World Therapy: Insomnia – Pipeline Review, H1 2012

• Publication date: February 2013
• Report size: 87 pages

This report provides data on the therapeutic development for Insomnia, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Insomnia. 'Insomnia - Pipeline Review, H1 2012' is built using data and information sourced from Global Industries Direct’s proprietary databases, Firms /University websites, SEC filings, investor presentations an...

This report provides data on the therapeutic development for Insomnia, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Insomnia. 'Insomnia - Pipeline Review, H1 2012' is built using data and information sourced from Global Industries Direct’s proprietary databases, Firms /University websites, SEC filings, investor presentations and featured press releases from firm /university sites and market -specific third party sources, put together by Global Industries Direct’s team.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.



Scope of the Research


- A snapshot of the global therapeutic scenario for Insomnia.
- A review of the Insomnia products under development by industry players and universities/research institutes based on information derived from industry player and market -specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Insomnia pipeline on the basis of route of administration and molecule type.
- Profiles of late-stage new product development featuring sections on product description, mechanism of action and research & development progress.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.



Reasons to buy


- Identify and understand important and diverse types of therapeutics under development for Insomnia.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and take over s effectively by identifying players with the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Insomnia pipeline depth and focus of Insomnia therapeutics.
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and grow business potential and scope.
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.

Global Therapy Industry

Table of Contents
Data table of Contents 2
List of Tables 6
List of Figures 7
Introduction 8
Global March kets Direct Report Coverage 8
Insomnia Overview 9
Therapeutics Development 10
An Overview of Pipeline Products for Insomnia 10
Insomnia Therapeutics under Development by Firms 12
Insomnia Therapeutics under Investigation by Universities/Institutes 14
Late Stage Products 15
Comparative Analysis 15
Mid Clinical Stage Products 16
Comparative Analysis 16
Early Clinical Stage Products 17
Comparative Analysis 17
Discovery and Pre-Clinical Stage Products 18
Comparative Analysis 18
Insomnia Therapeutics – Products under Development by Firms 19
Insomnia Therapeutics – Products under Investigation by Universities/Institutes 20
Companies Involved in Insomnia Therapeutics Development 21
Eli Lilly and Firms 21
Merck & Co., Inc. 22
Dainippon Sumitomo Pharma Co., Ltd. 23
Alexza Pharmaceuticals, Inc. 24
Eisai Co., Ltd. 25
Evotec Aktiengesellschaft 26
IntelGenx Technologies Corp. 27
MediciNovember a, Inc. 28
Jazz Pharmaceuticals, Inc. 29
Neurim Pharmaceuticals (1991) Ltd. 30
Intas Pharmaceuticals Ltd. 31
Intec Pharma ltd. 32
Rottapharm SpA 33
Somnus Therapeutics, Inc. 34
Intra-Cellular Therapies, Inc. 35
Heptares Therapeutics Ltd. 36
Eurofarma 37
Insomnia – Therapeutics Assessment 38
Assessment by Monotherapy Products 38
Assessment by Combination Products 39
Assessment by Route of Administration 40
Assessment by Molecule Type 42
Drug Profiles 44
JZP-6 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
LY2624803 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
MK-4305 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
AZ-007 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
SEP-0227018 - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
Neu-P11 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
MN-305 - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
SKP-1041 - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
Orexin 2 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
ITI-007 - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
CR 5542 Series - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
Melatonin - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
Escitalopram + Sertraline + Desvenlafaxine - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
Eszopiclone - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
Lunesta + Venlafaxine - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
Armodafinil - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
Armodafinil - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Armodafinil - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
Melatonin - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
MK-6096 - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Zaleplon GR - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
MK-3697 - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
SEP-190 - Drug Profile 70
Product Description 70
Mechanism of Action 70
R&D Progress 70
IN-AQUL-001 - Drug Profile 71
Product Description 71
Mechanism of Action 71
R&D Progress 71
INT0020 - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
Orexin Receptor Antagonist - Drug Profile 73
Product Description 73
Mechanism of Action 73
R&D Progress 73
UCM765 - Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
Orexin Receptor Antagonist - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
Insomnia Therapeutics – Drug Profile Updates 76
Insomnia Therapeutics – Discontinued Products 82
Insomnia Therapeutics - Dormant Products 83
Insomnia – Product Development Milestones 84
Featured News & Press Releases 84
February 06, 2012: Merck Provides Update On Development Program For Investigational Insomnia Drug, Suvorexant 84
January 18, 2012: Eisai Receives Approval To March ket Lunesta In Japan 84
December 21, 2011: Transcept Receives US$ 10m Milestone Payment From Purdue For Listing Of Intermezzo Formulation Patents In FDA Orange Book 85
December 14, 2011: McGill University Health Centre Researchers Discover Potential Insomnia Drug 85
November 23, 2011: Transcept Announces FDA Approval Of Intermezzo C-IV For Treatment Of Insomnia 86
October 07, 2011: Takeda Discontinues Development Of Ramelteon In Europe For Treatment Of Insomnia 86
October 04, 2011: Transcept Announces Intermezzo PDUFA Action Date 87
September 27, 2011: Transcept Pharmaceuticals Resubmits Intermezzo NDA To FDA 87
September 14, 2011: Transcept Pharmaceuticals Plans To Resubmit Intermezzo New Drug Application Following Meeting With FDA 87
September 13, 2011: Transcept Pharmaceuticals Announces FDA Response To Proposal In Support Of Intermezzo New Drug Application 88
Appendix 89
Methodology 89
Coverage 89
Secondary Research 89
Primary Research 89
Expert Panel Validation 90
Contact Us 90
Disclaimer 90

List of Tables

Number of Products Under Development for Insomnia, H1 2012 10
Products under Development for Insomnia – Comparative Analysis, H1 2012 11
Number of Products under Development by Firms, H1 2012 13
Number of Products under Investigation by Universities/Institutes, H1 2012 14
Comparative Analysis by Late Stage Development, H1 2012 15
Comparative Analysis by Mid Clinical Stage Development, H1 2012 16
Comparative Analysis by Early Clinical Stage Development, H1 2012 17
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H1 2012 18
Products under Development by Firms, H1 2012 19
Products under Investigation by Universities/Institutes, H1 2012 20
Eli Lilly and Firms, H1 2012 21
Merck & Co., Inc., H1 2012 22
Dainippon Sumitomo Pharma Co., Ltd., H1 2012 23
Alexza Pharmaceuticals, Inc., H1 2012 24
Eisai Co., Ltd., H1 2012 25
Evotec Aktiengesellschaft, H1 2012 26
IntelGenx Technologies Corp., H1 2012 27
MediciNovember a, Inc., H1 2012 28
Jazz Pharmaceuticals, Inc., H1 2012 29
Neurim Pharmaceuticals (1991) Ltd., H1 2012 30
Intas Pharmaceuticals Ltd., H1 2012 31
Intec Pharma ltd., H1 2012 32
Rottapharm SpA, H1 2012 33
Somnus Therapeutics, Inc., H1 2012 34
Intra-Cellular Therapies, Inc., H1 2012 35
Heptares Therapeutics Ltd., H1 2012 36
Eurofarma, H1 2012 37
Assessment by Monotherapy Products, H1 2012 38
Assessment by Combination Products, H1 2012 39
Assessment by Stage and Route of Administration, H1 2012 41
Assessment by Stage and Molecule Type, H1 2012 43
Insomnia Therapeutics – Drug Profile Updates 76
Insomnia Therapeutics – Discontinued Products 82
Insomnia Therapeutics – Dormant Products 83

List of Figures

Number of Products under Development for Insomnia, H1 2012 10
Products under Development for Insomnia – Comparative Analysis, H1 2012 11
Products under Development by Firms, H1 2012 12
Products under Investigation by Universities/Institutes, H1 2012 14
Late Stage Products, H1 2012 15
Mid Clinical Stage Products, H1 2012 16
Early Clinical Stage Products, H1 2012 17
Discovery and Pre-Clinical Stage Products, H1 2012 18
Assessment by Monotherapy Products, H1 2012 38
Assessment by Combination Products, H1 2012 39
Assessment by Route of Administration, H1 2012 40
Assessment by Stage and Route of Administration, H1 2012 41
Assessment by Molecule Type, H1 2012 42
Assessment by Stage and Molecule Type, H1 2012 43