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Gouty Arthritis (Gout)-Pipeline Review, H1 2015

Gouty Arthritis (Gout)-Pipeline Review, H1 2015


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Executive Summary

Gouty Arthritis (Gout)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Gouty Arthritis (Gout)-Pipeline Review, H1 2015', provides an overview of the Gouty Arthritis (Gout)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Gouty Arthritis (Gout), 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 Gouty Arthritis (Gout) 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 Gouty Arthritis (Gout)

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 Gouty Arthritis (Gout) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Gouty Arthritis (Gout) 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 Gouty Arthritis (Gout) 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 Gouty Arthritis (Gout)

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

Devise corrective measures for pipeline projects by understanding Gouty Arthritis (Gout) 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 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Gouty Arthritis (Gout) Overview 10

Therapeutics Development 11

Pipeline Products for Gouty Arthritis (Gout)-Overview 11

Pipeline Products for Gouty Arthritis (Gout)-Comparative Analysis 12

Gouty Arthritis (Gout)-Therapeutics under Development by Companies 13

Gouty Arthritis (Gout)-Therapeutics under Investigation by Universities/Institutes 15

Gouty Arthritis (Gout)-Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Unknown Stage Products 19

Gouty Arthritis (Gout)-Products under Development by Companies 20

Gouty Arthritis (Gout)-Products under Investigation by Universities/Institutes 23

Gouty Arthritis (Gout)-Companies Involved in Therapeutics Development 24

AstraZeneca PLC 24

Celtaxsys, Inc. 25

CymaBay Therapeutics, Inc. 26

Delenex Therapeutics AG 27

Immune Response BioPharma, Inc. 28

IOmet Pharma 29

JW Pharmaceutical Corporation 30

Kissei Pharmaceutical Co., Ltd. 31

LG Life Sciences, Ltd. 32

Nimbus Therapeutics, LLC 33

Nippon Chemiphar Co., Ltd. 34

Omni Bio Pharmaceutical Inc. 35

Opsona Therapeutics Ltd. 36

PLx Pharma Inc. 37

Polaris Pharmaceuticals, Inc. 38

Selecta Biosciences, Inc. 39

Takeda Pharmaceutical Company Limited 40

Teijin Pharma Limited 41

TWi Pharmaceuticals, Inc. 42

Wellstat Therapeutics Corporation 43

Gouty Arthritis (Gout)-Therapeutics Assessment 44

Assessment by Monotherapy Products 44

Assessment by Target 45

Assessment by Mechanism of Action 47

Assessment by Route of Administration 49

Assessment by Molecule Type 51

Drug Profiles 53

arhalofenate-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

CTX-4430-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

diacerein-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

DLX-2323-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

DLX-2681-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Fc-Alpha-1 Antitrypsin-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

FcAAT-2-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

FcAAT-3-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

febuxostat-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

febuxostat XR-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

IR-888-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

KUX-1151-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

LC-350189-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

lesinurad sodium-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

Monoclonal Antibody to Inhibit S100A9 Protein for Neurodegenerative Diseases, Chronic Inflammation and Autoimmune Disorders-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

NC-2500-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

ND-2110-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

ND-2158-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

ND-346-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

pegadricase-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

pegadricase-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

PL-4100-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

PN-XXXX-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

RDEA-3170-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

Recombinant Enzyme for Gout and Tumor Lysis Syndrome-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

REV-002-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

RLBN-1001-Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

RLBN-2020 Series-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

RLBN-3010 Series-Drug Profile 89

Product Description 89

Mechanism of Action 89

R&D Progress 89

Small Molecule Inflammasome Modulator Programme-Drug Profile 90

Product Description 90

Mechanism of Action 90

R&D Progress 90

Small Molecule to Inhibit Xanthine Oxidase for Gout and Hyperuricemia-Drug Profile 91

Product Description 91

Mechanism of Action 91

R&D Progress 91

Small Molecules to Inhibit GLUT9 for Gout-Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

URC-102-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

uriSHELS-Drug Profile 94

Product Description 94

Mechanism of Action 94

R&D Progress 94

X-0002-Drug Profile 95

Product Description 95

Mechanism of Action 95

R&D Progress 95

XEN-102-Drug Profile 97

Product Description 97

Mechanism of Action 97

R&D Progress 97

XEN-104-Drug Profile 98

Product Description 98

Mechanism of Action 98

R&D Progress 98

Gouty Arthritis (Gout)-Recent Pipeline Updates 99

Gouty Arthritis (Gout)-Dormant Projects 107

Gouty Arthritis (Gout)-Discontinued Products 109

Gouty Arthritis (Gout)-Product Development Milestones 110

Featured News & Press Releases 110

Mar 23, 2015: CymaBay Therapeutics to Host Key Opinion Leader Meeting on March 27 in New York City 110

Mar 03, 2015: Vince & Associates Clinical Research Completes CymaBay Therapeutics Clinical Trial of Arhalofenate in Combination with Febuxostat 110

Feb 26, 2015: Revive Therapeutics Expands its Orphan Drug Indication Pipeline to Include Cystinuria and Wilson Disease 110

Feb 24, 2015: CymaBay Therapeutics Announces Positive Results From Its Phase 2b Clinical Study Demonstrating That Arhalofenate Met the Primary Endpoint of Reduction in Gout Flares 111

Jan 22, 2015: Marketing Authorisation Application for gout treatment lesinurad accepted by European Medicines Agency 112

Jan 12, 2015: Cymabay Therapeutics Announces Positive Results From Its Phase 2 Clinical Study of Arhalofenate in Combination With Febuxostat 112

Dec 12, 2014: TWi Biotechnology Receives Approval of Protocol for Its Drug AC-201 Controlled-Release Tablet, Phase II Clinical Trial in Both the United States and Taiwan 114

Nov 26, 2014: Revive Therapeutics Announces US FDA Acceptance of IND to Commence Clinical Trial for Bucillamine for the Treatment of Gout 114

Nov 18, 2014: Omni Bio Successfully Completes Cell Line Optimization for Novel Recombinant Biologic 114

Nov 16, 2014: AstraZeneca Presents Data from Phase III Studies of Lesinurad in Combination with Allopurinol in Gout Patients at American College of Rheumatology 2014 Annual Meeting 115

Appendix 117

Methodology 117

Coverage 117

Secondary Research 117

Primary Research 117

Expert Panel Validation 117

Contact Us 117

Disclaimer 118

List of Tables

Number of Products under Development for Gouty Arthritis (Gout), H1 2015 11

Number of Products under Development for Gouty Arthritis (Gout)-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 13

Number of Products under Development by Companies, H1 2015 (Contd..1) 14

Number of Products under Investigation by Universities/Institutes, H1 2015 15

Comparative Analysis by Late Stage Development, H1 2015 16

Comparative Analysis by Clinical Stage Development, H1 2015 17

Comparative Analysis by Early Stage Development, H1 2015 18

Comparative Analysis by Unknown Stage Development, H1 2015 19

Products under Development by Companies, H1 2015 20

Products under Development by Companies, H1 2015 (Contd..1) 21

Products under Development by Companies, H1 2015 (Contd..2) 22

Products under Investigation by Universities/Institutes, H1 2015 23

Gouty Arthritis (Gout)-Pipeline by AstraZeneca PLC, H1 2015 24

Gouty Arthritis (Gout)-Pipeline by Celtaxsys, Inc., H1 2015 25

Gouty Arthritis (Gout)-Pipeline by CymaBay Therapeutics, Inc., H1 2015 26

Gouty Arthritis (Gout)-Pipeline by Delenex Therapeutics AG, H1 2015 27

Gouty Arthritis (Gout)-Pipeline by Immune Response BioPharma, Inc., H1 2015 28

Gouty Arthritis (Gout)-Pipeline by IOmet Pharma, H1 2015 29

Gouty Arthritis (Gout)-Pipeline by JW Pharmaceutical Corporation, H1 2015 30

Gouty Arthritis (Gout)-Pipeline by Kissei Pharmaceutical Co., Ltd., H1 2015 31

Gouty Arthritis (Gout)-Pipeline by LG Life Sciences, Ltd., H1 2015 32

Gouty Arthritis (Gout)-Pipeline by Nimbus Therapeutics, LLC, H1 2015 33

Gouty Arthritis (Gout)-Pipeline by Nippon Chemiphar Co., Ltd., H1 2015 34

Gouty Arthritis (Gout)-Pipeline by Omni Bio Pharmaceutical Inc., H1 2015 35

Gouty Arthritis (Gout)-Pipeline by Opsona Therapeutics Ltd., H1 2015 36

Gouty Arthritis (Gout)-Pipeline by PLx Pharma Inc., H1 2015 37

Gouty Arthritis (Gout)-Pipeline by Polaris Pharmaceuticals, Inc., H1 2015 38

Gouty Arthritis (Gout)-Pipeline by Selecta Biosciences, Inc., H1 2015 39

Gouty Arthritis (Gout)-Pipeline by Takeda Pharmaceutical Company Limited, H1 2015 40

Gouty Arthritis (Gout)-Pipeline by Teijin Pharma Limited, H1 2015 41

Gouty Arthritis (Gout)-Pipeline by TWi Pharmaceuticals, Inc., H1 2015 42

Gouty Arthritis (Gout)-Pipeline by Wellstat Therapeutics Corporation, H1 2015 43

Assessment by Monotherapy Products, H1 2015 44

Number of Products by Stage and Target, H1 2015 46

Number of Products by Stage and Mechanism of Action, H1 2015 48

Number of Products by Stage and Route of Administration, H1 2015 50

Number of Products by Stage and Molecule Type, H1 2015 52

Gouty Arthritis (Gout) Therapeutics-Recent Pipeline Updates, H1 2015 99

Gouty Arthritis (Gout)-Dormant Projects, H1 2015 107

Gouty Arthritis (Gout)-Dormant Projects (Contd..1), H1 2015 108

Gouty Arthritis (Gout)-Discontinued Products, H1 2015 109

List of Figures

Number of Products under Development for Gouty Arthritis (Gout), H1 2015 11

Number of Products under Development for Gouty Arthritis (Gout)-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 13

Comparative Analysis by Late Stage Development, H1 2015 16

Comparative Analysis by Clinical Stage Development, H1 2015 17

Comparative Analysis by Early Stage Products, H1 2015 18

Assessment by Monotherapy Products, H1 2015 44

Number of Products by Top 10 Targets, H1 2015 45

Number of Products by Stage and Top 10 Targets, H1 2015 46

Number of Products by Top 10 Mechanism of Actions, H1 2015 47

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 48

Number of Products by Top 10 Routes of Administration, H1 2015 49

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 50

Number of Products by Top 10 Molecule Types, H1 2015 51

Number of Products by Stage and Top 10 Molecule Types, H1 2015 52

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AstraZeneca PLC

Celtaxsys, Inc.

CymaBay Therapeutics, Inc.

Delenex Therapeutics AG

Immune Response BioPharma, Inc.

IOmet Pharma

JW Pharmaceutical Corporation

Kissei Pharmaceutical Co., Ltd.

LG Life Sciences, Ltd.

Nimbus Therapeutics, LLC

Nippon Chemiphar Co., Ltd.

Omni Bio Pharmaceutical Inc.

Opsona Therapeutics Ltd.

PLx Pharma Inc.

Polaris Pharmaceuticals, Inc.

Selecta Biosciences, Inc.

Takeda Pharmaceutical Company Limited

Teijin Pharma Limited

TWi Pharmaceuticals, Inc.

Wellstat Therapeutics Corporation

Gouty Arthritis (Gout) Therapeutic Products under Development, Key Players in Gouty Arthritis (Gout) Therapeutics, Gouty Arthritis (Gout) Pipeline Overview, Gouty Arthritis (Gout) Pipeline, Gouty Arthritis (Gout) Pipeline Assessment


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