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Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2 2011

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Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2 2011 Summary Global Market Direct’s pharmaceuticals report, “Dainippon Sumitomo Pharma Co., Ltd - Product Pipeline Review - H2 2011” provides data on the Dainippon Sumitomo Pharma Co., Ltd’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, Dainippon Sumitomo Pharma Co., Ltd’s corporate website, SEC filings, investor presentations and featured press releases, both from Dainippon Sumitomo Pharma Co., Ltd and industry-specific third party sources, put together by Global Markets Direct’s team. Scope - Dainippon Sumitomo Pharma Co., Ltd - Brief Dainippon Sumitomo Pharma Co., Ltd overview including business description, key information and facts, and its locations and subsidiaries. - Review of current pipeline of Dainippon Sumitomo Pharma Co., Ltd 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 Dainippon Sumitomo Pharma Co., Ltd with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Dainippon Sumitomo Pharma Co., Ltd’s pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products. Reasons to buy - Evaluate Dainippon Sumitomo Pharma Co., Ltd’s strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Dainippon Sumitomo Pharma Co., Ltd in its therapy areas of focus.

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									         Dainippon Sumitomo Pharma Co., Ltd. – Product
                   Pipeline Review – H2 2011
                                                                                          Reference Code: GMDHC01682CDB

                                                                                                 Publication Date: NOV 2011




Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2                          GMDHC01682CDB / Published NOV 2011
2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Dainippon Sumitomo Pharma 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
Dainippon Sumitomo Pharma Co., Ltd. Snapshot ....................................................................................................................................................11
      Dainippon Sumitomo Pharma Co., Ltd. Overview ..............................................................................................................................................11
      Key Information .................................................................................................................................................................................................11
      Key Facts ..........................................................................................................................................................................................................11
Dainippon Sumitomo Pharma Co., Ltd. – Research and Development Overview.....................................................................................................12
      Key Therapeutic Areas ......................................................................................................................................................................................12
Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Review .......................................................................................................................................15
      Pipeline Products by Stage of Development ......................................................................................................................................................15
      Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Products Glance ..................................................................................................................16
      Dainippon Sumitomo Pharma Co., Ltd. – Late Stage Pipeline ...........................................................................................................................16
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................16
            Phase III Products/Combination Treatment Modalities ................................................................................................................................17
      Dainippon Sumitomo Pharma Co., Ltd. Clinical Stage Pipeline Products...........................................................................................................18
            Phase II Products/Combination Treatment Modalities .................................................................................................................................18
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................19
      Dainippon Sumitomo Pharma Co., Ltd.–Early Stage Pipeline Products .............................................................................................................20
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................20
Dainippon Sumitomo Pharma Co., Ltd. – Drug Profiles ...........................................................................................................................................21
      AC-3933............................................................................................................................................................................................................21
            Product Description ....................................................................................................................................................................................21
            Mechanism of Action...................................................................................................................................................................................21
            R&D Progress .............................................................................................................................................................................................21
      AE-3763 ............................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
      Amrubicin Hydrochloride ...................................................................................................................................................................................23
            Product Description ....................................................................................................................................................................................23
            Mechanism of Action...................................................................................................................................................................................23
            R&D Progress .............................................................................................................................................................................................23
      AS-3201 ............................................................................................................................................................................................................25
            Product Description ....................................................................................................................................................................................25
            Mechanism of Action...................................................................................................................................................................................25
            R&D Progress .............................................................................................................................................................................................25
      DSP-3025 .........................................................................................................................................................................................................26
            Product Description ....................................................................................................................................................................................26
            Mechanism of Action...................................................................................................................................................................................26
            R&D Progress .............................................................................................................................................................................................26
      DSP-7238 .........................................................................................................................................................................................................28
            Product Description ....................................................................................................................................................................................28
            Mechanism of Action...................................................................................................................................................................................28
            R&D Progress .............................................................................................................................................................................................28
      DSP-8153 .........................................................................................................................................................................................................29




Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2 2011                                                                                    GMDHC01682CDB / Published NOV 2011

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



          Product Description ....................................................................................................................................................................................29
          Mechanism of Action...................................................................................................................................................................................29
          R&D Progress .............................................................................................................................................................................................29
    DSP-8658 .........................................................................................................................................................................................................30
          Product Description ....................................................................................................................................................................................30
          Mechanism of Action...................................................................................................................................................................................30
          R&D Progress .............................................................................................................................................................................................30
    KGA-3235 .........................................................................................................................................................................................................31
          Product Description ....................................................................................................................................................................................31
          Mechanism of Action...................................................................................................................................................................................31
          R&D Progress .............................................................................................................................................................................................31
    Latuda ...............................................................................................................................................................................................................33
          Product Description ....................................................................................................................................................................................33
          Mechanism of Action...................................................................................................................................................................................33
          R&D Progress .............................................................................................................................................................................................33
    Lunesta .............................................................................................................................................................................................................35
          Product Description ....................................................................................................................................................................................35
          Mechanism of Action...................................................................................................................................................................................35
          R&D Progress .............................................................................................................................................................................................35
    Lunesta + Venlafaxine.......................................................................................................................................................................................36
          Product Description ....................................................................................................................................................................................36
          Mechanism of Action...................................................................................................................................................................................36
          R&D Progress .............................................................................................................................................................................................36
    SEP-225289......................................................................................................................................................................................................37
          Product Description ....................................................................................................................................................................................37
          Mechanism of Action...................................................................................................................................................................................37
          R&D Progress .............................................................................................................................................................................................37
    SEP-225432......................................................................................................................................................................................................38
          Product Description ....................................................................................................................................................................................38
          Mechanism of Action...................................................................................................................................................................................38
          R&D Progress .............................................................................................................................................................................................38
    SEP-225441......................................................................................................................................................................................................39
          Product Description ....................................................................................................................................................................................39
          Mechanism of Action...................................................................................................................................................................................39
          R&D Progress .............................................................................................................................................................................................39
    SEP-228432......................................................................................................................................................................................................40
          Product Description ....................................................................................................................................................................................40
          Mechanism of Action...................................................................................................................................................................................40
          R&D Progress .............................................................................................................................................................................................40
    SMP-028 ...........................................................................................................................................................................................................41
          Product Description ....................................................................................................................................................................................41
          Mechanism of Action...................................................................................................................................................................................41
          R&D Progress .............................................................................................................................................................................................41
    SMP-508 ...........................................................................................................................................................................................................42
          Product Description ....................................................................................................................................................................................42
          Mechanism of Action...................................................................................................................................................................................42
          R&D Progress .............................................................................................................................................................................................42
    SMP-508 + Metformin .......................................................................................................................................................................................43




Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2 2011                                                                                   GMDHC01682CDB / Published NOV 2011

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



           Product Description ....................................................................................................................................................................................43
           Mechanism of Action...................................................................................................................................................................................43
           R&D Progress .............................................................................................................................................................................................43
     SMP-508 + Pioglitazone ....................................................................................................................................................................................44
           Product Description ....................................................................................................................................................................................44
           Mechanism of Action...................................................................................................................................................................................44
           R&D Progress .............................................................................................................................................................................................44
     SMP-797 ...........................................................................................................................................................................................................45
           Product Description ....................................................................................................................................................................................45
           Mechanism of Action...................................................................................................................................................................................45
           R&D Progress .............................................................................................................................................................................................45
     SMP-948 ...........................................................................................................................................................................................................46
           Product Description ....................................................................................................................................................................................46
           Mechanism of Action...................................................................................................................................................................................46
           R&D Progress .............................................................................................................................................................................................46
     SMP-986 ...........................................................................................................................................................................................................47
           Product Description ....................................................................................................................................................................................47
           Mechanism of Action...................................................................................................................................................................................47
           R&D Progress .............................................................................................................................................................................................47
     Stedesa.............................................................................................................................................................................................................48
           Product Description ....................................................................................................................................................................................48
           Mechanism of Action...................................................................................................................................................................................48
           R&D Progress .............................................................................................................................................................................................48
     WT4869 ............................................................................................................................................................................................................50
           Product Description ....................................................................................................................................................................................50
           Mechanism of Action...................................................................................................................................................................................50
           R&D Progress .............................................................................................................................................................................................50
Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Analysis .....................................................................................................................................51
     Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Products by Therapeutic Class ............................................................................................51
     Dainippon Sumitomo Pharma Co., Ltd. - Pipeline Products By Target ...............................................................................................................53
     Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Products by Route of Administration ....................................................................................55
     Dainippon Sumitomo Pharma Co., Ltd. – Pipeline Products by Molecule Type..................................................................................................56
Dainippon Sumitomo Pharma Co., Ltd. – Recent Pipeline Updates ........................................................................................................................57
Dainippon Sumitomo Pharma Co., Ltd. - Dormant Projects .....................................................................................................................................61
Dainippon Sumitomo Pharma Co., Ltd. - Discontinued Pipeline Products ................................................................................................................62
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................62
           AC-3933 .....................................................................................................................................................................................................62
           AC-5216 .....................................................................................................................................................................................................62
           SMP-114 ....................................................................................................................................................................................................63
           AC-3933 .....................................................................................................................................................................................................63
           AC-5216 .....................................................................................................................................................................................................63
           SEP-226330 ...............................................................................................................................................................................................63
           SEP-226332 ...............................................................................................................................................................................................64
           SEP-227162 ...............................................................................................................................................................................................64
           SEP-227900 ...............................................................................................................................................................................................64
           SMP-797 ....................................................................................................................................................................................................64
Dainippon Sumitomo Pharma Co., Ltd. – Company Statement ................................................................................................................................65
Dainippon Sumitomo Pharma Co., Ltd. – Locations And Subsidiaries .....................................................................................................................67




Dainippon Sumitomo Pharma Co., Ltd. – Product Pipeline Review – H2 2011                                                                                   GMDHC01682CDB / Published NOV 2011

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



     Head Office .......................................................................................................................................................................................................67
     Other Locations & Subsidiaries .........................................................................................................................................................................67
Recent Developments .............................................................................................................................................................................................70
           May 31, 2011: Dainippon Files Application For Partial Change Of Approval Of Dosage And Administration Of MEROPEN ........................70
           Jun 30, 2005: Sumitomo Licenses Amrubicin Hydrochloride To Conforma..................................................................................................70
           May 30, 2006: Chelsea Therapeutics Signs Exclusive Droxidopa License Agreement With Dainippon Sumitomo Pharma .........................71
           Oct 29, 2008: Data From Chelsea Therapeutics Phase III Trial Of Droxidopa in Neurogenic Orthostatic Hypotension To Be Presented At
           19th Annual International Symposium On The Autonomic Nervous System ................................................................................................71
           Sep 29, 2005: Dainippon And Eisai Signs Licensing Agreement For A Potential New Treatment For Diabetic Neuropathy .........................72
           Nov 28, 2006: Dainippon Sumitomo Pharma Co Decides To Discontinue AC-5216. ...................................................................................73
           Oct 28, 2010: FDA Approves Once-Daily Latuda (lurasidone HCl) For The Treatment Of Patients With Schizophrenia ..............................73
           Aug 28, 2003: Aventis Licenses Novel Dementia Drug AC-3933................................................................................................................73
           Oct 27, 2011: Sunovion's Double-Blind Extension Study Shows LATUDA Non-Inferior To SEROQUEL In Risk For Relapse .....................74
           Oct 26, 2006: Sepracor Initiates A Phase I For The Drug SEP-225289 ......................................................................................................76
           Aug 26, 2009: Lurasidone Demonstrated Efficacy in Treating Patients with Schizophrenia in Pivotal Phase 3 Study ..................................76
           Aug 26, 2008: Chelsea Therapeutics Receives Fast Track Designation For Droxidopa For Symptomatic Neurogenic Orthostatic
           Hypotension................................................................................................................................................................................................78
           Jul 26, 2006: Dainippon Sumitomo Enters Into Partnership Agreement With Bristol-Myers For SM-11355..................................................78
           Mar 25, 2008: Celgene Corporation Receives FDA Orphan Drug Designation To Amrubicin For The Treatment Of Small Cell Lung Cancer
           ...................................................................................................................................................................................................................79
           Jan 25, 2011: Dainippon Sumitomo Completes Long-Term Phase III Safety Trial For Latuda .....................................................................79
           Aug 23, 2011: Sunovion Pharmaceuticals Canada Receives Health Canada Acceptance Of Lurasidone New Drug Submission For
           Treatment Of Schizophrenia .......................................................................................................................................................................80
           Jul 23, 2008: Chelsea Therapeutics Granted MHRA Approval To Begin Phase II Trial Of Droxidopa In Fibromyalgia .................................80
           Jan 22, 2007: FDA Grants Chelsea Therapeutics Orphan Drug Designation For Droxidopa .......................................................................81
           Jul 21, 2001: Launch Of Meropen For Intravenous Drip Infusion 0.5g (kit) - Kit Preparation Of Carbapenem Antibiotic ...............................82
           May 20, 2009: Dainippon Sumitomo Pharma Announces Lurasidone Phase III Trial Data In Patients With Schizophrenia .........................83
           Jan 20, 2010: Dainippon Receives Manufacturing And Marketing Approval For METGLUCO .....................................................................83
           Nov 19, 2008: Chelsea Therapeutics Completes Enrollment In Phase II Trial Of Droxidopa In Intradialytic Hypotension ............................84
           Jul 19, 2009: Sepracor Provides Update On Clinical Trials For SEP-225289 And LUNESTA Pediatrics......................................................84
           Jan 18, 2010: Celgene/Nippon Kayaku's Calsed Will Become Decision Resources' New Clinical Gold Standard In 2013 For The Treatment
           Of Extensive-Disease Small-Cell Lung Cancer ...........................................................................................................................................85
           May 17, 2011: Sunovion Announces Encouraging Results From New Pooled Data Analysis Of Latuda .....................................................86
           Apr 17, 2009: Dainippon Sumitomo Pharma Announces The Discontinuation Of Development Of AC-3933, Atherapeutic Agent For
           Dementia ....................................................................................................................................................................................................87
           Sep 16, 2004: Sumitomo Pharmaceuticals Concludes A License Agreement With Novo Nordisk A/S For Repaglinide ..............................87
           Nov 15, 2006: Pharmion Acquires Cabrellis Pharmaceuticals, Gains Rights To Amrubicin For North America And The European Union ...87
           Jan 15, 2004: Respiratory Research Collaboration With AstraZeneca ........................................................................................................88
           Aug 14, 2007: European Commission Grants Chelsea Therapeutics Two Orphan Medicinal Product Designations For Droxidopa .............89
           Dec 13, 2006: Review Of Overseas Development Of Lurasidone (SM-13496), An Atypical Antipsychotic ...................................................89
           Mar 13, 2000: Sepracor Initiates Phase I Clinical Study of (S)-Doxazosin For The Treatment Of Benign Prostatic Hyperplasia .................90
           Nov 12, 2007: FDA Accepts Chelsea Therapeutics Investigational New Drug Application For Droxidopa ...................................................90
           Feb 12, 2002: Dainippon Pharmaceutical Concludes License Agreement With Novartis For AC-5216 .....................................................91
           May 11, 2011: Dainippon Sumitomo Pharma Announces Pan-Asia Study Results For Lurasidone .............................................................91
           May 11, 2011: Dainippon Sumitomo Pharma Announces Results Of Phase II Clinical Trial For Ranirestat For Diabetic Complications ......92
           Apr 11, 2008: Amrubicin designated as Orphan medicinal product by the European commission ...............................................................92
           Mar 11, 2010: DSPA's Lurasidone NDA Accepted For Review
								
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