Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2 2011

Document Sample
Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2 2011 Powered By Docstoc
					Chelsea Therapeutics International Ltd. – Product
Pipeline Review




        Chelsea Therapeutics International Ltd. – Product
                  Pipeline Review – H2 2011


                                                                                          Reference Code: GMDHC02129CDB
                                                                                                 Publication Date: DEC 2011




Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2                    GMDHC02129CDB / Published DEC 2011
2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                               Page(1)
Chelsea Therapeutics International Ltd. – Product
Pipeline Review



Table of Contents
Table of Contents ............................................................................................................................................................................... 2
    List of Tables ................................................................................................................................................................................. 5
    List of Figures ................................................................................................................................................................................ 6
Chelsea Therapeutics International Ltd. Snapshot ............................................................................................................................. 7
    Chelsea Therapeutics International Ltd. Overview ........................................................................................................................ 7
    Key Information ............................................................................................................................................................................. 7
    Key Facts....................................................................................................................................................................................... 7
Chelsea Therapeutics International Ltd. – Research and Development Overview ............................................................................. 8
    Key Therapeutic Areas .................................................................................................................................................................. 8
Chelsea Therapeutics International Ltd. – Pipeline Review.............................................................................................................. 10
    Pipeline Products by Stage of Development ............................................................................................................................... 10
    Pipeline Products – Monotherapy ............................................................................................................................................... 11
    Pipeline Products – Combination Treatment Modalities .............................................................................................................. 12
Chelsea Therapeutics International Ltd. – Pipeline Products Glance ............................................................................................... 13
    Chelsea Therapeutics International Ltd. – Late Stage Pipeline ................................................................................................... 13
        Registration Filed Products/Combination Treatment Modalities.............................................................................................. 13
        Phase III Products/Combination Treatment Modalities ........................................................................................................... 14
    Chelsea Therapeutics International Ltd. Clinical Stage Pipeline Products .................................................................................. 15
        Phase II Products/Combination Treatment Modalities ............................................................................................................ 15
Chelsea Therapeutics International Ltd. – Drug Profiles .................................................................................................................. 16
    CH-1504 ...................................................................................................................................................................................... 16
        Product Description................................................................................................................................................................. 16
        Mechanism of Action ............................................................................................................................................................... 16
        R&D Progress ......................................................................................................................................................................... 16
    CH-4051 ...................................................................................................................................................................................... 18
        Product Description................................................................................................................................................................. 18
        Mechanism of Action ............................................................................................................................................................... 18
        R&D Progress ......................................................................................................................................................................... 18
    Droxidopa + Carbidopa................................................................................................................................................................ 20
        Product Description................................................................................................................................................................. 20
        Mechanism of Action ............................................................................................................................................................... 20
        R&D Progress ......................................................................................................................................................................... 20
    Northera ...................................................................................................................................................................................... 22
        Product Description................................................................................................................................................................. 22
        Mechanism of Action ............................................................................................................................................................... 22
        R&D Progress ......................................................................................................................................................................... 22
Chelsea Therapeutics International Ltd. – Pipeline Analysis ............................................................................................................ 25
    Chelsea Therapeutics International Ltd. – Pipeline Products by Therapeutic Class .................................................................... 25
    Chelsea Therapeutics International Ltd. - Pipeline Products By Target....................................................................................... 27
    Chelsea Therapeutics International Ltd. – Pipeline Products by Route of Administration ........................................................... 28
    Chelsea Therapeutics International Ltd. – Pipeline Products by Molecule Type ......................................................................... 29
Chelsea Therapeutics International Ltd. – Recent Pipeline Updates............................................................................................... 30


Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2                                                                 GMDHC02129CDB / Published DEC 2011
2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                                                                      Page(2)
Chelsea Therapeutics International Ltd. – Product Pipeline Review



Chelsea Therapeutics International Ltd. - Dormant Projects ............................................................................................................ 34
Chelsea Therapeutics International Ltd. - Discontinued Pipeline Products ...................................................................................... 35
    Discontinued Pipeline Product Profiles ........................................................................................................................................ 35
        ABR-224050 ........................................................................................................................................................................... 35
Chelsea Therapeutics International Ltd. – Company Statement ...................................................................................................... 36
Chelsea Therapeutics International Ltd. – Locations And Subsidiaries ............................................................................................ 38
    Head Office.................................................................................................................................................................................. 38
Company's Recent Developments ................................................................................................................................................... 39
    Chelsea Therapeutics International Ltd., Recent Developments ................................................................................................. 39
        Jun 30, 2010: Chelsea Achieves Target Enrollment In Phase III Trial Of Northera In Neurogenic Orthostatic Hypotension .. 39
        May 30, 2006: Chelsea Therapeutics Signs Exclusive License Agreement With Dainippon Sumitomo Pharma For Droxidopa
        ................................................................................................................................................................................................ 39
        Jun 29, 2010: Chelsea Initiates Northera Study 306 In Neurogenic Orthostatic Hypotension Associated With Parkinson's
        Disease ................................................................................................................................................................................... 40
        Jun 29, 2010: Chelsea Provides Update On Status Of Phase II Study Of CH-4051 In Rheumatoid Arthritis ......................... 41
        Sep 28, 2011: Chelsea Therapeutics Submits New Drug Application For NORTHERA For Treatment Of Symptomatic NOH
        ................................................................................................................................................................................................ 42
        Jan 28, 2009: Chelsea Therapeutics Initiates Phase II Trial Of Droxidopa In Fibromyalgia.................................................... 42
        Jan 28, 2009: Chelsea Therapeutics Initiates Phase II Trial Of Droxidopa In Fibromyalgia.................................................... 43
        Sep 27, 2010: Chelsea Initiates CH-4051 Phase II Trial In Rheumatoid Arthritis.................................................................... 44
        Aug 26, 2010: Chelsea Receives FDA Approval Of CH-4051 Phase II Protocol .................................................................... 45
        Aug 26, 2008: Chelsea Therapeutics Receives Fast Track Designation For Droxidopa ......................................................... 46
        Jul 26, 2011: Chelsea Therapeutics Announces Preliminary Data From Phase II Study Demonstrating Significant Activity Of
        Droxidopa In Adult ADHD ....................................................................................................................................................... 46
        Sep 24, 2009: Chelsea Therapeutics Reports Preliminary Phase III Data Of Droxidopa ........................................................ 47
        Jul 23, 2008: Chelsea Therapeutics Granted MHRA Approval To Begin Phase II Trial Of Droxidopa In Fibromyalgia. ......... 48
        Jan 22, 2007: Chelsea Therapeutics Receives Orphan Drug Designation For Droxidopa From FDA .................................... 49
        Dec 20, 2010: Chelsea Accelerates Northera NDA Filing Following Meeting With FDA ......................................................... 49
        Sep 20, 2010: Chelsea Reports Data From Phase III Trial Of Northera In Neurogenic Orthostatic Hypotension ................... 50
        Jun 20, 2011: Chelsea Therapeutics Announces Successful Completion Of Northera QTc Study ......................................... 51
        Jan 20, 2011: Chelsea Reports Data Demonstrating Sustained Symptomatic Benefit Of Northera In Neurogenic Orthostatic
        Hypotension ............................................................................................................................................................................ 52
        Aug 19, 2010: Chelsea Initiates Investigator-Led Phase II Study Of Droxidopa In Chronic Fatigue Syndrome ...................... 54
        Feb 19, 2008: Chelsea Therapeutics Receives Special Protocol Assessment For Pivotal Phase 3 Study Of Droxidopa ....... 55
        May 18, 2010: Chelsea Reports Data From Study 303 Confirming Safety and Therapeutic Benefit Of Long-Term Northera
        Treatment In Neurogenic Orthostatic Hypotension ................................................................................................................. 55
        Apr 18, 2011: Chelsea Confirms Plan To File Northera NDA For Treatment Of Neurogenic Orthostatic Hypotension In Third
        Quarter 2011 ........................................................................................................................................................................... 57
        Nov 17, 2011: Chelsea Therapeutics Announces FDA Acceptance Of NDA For Filing And Designation Of Priority Review Of
        NORTHERA For Treatment Of Symptomatic NOH ................................................................................................................. 58
        Mar 17, 2010: Chelsea Reports Findings From Northera 24-Hour Blood Pressure Monitoring Study .................................... 59
        Dec 15, 2009: Chelsea Therapeutics Receives FDA Approval For Pivotal Phase III Study Of Droxidopa For The Treatment
        Of Symptomatic Neurogenic Orthostatic Hypotension (NOH) ................................................................................................. 59
        Jun 15, 2007: Active Biotech Announces Pre-Clinical Results For The Project I-3D At The Annual EULAR.......................... 60
        Dec 14, 2009: Chelsea Therapeutics Announces Phase III Study Results Of Droxidopa For The Treatment Of Symptomatic
        Heurogenic Orthostatic Hypotension ...................................................................................................................................... 61
        Aug 14, 2007: Chelsea Therapeutics Receives Two Orphan Medicinal Product Designations For Droxidopa From European
        Commission ............................................................................................................................................................................ 61
Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2                                                                     GMDHC02129CDB / Published DEC 2011
2011
©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                          Page(3)
Chelsea Therapeutics International Ltd. – Product Pipeline Review




        Nov 12, 2009: Chelsea Therapeutics' Presents Results Of Phase III Trial Of Droxidopa In Neurogenic Orthostatic
        Hypotension At Annual International Symposium On The Autonomic Nervous System ........................................................ 62
        Nov 12, 2007: FDA Accepts Chelsea Therapeutics' Investigational New Drug Application For Droxidopa............................. 63
        Feb 11, 2010: Chelsea Therapeutics Initiates Phase II Trial Of Droxidopa In Combination With Carbidopa In Adult Attention
        Deficit Hyperactivity Disorder .................................................................................................................................................. 64
        Jan 11, 2007: Chelsea Therapeutics Announces Results Of European Phase IIb Trial Of Droxidopa. .................................. 65
        Sep 09, 2009: Chelsea Therapeutics Achieves Target Enrollment In Second Pivotal Phase III Trial Of Droxidopa In
        Neurogenic Orthostatic Hypotension ...................................................................................................................................... 65
        Jun 09, 2011: Chelsea Therapeutics Presents New Data From Northera Phase III Program In NOH At MDS 15th
        International Congress Of Parkinson's Disease And Movement Disorders............................................................................. 66
        May 09, 2011: Chelsea Therapeutics Announces Approval To Open Enrollment Into 3.0mg Arms Of CH-4051 Phase II Trial
        In Rheumatoid Arthritis ........................................................................................................................................................... 67
        Feb 09, 2010: Chelsea Therapeutics Announces Selection And Preliminary Approval Of Northera Against Neurogenic
        Orthostatic Hypotension By The FDA ..................................................................................................................................... 68
        Aug 08, 2011: Chelsea Therapeutics Achieves Target Enrollment In Phase II Trial Of Droxidopa In Fibromyalgia................ 70
        Sep 07, 2006: Chelsea Therapeutics Files Orphan Drug Application And Forms Scientific Advisory Board For Droxidopa... 70
        Feb 07, 2008: Chelsea Therapeutics Begins Patient Dosing In Pivotal Phase III Trial Of Droxidopa In Neurogenic Orthostatic
        Hypotension. ........................................................................................................................................................................... 71
        Jan 07, 2008: Chelsea Therapeutics Initiates Phase II Study Of Droxidopa In Intradialytic Hypotension ............................... 72
        Sep 06, 2011: Chelsea Therapeutics Receives New Patent For Use Of Droxidopa In Fibromyalgia...................................... 73
        Nov 03, 2008: Chelsea Therapeutics Reports Significant Reduction In Severity Of Symptoms During Titration Phase Of
        Pivotal Droxidopa Study .......................................................................................................................................................... 73
        Nov 02, 2011: Chelsea Therapeutics Announces Preliminary Results Of Interim Analysis Of CH-4051 Phase II Trial In
        Rheumatoid Arthritis ............................................................................................................................................................... 74
        Sep 02, 2008: Chelsea Therapeutics Begins Patient Dosing In Second Pivotal Phase III Trial Of Droxidopa ........................ 75
        May 02, 2011: Chelsea Therapeutics Announces Northera Poster Presentations And Symposium On Neurogenic Orthostatic
        Hypotension At MDS 15th International Congress Of Parkinson's Disease And Movement Disorders .................................. 76
        Mar 02, 2009: Chelsea Therapeutics Reports Positive Preliminary Results Of Phase II Study Of Droxidopa In Intradialytic
        Hypote
				
DOCUMENT INFO
Description: Chelsea Therapeutics International Ltd. – Product Pipeline Review – H2 2011 Summary Global Market Direct’s pharmaceuticals report, “Chelsea Therapeutics International Ltd. - Product Pipeline Review - H2 2011” provides data on the Chelsea Therapeutics International 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, Chelsea Therapeutics International Ltd.’s corporate website, SEC filings, investor presentations and featured press releases, both from Chelsea Therapeutics International Ltd. and industry-specific third party sources, put together by Global Markets Direct’s team. Scope - Chelsea Therapeutics International Ltd. - Brief Chelsea Therapeutics International Ltd. overview including business description, key information and facts, and its locations and subsidiaries. - Review of current pipeline of Chelsea Therapeutics International 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 Chelsea Therapeutics International Ltd. with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Chelsea Therapeutics International Ltd.’s pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products. Reasons to buy - Evaluate Chelsea Therapeutics International Ltd.’s strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Chelsea Therap
BUY THIS DOCUMENT NOW PRICE: $500 100% MONEY BACK GUARANTEED
PARTNER GlobalMarketsDirect
Global Markets Direct is a leading provider of global business intelligence and market analysis. It publishes a range of high quality company and market reports created by its large research and analysis capability and drawing from its extensive unique databases of industry-specific information. Global Markets Direct has a broad range of coverage over key market segments. It has a global scope, covering a broad range of countries constituting more than 90% of global revenues in each of the industries it covers. With a large dedicated research and analysis capability, Global Markets Direct employs rigorous primary and secondary research techniques in developing unique data sets and research materials. Its status as an independent research company allows Analysts to conduct trade interviews with key industry players. Access to unique databases of in-house market information further strengthens research and analysis capabilities. Materials are reviewed shaped by an expert panel of leading industry figures and representatives from key players in the relevant industries