Insomnia - Pipeline Review, H2 2015 Is Released

Insomnia - Pipeline Review, H2 2015 Summary Global Markets Direct s, Insomnia - Pipeline Review, H2
2015, provides an overview of the Insomnias therapeutic pipeline. This report provides comprehensive
information on the therapeutic development for Insomnia, complete with comparative analysis at
various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of
administration (RoA) and molecule type, along with latest updates, and featured news and press
releases. It also reviews key players involved in the therapeutic development for Insomnia and special
features on late-stage and discontinued projects. Global Markets Directs report features investigational
drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built
using data and information sourced from Global Markets Directs proprietary databases,
Company/University websites, SEC filings, investor presentations and featured press releases from
company/university sites and industry-specific third party sources, put together by Global Markets
Direct s team. Drug profiles/records featured in the report undergoes periodic updation following a
stringent set of processes that ensures that all the profiles are updated with the latest set of
information. Additionally, processes including live news & deals tracking, browser based alert-box and
clinical trials registries tracking ensure that the most recent developments are captured on a real time
basis. The report enhances decision making capabilities and help to create effective counter strategies
to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to
produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed
or altered based on the availability and relevance of data for the indicated disease. Scope - The report
provides a snapshot of the global therapeutic landscape of Insomnia - The report reviews key pipeline
products under drug profile section which includes, product description, MoA and R&D brief, licensing
and collaboration details & other developmental activities - The report reviews key players involved in
the therapeutics development for Insomnia and enlists all their major and minor projects - The report
summarizes all the dormant and discontinued pipeline projects - A review of the Insomnia products
under development by companies and universities/research institutes based on information derived
from company and industry-specific sources - Pipeline products coverage based on various stages of
development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment
of monotherapy and combination therapy pipeline projects - Coverage of the Insomnia pipeline on the
basis of target, MoA, route of administration and molecule type - Latest news and deals relating related
to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis,
and insights to formulate effective R&D development strategies - Identify emerging players with
potentially strong product portfolio and create effective counter-strategies to gain competitive
advantage - Develop strategic initiatives by understanding the focus areas of leading companies Identify and understand important and diverse types of therapeutics under development for Insomnia Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline Devise corrective measures for pipeline projects by understanding Insomnia pipeline depth and focus of
Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying
prospective partners with the most attractive projects to enhance and expand business potential and
scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the
factors that drove them from pipeline.

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Table of Contents

Introduction 8
Global Markets Direct Report Coverage 8
Insomnia Overview 9
Therapeutics Development 10
Pipeline Products for Insomnia - Overview 10
Pipeline Products for Insomnia - Comparative Analysis 11
Insomnia - Therapeutics under Development by Companies 12
Insomnia - Therapeutics under Investigation by Universities/Institutes 14
Insomnia - Pipeline Products Glance 15
Late Stage Products 15
Clinical Stage Products 16
Early Stage Products 17
Insomnia - Products under Development by Companies 18
Insomnia - Products under Investigation by Universities/Institutes 19
Insomnia - Companies Involved in Therapeutics Development 20
Alexza Pharmaceuticals, Inc. 20
Eisai Co., Ltd. 21
Evotec AG 22
Grupo Ferrer Internacional, S.A. 23
Heptares Therapeutics Limited 24
Intec Pharma ltd. 25
Intra-Cellular Therapies, Inc. 26
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Johnson & Johnson 27

Merck & Co., Inc. 28
Neurim Pharmaceuticals Ltd 29
Novartis AG 30
Reviva Pharmaceuticals Inc. 31
Rottapharm SpA 32
Shionogi & Co., Ltd. 33
Somnus Therapeutics, Inc. 34
Takeda Pharmaceutical Company Limited 35
Insomnia - Therapeutics Assessment 36
Assessment by Monotherapy Products 36
Assessment by Target 37
Assessment by Mechanism of Action 39
Assessment by Route of Administration 41
Assessment by Molecule Type 43
Drug Profiles 44
CB-2810 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
CR-5542 Series - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
Drugs to Inhibit Angiotensin II Receptor Type 1 for Insomnia - Drug Profile 46
Product Description 46

Mechanism of Action 46
R&D Progress 46
EVT-201 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
HTL-6641 - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
ITI-007 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
JNJ-42847922 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
LASSBio-785 - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
LASSBio-786 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
lemborexant - Drug Profile 55
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Product Description 55
Mechanism of Action 55
R&D Progress 55
lorediplon - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
MK-1064 - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
MK-8133 - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
NEO-1940 - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
piromelatine - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
ramelteon - Drug Profile 62
Product Description 62
Mechanism of Action 62

R&D Progress 62
S-117957 - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
Small Molecule for Obesity and Insomnia - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Small Molecule to Inhibit OX2R for Insomnia - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
UCM-765 - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
zaleplon - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
zaleplon - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
zaleplon DR - Drug Profile 70
Product Description 70
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Mechanism of Action 70
R&D Progress 70
zolpidem tartrate - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
Insomnia - Recent Pipeline Updates 73
Insomnia - Dormant Projects 82
Insomnia - Discontinued Products 84
Insomnia - Product Development Milestones 85
Featured News & Press Releases 85
Sep 24, 2015: Minerva Neurosciences Provides Update on Clinical Development Program With MIN-202,
Selective Orexin-2 Receptor Antagonist 85
Jul 14, 2015: Ferrer initiates phase IIa clinical study of Lorediplon in patients with insomnia 85
Jun 16, 2015: Minerva Neurosciences Provides Update on MIN-202, Selective Orexin-2 Receptor
Antagonist 86
Jan 21, 2015: Minerva Neurosciences Reports Positive Phase 1 Data with MIN-202, Selective Orexin-2
Antagonist for Treatment of Sleep Disorders Including Primary and Comorbid Insomnia 87
Dec 10, 2014: Eisai Demonstrates Efficacy of Investigational Dual Orexin Receptor Antagonist E2006 in
Sleep Initiation and Maintenance 88
Sep 22, 2014: Minerva Neurosciences Announces Completion of FDA Review of Investigational New
Drug Application for MIN-202 and Plans for First U.S.-Based Clinical Trial 89
Jul 26, 2013: Takeda Pharma Receives FDA Approval for Rozerem 89
Feb 18, 2013: Neurim Pharma Announces Positive Phase II Clinical Trial Results Of Piromelatine For
Treatment Of Insomnia 90
Feb 09, 2012: Ferrer Announces Positive Results From Phase I Clinical Trials of Lorediplon In Insomnia 90
Dec 14, 2011: McGill University Health Centre Researchers Discover Potential Insomnia Drug 91
Appendix 93
Methodology 93

Coverage 93
Secondary Research 93
Primary Research 93
Expert Panel Validation 93
Contact Us 93
Disclaimer 94

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