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Myasthenia Gravis-Pipeline Review, H1 2015

Myasthenia Gravis-Pipeline Review, H1 2015


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Executive Summary

Myasthenia Gravis-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Myasthenia Gravis-Pipeline Review, H1 2015', provides an overview of the Myasthenia Gravis's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Myasthenia Gravis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Myasthenia Gravis and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

The report provides a snapshot of the global therapeutic landscape of Myasthenia Gravis

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Myasthenia Gravis and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Myasthenia Gravis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Myasthenia Gravis pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Myasthenia Gravis

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Myasthenia Gravis 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

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Myasthenia Gravis Overview 8

Therapeutics Development 9

Pipeline Products for Myasthenia Gravis-Overview 9

Pipeline Products for Myasthenia Gravis-Comparative Analysis 10

Myasthenia Gravis-Therapeutics under Development by Companies 11

Myasthenia Gravis-Therapeutics under Investigation by Universities/Institutes 13

Myasthenia Gravis-Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Myasthenia Gravis-Products under Development by Companies 17

Myasthenia Gravis-Products under Investigation by Universities/Institutes 18

Myasthenia Gravis-Companies Involved in Therapeutics Development 19

Alexion Pharmaceuticals, Inc. 19

Alnylam Pharmaceuticals, Inc. 20

Astellas Pharma Inc. 21

Biokine Therapeutics Ltd. 22

CuraVac, Inc. 23

Cytokinetics, Inc. 24

GlaxoSmithKline plc 25

Grifols, S.A. 26

HanAll Biopharma Co., Ltd. 27

Neurotune AG 28

Pfizer Inc. 29

Regenesance BV 30

Toleranzia AB 31

Myasthenia Gravis-Therapeutics Assessment 32

Assessment by Monotherapy Products 32

Assessment by Target 33

Assessment by Mechanism of Action 35

Assessment by Route of Administration 37

Assessment by Molecule Type 39

Drug Profiles 41

ALN-CC5-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

belimumab-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

BKT-130-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

CK-2066260-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

eculizumab-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

GL-2045-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

HL-161-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

immune globulin (human)-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

NT-1654-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

Recombinant Protein for Myasthenia Gravis-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

Recombinant Protein to Antagonize LTB4 and C5 for Respiratory, Immunological, CNS and Hematological Disorders-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Regenemab-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

tacrolimus-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

tirasemtiv-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Vaccine for Myasthenia Gravis-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

Vaccine for Myasthenia Gravis-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

Myasthenia Gravis-Recent Pipeline Updates 69

Myasthenia Gravis-Dormant Projects 85

Myasthenia Gravis-Discontinued Products 86

Myasthenia Gravis-Product Development Milestones 87

Featured News & Press Releases 87

Dec 10, 2014: Soliris (eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Myasthenia Gravis 87

Sep 16, 2014: Alnylam Presents New Pre-Clinical Data with ALN-CC5, a Subcutaneously Administered RNAi Therapeutic Targeting Complement Component C5 in Development for the Treatment of Complement-Mediated Diseases 88

Aug 01, 2014: European Commission Grants Orphan Drug Designation to Soliris (eculizumab) for the Treatment of Patients with Myasthenia Gravis (MG) 89

Jun 17, 2014: FDA Grants Orphan Drug Designation to Soliris (eculizumab) for the Treatment of Patients with Myasthenia Gravis 90

Jun 09, 2014: Alnylam Presents New Pre-Clinical Data with Development Candidate for ALN-CC5, a Subcutaneously Administered RNAi Therapeutic Targeting Complement Component C5 in Development for the Treatment of Complement-Mediated Diseases 90

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 92

Apr 24, 2014: Toleranzia supported by VINNOVA 93

Dec 08, 2013: New Alnylam Pre-clinical Results on ALN-CC5, an RNAi Therapeutic Targeting Complement Component C5 for the Treatment of Complement-Mediated Diseases, Demonstrate up to 98% Serum C5 Knockdown and up to 94% Inhibition of Hemolytic Activity in Non-Human Primates 93

Jun 20, 2013: Alnylam Scientists Present Preclinical Data With ALN-CC5 For Treatment Of Complement-mediated Diseases 96

Mar 21, 2013: Cytokinetics Announces Presentation Of Phase IIA Clinical Trial Data Of Tirasemtiv In Patients With Myasthenia Gravis 97

Appendix 99

Methodology 99

Coverage 99

Secondary Research 99

Primary Research 99

Expert Panel Validation 99

Contact Us 100

Disclaimer 100

List of Tables

Number of Products under Development for Myasthenia Gravis, H1 2015 9

Number of Products under Development for Myasthenia Gravis-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 12

Number of Products under Investigation by Universities/Institutes, H1 2015 13

Comparative Analysis by Late Stage Development, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Development, H1 2015 16

Products under Development by Companies, H1 2015 17

Products under Investigation by Universities/Institutes, H1 2015 18

Myasthenia Gravis-Pipeline by Alexion Pharmaceuticals, Inc., H1 2015 19

Myasthenia Gravis-Pipeline by Alnylam Pharmaceuticals, Inc., H1 2015 20

Myasthenia Gravis-Pipeline by Astellas Pharma Inc., H1 2015 21

Myasthenia Gravis-Pipeline by Biokine Therapeutics Ltd., H1 2015 22

Myasthenia Gravis-Pipeline by CuraVac, Inc., H1 2015 23

Myasthenia Gravis-Pipeline by Cytokinetics, Inc., H1 2015 24

Myasthenia Gravis-Pipeline by GlaxoSmithKline plc, H1 2015 25

Myasthenia Gravis-Pipeline by Grifols, S.A., H1 2015 26

Myasthenia Gravis-Pipeline by HanAll Biopharma Co., Ltd., H1 2015 27

Myasthenia Gravis-Pipeline by Neurotune AG, H1 2015 28

Myasthenia Gravis-Pipeline by Pfizer Inc., H1 2015 29

Myasthenia Gravis-Pipeline by Regenesance BV, H1 2015 30

Myasthenia Gravis-Pipeline by Toleranzia AB, H1 2015 31

Assessment by Monotherapy Products, H1 2015 32

Number of Products by Stage and Target, H1 2015 34

Number of Products by Stage and Mechanism of Action, H1 2015 36

Number of Products by Stage and Route of Administration, H1 2015 38

Number of Products by Stage and Molecule Type, H1 2015 40

Myasthenia Gravis Therapeutics-Recent Pipeline Updates, H1 2015 69

Myasthenia Gravis-Dormant Projects, H1 2015 85

Myasthenia Gravis-Discontinued Products, H1 2015 86

List of Figures

Number of Products under Development for Myasthenia Gravis, H1 2015 9

Number of Products under Development for Myasthenia Gravis-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Products, H1 2015 16

Assessment by Monotherapy Products, H1 2015 32

Number of Products by Top 10 Targets, H1 2015 33

Number of Products by Stage and Top 10 Targets, H1 2015 34

Number of Products by Top 10 Mechanism of Actions, H1 2015 35

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 36

Number of Products by Top 10 Routes of Administration, H1 2015 37

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 38

Number of Products by Top 10 Molecule Types, H1 2015 39

Number of Products by Stage and Top 10 Molecule Types, H1 2015 40

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Alexion Pharmaceuticals, Inc.

Alnylam Pharmaceuticals, Inc.

Astellas Pharma Inc.

Biokine Therapeutics Ltd.

CuraVac, Inc.

Cytokinetics, Inc.

GlaxoSmithKline plc

Grifols, S.A.

HanAll Biopharma Co., Ltd.

Neurotune AG

Pfizer Inc.

Regenesance BV

Toleranzia AB

Myasthenia Gravis Therapeutic Products under Development, Key Players in Myasthenia Gravis Therapeutics, Myasthenia Gravis Pipeline Overview, Myasthenia Gravis Pipeline, Myasthenia Gravis Pipeline Assessment


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