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Bipolar Disorder (Manic Depression) - Pipeline Review, H1 2016

  • May 2016
  • -
  • Global Markets Direct
  • -
  • 126 pages

Bipolar Disorder (Manic Depression) - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Bipolar Disorder (Manic Depression) - Pipeline Review, H1 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

Table Of Contents

Bipolar Disorder (Manic Depression) - Pipeline Review, H1 2016
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
D-Pharm Ltd. 26
Delpor, Inc. 27
Intas Pharmaceuticals Ltd. 28
Intra-Cellular Therapies, Inc. 29
Johnson and Johnson 30
KemPharm, Inc. 31
Mapi Pharma Ltd. 32
Navya Biologicals Pvt Ltd 33
Neurocrine Biosciences, Inc. 34
Omeros Corporation 35
Otsuka Holdings Co., Ltd. 36
Pfizer Inc. 37
Reviva Pharmaceuticals Inc. 38
SK Biopharmaceuticals Co., Ltd. 39
Sumitomo Dainippon Pharma Co., Ltd. 40
Zogenix, Inc. 41
Zysis Limited 42
Bipolar Disorder (Manic Depression) - Therapeutics Assessment 43
Assessment by Monotherapy Products 43
Assessment by Combination Products 44
Assessment by Target 45
Assessment by Mechanism of Action 47
Assessment by Route of Administration 49
Assessment by Molecule Type 51
Drug Profiles 53
(cycloserine + lurasidone hydrochloride) - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
aripiprazole - Drug Profile 54
Product Description 54
Mechanism of Action 54
RandD Progress 54
aripiprazole CR - Drug Profile 55
Product Description 55
Mechanism of Action 55
RandD Progress 55
aripiprazole ER - Drug Profile 57
Product Description 57
Mechanism of Action 57
RandD Progress 57
CNV-1061436 - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
DP-VPA - Drug Profile 60
Product Description 60
Mechanism of Action 60
RandD Progress 60
Drug for Bipolar Disorder - Drug Profile 62
Product Description 62
Mechanism of Action 62
RandD Progress 62
ebselen - Drug Profile 63
Product Description 63
Mechanism of Action 63
RandD Progress 63
Endoxifen - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
ITI-007 - Drug Profile 66
Product Description 66
Mechanism of Action 66
RandD Progress 66
JNJ-18038683 - Drug Profile 69
Product Description 69
Mechanism of Action 69
RandD Progress 69
KP-303 - Drug Profile 71
Product Description 71
Mechanism of Action 71
RandD Progress 71
lurasidone hydrochloride - Drug Profile 72
Product Description 72
Mechanism of Action 72
RandD Progress 72
NAV-003 - Drug Profile 75
Product Description 75
Mechanism of Action 75
RandD Progress 75
paliperidone palmitate - Drug Profile 76
Product Description 76
Mechanism of Action 76
RandD Progress 76
PGW-5 - Drug Profile 77
Product Description 77
Mechanism of Action 77
RandD Progress 77
quetiapine fumarate ER - Drug Profile 78
Product Description 78
Mechanism of Action 78
RandD Progress 78
risperidone - Drug Profile 79
Product Description 79
Mechanism of Action 79
RandD Progress 79
risperidone - Drug Profile 80
Product Description 80
Mechanism of Action 80
RandD Progress 80
risperidone - Drug Profile 81
Product Description 81
Mechanism of Action 81
RandD Progress 81
RP-5063 - Drug Profile 82
Product Description 82
Mechanism of Action 82
RandD Progress 82
SKL-PSY - Drug Profile 83
Product Description 83
Mechanism of Action 83
RandD Progress 83
Small Molecule for Bipolar Disorder - Drug Profile 84
Product Description 84
Mechanism of Action 84
RandD Progress 84
Small Molecule for Cancer and Neurodegenerative Disease - Drug Profile 85
Product Description 85
Mechanism of Action 85
RandD Progress 85
Small Molecule to Antagonize GPR78 for Bipolar Disorder and Schizophrenia - Drug Profile 86
Product Description 86
Mechanism of Action 86
RandD Progress 86
Small Molecule to Inhibit VMAT-2 for Bipolar Disorder, Movement Disorders and Schizophrenia - Drug Profile 87
Product Description 87
Mechanism of Action 87
RandD Progress 87
Small Molecule to Target GPR50 for CNS and Metabolic Disorders - Drug Profile 88
Product Description 88
Mechanism of Action 88
RandD Progress 88
Small Molecules for Bipolar Depression - Drug Profile 89
Product Description 89
Mechanism of Action 89
RandD Progress 89
Small Molecules to Antagonize NMDA Receptor and CHRNA7 for Central Nervous System - Drug Profile 90
Product Description 90
Mechanism of Action 90
RandD Progress 90
Synthetic Peptides to Inhibit IMPase for Bipolar Disorder - Drug Profile 91
Product Description 91
Mechanism of Action 91
RandD Progress 91
YKP-3089 - Drug Profile 92
Product Description 92
Mechanism of Action 92
RandD Progress 92
ziprasidone mesylate - Drug Profile 94
Product Description 94
Mechanism of Action 94
RandD Progress 94
Bipolar Disorder (Manic Depression) - Recent Pipeline Updates 95
Bipolar Disorder (Manic Depression) - Dormant Projects 112
Bipolar Disorder (Manic Depression) - Discontinued Products 115
Bipolar Disorder (Manic Depression) - Product Development Milestones 116
Featured News and Press Releases 116
Apr 26, 2016: FDA Issues Complete Response Letter For Digital Medicine New Drug Application 116
Feb 25, 2016: Intra-Cellular Therapies Provides Product Update 116
Feb 04, 2016: Aequus Announces Positive Results from Single-Dose Bioavailability Study of Aripiprazole Transdermal Patch 118
Dec 23, 2015: Intra-Cellular Therapies Reports Initiation of Patient Enrollment for ITI-007 Phase 3 Clinical Trials in Bipolar Depression 118
Dec 16, 2015: NeuroRx Provides Clinical Development Update for Cyclurad, a Novel Treatment for Acute Suicidal Crisis in Bipolar Disorder 119
Nov 16, 2015: Aequus Receives Approval from Health Canada to Initiate Phase 1 Clinical Trial of Aripiprazole Transdermal Patch 121
Jul 23, 2015: Positive Preclinical Results and Patent Allowed for Aequus' Once-Weekly Transdermal Aripiprazole 121
Jul 22, 2015: Intra-Cellular Therapies Announces Phase 3 Clinical Development Program for the Treatment of Depressive Episodes Associated With Bipolar Disorder 122
May 28, 2015: Aequus Announces Positive Skin Irritation Results for Once-Weekly Transdermal Aripiprazole 122
Mar 30, 2015: Sunovion Pharmaceuticals Europe to Present New Data on LATUDA (lurasidone) at the 23rd European Congress of Psychiatry 123
Appendix 125
Methodology 125
Coverage 125
Secondary Research 125
Primary Research 125
Expert Panel Validation 125
Contact Us 125
Disclaimer 126

List of Tables
Number of Products under Development for Bipolar Disorder (Manic Depression), H1 2016 11
Number of Products under Development for Bipolar Disorder (Manic Depression) - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 14
Number of Products under Investigation by Universities/Institutes, H1 2016 15
Comparative Analysis by Late Stage Development, H1 2016 16
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Development, H1 2016 18
Products under Development by Companies, H1 2016 19
Products under Development by Companies, H1 2016 (Contd..1) 20
Products under Investigation by Universities/Institutes, H1 2016 21
Bipolar Disorder (Manic Depression) - Pipeline by Aequus Pharmaceuticals Inc., H1 2016 22
Bipolar Disorder (Manic Depression) - Pipeline by Amorsa Therapeutics Inc., H1 2016 23
Bipolar Disorder (Manic Depression) - Pipeline by AstraZeneca Plc, H1 2016 24
Bipolar Disorder (Manic Depression) - Pipeline by Biogen, Inc., H1 2016 25
Bipolar Disorder (Manic Depression) - Pipeline by D-Pharm Ltd., H1 2016 26
Bipolar Disorder (Manic Depression) - Pipeline by Delpor, Inc., H1 2016 27
Bipolar Disorder (Manic Depression) - Pipeline by Intas Pharmaceuticals Ltd., H1 2016 28
Bipolar Disorder (Manic Depression) - Pipeline by Intra-Cellular Therapies, Inc., H1 2016 29
Bipolar Disorder (Manic Depression) - Pipeline by Johnson and Johnson, H1 2016 30
Bipolar Disorder (Manic Depression) - Pipeline by KemPharm, Inc., H1 2016 31
Bipolar Disorder (Manic Depression) - Pipeline by Mapi Pharma Ltd., H1 2016 32
Bipolar Disorder (Manic Depression) - Pipeline by Navya Biologicals Pvt Ltd, H1 2016 33
Bipolar Disorder (Manic Depression) - Pipeline by Neurocrine Biosciences, Inc., H1 2016 34
Bipolar Disorder (Manic Depression) - Pipeline by Omeros Corporation, H1 2016 35
Bipolar Disorder (Manic Depression) - Pipeline by Otsuka Holdings Co., Ltd., H1 2016 36
Bipolar Disorder (Manic Depression) - Pipeline by Pfizer Inc., H1 2016 37
Bipolar Disorder (Manic Depression) - Pipeline by Reviva Pharmaceuticals Inc., H1 2016 38
Bipolar Disorder (Manic Depression) - Pipeline by SK Biopharmaceuticals Co., Ltd., H1 2016 39
Bipolar Disorder (Manic Depression) - Pipeline by Sumitomo Dainippon Pharma Co., Ltd., H1 2016 40
Bipolar Disorder (Manic Depression) - Pipeline by Zogenix, Inc., H1 2016 41
Bipolar Disorder (Manic Depression) - Pipeline by Zysis Limited, H1 2016 42
Assessment by Monotherapy Products, H1 2016 43
Assessment by Combination Products, H1 2016 44
Number of Products by Stage and Target, H1 2016 46
Number of Products by Stage and Mechanism of Action, H1 2016 48
Number of Products by Stage and Route of Administration, H1 2016 50
Number of Products by Stage and Molecule Type, H1 2016 52
Bipolar Disorder (Manic Depression) Therapeutics - Recent Pipeline Updates, H1 2016 95
Bipolar Disorder (Manic Depression) - Dormant Projects, H1 2016 112
Bipolar Disorder (Manic Depression) - Dormant Projects (Contd..1), H1 2016 113
Bipolar Disorder (Manic Depression) - Dormant Projects (Contd..2), H1 2016 114
Bipolar Disorder (Manic Depression) - Discontinued Products, H1 2016 115

List of Figures
Number of Products under Development for Bipolar Disorder (Manic Depression), H1 2016 11
Number of Products under Development for Bipolar Disorder (Manic Depression) - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 13
Number of Products under Investigation by Universities/Institutes, H1 2016 15
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Products, H1 2016 18
Assessment by Monotherapy Products, H1 2016 43
Number of Products by Top 10 Targets, H1 2016 45
Number of Products by Stage and Top 10 Targets, H1 2016 45
Number of Products by Top 10 Mechanism of Actions, H1 2016 47
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2016 47
Number of Products by Routes of Administration, H1 2016 49
Number of Products by Stage and Routes of Administration, H1 2016 49
Number of Products by Molecule Types, H1 2016 51
Number of Products by Stage and Top 10 Molecule Types, H1 2016 51

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