Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline Review, H2 2016’, provides an overview of the Secondary Progressive Multiple Sclerosis (SPMS) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Secondary Progressive Multiple Sclerosis (SPMS), 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 Secondary Progressive Multiple Sclerosis (SPMS) 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 Secondary Progressive Multiple Sclerosis (SPMS)

The report reviews pipeline therapeutics for Secondary Progressive Multiple Sclerosis (SPMS) 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 Secondary Progressive Multiple Sclerosis (SPMS) therapeutics and enlists all their major and minor projects

The report assesses Secondary Progressive Multiple Sclerosis (SPMS) 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 Secondary Progressive Multiple Sclerosis (SPMS)

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 Secondary Progressive Multiple Sclerosis (SPMS)

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 Secondary Progressive Multiple Sclerosis (SPMS) 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

AB Science SA

Actelion Ltd

Biogen, Inc.

F. Hoffmann-La Roche Ltd.

Genzyme Corporation

Glialogix, Inc.

Immune Response BioPharma, Inc.

Innate Immunotherapeutics Ltd

Kyorin Pharmaceutical Co., Ltd.

Mallinckrodt Plc

MedDay SA

MedImmune, LLC

Merck KGaA

Meta-IQ ApS

Novartis AG

Opexa Therapeutics, Inc.

Xenetic Biosciences (UK) Limited

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Secondary Progressive Multiple Sclerosis (SPMS) Overview 9

Therapeutics Development 10

Pipeline Products for Secondary Progressive Multiple Sclerosis (SPMS) - Overview 10

Secondary Progressive Multiple Sclerosis (SPMS) - Therapeutics under Development by Companies 11

Secondary Progressive Multiple Sclerosis (SPMS) - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Secondary Progressive Multiple Sclerosis (SPMS) - Products under Development by Companies 16

Secondary Progressive Multiple Sclerosis (SPMS) - Companies Involved in Therapeutics Development 17

AB Science SA 17

Actelion Ltd 18

Biogen, Inc. 19

F. Hoffmann-La Roche Ltd. 20

Genzyme Corporation 21

Glialogix, Inc. 22

Immune Response BioPharma, Inc. 23

Innate Immunotherapeutics Ltd 24

Kyorin Pharmaceutical Co., Ltd. 25

Mallinckrodt Plc 26

MedDay SA 27

MedImmune, LLC 28

Merck KGaA 29

Meta-IQ ApS 30

Novartis AG 31

Opexa Therapeutics, Inc. 32

Xenetic Biosciences (UK) Limited 33

Secondary Progressive Multiple Sclerosis (SPMS) - Therapeutics Assessment 34

Assessment by Monotherapy Products 34

Assessment by Target 35

Assessment by Mechanism of Action 38

7Assessment by Route of Administration 41

Assessment by Molecule Type 43

Drug Profiles 45

biotin - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

DC-TAB - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

etomoxir - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

GLX-1112 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

GZ-402668 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

IB-MS - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

ibudilast - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

imilecleucel-T - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

inebilizumab - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

interferon beta-1b - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

IR-902 - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

M-2736 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

masitinib - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

methoxsalen - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

MIS-416 - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

ocrelizumab - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

opicinumab - Drug Profile 97

Product Description 97

Mechanism Of Action 97

R&D Progress 97

OSX-110 - Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

ponesimod - Drug Profile 101

Product Description 101

Mechanism Of Action 101

R&D Progress 101

siponimod - Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

Xemys - Drug Profile 106

Product Description 106

Mechanism Of Action 106

R&D Progress 106

Secondary Progressive Multiple Sclerosis (SPMS) - Dormant Projects 108

Secondary Progressive Multiple Sclerosis (SPMS) - Discontinued Products 109

Secondary Progressive Multiple Sclerosis (SPMS) - Product Development Milestones 110

Featured News & Press Releases 110

May 25, 2016: MedDay attends European Academy of Neurology 2016 and presents extension phase results of the MS-SPI trial 110

Apr 21, 2016: MedDay reports full data from pivotal Phase IIb/III MS-SPI / MS-ON studies with MD1003 in Multiple Sclerosis at AAN 110

Apr 13, 2016: Innate Immunotherapeutics announces clinical trial fully enrolled and receives strong interest from potential Pharma partners 112

Apr 01, 2016: PJSC Pharmsynthez Completes Follow Up and Data Analysis From a Phase 2 Study of Novel Therapeutic Vaccine Xemys for Multiple Sclerosis 113

Mar 22, 2016: FDA Grants Fast Track Designation for MediciNovas MN-166 (ibudilast) for Progressive Multiple Sclerosis 114

Dec 01, 2015: MedDay provides update on MS-ON study of MD-1003 114

Oct 07, 2015: MedDay reports additional positive analyses of its pivotal study with MD1003 in patients with primary and secondary Progressive Multiple Sclerosis 116

Oct 06, 2015: Opexa Announces Granting of New T-cell Patents Covering Tcelna; Patent Estate Increases to 160 Issued Patents 117

Aug 06, 2015: Medical Need Europe appoints Durbin as latest distribution partner 117

Mar 04, 2015: MedDay to present Pivotal Phase III data in Progressive Multiple Sclerosis at AAN Annual Meeting 118

Feb 01, 2015: MN-166 (ibudilast) Progressive MS Abstract Accepted for Presentation at AAN 67th Annual Meeting in Washington, DC 118

Oct 07, 2014: Update on Innate’s Phase 2B trial and other recent activities 119

Aug 19, 2014: Innate’s Phase 2B clinical trial on SPMS to start recruiting patients following Perth site obtaining ethics approval 119

Jun 20, 2014: Update on Phase 2B Trial of MIS416 in Patients with Secondary Progressive Multiple Sclerosis 120

Jun 18, 2014: Compassionate Use Programme Update 121

Appendix 122

Methodology 122

Coverage 122

Secondary Research 122

Primary Research 122

Expert Panel Validation 122

Contact Us 122

Disclaimer 123

List of Tables

List of Tables

Number of Products under Development for Secondary Progressive Multiple Sclerosis (SPMS), H2 2016 10

Number of Products under Development by Companies, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by AB Science SA, H2 2016 17

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Actelion Ltd, H2 2016 18

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Biogen, Inc., H2 2016 19

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 20

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Genzyme Corporation, H2 2016 21

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Glialogix, Inc., H2 2016 22

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Immune Response BioPharma, Inc., H2 2016 23

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Innate Immunotherapeutics Ltd, H2 2016 24

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Kyorin Pharmaceutical Co., Ltd., H2 2016 25

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Mallinckrodt Plc, H2 2016 26

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by MedDay SA, H2 2016 27

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by MedImmune, LLC, H2 2016 28

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Merck KGaA, H2 2016 29

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Meta-IQ ApS, H2 2016 30

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Novartis AG, H2 2016 31

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Opexa Therapeutics, Inc., H2 2016 32

Secondary Progressive Multiple Sclerosis (SPMS) – Pipeline by Xenetic Biosciences (UK) 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 39

Number of Products by Stage and Route of Administration, H2 2016 42

Number of Products by Stage and Molecule Type, H2 2016 44

Secondary Progressive Multiple Sclerosis (SPMS) – Dormant Projects, H2 2016 108

Secondary Progressive Multiple Sclerosis (SPMS) – Discontinued Products, H2 2016 109

List of Figures

List of Figures

Number of Products under Development for Secondary Progressive Multiple Sclerosis (SPMS), H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 14

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 38

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 38

Number of Products by Routes of Administration, H2 2016 41

Number of Products by Stage and Routes of Administration, H2 2016 41

Number of Products by Molecule Types, H2 2016 43

Number of Products by Stage and Molecule Types, H2 2016 43

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