations and featured press releases, both from Bayer AG and industry-specific third party sources, put together by Global Markets Direct’s team. Scope - Bayer AG - Brief Bayer AG overview including business description, key information and facts, and its locations and subsidiaries. - Review of current pipeline of Bayer AG 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 Bayer AG with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Bayer AG’s pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products. Reasons to buy - Evaluate Bayer AG’s strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Bayer AG in its therapy areas of focus. - Identify new drug targets and therapeutic classes in the Bayer AG’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 portfolio gaps. - Exploit collaboration and partnership opportunit
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