Infantile Spasm (West Syndrome) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Infantile Spasm (West Syndrome) – Pipeline Review, H2 2016’, provides an overview of the Infantile Spasm (West Syndrome) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Infantile Spasm (West Syndrome), 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 Infantile Spasm (West Syndrome) 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 Infantile Spasm (West Syndrome)

The report reviews pipeline therapeutics for Infantile Spasm (West Syndrome) 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 Infantile Spasm (West Syndrome) therapeutics and enlists all their major and minor projects

The report assesses Infantile Spasm (West Syndrome) 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 Infantile Spasm (West Syndrome)

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 Infantile Spasm (West Syndrome)

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 Infantile Spasm (West Syndrome) 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

Anavex Life Sciences Corp

Catalyst Pharmaceuticals Inc

GW Pharmaceuticals Plc

INSYS Therapeutics Inc

Novartis AG

Retrophin 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

Infantile Spasm (West Syndrome) Overview 6

Therapeutics Development 7

Pipeline Products for Infantile Spasm (West Syndrome) - Overview 7

Infantile Spasm (West Syndrome) - Therapeutics under Development by Companies 8

Infantile Spasm (West Syndrome) - Pipeline Products Glance 9

Clinical Stage Products 9

Early Stage Products 10

Infantile Spasm (West Syndrome) - Products under Development by Companies 11

Infantile Spasm (West Syndrome) - Companies Involved in Therapeutics Development 12

Anavex Life Sciences Corp 12

Catalyst Pharmaceuticals Inc 13

GW Pharmaceuticals Plc 14

INSYS Therapeutics Inc 15

Novartis AG 16

Retrophin Inc 17

Infantile Spasm (West Syndrome) - Therapeutics Assessment 18

Assessment by Monotherapy Products 18

Assessment by Target 19

Assessment by Mechanism of Action 21

Assessment by Route of Administration 23

Assessment by Molecule Type 25

Drug Profiles 27

ANAVEX-273 - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

AVL-5189 - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

cannabidiol - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

cannabidiol - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

cosyntropin - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

cosyntropin ER - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

CPP-115 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

JBPOS-0101 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

Infantile Spasm (West Syndrome) - Dormant Projects 52

Infantile Spasm (West Syndrome) - Product Development Milestones 53

Featured News & Press Releases 53

Sep 19, 2016: Catalyst Pharmaceuticals Announces Publication of CPP-115 Clinical Efficacy Data for Infantile Spasms in Epilepsy & Behavior Case Reports 53

Jun 22, 2016: Anavex Announces U.S. FDA Orphan Drug Designation for ANAVEX 2-73 for Treatment of Infantile Spasms 53

Jun 21, 2016: GW Pharmaceuticals Announces New Planned Epidiolex (Cannabidiol or CBD) Development Program in Infantile Spasms (IS) 54

May 18, 2016: Anavex Announces Positive Preclinical Data for ANAVEX 2-73 in Infantile Spasms 54

Feb 09, 2016: Insys Therapeutics Enrolls First Patient in Phase II Study for the Treatment of Infantile Spasms Using Pharmaceutical CBD 55

Dec 16, 2015: Catalyst Pharmaceuticals Announces Top-Line Results in Phase 1(b) Trial of CPP-115 55

Aug 04, 2015: Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol for the Treatment of Infantile Spasms 56

Nov 24, 2014: Catalyst Pharmaceuticals Announces Notice of Allowance of U.S. Patent Application for the Reduction or Elimination of Visual Field Defects by Treating Patients With CPP-115 56

Sep 02, 2014: Catalyst Pharmaceutical Partners Initiates Phase 1(b) Safety and Tolerance Study for CPP-115 57

Nov 18, 2013: Catalyst Pharmaceutical Partners Announces Publication of Preclinical Proof-of-Principle of CPP-115 Efficacy in Suppressing Infantile Spasms in Epilepsia 58

Feb 13, 2012: Catalyst Receives Orphan Medicinal Product Designation In EU For CPP-115 To Treat West Syndrome 58

Jan 31, 2012: Catalyst Pharmaceutical Partners To Present CPP-115 Progress At 2012 Epilepsy Pipeline Update Conference 59

Dec 15, 2011: Catalyst Announces Scientific Paper Regarding CPP-115 For Treatment Of Cocaine Addiction Accepted For Publication In Journal Of Medicinal Chemistry 60

Dec 13, 2011: Catalyst Starts Phase Ia Safety Study For CPP-115 60

Dec 02, 2011: Catalyst To Present Data On CPP-115 At American Epilepsy Society's 65th Annual Meeting 61

Appendix 62

Methodology 62

Coverage 62

Secondary Research 62

Primary Research 62

Expert Panel Validation 62

Contact Us 62

Disclaimer 63

List of Tables

List of Tables

Number of Products under Development for Infantile Spasm (West Syndrome), H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Clinical Stage Development, H2 2016 9

Comparative Analysis by Early Stage Development, H2 2016 10

Products under Development by Companies, H2 2016 11

Infantile Spasm (West Syndrome) – Pipeline by Anavex Life Sciences Corp, H2 2016 12

Infantile Spasm (West Syndrome) – Pipeline by Catalyst Pharmaceuticals Inc, H2 2016 13

Infantile Spasm (West Syndrome) – Pipeline by GW Pharmaceuticals Plc, H2 2016 14

Infantile Spasm (West Syndrome) – Pipeline by INSYS Therapeutics Inc, H2 2016 15

Infantile Spasm (West Syndrome) – Pipeline by Novartis AG, H2 2016 16

Infantile Spasm (West Syndrome) – Pipeline by Retrophin Inc, H2 2016 17

Assessment by Monotherapy Products, H2 2016 18

Number of Products by Stage and Target, H2 2016 20

Number of Products by Stage and Mechanism of Action, H2 2016 22

Number of Products by Stage and Route of Administration, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 26

Infantile Spasm (West Syndrome) – Dormant Projects, H2 2016 52

List of Figures

List of Figures

Number of Products under Development for Infantile Spasm (West Syndrome), H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Clinical Stage Development, H2 2016 9

Assessment by Monotherapy Products, H2 2016 18

Number of Products by Top 10 Targets, H2 2016 19

Number of Products by Stage and Top 10 Targets, H2 2016 19

Number of Products by Top 10 Mechanism of Actions, H2 2016 21

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 21

Number of Products by Routes of Administration, H2 2016 23

Number of Products by Stage and Routes of Administration, H2 2016 23

Number of Products by Molecule Types, H2 2016 25

Number of Products by Stage and Molecule Types, H2 2016 25

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