Lennox-Gastaut Syndrome – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Lennox-Gastaut Syndrome – Pipeline Review, H2 2016’, provides an overview of the Lennox-Gastaut Syndrome pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Lennox-Gastaut 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 Lennox-Gastaut 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 Lennox-Gastaut Syndrome

The report reviews pipeline therapeutics for Lennox-Gastaut 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 Lennox-Gastaut Syndrome therapeutics and enlists all their major and minor projects

The report assesses Lennox-Gastaut 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 Lennox-Gastaut 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 Lennox-Gastaut 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 Lennox-Gastaut 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

Eisai Co Ltd

GW Pharmaceuticals Plc

INSYS Therapeutics Inc

Zogenix 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

Lennox-Gastaut Syndrome Overview 6

Therapeutics Development 7

Pipeline Products for Lennox-Gastaut Syndrome - Overview 7

Pipeline Products for Lennox-Gastaut Syndrome - Comparative Analysis 8

Lennox-Gastaut Syndrome - Therapeutics under Development by Companies 9

Lennox-Gastaut Syndrome - Therapeutics under Investigation by Universities/Institutes 10

Lennox-Gastaut Syndrome - Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Lennox-Gastaut Syndrome - Products under Development by Companies 14

Lennox-Gastaut Syndrome - Products under Investigation by Universities/Institutes 15

Lennox-Gastaut Syndrome - Companies Involved in Therapeutics Development 16

Eisai Co Ltd 16

GW Pharmaceuticals Plc 17

INSYS Therapeutics Inc 18

Zogenix Inc 19

Lennox-Gastaut Syndrome - Therapeutics Assessment 20

Assessment by Monotherapy Products 20

Assessment by Target 21

Assessment by Mechanism of Action 23

Assessment by Route of Administration 25

Assessment by Molecule Type 26

Drug Profiles 28

cannabidiol - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

cannabidiol - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

fenfluramine hydrochloride - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

NRP-2945 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

perampanel - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

Small Molecules to Inhibit Voltage Gated Sodium Channels for Lennox Gastaut Syndrome - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Lennox-Gastaut Syndrome - Product Development Milestones 51

Featured News & Press Releases 51

Nov 22, 2016: New Data on Zogenixs ZX008 for Lennox Gastaut Syndrome & Dravet Syndrome to be Presented at 70th Annual American Epilepsy Society Meeting 51

Oct 28, 2016: Eisai To Initiate Two Phase III Clinical Studies For Antiepileptic Drug Perampanel (Fycompa) in Pediatric Patients With Partial-Onset or Primary Generalized Tonic-Clonic Seizures And In Patients With Seizures Associated With Lennox-Gastaut Syndrome 52

Sep 26, 2016: GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome 54

Jun 27, 2016: GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome 56

Feb 25, 2016: Edison Issues ADR Update on GW Pharmaceuticals 58

Dec 07, 2015: GW Pharmaceuticals Announces New Physician Reports of Epidiolex Treatment Effect in Children and Young Adults With Treatment-Resistant Epilepsy 58

Jun 11, 2015: GW Pharmaceuticals Initiates Second Phase 3 Pivotal Study of Epidiolex in Lennox-Gastaut Syndrome 61

May 11, 2015: GW Pharmaceuticals Initiates Phase 3 Pivotal Study of Epidiolex (CBD) in Lennox-Gastaut Syndrome 62

Apr 23, 2015: Insys Therapeutics Commences Dosing in Phase 1/2 Safety and Pharmacokinetic Study of Cannabidiol Oral Solution in Pediatric Epilepsy Patients 63

Jan 12, 2015: Insys Therapeutics To Initiate Phase III study For An Epileptic Drug 63

Jun 25, 2014: Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Rare Form of Epilepsy, Lennox-Gastaut Syndrome 64

May 07, 2014: GW Pharmaceuticals Receives Investigational New Drug From FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome 64

Feb 28, 2014: GW Pharmaceuticals Receives Orphan Drug Designation by FDA for Epidiolex in the Treatment of Lennox-Gastaut Syndrome 65

Sep 25, 2006: FDA Approves New Epilepsy Indication For Lamictal 66

Jan 15, 2004: New Expanded Indication For Lamictal Offers Additional Treatment Options For Adults With Partial Seizures 66

Appendix 67

Methodology 67

Coverage 67

Secondary Research 67

Primary Research 67

Expert Panel Validation 67

Contact Us 67

Disclaimer 68

List of Tables

List of Tables

Number of Products under Development for Lennox-Gastaut Syndrome, H2 2016 7

Number of Products under Development for Lennox-Gastaut Syndrome – Comparative Analysis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Number of Products under Investigation by Universities/Institutes, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Development, H2 2016 13

Products under Development by Companies, H2 2016 14

Products under Investigation by Universities/Institutes, H2 2016 15

Lennox-Gastaut Syndrome – Pipeline by Eisai Co Ltd, H2 2016 16

Lennox-Gastaut Syndrome – Pipeline by GW Pharmaceuticals Plc, H2 2016 17

Lennox-Gastaut Syndrome – Pipeline by INSYS Therapeutics Inc, H2 2016 18

Lennox-Gastaut Syndrome – Pipeline by Zogenix Inc, H2 2016 19

Assessment by Monotherapy Products, H2 2016 20

Number of Products by Stage and Target, H2 2016 22

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

Number of Products by Stage and Route of Administration, H2 2016 25

Number of Products by Stage and Molecule Type, H2 2016 27

List of Figures

List of Figures

Number of Products under Development for Lennox-Gastaut Syndrome, H2 2016 7

Number of Products under Development for Lennox-Gastaut Syndrome – Comparative Analysis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Early Stage Products, H2 2016 13

Assessment by Monotherapy Products, H2 2016 20

Number of Products by Targets, H2 2016 21

Number of Products by Stage and Targets, H2 2016 21

Number of Products by Top 10 Mechanism of Actions, H2 2016 23

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 23

Number of Products by Stage and Routes of Administration, H2 2016 25

Number of Products by Molecule Types, H2 2016 26

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

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