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
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 On Otsuka's Investigational Product for Hyponatremia Presented at American Heart Association Annual Meeting Results of the SALT-1 and SALT-2 Trials Show Tolvaptan Improves Serum Sodium Levels in Patients with Hyponatremia 34
Nov 10, 2003: Otsuka’s Tolvaptan Shows Decreased Fluid Retention In Hospitalized Patients With Worsening Congestive Heart Failure Data on Novel Phase III Agent Presented at Late Breaking Clinical Trials Session During American Heart Association’s Scientific Sessions 2003 34
Appendix 36
Methodology 36
Coverage 36
Secondary Research 36
Primary Research 36
Expert Panel Validation 36
Contact Us 37
Disclaimer 37
List of Tables
Number of Products Under Development for Hyponatremia, H1 2012 7
Products under Development for Hyponatremia – Comparative Analysis, H1 2012 8
Number of Products under Development by Companies, H1 2012 9
Number of Products under Investigation by Universities/Institutes, H1 2012 10
Comparative Analysis by Late Stage Development, H1 2012 11
Products under Development by Companies, H1 2012 12
Products under Investigation by Universities/Institutes, H1 2012 13
Cornerstone Therapeutics Inc., H1 2012 14
Assessment by Monotherapy Products, H1 2012 15
Assessment by Stage and Route of Administration, H1 2012 17
Assessment by Stage and Molecule Type, H1 2012 19
Hyponatremia Therapeutics – Drug Profile Updates 26
Hyponatremia Therapeutics – Discontinued Products 27
Hyponatremia Therapeutics – Dormant Products 28
List of Figures
Number of Products under Development for Hyponatremia, H1 2012 7
Products under Development for Hyponatremia – Comparative Analysis, H1 2012 8
Products under Development by Companies, H1 2012 9
Products under Investigation by Universities/Institutes, H1 2012 10
Late Stage Products, H1 2012 11
Assessment by Monotherapy Products, H1 2012 15
Assessment by Route of Administration, H1 2012 16
Assessment by Stage and Route of Administration, H1 2012 17
Assessment by Molecule Type, H1 2012 18
Assessment by Stage and Molecule Type, H1 2012 19