Binge Eating Disorder – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Binge Eating Disorder – Pipeline Review, H2 2016’, provides an overview of the Binge Eating Disorder pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Binge Eating Disorder, 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 Binge Eating Disorder 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 Binge Eating Disorder

The report reviews pipeline therapeutics for Binge Eating Disorder 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 Binge Eating Disorder therapeutics and enlists all their major and minor projects

The report assesses Binge Eating Disorder 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 Binge Eating Disorder

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 Binge Eating Disorder

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 Binge Eating Disorder 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

Chronos Therapeutics Limited

F. Hoffmann-La Roche Ltd.

Heptares Therapeutics Limited

Highland Therapeutics, Inc.

Omeros Corporation

Opiant Pharmaceuticals, Inc.

Shire Plc

Sunovion Pharmaceuticals Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Binge Eating Disorder Overview 6

Therapeutics Development 7

Pipeline Products for Binge Eating Disorder - Overview 7

Binge Eating Disorder - Therapeutics under Development by Companies 8

Binge Eating Disorder - Pipeline Products Glance 9

Late Stage Products 9

Clinical Stage Products 10

Early Stage Products 11

Binge Eating Disorder - Products under Development by Companies 12

Binge Eating Disorder - Companies Involved in Therapeutics Development 13

Chronos Therapeutics Limited 13

F. Hoffmann-La Roche Ltd. 14

Heptares Therapeutics Limited 15

Highland Therapeutics, Inc. 16

Omeros Corporation 17

Opiant Pharmaceuticals, Inc. 18

Shire Plc 19

Sunovion Pharmaceuticals Inc. 20

Binge Eating Disorder - Therapeutics Assessment 21

Assessment by Monotherapy Products 21

Assessment by Target 22

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 28

Drug Profiles 29

CTDP-002 - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

dasotraline hydrochloride - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

dextroamphetamine - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

lisdexamfetamine dimesylate - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

naloxone hydrochloride - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

OMS-527 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

RO-5256390 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

Small Molecule to Antagonize Orexin 1 for Central Nervous System Disorders - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Binge Eating Disorder - Dormant Projects 45

Binge Eating Disorder - Discontinued Products 46

Binge Eating Disorder - Product Development Milestones 47

Featured News & Press Releases 47

Oct 17, 2016: Shire Announces Update to Vyvanse (lisdexamfetamine dimesylate) U.S. Labeling to Include New Longer-Term Maintenance of Efficacy Data in Adults with Moderate to Severe Binge Eating Disorder 47

Oct 06, 2016: Study Finds New Approach to Block Binge Eating 48

Apr 14, 2016: Shire Submits NDA to FDA for New Formulation of Vyvanse (lisdexamfetamine dimesylate) CII as Chewable Tablets 48

Jan 25, 2016: Sunovion Announces Results from a Study Evaluating the Abuse Potential of Investigational Drug Dasotraline 49

Jul 22, 2015: Vyvanse (lisdexamfetamine dimesylate) Positive Top-Line Results in Maintenance of Efficacy Study in Adults with Moderate to Severe Binge Eating Disorder 50

Jun 13, 2015: PTAB Invalidates Lucerne Biosciences' '813 Patent for the Treatment of Binge Eating Disorder with Lisdexamfetamine Dimesylate 52

May 11, 2015: Shire to Present New Research at American Psychiatric Association Annual Meeting 52

Jan 30, 2015: Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder 53

Sep 15, 2014: Shire Announces FDA Acceptance for Filing with Priority Review of Supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for Adults with Binge Eating Disorder 54

Nov 05, 2013: Positive Top-line Results Shown for Vyvanse Capsules in Adults with Binge Eating Disorder 54

May 17, 2013: Shire To Present Scientific Data On Vyvanse At 166th APA Annual Meeting 2013 55

Appendix 57

Methodology 57

Coverage 57

Secondary Research 57

Primary Research 57

Expert Panel Validation 57

Contact Us 57

Disclaimer 58

List of Tables

List of Tables

Number of Products under Development for Binge Eating Disorder, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Development, H2 2016 11

Products under Development by Companies, H2 2016 12

Binge Eating Disorder – Pipeline by Chronos Therapeutics Limited, H2 2016 13

Binge Eating Disorder – Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 14

Binge Eating Disorder – Pipeline by Heptares Therapeutics Limited, H2 2016 15

Binge Eating Disorder – Pipeline by Highland Therapeutics, Inc., H2 2016 16

Binge Eating Disorder – Pipeline by Omeros Corporation, H2 2016 17

Binge Eating Disorder – Pipeline by Opiant Pharmaceuticals, Inc., H2 2016 18

Binge Eating Disorder – Pipeline by Shire Plc, H2 2016 19

Binge Eating Disorder – Pipeline by Sunovion Pharmaceuticals Inc., H2 2016 20

Assessment by Monotherapy Products, H2 2016 21

Number of Products by Stage and Target, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 25

Number of Products by Stage and Route of Administration, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 28

Binge Eating Disorder – Dormant Projects, H2 2016 45

Binge Eating Disorder – Discontinued Products, H2 2016 46

List of Figures

List of Figures

Number of Products under Development for Binge Eating Disorder, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Assessment by Monotherapy Products, H2 2016 21

Number of Products by Targets, H2 2016 22

Number of Products by Stage and Targets, H2 2016 22

Number of Products by Mechanism of Actions, H2 2016 24

Number of Products by Stage and Mechanism of Actions, H2 2016 24

Number of Products by Routes of Administration, H2 2016 26

Number of Products by Stage and Routes of Administration, H2 2016 26

Number of Products by Stage and Molecule Types, H2 2016 28

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