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									        Actelion Ltd – Product Pipeline Review – H2 2011
                                                                                          Reference Code: GMDHC01615CDB

                                                                                                 Publication Date: NOV 2011




Actelion Ltd – Product Pipeline Review – H2 2011                                            GMDHC01615CDB / Published NOV 2011

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




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 5
      List of Figures .................................................................................................................................................................................................... 6
Actelion Ltd Snapshot............................................................................................................................................................................................... 7
      Actelion Ltd Overview ........................................................................................................................................................................................ 7
      Key Information .................................................................................................................................................................................................. 7
      Key Facts ........................................................................................................................................................................................................... 7
Actelion Ltd – Research and Development Overview ............................................................................................................................................... 8
      Key Therapeutic Areas ....................................................................................................................................................................................... 8
Actelion Ltd – Pipeline Review.................................................................................................................................................................................10
      Pipeline Products by Stage of Development ......................................................................................................................................................10
      Pipeline Products – Monotherapy .....................................................................................................................................................................11
Actelion Ltd – Pipeline Products Glance ..................................................................................................................................................................12
      Actelion Ltd – Late Stage Pipeline .....................................................................................................................................................................12
            Phase III Products/Combination Treatment Modalities ................................................................................................................................12
      Actelion Ltd Clinical Stage Pipeline Products ....................................................................................................................................................13
            Phase II Products/Combination Treatment Modalities .................................................................................................................................13
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................14
      Actelion Ltd–Early Stage Pipeline Products .......................................................................................................................................................15
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................15
Actelion Ltd – Drug Profiles .....................................................................................................................................................................................16
      Antibiotic ...........................................................................................................................................................................................................16
            Product Description ....................................................................................................................................................................................16
            Mechanism of Action...................................................................................................................................................................................16
            R&D Progress .............................................................................................................................................................................................16
      Cadazolid ..........................................................................................................................................................................................................17
            Product Description ....................................................................................................................................................................................17
            Mechanism of Action...................................................................................................................................................................................17
            R&D Progress .............................................................................................................................................................................................17
      CRTH2 Antagonist ............................................................................................................................................................................................18
            Product Description ....................................................................................................................................................................................18
            Mechanism of Action...................................................................................................................................................................................18
            R&D Progress .............................................................................................................................................................................................18
      Drug for Multiple sclerosis .................................................................................................................................................................................19
            Product Description ....................................................................................................................................................................................19
            Mechanism of Action...................................................................................................................................................................................19
            R&D Progress .............................................................................................................................................................................................19
      Macitentan ........................................................................................................................................................................................................20
            Product Description ....................................................................................................................................................................................20
            Mechanism of Action...................................................................................................................................................................................20
            R&D Progress .............................................................................................................................................................................................20
      Ponesimod ........................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
      S1P1 Agonist ....................................................................................................................................................................................................23




Actelion Ltd – Product Pipeline Review – H2 2011                                                                                                            GMDHC01615CDB / Published NOV 2011

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



           Product Description ....................................................................................................................................................................................23
           Mechanism of Action...................................................................................................................................................................................23
           R&D Progress .............................................................................................................................................................................................23
     Selexipag ..........................................................................................................................................................................................................24
           Product Description ....................................................................................................................................................................................24
           Mechanism of Action...................................................................................................................................................................................24
           R&D Progress .............................................................................................................................................................................................24
     Tezosentan .......................................................................................................................................................................................................26
           Product Description ....................................................................................................................................................................................26
           Mechanism of Action...................................................................................................................................................................................26
           R&D Progress .............................................................................................................................................................................................26
Actelion Ltd – Pipeline Analysis ...............................................................................................................................................................................28
     Actelion Ltd – Pipeline Products by Therapeutic Class ......................................................................................................................................28
     Actelion Ltd - Pipeline Products By Target ........................................................................................................................................................29
     Actelion Ltd – Pipeline Products by Route of Administration ..............................................................................................................................30
     Actelion Ltd – Pipeline Products by Molecule Type ...........................................................................................................................................31
Actelion Ltd – Recent Pipeline Updates ..................................................................................................................................................................32
Actelion Ltd - Discontinued Pipeline Products ..........................................................................................................................................................34
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................34
           Almorexant .................................................................................................................................................................................................34
           Palosuran ...................................................................................................................................................................................................34
           Tezosentan .................................................................................................................................................................................................34
           Ventavis + Sildenafil + Bosentan.................................................................................................................................................................35
Actelion Ltd – Company Statement .........................................................................................................................................................................36
Actelion Ltd – Locations And Subsidiaries ...............................................................................................................................................................37
     Head Office .......................................................................................................................................................................................................37
     Other Locations & Subsidiaries .........................................................................................................................................................................37
Recent Developments .............................................................................................................................................................................................39
           Sep 30, 2003: Actelion Acquires Privately Held Axovan AG ........................................................................................................................39
           Aug 30, 2005: Co Therix Receives Expanded Approval For Ventavis from the US FDA ..............................................................................39
           Dec 29, 2004: Co Therix Receives Approval for Ventavis from the US FDA ................................................................................................40
           Aug 29, 2011: Actelion Reports Results From Exploratory Phase II Study With Macitentan In Patients With Idiopathic Pulmonary Fibrosis40
           Nov 28, 2005: Bosentan Studies In Pulmonary Fibrosis Show No Effect On Primary Exercise Improvement Endpoint ...............................41
           Jan 28, 2011: GSK And Actelion Discontinue Clinical Development Of Almorexant ....................................................................................43
           Sep 27, 2010: Actelion's CONSCIOUS-2 Study With Clazosentan Does Not Meet Primary Endpoint .........................................................43
           Jun 27, 2008: GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg .........................................................................44
           May 27, 2003: Ventavis receives a positive opinion from Committee of Proprietary Medicinal Products for the treatment of PAH ...............44
           May 23, 2011: Actelion's New Crth2 Antagonist Meets Primary Endpoint In Phase II Study In Patients With Seasonal Allergic Rhinitis......44
           May 23, 2006: ATS Presentation Highlights Strong Rationale For A Morbidity/Mortality Study With Bosentan In Idiopathic Pulmonary
           Fibrosis (IPF) ..............................................................................................................................................................................................45
           Feb 23, 2009: GeneraMedix, Inc. Announces Sale of Innovative Epoprostenol Formulation to Actelion Ltd ................................................46
           Apr 22, 2010: Actelion Pharmaceuticals Announces Commercial Availability of Epoprostenol for Injection for the Treatment of Pulmonary
           Arterial Hypertension ..................................................................................................................................................................................47
           Mar 22, 2005: Co Therix Launches Ventavis Inhalation solution, indicated for the treatment of PAH...........................................................47
           Dec 21, 2009: Actelion Announces Phase III Study Results Of Almorexant (RESTORA 1) For The Treatment Of Sleep Disorders ............48
           Dec 20, 2007: Actelion Initiates Phase III Development Program Of Almorexant ........................................................................................48
           Apr 20, 2001: Phase III Clinical Trial Of Veletri For The Treatment Of Acute Heart Failure Symptoms Does Not Meet Primary Efficacy
           Objective ....................................................................................................................................................................................................49
           Dec 19, 2007: Actelion Initiates A Phase III Study Of Actelion-1 In PAH To Demonstrate Morbidity/Mortality Benefits ...............................50




Actelion Ltd – Product Pipeline Review – H2 2011                                                                                                          GMDHC01615CDB / Published NOV 2011

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



           Jan 19, 2005: Co Therix Selects Accredo Health, Inc. For the distribution of Ventavis ................................................................................50
           Dec 18, 2008: Eur 7 Million Grants Boost Trophos Cholesterol-Oxime Programs For ALS, MS And Other Neurodegenerative Diseases ...50
           Dec 17, 2007: Actelion Provides Update On Bosentan In Metastatic Melanoma .........................................................................................51
           Jul 17, 2009: Actelion's PGI2 Receptor Agonist Demonstrates Efficacy In Pulmonary Arterial Hypertension Patients .................................51
           Jul 17, 2006: Actelion And Roche Enter Into Autoimmune Disorder Collaboration ......................................................................................52
           May 17, 2010: Actelion Announces Presentation Of Positive Phase II Results With Selexipag In Patients With Pulmonary Arterial
           Hypertension .................................................................................................................................................................
								
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