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Dyskinesia-Pipeline Review, H1 2015

Dyskinesia-Pipeline Review, H1 2015


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Executive Summary

Dyskinesia-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Dyskinesia, 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 Dyskinesia 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.

Scope

The report provides a snapshot of the global therapeutic landscape of Dyskinesia

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 Dyskinesia and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Dyskinesia 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 Dyskinesia 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 Dyskinesia

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Dyskinesia 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 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Dyskinesia Overview 10

Therapeutics Development 11

Pipeline Products for Dyskinesia-Overview 11

Pipeline Products for Dyskinesia-Comparative Analysis 12

Dyskinesia-Therapeutics under Development by Companies 13

Dyskinesia-Therapeutics under Investigation by Universities/Institutes 16

Dyskinesia-Pipeline Products Glance 17

Late Stage Products 17

Clinical Stage Products 18

Early Stage Products 19

Dyskinesia-Products under Development by Companies 20

Dyskinesia-Products under Investigation by Universities/Institutes 23

Dyskinesia-Companies Involved in Therapeutics Development 24

Adamas Pharmaceuticals, Inc. 24

Addex Therapeutics Ltd 25

Advicenne Pharma 26

Amarantus Bioscience Holdings, Inc. 27

Astraea Therapeutics, LLC 28

Auspex Pharmaceuticals, Inc. 29

BioMarin Pharmaceutical Inc. 30

Catalyst Pharmaceutical Partners, Inc. 31

Contera Pharma ApS 32

EpiVax, Inc. 33

Heptares Therapeutics Ltd. 34

Integrative Research Laboratories Sweden AB 35

Ipsen S.A. 36

Medicure Inc. 37

Medy-Tox Inc. 38

Merz Pharmaceuticals GmbH 39

Neurim Pharmaceuticals Ltd 40

Neurocrine Biosciences, Inc. 41

Neurolixis Inc. 42

Novartis AG 43

Osmotica Pharmaceutical Corp. 44

Otsuka Holdings Co., Ltd. 45

Santhera Pharmaceuticals Holding AG 46

SciFluor Life Sciences, LLC 47

Synchroneuron Inc. 48

Targacept, Inc. 49

Upsher-Smith Laboratories, Inc. 50

Dyskinesia-Therapeutics Assessment 51

Assessment by Monotherapy Products 51

Assessment by Combination Products 52

Assessment by Target 53

Assessment by Mechanism of Action 55

Assessment by Route of Administration 57

Assessment by Molecule Type 59

Drug Profiles 61

(dextromethorphan hydrobromide + quinidine sulfate)-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

abobotulinumtoxin A-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

abobotulinumtoxin A next generation-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

acamprosate calcium SR-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

ADV-6979-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

amantadine hydrochloride ER-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

amantadine hydrochloride ER-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

AQW-051-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

AT-127-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

AT-326-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

AT-403-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

AVP-786-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

befiradol-Drug Profile 78

Product Description 78

Mechanism of Action 78

R&D Progress 78

CPP-115-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

dipraglurant ER-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

dipraglurant IR-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

Drugs for Dyskinesia-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

Drugs for Tardive Dyskinesia-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

dutetrabenazine ER-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

eltoprazine-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

fipamezole-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

HTL-14242-Drug Profile 90

Product Description 90

Mechanism of Action 90

R&D Progress 90

IRL-790-Drug Profile 91

Product Description 91

Mechanism of Action 91

R&D Progress 91

JM-010-Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

MRZ-8676-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

naluzotan-Drug Profile 94

Product Description 94

Mechanism of Action 94

R&D Progress 94

Neu-120-Drug Profile 95

Product Description 95

Mechanism of Action 95

R&D Progress 95

Neu-240-Drug Profile 96

Product Description 96

Mechanism of Action 96

R&D Progress 96

onabotulinumtoxin A-Drug Profile 97

Product Description 97

Mechanism of Action 97

R&D Progress 97

onabotulinumtoxin A-Drug Profile 98

Product Description 98

Mechanism of Action 98

R&D Progress 98

PEUN-3-Drug Profile 99

Product Description 99

Mechanism of Action 99

R&D Progress 99

RG-2833-Drug Profile 100

Product Description 100

Mechanism of Action 100

R&D Progress 100

Small Molecule for Dyskinesia-Drug Profile 102

Product Description 102

Mechanism of Action 102

R&D Progress 102

Small Molecule for Dyskinesia and Hyperkinesia-Drug Profile 103

Product Description 103

Mechanism of Action 103

R&D Progress 103

Small Molecules to Antagonize Metabotropic Glutamate Receptor 5 (mGluR5) for Dyskinesia-Drug Profile 104

Product Description 104

Mechanism of Action 104

R&D Progress 104

Tardoxal-Drug Profile 105

Product Description 105

Mechanism of Action 105

R&D Progress 105

TC-8831-Drug Profile 106

Product Description 106

Mechanism of Action 106

R&D Progress 106

valbenazine-Drug Profile 107

Product Description 107

Mechanism of Action 107

R&D Progress 107

Dyskinesia-Recent Pipeline Updates 109

Dyskinesia-Dormant Projects 136

Dyskinesia-Discontinued Products 138

Dyskinesia-Product Development Milestones 139

Featured News & Press Releases 139

Feb 10, 2015: Amarantus Announces Publication in BRAIN of Eltoprazine Phase 2a Clinical Study for Treating Parkinson's Disease Levodopa-Induced Dyskinesia 139

Feb 09, 2015: Adamas Pharmaceuticals' Phase 2/3 Clinical Study Published in Movement Disorders 140

Feb 03, 2015: Auspex Pharmaceuticals Completes Enrollment in a Pivotal Clinical Trial of SD-809 in Tardive Dyskinesia 141

Jan 19, 2015: Addex and Dystonia Medical Research Foundation Announce Partnership to Explore the Therapeutic use of Dipraglurant in the Treatment of Dystonia 142

Jan 12, 2015: Auspex Announces Favorable Topline Results From Thorough QT Clinical Trial of SD-809 143

Jan 08, 2015: Amarantus to Participate in the Eighth Annual OneMedForum Conference on January 12-13, 2015 144

Oct 30, 2014: Auspex Pharmaceuticals Initiates Second Pivotal Clinical Trial for SD-809 in Tardive Dyskinesia 144

Oct 30, 2014: Neurocrine Biosciences Receives Breakthrough Therapy Designation for NBI-98854 in Tardive Dyskinesia 145

Oct 28, 2014: Adamas Pharmaceuticals Expands Its Phase 3 Program With ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease 146

Oct 20, 2014: Neurocrine Announces Initiation Of Phase III Study For VMAT2 Inhibitor NBI-98854 147

Appendix 148

Methodology 148

Coverage 148

Secondary Research 148

Primary Research 148

Expert Panel Validation 148

Contact Us 148

Disclaimer 149

List of Tables

Number of Products under Development for Dyskinesia, H1 2015 11

Number of Products under Development for Dyskinesia-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 14

Number of Products under Development by Companies, H1 2015 (Contd..1) 15

Number of Products under Investigation by Universities/Institutes, H1 2015 16

Comparative Analysis by Late Stage Development, H1 2015 17

Comparative Analysis by Clinical Stage Development, H1 2015 18

Comparative Analysis by Early Stage Development, H1 2015 19

Products under Development by Companies, H1 2015 20

Products under Development by Companies, H1 2015 (Contd..1) 21

Products under Development by Companies, H1 2015 (Contd..2) 22

Products under Investigation by Universities/Institutes, H1 2015 23

Dyskinesia-Pipeline by Adamas Pharmaceuticals, Inc., H1 2015 24

Dyskinesia-Pipeline by Addex Therapeutics Ltd, H1 2015 25

Dyskinesia-Pipeline by Advicenne Pharma, H1 2015 26

Dyskinesia-Pipeline by Amarantus Bioscience Holdings, Inc., H1 2015 27

Dyskinesia-Pipeline by Astraea Therapeutics, LLC, H1 2015 28

Dyskinesia-Pipeline by Auspex Pharmaceuticals, Inc., H1 2015 29

Dyskinesia-Pipeline by BioMarin Pharmaceutical Inc., H1 2015 30

Dyskinesia-Pipeline by Catalyst Pharmaceutical Partners, Inc., H1 2015 31

Dyskinesia-Pipeline by Contera Pharma ApS, H1 2015 32

Dyskinesia-Pipeline by EpiVax, Inc., H1 2015 33

Dyskinesia-Pipeline by Heptares Therapeutics Ltd., H1 2015 34

Dyskinesia-Pipeline by Integrative Research Laboratories Sweden AB, H1 2015 35

Dyskinesia-Pipeline by Ipsen S.A., H1 2015 36

Dyskinesia-Pipeline by Medicure Inc., H1 2015 37

Dyskinesia-Pipeline by Medy-Tox Inc., H1 2015 38

Dyskinesia-Pipeline by Merz Pharmaceuticals GmbH, H1 2015 39

Dyskinesia-Pipeline by Neurim Pharmaceuticals Ltd, H1 2015 40

Dyskinesia-Pipeline by Neurocrine Biosciences, Inc., H1 2015 41

Dyskinesia-Pipeline by Neurolixis Inc., H1 2015 42

Dyskinesia-Pipeline by Novartis AG, H1 2015 43

Dyskinesia-Pipeline by Osmotica Pharmaceutical Corp., H1 2015 44

Dyskinesia-Pipeline by Otsuka Holdings Co., Ltd., H1 2015 45

Dyskinesia-Pipeline by Santhera Pharmaceuticals Holding AG, H1 2015 46

Dyskinesia-Pipeline by SciFluor Life Sciences, LLC, H1 2015 47

Dyskinesia-Pipeline by Synchroneuron Inc., H1 2015 48

Dyskinesia-Pipeline by Targacept, Inc., H1 2015 49

Dyskinesia-Pipeline by Upsher-Smith Laboratories, Inc., H1 2015 50

Assessment by Monotherapy Products, H1 2015 51

Assessment by Combination Products, H1 2015 52

Number of Products by Stage and Target, H1 2015 54

Number of Products by Stage and Mechanism of Action, H1 2015 56

Number of Products by Stage and Route of Administration, H1 2015 58

Number of Products by Stage and Molecule Type, H1 2015 60

Dyskinesia Therapeutics-Recent Pipeline Updates, H1 2015 109

Dyskinesia-Dormant Projects, H1 2015 136

Dyskinesia-Dormant Projects (Contd..1), H1 2015 137

Dyskinesia-Discontinued Products, H1 2015 138

List of Figures

Number of Products under Development for Dyskinesia, H1 2015 11

Number of Products under Development for Dyskinesia-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 13

Comparative Analysis by Clinical Stage Development, H1 2015 18

Comparative Analysis by Early Stage Products, H1 2015 19

Assessment by Monotherapy Products, H1 2015 51

Number of Products by Top 10 Targets, H1 2015 53

Number of Products by Stage and Top 10 Targets, H1 2015 53

Number of Products by Top 10 Mechanism of Actions, H1 2015 55

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 55

Number of Products by Top 10 Routes of Administration, H1 2015 57

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 58

Number of Products by Top 10 Molecule Types, H1 2015 59

Number of Products by Stage and Top 10 Molecule Types, H1 2015 60

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Adamas Pharmaceuticals, Inc.

Addex Therapeutics Ltd

Advicenne Pharma

Amarantus Bioscience Holdings, Inc.

Astraea Therapeutics, LLC

Auspex Pharmaceuticals, Inc.

BioMarin Pharmaceutical Inc.

Catalyst Pharmaceutical Partners, Inc.

Contera Pharma ApS

EpiVax, Inc.

Heptares Therapeutics Ltd.

Integrative Research Laboratories Sweden AB

Ipsen S.A.

Medicure Inc.

Medy-Tox Inc.

Merz Pharmaceuticals GmbH

Neurim Pharmaceuticals Ltd

Neurocrine Biosciences, Inc.

Neurolixis Inc.

Novartis AG

Osmotica Pharmaceutical Corp.

Otsuka Holdings Co., Ltd.

Santhera Pharmaceuticals Holding AG

SciFluor Life Sciences, LLC

Synchroneuron Inc.

Targacept, Inc.

Upsher-Smith Laboratories, Inc.

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


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