Glomerulonephritis - Pipeline Review, H2 2016

Glomerulonephritis - Pipeline Review, H2 2016


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Executive Summary

Glomerulonephritis - Pipeline Review, H2 2016

Summary

Global Markets Direct's, 'Glomerulonephritis - Pipeline Review, H2 2016', provides an overview of the Glomerulonephritis pipeline landscape.

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

- The report reviews pipeline therapeutics for Glomerulonephritis 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 Glomerulonephritis therapeutics and enlists all their major and minor projects

- The report assesses Glomerulonephritis 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 Glomerulonephritis

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 Glomerulonephritis

- 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 Glomerulonephritis 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

Glomerulonephritis Overview 9

Therapeutics Development 10

Pipeline Products for Glomerulonephritis - Overview 10

Pipeline Products for Glomerulonephritis - Comparative Analysis 11

Glomerulonephritis - Therapeutics under Development by Companies 12

Glomerulonephritis - Therapeutics under Investigation by Universities/Institutes 15

Glomerulonephritis - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Glomerulonephritis - Products under Development by Companies 19

Glomerulonephritis - Products under Investigation by Universities/Institutes 21

Glomerulonephritis - Companies Involved in Therapeutics Development 22

Achillion Pharmaceuticals, Inc. 22

Alexion Pharmaceuticals Inc 23

Amyndas Pharmaceuticals LLC 24

Anthera Pharmaceuticals Inc 25

Avexxin AS 26

Biogen Inc 27

Complexa, Inc. 28

Dimerix Bioscience Pty Ltd 29

GlaxoSmithKline Plc 30

Mallinckrodt Plc 31

Omeros Corporation 32

Pfizer Inc. 33

Pharmalink AB 34

Retrophin Inc. 35

Rigel Pharmaceuticals, Inc. 36

Shire Plc 37

Toray Industries, Inc. 38

Variant Pharmaceuticals, Inc. 39

Glomerulonephritis - Therapeutics Assessment 40

Assessment by Monotherapy Products 40

Assessment by Combination Products 41

Assessment by Target 42

Assessment by Mechanism of Action 44

Assessment by Route of Administration 46

Assessment by Molecule Type 48

Drug Profiles 50

(irbesartan + propagermanium) - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

ACH-4471 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

AMY-101 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

AVX-002 - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

belimumab - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

blisibimod - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

budesonide - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

corticotropin - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

CXA-10 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

eculizumab - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

fostamatinib disodium - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

losmapimod - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

Monoclonal Antibodies to Inhibit Glycoprotein Ib Alpha for Vasculitis and Glomerulonephritis - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

OMS-721 - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

PF-1355 - Drug Profile 97

Product Description 97

Mechanism Of Action 97

R&D Progress 97

Recombinant Enzyme for Immunoglobulin A Nephropathy - Drug Profile 98

Product Description 98

Mechanism Of Action 98

R&D Progress 98

rituximab - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

SHP-627 - Drug Profile 103

Product Description 103

Mechanism Of Action 103

R&D Progress 103

Small Molecule to Inhibit Vitamin K Epoxide Reductase for Glomerulonephritis - Drug Profile 105

Product Description 105

Mechanism Of Action 105

R&D Progress 105

sparsentan - Drug Profile 106

Product Description 106

Mechanism Of Action 106

R&D Progress 106

TM-5484 - Drug Profile 108

Product Description 108

Mechanism Of Action 108

R&D Progress 108

Vaccine to Target CD40 for Membranous Glomerulonephritis - Drug Profile 109

Product Description 109

Mechanism Of Action 109

R&D Progress 109

VAR-200 - Drug Profile 110

Product Description 110

Mechanism Of Action 110

R&D Progress 110

Glomerulonephritis - Dormant Projects 111

Glomerulonephritis - Discontinued Products 113

Glomerulonephritis - Product Development Milestones 114

Featured News & Press Releases 114

Aug 01, 2016: Dimerix announces outcomes of DMX-200 pre-IND meeting with the FDA 114

May 17, 2016: First Patient Enrolled in Mallinckrodt Phase 4 Trial of H.P. Acthar Gel for Rare Cause of Nephrotic Syndrome 115

Mar 30, 2016: Retrophin Completes Enrollment of Phase 2 DUET Study of Sparsentan in Focal Segmental Glomerulosclerosis 115

Mar 04, 2016: Amyndas' lead candidate AMY-101 receives orphan drug status from the FDA and the EMA for the treatment of C3 glomerulopathy 116

Dec 14, 2015: Dimerix receives Orphan Designation for its lead drug candidate targeting patients with chronic kidney disease 116

Nov 16, 2015: Retrophin Receives European Orphan Drug Designation for Sparsentan for the Treatment of Focal Segmental Glomerulosclerosis 117

Jan 09, 2015: Ligand Partner Retrophin Receives Orphan Drug Designation for Sparsentan 117

Feb 25, 2013: Ligand Receives $1.4m Milestone Payment From Retrophin 118

Jan 09, 2013: Ligand Receives Equity Milestone Payment From Retrophin 118

Oct 31, 2012: Pharmalink Signs Manufacturing Agreement For Nefecon 119

Oct 13, 2010: Pharmalink Receives US Orphan Drug Designation For Nefecon 120

Oct 26, 2009: Japanese Patent granted for Pharmalink AB's Nefecon 120

Apr 29, 2009: Pharmalink AB Completes Phase II Clinical Study With Renal Disease Drug Nefecon 121

Mar 31, 2008: Pharmalink Reports Promising Interim Results From Phase II Trials For New Renal Disease Drug Nefecon 121

Appendix 123

Methodology 123

Coverage 123

Secondary Research 123

Primary Research 123

Expert Panel Validation 123

Contact Us 123

Disclaimer 124

List of Figures

Number of Products under Development for Glomerulonephritis, H2 2016 10

Number of Products under Development for Glomerulonephritis - Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 40

Number of Products by Top 10 Targets, H2 2016 42

Number of Products by Stage and Top 10 Targets, H2 2016 42

Number of Products by Top 10 Mechanism of Actions, H2 2016 44

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 44

Number of Products by Routes of Administration, H2 2016 46

Number of Products by Stage and Routes of Administration, H2 2016 46

Number of Products by Molecule Types, H2 2016 48

Number of Products by Stage and Molecule Types, H2 2016 48

List of Tables

Number of Products under Development for Glomerulonephritis, H2 2016 10

Number of Products under Development for Glomerulonephritis - Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 13

Number of Products under Development by Companies, H2 2016 (Contd..1) 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Development by Companies, H2 2016 (Contd..1) 20

Products under Investigation by Universities/Institutes, H2 2016 21

Glomerulonephritis - Pipeline by Achillion Pharmaceuticals, Inc., H2 2016 22

Glomerulonephritis - Pipeline by Alexion Pharmaceuticals Inc, H2 2016 23

Glomerulonephritis - Pipeline by Amyndas Pharmaceuticals LLC, H2 2016 24

Glomerulonephritis - Pipeline by Anthera Pharmaceuticals Inc, H2 2016 25

Glomerulonephritis - Pipeline by Avexxin AS, H2 2016 26

Glomerulonephritis - Pipeline by Biogen Inc, H2 2016 27

Glomerulonephritis - Pipeline by Complexa, Inc., H2 2016 28

Glomerulonephritis - Pipeline by Dimerix Bioscience Pty Ltd, H2 2016 29

Glomerulonephritis - Pipeline by GlaxoSmithKline Plc, H2 2016 30

Glomerulonephritis - Pipeline by Mallinckrodt Plc, H2 2016 31

Glomerulonephritis - Pipeline by Omeros Corporation, H2 2016 32

Glomerulonephritis - Pipeline by Pfizer Inc., H2 2016 33

Glomerulonephritis - Pipeline by Pharmalink AB, H2 2016 34

Glomerulonephritis - Pipeline by Retrophin Inc., H2 2016 35

Glomerulonephritis - Pipeline by Rigel Pharmaceuticals, Inc., H2 2016 36

Glomerulonephritis - Pipeline by Shire Plc, H2 2016 37

Glomerulonephritis - Pipeline by Toray Industries, Inc., H2 2016 38

Glomerulonephritis - Pipeline by Variant Pharmaceuticals, Inc., H2 2016 39

Assessment by Monotherapy Products, H2 2016 40

Assessment by Combination Products, H2 2016 41

Number of Products by Stage and Target, H2 2016 43

Number of Products by Stage and Mechanism of Action, H2 2016 45

Number of Products by Stage and Route of Administration, H2 2016 47

Number of Products by Stage and Molecule Type, H2 2016 49

Glomerulonephritis - Dormant Projects, H2 2016 111

Glomerulonephritis - Dormant Projects (Contd..1), H2 2016 112

Glomerulonephritis - Discontinued Products, H2 2016 113

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Achillion Pharmaceuticals, Inc.

Alexion Pharmaceuticals Inc

Amyndas Pharmaceuticals LLC

Anthera Pharmaceuticals Inc

Avexxin AS

Biogen Inc

Complexa, Inc.

Dimerix Bioscience Pty Ltd

GlaxoSmithKline Plc

Mallinckrodt Plc

Omeros Corporation

Pfizer Inc.

Pharmalink AB

Retrophin Inc.

Rigel Pharmaceuticals, Inc.

Shire Plc

Toray Industries, Inc.

Variant Pharmaceuticals, Inc.

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

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