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									                      Hyponatremia – Pipeline Review, H1 2012


                                                                                          Reference Code: GMDHC2010IDB
                                                                                              Publication Date: April 2012




Hyponatremia – Pipeline Review, H1 2012                                                       GMDHC2010IDB / Pub April 2012
© Global Markets Direct. This report is a licensed product and is not to be photocopied                             Page(1)
Hyponatremia – Pipeline Review, H1 2012




Table of Contents
Table of Contents ............................................................................................................................................................................... 2
    List of Tables ................................................................................................................................................................................. 3
    List of Figures ................................................................................................................................................................................ 4
Introduction......................................................................................................................................................................................... 5
    Global Markets Direct Report Coverage ........................................................................................................................................ 5
Hyponatremia Overview ..................................................................................................................................................................... 6
Therapeutics Development................................................................................................................................................................. 7
    An Overview of Pipeline Products for Hyponatremia ..................................................................................................................... 7
Hyponatremia Therapeutics under Development by Companies ....................................................................................................... 9
Hyponatremia Therapeutics under Investigation by Universities/Institutes ....................................................................................... 10
Late Stage Products ......................................................................................................................................................................... 11
    Comparative Analysis .................................................................................................................................................................. 11
Hyponatremia Therapeutics – Products under Development by Companies ................................................................................... 12
Hyponatremia Therapeutics – Products under Investigation by Universities/Institutes..................................................................... 13
Companies Involved in Hyponatremia Therapeutics Development .................................................................................................. 14
    Cornerstone Therapeutics Inc. .................................................................................................................................................... 14
Hyponatremia – Therapeutics Assessment ...................................................................................................................................... 15
    Assessment by Monotherapy Products ....................................................................................................................................... 15
    Assessment by Route of Administration ...................................................................................................................................... 16
    Assessment by Molecule Type .................................................................................................................................................... 18
Drug Profiles..................................................................................................................................................................................... 20
    Lixivaptan - Drug Profile .............................................................................................................................................................. 20
         Product Description................................................................................................................................................................. 20
         Mechanism of Action ............................................................................................................................................................... 20
         R&D Progress ......................................................................................................................................................................... 20
    Isotonic Parenteral Fluid - Drug Profile ........................................................................................................................................ 22
         Product Description................................................................................................................................................................. 22
         Mechanism of Action ............................................................................................................................................................... 22
         R&D Progress ......................................................................................................................................................................... 22
    Hypotonic Parenteral Fluid (Hamilton Health Sciences) - Drug Profile ........................................................................................ 24
         Product Description................................................................................................................................................................. 24
         Mechanism of Action ............................................................................................................................................................... 24
         R&D Progress ......................................................................................................................................................................... 24
Hyponatremia Therapeutics – Drug Profile Updates ........................................................................................................................ 26
Hyponatremia Therapeutics – Discontinued Products ...................................................................................................................... 27
Hyponatremia Therapeutics - Dormant Products ............................................................................................................................. 28
Hyponatremia – Product Development Milestones........................................................................................................................... 29
    Featured News & Press Releases ............................................................................................................................................... 29
         Mar 12, 2010: Seattle Genetics Expands Antibody-Drug Conjugate Patent Portfolio ............................................................. 29
         Aug 03, 2009: The European Commission Approves Otsuka Pharmaceutical's Samsca (tolvaptan) For Hyponatremia........ 29
         May 21, 2009: FDA Approves Otsuka Pharmaceutical's Samsca (tolvaptan) To Treat Patients With Clinically Significant
         Hypervolemic And Euvolemic Hyponatremia .......................................................................................................................... 30



Hyponatremia – Pipeline Review, H1 2012                                                                                                            GMDHC2010IDB / Pub April 2012
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                                                                   Page(2)
Hyponatremia – Pipeline Review, H1 2012




         Jun 25, 2008: U.S. Food And Drug Administration Advisory Committee Recommends Approval Of Tolvaptan, An
         Investigational Treatment For Hyponatremia .......................................................................................................................... 32
         Dec 21, 2007: Otsuka Pharmaceutical's Files New Drug Application For Tolvaptan .............................................................. 32
         Sep 19, 2007: ECLIPSE Data on Effects of Otsuka’s Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure
         Patients’ Hemodynamics and Urine Output Featured in Heart Failure Society of America’s Late Breaking Trials.................. 33
         Mar 25, 2007: EVEREST Data on Short- and Long-Term Use of Otsuka’s Investigational Novel Treatment, Tolvaptan,
         Published in Journal of the American Medical Association and Featured in ACC’s Late Breaking Clinical Trials ................... 33
         Dec 05, 2006: New Data 
								
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