Status Epilepticus – Pipeline Review, H2 2016

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

The report provides comprehensive information on the therapeutics under development for Status Epilepticus, 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 Status Epilepticus 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 Status Epilepticus

The report reviews pipeline therapeutics for Status Epilepticus 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 Status Epilepticus therapeutics and enlists all their major and minor projects

The report assesses Status Epilepticus 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 Status Epilepticus

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 Status Epilepticus

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 Status Epilepticus 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

Marinus Pharmaceuticals, Inc.

Sage Therapeutics, Inc.

Shire Plc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Status Epilepticus Overview 7

Therapeutics Development 8

Pipeline Products for Status Epilepticus - Overview 8

Pipeline Products for Status Epilepticus - Comparative Analysis 9

Status Epilepticus - Therapeutics under Development by Companies 10

Status Epilepticus - Therapeutics under Investigation by Universities/Institutes 11

Status Epilepticus - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Status Epilepticus - Products under Development by Companies 15

Status Epilepticus - Products under Investigation by Universities/Institutes 16

Status Epilepticus - Companies Involved in Therapeutics Development 17

Marinus Pharmaceuticals, Inc. 17

Sage Therapeutics, Inc. 18

Shire Plc 19

Status Epilepticus - 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 27

Drug Profiles 29

AMPX-0079 - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

fosphenytoin sodium - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

ganaxolone - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

LSPGR-1 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

midazolam hydrochloride - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

SAGE-217 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

SAGE-689 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

sepranolone - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

Small Molecule to Inhibit GABA Transaminase for Migraine and Status Epilepticus - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

TG-4155 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

Status Epilepticus - Dormant Projects 50

Status Epilepticus - Product Development Milestones 51

Featured News & Press Releases 51

Jun 22, 2016: Marinus Pharmaceuticals Doses First Subject in Phase 1 Clinical Trial for Ganaxolone IV 51

Jun 13, 2016: Marinus Pharmaceuticals Announces Top-Line Results from Phase 3 Trial in Adult Focal Onset Seizures 51

Apr 19, 2016: Marinus Pharmaceuticals Ganaxolone IV Demonstrates Robust Efficacy in Benzodiazepine-Resistant Model of Status Epilepticus 52

Apr 17, 2016: Sage Therapeutics Expands Scientific, Clinical and Burden of Illness Data for SAGE-547 in SRSE and Essential Tremor at the 2016 American Academy of Neurology Annual Meeting 53

Apr 15, 2016: Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone IV to Treat Status Epilepticus 55

Apr 12, 2016: Marinus Pharmaceuticals to Present Ganaxolone IV Data at American Academy of Neurology Annual Meeting 55

Mar 03, 2016: Sage Therapeutics to Present SAGE-547 Clinical Data and SRSE Health Economic Data in Five Abstracts at the American Academy of Neurology 2016 Annual Meeting 56

Dec 15, 2015: SAGE Updates Guidance for Top-Line Results of Phase 3 STATUS Trial of SAGE-547 56

Dec 02, 2015: SAGE to Present Poster Presentations on SAGE-547 at the American Epilepsy Society 69th Annual Meeting 57

Aug 17, 2015: SAGE Announces First Patient Treated in Phase 3 STATUS Trial of SAGE-547 in Super-Refractory Status Epilepticus 58

Aug 06, 2015: SAGE Receives Special Protocol Assessment for Phase 3 STATUS Trial of SAGE-547 in Super-Refractory Status Epilepticus 58

Jun 09, 2015: SAGE Therapeutics Announces Positive Top-Line Data in Exploratory Trial of SAGE-547 in Postpartum Depression 59

May 14, 2015: SAGE Therapeutics Achieves 77 Percent Response Rate in Completed Phase 1/2 Clinical Trial of SAGE-547 in Super-Refractory Status Epilepticus 60

Apr 22, 2015: Ligand Earns Milestone from SAGE Therapeutics for SAGE-547 62

Apr 20, 2015: SAGE Therapeutics Announces First Patient Treated Under Phase 3 Expanded Access Protocol to Evaluate SAGE-547 in Patients With Super-Refractory Status Epilepticus 63

Appendix 64

Methodology 64

Coverage 64

Secondary Research 64

Primary Research 64

Expert Panel Validation 64

Contact Us 64

Disclaimer 65

List of Tables

List of Tables

Number of Products under Development for Status Epilepticus, H2 2016 8

Number of Products under Development for Status Epilepticus – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Number of Products under Investigation by Universities/Institutes, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Development, H2 2016 14

Products under Development by Companies, H2 2016 15

Products under Investigation by Universities/Institutes, H2 2016 16

Status Epilepticus – Pipeline by Marinus Pharmaceuticals, Inc., H2 2016 17

Status Epilepticus – Pipeline by Sage Therapeutics, Inc., H2 2016 18

Status Epilepticus – Pipeline by Shire Plc, 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 26

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

Status Epilepticus – Dormant Projects, H2 2016 50

List of Figures

List of Figures

Number of Products under Development for Status Epilepticus, H2 2016 8

Number of Products under Development for Status Epilepticus – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 14

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 Mechanism of Actions, H2 2016 23

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

Number of Products by Routes of Administration, H2 2016 25

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

Number of Products by Molecule Types, H2 2016 27

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

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