Neuromyelitis Optica (Devic's Syndrome) - Pipeline Review, H2 2016

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Date: 14-Sep-2016
No. of pages: 98
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Global Markets Direct's, ‘Neuromyelitis Optica (Devic's Syndrome) - Pipeline Review, H2 2016', provides an overview of the Neuromyelitis Optica (Devic's Syndrome) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's Syndrome)

  • The report reviews pipeline therapeutics for Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's Syndrome) therapeutics and enlists all their major and minor projects

  • The report assesses Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's 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 Neuromyelitis Optica (Devic's 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

Neuromyelitis Optica (Devic's Syndrome) - Pipeline Review, H2 2016

Table of Contents

Table of Contents 2
List of Tables 6
List of Figures 7
Introduction 8
Global Markets Direct Report Coverage 8
Neuromyelitis Optica (Devic's Syndrome) Overview 9
Therapeutics Development 10
Pipeline Products for Neuromyelitis Optica (Devic's Syndrome) - Overview 10
Pipeline Products for Neuromyelitis Optica (Devic's Syndrome) - Comparative Analysis 11
Neuromyelitis Optica (Devic's Syndrome) - Therapeutics under Development by Companies 12
Neuromyelitis Optica (Devic's Syndrome) - Therapeutics under Investigation by Universities/Institutes 14
Neuromyelitis Optica (Devic's Syndrome) - Pipeline Products Glance 15
Late Stage Products 15
Clinical Stage Products 16
Early Stage Products 17
Neuromyelitis Optica (Devic's Syndrome) - Products under Development by Companies 18
Neuromyelitis Optica (Devic's Syndrome) - Products under Investigation by Universities/Institutes 19
Neuromyelitis Optica (Devic's Syndrome) - Companies Involved in Therapeutics Development 20
Acorda Therapeutics, Inc. 20
Alexion Pharmaceuticals Inc 21
Biogen Inc 22
Bionure Farma, S.L. 23
Chugai Pharmaceutical Co., Ltd. 24
Clene Nanomedicine, Inc. 25
HanAll Biopharma Co., Ltd. 26
Karus Therapeutics Limited 27
LFB S.A. 28
Marathon Pharmaceuticals, LLC 29
MedImmune, LLC 30
Opexa Therapeutics, Inc. 31
Shire Plc 32
Takeda Pharmaceutical Company Limited 33
Neuromyelitis Optica (Devic's Syndrome) - Therapeutics Assessment 34
Assessment by Monotherapy Products 34
Assessment by Target 35
Assessment by Mechanism of Action 37
Assessment by Route of Administration 39
Assessment by Molecule Type 41
Drug Profiles 43
ANV-201 - Drug Profile 43
Product Description 43
Mechanism Of Action 43
R&D Progress 43
BN-201 - Drug Profile 44
Product Description 44
Mechanism Of Action 44
R&D Progress 44
C1 esterase inhibitor (human) - Drug Profile 46
Product Description 46
Mechanism Of Action 46
R&D Progress 46
Cellular Immunotherapy for Central Nervous System Disorders - Drug Profile 51
Product Description 51
Mechanism Of Action 51
R&D Progress 51
cladribine - Drug Profile 52
Product Description 52
Mechanism Of Action 52
R&D Progress 52
CNMAU-8 - Drug Profile 53
Product Description 53
Mechanism Of Action 53
R&D Progress 53
D-15107 - Drug Profile 54
Product Description 54
Mechanism Of Action 54
R&D Progress 54
dalfampridine ER - Drug Profile 55
Product Description 55
Mechanism Of Action 55
R&D Progress 55
eculizumab - Drug Profile 58
Product Description 58
Mechanism Of Action 58
R&D Progress 58
HL-161 - Drug Profile 67
Product Description 67
Mechanism Of Action 67
R&D Progress 67
immune globulin (human) - Drug Profile 68
Product Description 68
Mechanism Of Action 68
R&D Progress 68
inebilizumab - Drug Profile 69
Product Description 69
Mechanism Of Action 69
R&D Progress 69
KA-1463 - Drug Profile 71
Product Description 71
Mechanism Of Action 71
R&D Progress 71
OPX-212 - Drug Profile 72
Product Description 72
Mechanism Of Action 72
R&D Progress 72
Recombinant Enzyme to Inhibit IgG for Neuromyelitis Optica - Drug Profile 73
Product Description 73
Mechanism Of Action 73
R&D Progress 73
rituximab - Drug Profile 74
Product Description 74
Mechanism Of Action 74
R&D Progress 74
SA-237 - Drug Profile 79
Product Description 79
Mechanism Of Action 79
R&D Progress 79
Small Molecule for Neuromyelitis Optica - Drug Profile 80
Product Description 80
Mechanism Of Action 80
R&D Progress 80
ublituximab - Drug Profile 81
Product Description 81
Mechanism Of Action 81
R&D Progress 81
Neuromyelitis Optica (Devic's Syndrome) - Dormant Projects 88
Neuromyelitis Optica (Devic's Syndrome) - Product Development Milestones 89
Featured News & Press Releases 89
Aug 26, 2016: TG Therapeutics Announces Orphan Drug Designation for TG-1101 for the Treatment of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder 89
Nov 24, 2015: MS Trial Alert: Investigators Recruiting People with Relapsing NMOSD for Study of an Investigational Medicine (Eculizumab) 89
Nov 10, 2015: Opexa Therapeutics Announces Supportive Preclinical Study Results for its Neuromyelitis Optica Program 90
Sep 29, 2015: FDA Approval To Commence Phase I Single Ascending Dose Protocol 91
May 08, 2015: Initiation Of Phase I Clinical Program 91
Apr 20, 2015: Opexa Therapeutics Invited to Present Biomarker Data from NMO Patients at The American Academy of Neurology 2015 Annual Meeting 91
Apr 15, 2015: Clene Receives IMPD Approval; Phase I Clinical Program Planned 92
Nov 25, 2014: Soliris (eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Neuromyelitis Optica 92
Sep 08, 2014: Opexa Therapeutics to Target Rare Disease Neuromyelitis Optica as next Development Program 92
Aug 27, 2014: Clene Files Investigational New Drug Application With FDA 93
Apr 24, 2014: Alexion Initiates Multinational Registration Trials of Eculizumab as a Potential Treatment for Patients with Relapsing Neuromyelitis Optica and Refractory Generalized Myasthenia Gravis 93
Apr 01, 2014: Clene Nanomedicine Requests Pre-IND Meeting With FDA 94
Dec 16, 2013: Soliris Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles 95
Dec 13, 2013: Alexion Provides Update on Previously Communicated November 2013 Voluntary Nationwide Recall of Two Lots of Soliris Concentrated Solution for Intravenous Infusion 95
Jul 16, 2013: Alexion's Soliris Receives Positive Opinion from the Committee for Orphan Medicinal Products for Treatment of Neuromyelitis Optica 96
Appendix 97
Methodology 97
Coverage 97
Secondary Research 97
Primary Research 97
Expert Panel Validation 97
Contact Us 97
Disclaimer 98

List of Tables

Number of Products under Development for Neuromyelitis Optica (Devic's Syndrome), H2 2016 10
Number of Products under Development for Neuromyelitis Optica (Devic's Syndrome) - Comparative Analysis, H2 2016 11
Number of Products under Development by Companies, H2 2016 13
Number of Products under Investigation by Universities/Institutes, H2 2016 14
Comparative Analysis by Late Stage Development, H2 2016 15
Comparative Analysis by Clinical Stage Development, H2 2016 16
Comparative Analysis by Early Stage Development, H2 2016 17
Products under Development by Companies, H2 2016 18
Products under Investigation by Universities/Institutes, H2 2016 19
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Acorda Therapeutics, Inc., H2 2016 20
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Alexion Pharmaceuticals Inc, H2 2016 21
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Biogen Inc, H2 2016 22
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Bionure Farma, S.L., H2 2016 23
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Chugai Pharmaceutical Co., Ltd., H2 2016 24
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Clene Nanomedicine, Inc., H2 2016 25
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by HanAll Biopharma Co., Ltd., H2 2016 26
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Karus Therapeutics Limited, H2 2016 27
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by LFB S.A., H2 2016 28
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Marathon Pharmaceuticals, LLC, H2 2016 29
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by MedImmune, LLC, H2 2016 30
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Opexa Therapeutics, Inc., H2 2016 31
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Shire Plc, H2 2016 32
Neuromyelitis Optica (Devic's Syndrome) - Pipeline by Takeda Pharmaceutical Company Limited, H2 2016 33
Assessment by Monotherapy Products, H2 2016 34
Number of Products by Stage and Target, H2 2016 36
Number of Products by Stage and Mechanism of Action, H2 2016 38
Number of Products by Stage and Route of Administration, H2 2016 40
Number of Products by Stage and Molecule Type, H2 2016 42
Neuromyelitis Optica (Devic's Syndrome) - Dormant Projects, H2 2016 88

List of Figures

Number of Products under Development for Neuromyelitis Optica (Devic's Syndrome), H2 2016 10
Number of Products under Development for Neuromyelitis Optica (Devic's Syndrome) - Comparative Analysis, H2 2016 11
Number of Products under Development by Companies, H2 2016 12
Number of Products under Investigation by Universities/Institutes, H2 2016 14
Comparative Analysis by Clinical Stage Development, H2 2016 16
Comparative Analysis by Early Stage Products, H2 2016 17
Assessment by Monotherapy Products, H2 2016 34
Number of Products by Top 10 Targets, H2 2016 35
Number of Products by Stage and Top 10 Targets, H2 2016 35
Number of Products by Top 10 Mechanism of Actions, H2 2016 37
Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 37
Number of Products by Routes of Administration, H2 2016 39
Number of Products by Stage and Routes of Administration, H2 2016 39
Number of Products by Molecule Types, H2 2016 41
Number of Products by Stage and Molecule Types, H2 2016 41
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