Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012 by GlobalMarketsDirect

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									   Systemic Sclerosis (Scleroderma) – Pipeline Review,
                        H1 2012


                                                                                          Reference Code: GMDHC1919IDB
                                                                                              Publication Date: April 2012




Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012                                   GMDHC1919IDB / Pub April 2012
© Global Markets Direct. This report is a licensed product and is not to be photocopied                             Page(1)
Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012




Table of Contents
Table of Contents ............................................................................................................................................................................... 2
    List of Tables ................................................................................................................................................................................. 7
    List of Figures ................................................................................................................................................................................ 8
Introduction......................................................................................................................................................................................... 9
    Global Markets Direct Report Coverage ........................................................................................................................................ 9
Systemic Sclerosis (Scleroderma) Overview .................................................................................................................................... 10
Therapeutics Development............................................................................................................................................................... 11
    An Overview of Pipeline Products for Systemic Sclerosis (Scleroderma).................................................................................... 11
Systemic Sclerosis (Scleroderma) Therapeutics under Development by Companies ...................................................................... 13
Systemic Sclerosis (Scleroderma) Therapeutics under Investigation by Universities/Institutes ....................................................... 15
Late Stage Products ......................................................................................................................................................................... 17
    Comparative Analysis .................................................................................................................................................................. 17
Mid Clinical Stage Products.............................................................................................................................................................. 18
    Comparative Analysis .................................................................................................................................................................. 18
Early Clinical Stage Products ........................................................................................................................................................... 19
    Comparative Analysis .................................................................................................................................................................. 19
Discovery and Pre-Clinical Stage Products ...................................................................................................................................... 20
    Comparative Analysis .................................................................................................................................................................. 20
Systemic Sclerosis (Scleroderma) Therapeutics – Products under Development by Companies .................................................... 21
Systemic Sclerosis (Scleroderma) Therapeutics – Products under Investigation by Universities/Institutes ..................................... 22
Companies Involved in Systemic Sclerosis (Scleroderma) Therapeutics Development ................................................................... 23
    United Therapeutics Corporation ................................................................................................................................................. 23
    Sanofi-Aventis ............................................................................................................................................................................. 24
    AstraZeneca PLC ........................................................................................................................................................................ 25
    MedImmune LLC ......................................................................................................................................................................... 26
    FibroGen, Inc. .............................................................................................................................................................................. 27
    Mitsubishi Tanabe Pharma Corporation ...................................................................................................................................... 28
    Celgene Corporation ................................................................................................................................................................... 29
    Active Biotech AB ........................................................................................................................................................................ 30
    Digna Biotech, S.L. ...................................................................................................................................................................... 31
    Amira Pharmaceuticals, Inc. ........................................................................................................................................................ 32
    Angion Biomedica Corp. .............................................................................................................................................................. 33
    Daval International Ltd................................................................................................................................................................. 34
    Advanced Cancer Therapeutics .................................................................................................................................................. 35
Systemic Sclerosis (Scleroderma) – Therapeutics Assessment....................................................................................................... 36
    Assessment by Monotherapy Products ....................................................................................................................................... 36
    Assessment by Combination Products ........................................................................................................................................ 37
    Assessment by Route of Administration ...................................................................................................................................... 38
    Assessment by Molecule Type .................................................................................................................................................... 40
Drug Profiles..................................................................................................................................................................................... 42
    ABR-215757 - Drug Profile .......................................................................................................................................................... 42
         Product Description................................................................................................................................................................. 42



Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012                                                                                        GMDHC1919IDB / Pub April 2012
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                                                                   Page(2)
Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012




        Mechanism of Action ............................................................................................................................................................... 42
        R&D Progress ......................................................................................................................................................................... 42
    FG-3019 - Drug Profile ................................................................................................................................................................ 44
        Product Description................................................................................................................................................................. 44
        Mechanism of Action ............................................................................................................................................................... 44
        R&D Progress ......................................................................................................................................................................... 44
    P144 - Drug Profile ...................................................................................................................................................................... 46
        Product Description................................................................................................................................................................. 46
        Mechanism of Action ............................................................................................................................................................... 46
        R&D Progress ......................................................................................................................................................................... 46
    P144 - Drug Profile ...................................................................................................................................................................... 48
        Product Description................................................................................................................................................................. 48
        Mechanism of Action ............................................................................................................................................................... 48
        R&D Progress ......................................................................................................................................................................... 48
    UT-15C SR - Drug Profile ............................................................................................................................................................ 50
        Product Description................................................................................................................................................................. 50
        Mechanism of Action ............................................................................................................................................................... 50
        R&D Progress ......................................................................................................................................................................... 50
    MEDI-546 - Drug Profile .............................................................................................................................................................. 52
        Product Description................................................................................................................................................................. 52
        Mechanism of Action ............................................................................................................................................................... 52
        R&D Progress ......................................................................................................................................................................... 52
    MEDI-551 - Drug Profile .............................................................................................................................................................. 53
        Product Description................................................................................................................................................................. 53
        Mechanism of Action ............................................................................................................................................................... 53
        R&D Progress ......................................................................................................................................................................... 53
    Cellcept - Drug Profile ................................................................................................................................................................. 54
        Product Description................................................................................................................................................................. 54
        Mechanism of Action ............................................................................................................................................................... 54
        R&D Progress ......................................................................................................................................................................... 54
    Cyclophosphamide + Mesna + G-CSF - Drug Profile .................................................................................................................. 55
        Product Description................................................................................................................................................................. 55
        Mechanism of Action ............................................................................................................................................................... 55
        R&D Progress ......................................................................................................................................................................... 55
    MIF - Drug Profile ........................................................................................................................................................................ 57
        Product Description................................................................................................................................................................. 57
        Mechanism of Action ............................................................................................................................................................... 57
        R&D Progress ......................................................................................................................................................................... 57
    Allogeneic Mesenchymal Stem Cells - Drug Profile..................................................................................................................... 58
        Product Description................................................................................................................................................................. 58
        Mechanism of Action ............................................................................................................................................................... 58
        R&D Progress ......................................................................................................................................................................... 58
    Actimid - Drug Profile................................................................................................................................................................... 59
        Product Description................................................................................................................................................................. 59


Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012                                                                                    GMDHC1919IDB / Pub April 2012
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                                                               Page(3)
Systemic Sclerosis (Scleroderma) – Pipeline Review, H1 2012




        Mechanism of Action ............................................................................................................................................................... 59
        R&D Progress ......................................................................................................................................................................... 59
    Rituximab - Drug Profile .............................................................................................................................................................. 60
        Product Description................................................................................................................................................................. 60
        Mechanism of Action ............................................................................................................................................................... 60
        R&D Progress ......................................................................................................................................................................... 60
    Cyclophosphamide + Filgrastim - Drug Profile ............................................................................................................................ 62
        Product Description................................................................................................................................................................. 62
        Mechanism of Action ............................................................................................................................................................... 62
        R&D Progress ......................................................................................................................................................................... 62
    Fludarabine + Tacrolimus + Mycophenolate Mofetil + Radiation Therapy + Allogeneic Peripheral Blood Stem Cell
    Transplantation - Drug Profile ...................................................................................................................................................... 63
        Product Description................................................................................................................................................................. 63
        Mechanism of Action ............................................................................................................................................................... 63
        R&D Progress ......................................................................................................................................................................... 64
    Tocilizumabbb - Drug Profile ....................................................................................................................................................... 65
        Product Description................................................................................................................................................................. 65
        Mechanism of Action ............................................................................................................................................................... 65
        R&D Progress ......................................................................................................................................................................... 65
    Imatinib - Drug Profile .................................................................................................................................................................. 66
        Product Description................................................................................................................................................................. 66
        Mechanism of Action ............................................................................................................................................................... 66
        R&D Progress ......................................................................................................................................................................... 66
    Cyclophosphamide - Drug Profile ................................................................................................................................................ 67
        Product Description................................................................................................................................................................. 67
        Mechanism of Action ............................................................................................................................................................... 67
        R&D Progress ......................................................................................................................................................................... 67
    Cyclosphosphamide + Equine antithymocyte globulin + Autologous stem cell transplantation + Methylprednisolone + Growth
    colony stimulating factor + Total body irradiation - Drug Profile ................................................................................................... 68
        Product Description................................................................................................................................................................. 68
        Mechanism of Action ............................................................................................................................................................... 68
        R&D Progress ......................................................................................................................................................................... 68
    Rituximab + Methylprednisolone - Drug Profile ........................................................................................................................... 70
        Product Description................................................................................................................................................................. 70
        Mechanism of Action ............................................................................................................................................................... 70
        R&D Progress ......................................................................................................................................................................... 70
    Everolimus - Drug Profile ............................................................................................................................................................. 71
        Product Description................................................................................................................................................................. 71
        Mechanism of Action ............................................................................................................................................................... 71
        R&D Progress ......................................................................................................................................................................... 71
    Venoglobulin-IH - Drug Profile .................................................................
								
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