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Insomnia-Pipeline Review, H1 2015

Insomnia-Pipeline Review, H1 2015

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Executive Summary

Insomnia-Pipeline Review, H1 2015


Global Markets Direct's, 'Insomnia-Pipeline Review, H1 2015', provides an overview of the Insomnia's 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 Direct's 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 Direct's 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.


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

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

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 20

Insomnia-Companies Involved in Therapeutics Development 21

Actelion Ltd 21

Alexza Pharmaceuticals, Inc. 22

Eisai Co., Ltd. 23

Evotec AG 24

Grupo Ferrer Internacional, S.A. 25

Heptares Therapeutics Ltd. 26

Intec Pharma ltd. 27

Intra-Cellular Therapies, Inc. 28

Johnson & Johnson 29

Merck & Co., Inc. 30

Minerva Neurosciences, Inc. 31

Neurim Pharmaceuticals Ltd 32

Novartis AG 33

Reviva Pharmaceuticals Inc. 34

Rottapharm SpA 35

Shionogi & Co., Ltd. 36

Somnus Therapeutics, Inc. 37

Takeda Pharmaceutical Company Limited 38

Insomnia-Therapeutics Assessment 39

Assessment by Monotherapy Products 39

Assessment by Target 40

Assessment by Mechanism of Action 42

Assessment by Route of Administration 44

Assessment by Molecule Type 46

Drug Profiles 47

ACT-462206-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

CR-5542 Series-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

Drugs to Inhibit Angiotensin II Receptor Type 1 for Insomnia-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

EVT-201-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

ITI-007-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

JNJ-42847922-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

LASSBio-785-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

LASSBio-786-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

lemborexant-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

lorediplon-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

MIN-202-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

MK-8133-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

RP-15000-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

S-117957-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

Small Molecule to Antagonize Orexin 1 and 2 Receptors for Insomnia-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

Small Molecule to Inhibit OX2R for Insomnia-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

UCM-765-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 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

zaleplon GR-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

zolpidem tartrate-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

Insomnia-Recent Pipeline Updates 73

Insomnia-Dormant Projects 80

Insomnia-Discontinued Products 83

Insomnia-Product Development Milestones 85

Featured News & Press Releases 85

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 85

Dec 10, 2014: Eisai Demonstrates Efficacy Of Investigational Dual Orexin Receptor Antagonist E2006 In Sleep Initiation And Maintenance 86

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 87

Feb 18, 2013: Neurim Pharma Announces Positive Phase II Clinical Trial Results Of Piromelatine For Treatment Of Insomnia 87

Feb 09, 2012: Ferrer Announces Positive Results From Phase I Clinical Trials Of Lorediplon In Insomnia 88

Dec 14, 2011: McGill University Health Centre Researchers Discover Potential Insomnia Drug 89

Oct 07, 2011: Takeda Discontinues Development Of Ramelteon In Europe For Treatment Of Insomnia 90

Jul 24, 2011: Neurim Announces Positive Results From Phase I And Phase Ib Clinical Trials With Neu-P11 90

Jun 15, 2011: Somnus's Phase II Study Of SKP-1041 For Sleep Maintenance Insomnia Shows Significant Reduction Of Mid-Night Awakenings without Next-Day Cognitive Impairment 91

Jun 01, 2011: Somnus Therapeutics Completes Successful Phase II Study Of SKP-1041 For Sleep Maintenance Insomnia 92

Appendix 93

Methodology 93

Coverage 93

Secondary Research 93

Primary Research 93

Expert Panel Validation 93

Contact Us 93

Disclaimer 94

List of Tables

Number of Products under Development for Insomnia, H1 2015 10

Number of Products under Development for Insomnia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Development, H1 2015 17

Products under Development by Companies, H1 2015 18

Products under Development by Companies, H1 2015 (Contd..1) 19

Products under Investigation by Universities/Institutes, H1 2015 20

Insomnia-Pipeline by Actelion Ltd, H1 2015 21

Insomnia-Pipeline by Alexza Pharmaceuticals, Inc., H1 2015 22

Insomnia-Pipeline by Eisai Co., Ltd., H1 2015 23

Insomnia-Pipeline by Evotec AG, H1 2015 24

Insomnia-Pipeline by Grupo Ferrer Internacional, S.A., H1 2015 25

Insomnia-Pipeline by Heptares Therapeutics Ltd., H1 2015 26

Insomnia-Pipeline by Intec Pharma ltd., H1 2015 27

Insomnia-Pipeline by Intra-Cellular Therapies, Inc., H1 2015 28

Insomnia-Pipeline by Johnson & Johnson, H1 2015 29

Insomnia-Pipeline by Merck & Co., Inc., H1 2015 30

Insomnia-Pipeline by Minerva Neurosciences, Inc., H1 2015 31

Insomnia-Pipeline by Neurim Pharmaceuticals Ltd, H1 2015 32

Insomnia-Pipeline by Novartis AG, H1 2015 33

Insomnia-Pipeline by Reviva Pharmaceuticals Inc., H1 2015 34

Insomnia-Pipeline by Rottapharm SpA, H1 2015 35

Insomnia-Pipeline by Shionogi & Co., Ltd., H1 2015 36

Insomnia-Pipeline by Somnus Therapeutics, Inc., H1 2015 37

Insomnia-Pipeline by Takeda Pharmaceutical Company Limited, H1 2015 38

Assessment by Monotherapy Products, H1 2015 39

Number of Products by Stage and Target, H1 2015 41

Number of Products by Stage and Mechanism of Action, H1 2015 43

Number of Products by Stage and Route of Administration, H1 2015 45

Number of Products by Stage and Molecule Type, H1 2015 46

Insomnia Therapeutics-Recent Pipeline Updates, H1 2015 73

Insomnia-Dormant Projects, H1 2015 80

Insomnia-Dormant Projects (Contd..1), H1 2015 81

Insomnia-Dormant Projects (Contd..2), H1 2015 82

Insomnia-Discontinued Products, H1 2015 83

Insomnia-Discontinued Products (Contd..1), H1 2015 84

List of Figures

Number of Products under Development for Insomnia, H1 2015 10

Number of Products under Development for Insomnia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Products, H1 2015 17

Assessment by Monotherapy Products, H1 2015 39

Number of Products by Top 10 Targets, H1 2015 40

Number of Products by Stage and Top 10 Targets, H1 2015 40

Number of Products by Top 10 Mechanism of Actions, H1 2015 42

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 42

Number of Products by Top 10 Routes of Administration, H1 2015 44

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 45

Number of Products by Stage and Top 10 Molecule Types, H1 2015 46

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To know more information on Purchase by Section, please send a mail to query [@]

Actelion Ltd

Alexza Pharmaceuticals, Inc.

Eisai Co., Ltd.

Evotec AG

Grupo Ferrer Internacional, S.A.

Heptares Therapeutics Ltd.

Intec Pharma ltd.

Intra-Cellular Therapies, Inc.

Johnson & Johnson

Merck & Co., Inc.

Minerva Neurosciences, Inc.

Neurim Pharmaceuticals Ltd

Novartis AG

Reviva Pharmaceuticals Inc.

Rottapharm SpA

Shionogi & Co., Ltd.

Somnus Therapeutics, Inc.

Takeda Pharmaceutical Company Limited

Insomnia Therapeutic Products under Development, Key Players in Insomnia Therapeutics, Insomnia Pipeline Overview, Insomnia Pipeline, Insomnia Pipeline Assessment

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