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Insomnia - Pipeline Review, H2 2015 Is Released

Press Release   •   Jan 27, 2016 12:03 IST

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

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

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

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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