Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline Review, H2 2016’, provides an overview of the Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis), 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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) 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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis)

The report reviews pipeline therapeutics for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) 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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) therapeutics and enlists all their major and minor projects

The report assesses Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) 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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis)

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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis)

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 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) 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

Bionovis SA

Bristol-Myers Squibb Company

ChemoCentryx, Inc.

Coherus BioSciences, Inc.

Genor BioPharma Co., Ltd.

GlaxoSmithKline Plc

KPI Therapeutics, Inc.

Panacea Biotec Limited

Sandoz International GmbH ...

Bionovis SA

Bristol-Myers Squibb Company

ChemoCentryx, Inc.

Coherus BioSciences, Inc.

Genor BioPharma Co., Ltd.

GlaxoSmithKline Plc

KPI Therapeutics, Inc.

Panacea Biotec Limited

Sandoz International GmbH

The International Biotechnology Center (IBC) Generium

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 7

Global Markets Direct Report Coverage 7

Anti-Neutrophil Cytoplasmic ...

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 7

Global Markets Direct Report Coverage 7

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) Overview 8

Therapeutics Development 9

Pipeline Products for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Overview 9

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Therapeutics under Development by Companies 10

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Unknown Stage Products 14

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Products under Development by Companies 15

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Companies Involved in Therapeutics Development 16

Bionovis SA 16

Bristol-Myers Squibb Company 17

ChemoCentryx, Inc. 18

Coherus BioSciences, Inc. 19

Genor BioPharma Co., Ltd. 20

GlaxoSmithKline Plc 21

KPI Therapeutics, Inc. 22

Panacea Biotec Limited 23

Sandoz International GmbH 24

The International Biotechnology Center (IBC) Generium 25

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Therapeutics Assessment 26

Assessment by Monotherapy Products 26

Assessment by Target 27

Assessment by Mechanism of Action 29

Assessment by Route of Administration 31

Assessment by Molecule Type 33

Drug Profiles 35

abatacept - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

belimumab - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

CCX-168 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

dalazatide - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

mepolizumab - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

rituximab biosimilar - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

rituximab biosimilar - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

rituximab biosimilar - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

rituximab biosimilar - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

rituximab biosimilar - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

rituximab biosimilar - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

rituximab biosimilar - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Dormant Projects 69

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Discontinued Products 70

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Product Development Milestones 71

Featured News & Press Releases 71

Jun 16, 2016: ChemoCentryx Announces Positive Top-Line Results for CCX168 from the Phase II ANCA-Associated Vasculitis CLASSIC Study and Advances Plans to Initiate Phase III Development 71

Jun 01, 2016: ChemoCentryx Receives European Medicines Agency PRIority MEdicines (PRIME) Designation for Accelerated Assessment of Complement 5a Receptor Inhibitor CCX168 for Treatment of Patients with ANCA-Associated Vasculitis 72

May 23, 2016: ChemoCentryx Announces Presentation of Positive Results from Phase II ANCA-Associated Vasculitis CLEAR Trial of Orally Administered Complement 5a Receptor Inhibitor CCX168 at the 53rd ERA-EDTA Congress 73

Apr 28, 2016: ChemoCentryx Receives FDA Orphan Products Development Grant for Orally Administered Complement 5a Receptor Inhibitor CCX168 for Treatment of ANCA-Associated Vasculitis 75

Jan 06, 2016: ChemoCentryx Announces Positive Results in Phase II ANCA-Associated Vasculitis CLEAR Trial of Orally Administered Complement 5a Receptor Inhibitor CCX168 76

Nov 09, 2015: Kineta Presents New Data Demonstrating Positive, Predictive Responses to Dalazatide in Psoriasis Patients and in Lupus, ANCA Vasculitis Studies at American College of Rheumatology Annual Meeting 78

Apr 21, 2015: Kineta, University of Groningen Present New, Positive Data for Dalazatide in ANCA Vasculitis, an Orphan Disease 78

Dec 04, 2014: ChemoCentryx Granted EU Orphan Drug Designation for CCX168, an Orally Administered Complement C5a Receptor Inhibitor, for the Treatment of Microscopic Polyangiitis and Granulomatosis With Polyangiitis, Two Forms of ANCA-Associated Vasculitis 79

Nov 17, 2014: ChemoCentryx's Orally Administered C5aR Inhibitor CCX168 Shows Benefit In Non-Renal ANCA Vasculitis Disease Activity, In Addition To Previously Shown Kidney Disease Improvements 80

Jun 02, 2014: ChemoCentryx's Orally-Administered Complement 5a Receptor Inhibitor, CCX168, Shows Benefit in ANCA-Associated Vasculitis Based on Birmingham Vasculitis Activity Score and Renal Disease Measurements 81

Feb 14, 2014: GSK announces start of Phase lll study for mepolizumab in patients with Eosinophilic Granulomatosis with Polyangiitis 82

Dec 03, 2013: ChemoCentryx Announces Positive Top-Line CCX168 Phase II Data in ANCA-Associated Renal Vasculitis 83

Nov 10, 2010: ChemoCentryx Presents Positive Phase I Results For CCX168 At Annual American College Of Rheumatology Meeting 84

Appendix 86

Methodology 86

Coverage 86

Secondary Research 86

Primary Research 86

Expert Panel Validation 86

Contact Us 86

Disclaimer 87

List of Tables

List of Tables

Number of Products under Development for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis), H2 2016 9

Number of Products under Development by Companies, ...

List of Tables

Number of Products under Development for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis), H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Development, H2 2016 13

Comparative Analysis by Unknown Stage Development, H2 2016 14

Products under Development by Companies, H2 2016 15

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Bionovis SA, H2 2016 16

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Bristol-Myers Squibb Company, H2 2016 17

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by ChemoCentryx, Inc., H2 2016 18

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Coherus BioSciences, Inc., H2 2016 19

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Genor BioPharma Co., Ltd., H2 2016 20

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by GlaxoSmithKline Plc, H2 2016 21

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by KPI Therapeutics, Inc., H2 2016 22

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Panacea Biotec Limited, H2 2016 23

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by Sandoz International GmbH, H2 2016 24

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Pipeline by The International Biotechnology Center (IBC) Generium, H2 2016 25

Assessment by Monotherapy Products, H2 2016 26

Number of Products by Stage and Target, H2 2016 28

Number of Products by Stage and Mechanism of Action, H2 2016 30

Number of Products by Stage and Route of Administration, H2 2016 32

Number of Products by Stage and Molecule Type, H2 2016 34

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Dormant Projects, H2 2016 69

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) - Discontinued Products, H2 2016 70

List of Figures

List of Figures

Number of Products under Development for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis), H2 2016 9

Number of Products under Development by Companies, ...

List of Figures

Number of Products under Development for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis), H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 13

Assessment by Monotherapy Products, H2 2016 26

Number of Products by Targets, H2 2016 27

Number of Products by Stage and Targets, H2 2016 27

Number of Products by Mechanism of Actions, H2 2016 29

Number of Products by Stage and Mechanism of Actions, H2 2016 29

Number of Products by Routes of Administration, H2 2016 31

Number of Products by Stage and Routes of Administration, H2 2016 31

Number of Products by Molecule Types, H2 2016 33

Number of Products by Stage and Molecule Types, H2 2016 33

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