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

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


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Executive Summary

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

Summary

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



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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 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

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

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Acorda Therapeutics, Inc.

Alexion Pharmaceuticals Inc

Biogen Inc

Bionure Farma, S.L.

Chugai Pharmaceutical Co., Ltd.

Clene Nanomedicine, Inc.

HanAll Biopharma Co., Ltd.

Karus Therapeutics Limited

LFB S.A.

Marathon Pharmaceuticals, LLC

MedImmune, LLC

Opexa Therapeutics, Inc.

Shire Plc

Takeda Pharmaceutical Company Limited

Neuromyelitis Optica (Devic's Syndrome) Therapeutic Products under Development, Key Players in Neuromyelitis Optica (Devic�s Syndrome) Therapeutics, Neuromyelitis Optica (Devic�s Syndrome) Pipeline Overview, Neuromyelitis Optica (Devic�s Syndrome) Pipeline, Neuromyelitis Optica (Devic�s Syndrome) Pipeline Assessment

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