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									           Kyowa Hakko Kirin Co., Ltd. – Product Pipeline
                       Review – H2 2011
                                                                                          Reference Code: GMDHC01684CDB

                                                                                                 Publication Date: NOV 2011




Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review – H2 2011                             GMDHC01684CDB / Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 8
      List of Figures ...................................................................................................................................................................................................10
Kyowa Hakko Kirin Co., Ltd. Snapshot ....................................................................................................................................................................11
      Kyowa Hakko Kirin Co., Ltd. Overview ..............................................................................................................................................................11
      Key Information .................................................................................................................................................................................................11
      Key Facts ..........................................................................................................................................................................................................11
Kyowa Hakko Kirin Co., Ltd. – Research and Development Overview .....................................................................................................................12
      Key Therapeutic Areas ......................................................................................................................................................................................12
Kyowa Hakko Kirin Co., Ltd. – Pipeline Review .......................................................................................................................................................17
      Pipeline Products by Stage of Development ......................................................................................................................................................17
      Kyowa Hakko Kirin Co., Ltd. – Pipeline Products Glance ..................................................................................................................................18
      Kyowa Hakko Kirin Co., Ltd. – Late Stage Pipeline ...........................................................................................................................................18
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................18
            Phase III Products/Combination Treatment Modalities ................................................................................................................................19
      Kyowa Hakko Kirin Co., Ltd. Clinical Stage Pipeline Products ...........................................................................................................................20
            Phase II Products/Combination Treatment Modalities .................................................................................................................................20
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................22
      Kyowa Hakko Kirin Co., Ltd.–Early Stage Pipeline Products .............................................................................................................................23
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................23
Kyowa Hakko Kirin Co., Ltd. – Drug Profiles ............................................................................................................................................................24
      Abstral ..............................................................................................................................................................................................................24
            Product Description ....................................................................................................................................................................................24
            Mechanism of Action...................................................................................................................................................................................24
            R&D Progress .............................................................................................................................................................................................24
      ARQ 197 ...........................................................................................................................................................................................................25
            Product Description ....................................................................................................................................................................................25
            Mechanism of Action...................................................................................................................................................................................25
            R&D Progress .............................................................................................................................................................................................25
      ARQ197 + Erlotinib ...........................................................................................................................................................................................26
            Product Description ....................................................................................................................................................................................26
            Mechanism of Action...................................................................................................................................................................................26
            R&D Progress .............................................................................................................................................................................................26
      Bardoxolone Methyl ..........................................................................................................................................................................................28
            Product Description ....................................................................................................................................................................................28
            Mechanism of Action...................................................................................................................................................................................28
            R&D Progress .............................................................................................................................................................................................28
      BIW-8137 ..........................................................................................................................................................................................................29
            Product Description ....................................................................................................................................................................................29
            Mechanism of Action...................................................................................................................................................................................29
            R&D Progress .............................................................................................................................................................................................29
      BIW-8962 ..........................................................................................................................................................................................................30
            Product Description ....................................................................................................................................................................................30
            Mechanism of Action...................................................................................................................................................................................30
            R&D Progress .............................................................................................................................................................................................30
      KHK4563 ..........................................................................................................................................................................................................31




Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review – H2 2011                                                                                             GMDHC01684CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                                 Page(2)
Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review



          Product Description ....................................................................................................................................................................................31
          Mechanism of Action...................................................................................................................................................................................31
          R&D Progress .............................................................................................................................................................................................31
    KHK6188 ..........................................................................................................................................................................................................32
          Product Description ....................................................................................................................................................................................32
          Mechanism of Action...................................................................................................................................................................................32
          R&D Progress .............................................................................................................................................................................................32
    KRN125 ............................................................................................................................................................................................................33
          Product Description ....................................................................................................................................................................................33
          Mechanism of Action...................................................................................................................................................................................33
          R&D Progress .............................................................................................................................................................................................33
    KRN23 ..............................................................................................................................................................................................................34
          Product Description ....................................................................................................................................................................................34
          Mechanism of Action...................................................................................................................................................................................34
          R&D Progress .............................................................................................................................................................................................34
    KRN330 ............................................................................................................................................................................................................35
          Product Description ....................................................................................................................................................................................35
          Mechanism of Action...................................................................................................................................................................................35
          R&D Progress .............................................................................................................................................................................................35
    KRN330 + Irinotecan .........................................................................................................................................................................................36
          Product Description ....................................................................................................................................................................................36
          Mechanism of Action...................................................................................................................................................................................36
          R&D Progress .............................................................................................................................................................................................36
    KW-0761 ...........................................................................................................................................................................................................37
          Product Description ....................................................................................................................................................................................37
          Mechanism of Action...................................................................................................................................................................................37
          R&D Progress .............................................................................................................................................................................................37
    KW-0761 + mLSG15 .........................................................................................................................................................................................39
          Product Description ....................................................................................................................................................................................39
          Mechanism of Action...................................................................................................................................................................................39
          R&D Progress .............................................................................................................................................................................................40
    KW-2450 ...........................................................................................................................................................................................................41
          Product Description ....................................................................................................................................................................................41
          Mechanism of Action...................................................................................................................................................................................41
          R&D Progress .............................................................................................................................................................................................41
    KW-2450 + Lapatinib + Letrozole ......................................................................................................................................................................42
          Product Description ....................................................................................................................................................................................42
          Mechanism of Action...................................................................................................................................................................................42
          R&D Progress .............................................................................................................................................................................................42
    KW-2478 ...........................................................................................................................................................................................................44
          Product Description ....................................................................................................................................................................................44
          Mechanism of Action...................................................................................................................................................................................44
          R&D Progress .............................................................................................................................................................................................44
    KW-2478 + Bortezomib .....................................................................................................................................................................................45
          Product Description ....................................................................................................................................................................................45
          Mechanism of Action...................................................................................................................................................................................45
          R&D Progress .............................................................................................................................................................................................45
    KW-3357 ...........................................................................................................................................................................................................46




Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review – H2 2011                                                                                          GMDHC01684CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                             Page(3)
Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review



           Product Description ....................................................................................................................................................................................46
           Mechanism of Action...................................................................................................................................................................................46
           R&D Progress .............................................................................................................................................................................................46
     KW-6002 ...........................................................................................................................................................................................................47
           Product Description ....................................................................................................................................................................................47
           Mechanism of Action...................................................................................................................................................................................47
           R&D Progress .............................................................................................................................................................................................47
     KW-6356 ...........................................................................................................................................................................................................49
           Product Description ....................................................................................................................................................................................49
           Mechanism of Action...................................................................................................................................................................................49
           R&D Progress .............................................................................................................................................................................................49
     KW-6485 ...........................................................................................................................................................................................................50
           Product Description ....................................................................................................................................................................................50
           Mechanism of Action...................................................................................................................................................................................50
           R&D Progress .............................................................................................................................................................................................50
     KW-6500 ...........................................................................................................................................................................................................51
           Product Description ....................................................................................................................................................................................51
           Mechanism of Action...................................................................................................................................................................................51
           R&D Progress .............................................................................................................................................................................................51
     LY2523355 .......................................................................................................................................................................................................52
           Product Description ....................................................................................................................................................................................52
           Mechanism of Action...................................................................................................................................................................................52
           R&D Progress .............................................................................................................................................................................................52
     LY2523355 + Pegfilgrastim ...............................................................................................................................................................................53
           Product Description ....................................................................................................................................................................................53
           Mechanism of Action...................................................................................................................................................................................53
           R&D Progress .............................................................................................................................................................................................53
     NESP ................................................................................................................................................................................................................55
           Product Description ....................................................................................................................................................................................55
           Mechanism of Action...................................................................................................................................................................................55
           R&D Progress .............................................................................................................................................................................................55
     Tivozanib ..........................................................................................................................................................................................................56
           Product Description ....................................................................................................................................................................................56
           Mechanism of Action...................................................................................................................................................................................56
           R&D Progress .............................................................................................................................................................................................56
     XAGRID ............................................................................................................................................................................................................58
           Product Description ....................................................................................................................................................................................58
           Mechanism of Action...................................................................................................................................................................................58
           R&D Progress .............................................................................................................................................................................................58
Kyowa Hakko Kirin Co., Ltd. – Pipeline Analysis......................................................................................................................................................59
     Kyowa Hakko Kirin Co., Ltd. – Pipeline Products by Therapeutic Class.............................................................................................................59
     Kyowa Hakko Kirin Co., Ltd. - Pipeline Products By Target ...............................................................................................................................61
     Kyowa Hakko Kirin Co., Ltd. – Pipeline Products by Route of Administration ....................................................................................................63
     Kyowa Hakko Kirin Co., Ltd. – Pipeline Products by Molecule Type ..................................................................................................................64
Kyowa Hakko Kirin Co., Ltd. – Recent Pipeline Updates.........................................................................................................................................65
Kyowa Hakko Kirin Co., Ltd. - Dormant Projects ......................................................................................................................................................70
Kyowa Hakko Kirin Co., Ltd. - Discontinued Pipeline Products ................................................................................................................................71
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................71




Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review – H2 2011                                                                                            GMDHC01684CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                               Page(4)
Kyowa Hakko Kirin Co., Ltd. – Product Pipeline Review



           KW-2170 ....................................................................................................................................................................................................71
           KW-2449 ....................................................................................................................................................................................................71
           KW-7158 ....................................................................................................................................................................................................71
           XAGRID ......................................................................................................................................................................................................72
Kyowa Hakko Kirin Co., Ltd. – Company Statement ................................................................................................................................................73
Kyowa Hakko Kirin Co., Ltd. – Locations And Subsidiaries ......................................................................................................................................74
     Head Office .......................................................................................................................................................................................................74
     Other Locations & Subsidiaries .........................................................................................................................................................................74
Recent Developments .............................................................................................................................................................................................77
           Oct 31, 2006: BioWa, Inc. Begins Phase I Clinical Trial In Asthma..............................................................................................................77
           Jan 31, 2008: AVEO Initiates Phase 1b Combination Clinical Trial Of Novel Triple VEGF Receptor Inhibitor AV-951 In Metastatic Renal
           Cell Carcinoma ...........................................................................................................................................................................................77
           Jun 29, 2011: Kyowa Hakko Kirin Initiates Phase III Clinical Study Of KW-3357 In Japan...........................................................................78
           May 29, 2009: AV-951 Demonstrates Phase 2 Data At ASCO ....................................................................................................................78
           May 29, 2009: AVEO Pharmaceuticals Phase 2 Data Presents At ASCO ...................................................................................................79
           May 29, 2008: AVEO Pharmaceuticals Completes Enrollment In Phase 2 Clinical Trial Of AV-951 In Patients With Metastatic Renal Cell
           Carcinoma ..................................................................................................................................................................................................80
           May 29, 2008: AVEO Pharmaceuticals Completes Enrollment In Phase 2 Clinical Trial Of AV-951 In Patients With Metastatic Renal Cell
           Carcinoma ..................................................................................................................................................................................................80
           Feb 28, 2008: Kyowa Hakko Receives Not Approvable Letter From FDA For Istradefylline (KW-6002) ......................................................81
           Apr 27, 2007: Kyowa Hakko Submits New Drug Application For Istradefylline (KW-6002) For Parkinson's Disease....................................81
           Apr 26, 2011: Kyowa Hakko Kirin Files New Drug Application In Japan For KW-0761 ................................................................................82
           Feb 26, 2009: Two First-In-Human, Open-Label, Phase I Dose-Escalation Safety Trials Of MEDI-528, A Monoclonal Antibody Against
           Interleukin-9, In Healthy Adult Volunteers. ..................................................................................................................................................82
           Aug 25, 2008: AVEO Initiates Phase 1b Combination Trial Of AV-951 With FOLFOX6 In Patients With Advanced Colorectal And Other
           Gastrointestinal Cancers .............................................................................................................................................................................83
           Feb 25, 2010: Orexo Announces Kyowa Hakko Kirin's Submission Of KW-2246 NDA For Approval In Japan ............................................84
           Feb 25, 2009: AVEO Pharmaceuticals Oral Triple VEGF Receptor Inhibitor AV-951 Shows Robust Activity In Patents With Advanced
           Kidney Cancer ............................................................................................................................................................................................84
           Jun 24, 2010: AVEO Receives European Orphan Medicinal Product Designation For Tivozanib For Treatment Of Renal Cell Carcinoma .85
           Apr 23, 2004: Kyowa Hakko Plans Phase III Clinical Trials Of KW-6002 For Parkinson’s Disease ..............................................................85
           Sep 20, 1999: Kyowa Hakko Starts Phase II Clinical Trials Of KW-6002 For Parkinson Disease ................................................................86
           Dec 19, 2006: MedImmune Strengthens Inflammatory Disease Pipeline Through Collaboration With Biowa ..............................................86
           Feb 18, 2002: Kyowa Hakko Announces Phase II Clinical Trial Results Of KW-6002..................................................................................87
           Nov 17, 2009: AVEO Pharmaceuticals Presents Preliminary Results At AACR-NCI-EORTC ......................................................................88
           Sep 17, 2002: Kyowa Hakko’s Antiasthmatic Agent, KW-4490, Has Entered Early Phase II Clinical Studies In Europe ..............................88
           Apr 15, 2008: MedImmune Advances Asthma Program With Start Of A Phase II Trial In Europe And Australia And First U.S.-Based Clinical
           Trial For Antibody Targeting IL-13...............................................................................................................................................................89
           Jan 15, 2009: Kyowa Hakko Kirin Announces Development Policy For The Anti-Parkinson's Disease Drug KW-6002................................89
           May 14, 2002: Kyowa Hakko Begins Clinical Phase II Trials In The U.S. And Europe Of KW-7158, A Treatment For Urinary Incontinence 90
           Apr 14, 2008: AVEO Pharmaceuticals Novel Triple VEGF Receptor Inhibitor Shows Tumor Regression In Patients With Advanced Renal
           Cancer ........................................................................................................................................................................................................91
           Aug 12, 2010: AVEO Achieves Enrollment Target Ahead Of Schedule For Pivotal Phase III Trial Of Tivozanib ..........................................92
           Jul 11, 2000: Kyowa Hakko Starts Phase II Clinical Trials Of
								
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