Bipolar Disorder (Manic Depression) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Bipolar Disorder (Manic Depression) – Pipeline Review, H2 2016’, provides an overview of the Bipolar Disorder (Manic Depression) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Bipolar Disorder (Manic Depression), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Bipolar Disorder (Manic Depression) and features dormant 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, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

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

Scope

The report provides a snapshot of the global therapeutic landscape of Bipolar Disorder (Manic Depression)

The report reviews pipeline therapeutics for Bipolar Disorder (Manic Depression) by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Bipolar Disorder (Manic Depression) therapeutics and enlists all their major and minor projects

The report assesses Bipolar Disorder (Manic Depression) therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Bipolar Disorder (Manic Depression)

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Bipolar Disorder (Manic Depression)

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Bipolar Disorder (Manic Depression) 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

Companies mentioned

Aequus Pharmaceuticals Inc.

Amorsa Therapeutics Inc.

AstraZeneca Plc

Biogen Inc

Delpor, Inc.

Intas Pharmaceuticals Ltd.

Intra-Cellular Therapies, Inc.

Johnson & Johnson

KemPharm, Inc.

Mapi Pharma Ltd.

Navya Biologicals Pvt Ltd

Neurocrine Biosciences Inc

Omeros Corporation

Otsuka Holdings Co., Ltd.

Pfizer Inc.

Reviva Pharmaceuticals Inc.

SK Biopharmaceuticals Co., Ltd.

Sumitomo Dainippon Pharma Co Ltd

Zogenix, Inc.

Zysis Limited

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Bipolar Disorder (Manic Depression) Overview 10

Therapeutics Development 11

Pipeline Products for Bipolar Disorder (Manic Depression) - Overview 11

Pipeline Products for Bipolar Disorder (Manic Depression) - Comparative Analysis 12

Bipolar Disorder (Manic Depression) - Therapeutics under Development by Companies 13

Bipolar Disorder (Manic Depression) - Therapeutics under Investigation by Universities/Institutes 15

Bipolar Disorder (Manic Depression) - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Bipolar Disorder (Manic Depression) - Products under Development by Companies 19

Bipolar Disorder (Manic Depression) - Products under Investigation by Universities/Institutes 21

Bipolar Disorder (Manic Depression) - Companies Involved in Therapeutics Development 22

Aequus Pharmaceuticals Inc. 22

Amorsa Therapeutics Inc. 23

AstraZeneca Plc 24

Biogen Inc 25

Delpor, Inc. 26

Intas Pharmaceuticals Ltd. 27

Intra-Cellular Therapies, Inc. 28

Johnson & Johnson 29

KemPharm, Inc. 30

Mapi Pharma Ltd. 31

Navya Biologicals Pvt Ltd 32

Neurocrine Biosciences Inc 33

Omeros Corporation 34

Otsuka Holdings Co., Ltd. 35

Pfizer Inc. 36

Reviva Pharmaceuticals Inc. 37

SK Biopharmaceuticals Co., Ltd. 38

Sumitomo Dainippon Pharma Co Ltd 39

Zogenix, Inc. 40

Zysis Limited 41

Bipolar Disorder (Manic Depression) - Therapeutics Assessment 42

Assessment by Monotherapy Products 42

Assessment by Combination Products 43

Assessment by Target 44

Assessment by Mechanism of Action 46

Assessment by Route of Administration 48

Assessment by Molecule Type 50

Drug Profiles 52

(cycloserine + lurasidone hydrochloride) - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

aripiprazole - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

aripiprazole CR - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

aripiprazole ER - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

CB-1407 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

CB-2803 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Cenobamate - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

CNV-1061436 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

ebselen - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

Endoxifen - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

ITI-007 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

JNJ-18038683 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

KP-303 - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

lurasidone hydrochloride - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

NAV-003 - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

paliperidone palmitate - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

PGW-5 - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

quetiapine fumarate ER - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

risperidone - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

risperidone - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

risperidone - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

RP-5063 - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

SKL-PSY - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

Small Molecule for Bipolar Disorder - Drug Profile 95

Product Description 95

Mechanism Of Action 95

R&D Progress 95

Small Molecule for Cancer and Neurodegenerative Disease - Drug Profile 96

Product Description 96

Mechanism Of Action 96

R&D Progress 96

Small Molecule to Antagonize GPR78 for Bipolar Disorder and Schizophrenia - Drug Profile 97

Product Description 97

Mechanism Of Action 97

R&D Progress 97

Small Molecule to Inhibit VMAT-2 for Bipolar Disorder, Movement Disorders and Schizophrenia - Drug Profile 98

Product Description 98

Mechanism Of Action 98

R&D Progress 98

Small Molecule to Target GPR50 for Bipolar Disorder and Metabolic Disorders - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

Small Molecules to Antagonize NMDA Receptor and CHRNA7 for Central Nervous System - Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

Small Molecules to Target NMDA Receptor for Bipolar Depression - Drug Profile 101

Product Description 101

Mechanism Of Action 101

R&D Progress 101

Synthetic Peptides to Inhibit IMPase for Bipolar Disorder - Drug Profile 102

Product Description 102

Mechanism Of Action 102

R&D Progress 102

ziprasidone mesylate - Drug Profile 103

Product Description 103

Mechanism Of Action 103

R&D Progress 103

Bipolar Disorder (Manic Depression) - Dormant Projects 104

Bipolar Disorder (Manic Depression) - Discontinued Products 107

Bipolar Disorder (Manic Depression) - Product Development Milestones 108

Featured News & Press Releases 108

Oct 27, 2016: Sunovion Announces Positive Clinical Study Results for Latuda (lurasidone HCl) in Adolescents with Schizophrenia 108

Oct 18, 2016: NeuroRx Solidifies Intellectual Property Position Receives Notice of Allowance by US Patent Office 109

Sep 16, 2016: Sunovion to Present Data on Latuda (lurasidone) at the 29th European College of Neuropsychopharmacology (ECNP) Congress 110

Aug 09, 2016: Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan 111

Jun 01, 2016: NeuroRx Awarded First Prize in Annual Israel BIOMED Startup Competition 111

May 23, 2016: Sunovion Announces Publication of Data Evaluating the Long-Term Safety and Tolerability of Latuda (lurasidone HCl) in the Treatment of Bipolar Depression 112

May 12, 2016: Sunovion to Present Data on Latuda (lurasidone HCl) at the 169th Annual Meeting of the American Psychiatric Association 113

Feb 25, 2016: Intra-Cellular Therapies Provides Product Update 114

Feb 04, 2016: Aequus Announces Positive Results from Single-Dose Bioavailability Study of Aripiprazole Transdermal Patch 116

Dec 23, 2015: Intra-Cellular Therapies Reports Initiation of Patient Enrollment for ITI-007 Phase 3 Clinical Trials in Bipolar Depression 116

Dec 16, 2015: NeuroRx Provides Clinical Development Update for Cyclurad, a Novel Treatment for Acute Suicidal Crisis in Bipolar Disorder 117

Nov 16, 2015: Aequus Receives Approval from Health Canada to Initiate Phase 1 Clinical Trial of Aripiprazole Transdermal Patch 118

Jul 23, 2015: Positive Preclinical Results and Patent Allowed for Aequus' Once-Weekly Transdermal Aripiprazole 119

Jul 22, 2015: Intra-Cellular Therapies Announces Phase 3 Clinical Development Program for the Treatment of Depressive Episodes Associated With Bipolar Disorder 120

May 28, 2015: Aequus Announces Positive Skin Irritation Results for Once-Weekly Transdermal Aripiprazole 120

Appendix 121

Methodology 121

Coverage 121

Secondary Research 121

Primary Research 121

Expert Panel Validation 121

Contact Us 121

Disclaimer 122

List of Tables

List of Tables

Number of Products under Development for Bipolar Disorder (Manic Depression), H2 2016 11

Number of Products under Development for Bipolar Disorder (Manic Depression) – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Development by Companies, H2 2016 (Contd..1) 20

Products under Investigation by Universities/Institutes, H2 2016 21

Bipolar Disorder (Manic Depression) – Pipeline by Aequus Pharmaceuticals Inc., H2 2016 22

Bipolar Disorder (Manic Depression) – Pipeline by Amorsa Therapeutics Inc., H2 2016 23

Bipolar Disorder (Manic Depression) – Pipeline by AstraZeneca Plc, H2 2016 24

Bipolar Disorder (Manic Depression) – Pipeline by Biogen Inc, H2 2016 25

Bipolar Disorder (Manic Depression) – Pipeline by Delpor, Inc., H2 2016 26

Bipolar Disorder (Manic Depression) – Pipeline by Intas Pharmaceuticals Ltd., H2 2016 27

Bipolar Disorder (Manic Depression) – Pipeline by Intra-Cellular Therapies, Inc., H2 2016 28

Bipolar Disorder (Manic Depression) – Pipeline by Johnson & Johnson, H2 2016 29

Bipolar Disorder (Manic Depression) – Pipeline by KemPharm, Inc., H2 2016 30

Bipolar Disorder (Manic Depression) – Pipeline by Mapi Pharma Ltd., H2 2016 31

Bipolar Disorder (Manic Depression) – Pipeline by Navya Biologicals Pvt Ltd, H2 2016 32

Bipolar Disorder (Manic Depression) – Pipeline by Neurocrine Biosciences Inc, H2 2016 33

Bipolar Disorder (Manic Depression) – Pipeline by Omeros Corporation, H2 2016 34

Bipolar Disorder (Manic Depression) – Pipeline by Otsuka Holdings Co., Ltd., H2 2016 35

Bipolar Disorder (Manic Depression) – Pipeline by Pfizer Inc., H2 2016 36

Bipolar Disorder (Manic Depression) – Pipeline by Reviva Pharmaceuticals Inc., H2 2016 37

Bipolar Disorder (Manic Depression) – Pipeline by SK Biopharmaceuticals Co., Ltd., H2 2016 38

Bipolar Disorder (Manic Depression) – Pipeline by Sumitomo Dainippon Pharma Co Ltd, H2 2016 39

Bipolar Disorder (Manic Depression) – Pipeline by Zogenix, Inc., H2 2016 40

Bipolar Disorder (Manic Depression) – Pipeline by Zysis Limited, H2 2016 41

Assessment by Monotherapy Products, H2 2016 42

Assessment by Combination Products, H2 2016 43

Number of Products by Stage and Target, H2 2016 45

Number of Products by Stage and Mechanism of Action, H2 2016 47

Number of Products by Stage and Route of Administration, H2 2016 49

Number of Products by Stage and Molecule Type, H2 2016 51

Bipolar Disorder (Manic Depression) – Dormant Projects, H2 2016 104

Bipolar Disorder (Manic Depression) – Dormant Projects (Contd..1), H2 2016 105

Bipolar Disorder (Manic Depression) – Dormant Projects (Contd..2), H2 2016 106

Bipolar Disorder (Manic Depression) – Discontinued Products, H2 2016 107

List of Figures

List of Figures

Number of Products under Development for Bipolar Disorder (Manic Depression), H2 2016 11

Number of Products under Development for Bipolar Disorder (Manic Depression) – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 42

Number of Products by Top 10 Targets, H2 2016 44

Number of Products by Stage and Top 10 Targets, H2 2016 44

Number of Products by Top 10 Mechanism of Actions, H2 2016 46

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 46

Number of Products by Routes of Administration, H2 2016 48

Number of Products by Stage and Routes of Administration, H2 2016 48

Number of Products by Molecule Types, H2 2016 50

Number of Products by Stage and Molecule Types, H2 2016 50

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