Axial Spondyloarthritis – Pipeline Review, H2 2017

Global Markets Direct’s, ‘Axial Spondyloarthritis – Pipeline Review, H2 2017’, provides an overview of the Axial Spondyloarthritis pipeline landscape.

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

The report reviews pipeline therapeutics for Axial Spondyloarthritis 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 Axial Spondyloarthritis therapeutics and enlists all their major and minor projects

The report assesses Axial Spondyloarthritis 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 Axial Spondyloarthritis

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 Axial Spondyloarthritis

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 Axial Spondyloarthritis 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

AstraZeneca Plc

Eli Lilly and Co

Novartis AG

Sandoz International GmbH

Sun Pharma Advanced Research Company Ltd

UCB SA

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Axial Spondyloarthritis - Overview 6

Axial Spondyloarthritis - Therapeutics Development 7

Pipeline Overview 7

Pipeline by Companies 8

Products under Development by Companies 9

Axial Spondyloarthritis - Therapeutics Assessment 10

Assessment by Target 10

Assessment by Mechanism of Action 12

Assessment by Route of Administration 14

Assessment by Molecule Type 16

Axial Spondyloarthritis - Companies Involved in Therapeutics Development 18

AstraZeneca Plc 18

Eli Lilly and Co 18

Novartis AG 19

Sandoz International GmbH 19

Sun Pharma Advanced Research Company Ltd 20

UCB SA 20

Axial Spondyloarthritis - Drug Profiles 22

adalimumab biosimilar - Drug Profile 22

Product Description 22

Mechanism Of Action 22

R&D Progress 22

adalimumab biosimilar - Drug Profile 23

Product Description 23

Mechanism Of Action 23

R&D Progress 23

brodalumab - Drug Profile 24

Product Description 24

Mechanism Of Action 24

R&D Progress 24

certolizumab pegol - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

etanercept biosimilar - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

ixekizumab - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

secukinumab - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Small Molecule to Antagonize ROR-Gamma for Psoriasis, Psoriatic Arthritis and Axial Spondyloarthritis - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

tildrakizumab - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Axial Spondyloarthritis - Dormant Projects 76

Axial Spondyloarthritis - Product Development Milestones 77

Featured News & Press Releases 77

Jun 27, 2017: Sandoz receives approval in Europe for Erelzi (biosimilar etanercept) to treat multiple inflammatory diseases 77

Jun 14, 2017: Results from CRIB study on CIMZIA (certolizumab pegol) demonstrate minimal to no placental transfer of drug from mother to infant during third trimester of pregnancy 77

Jun 14, 2017: UCB announces four-year imaging results demonstrating low disease progression and long-term efficacy of CIMZIA (certolizumab pegol) in patients with axial spondyloarthritis 79

Apr 24, 2017: Kyowa Hakko Kirin Announces Initiation of Global Phase 3 Study of KHK4827 (Brodalumab) in Patients with Axial Spondyloarthritis (axSpA) 80

Apr 21, 2017: Sandoz Receives CHMP Positive Opinion For Erelzi 80

Mar 06, 2017: First CIMZIA Study of Its Kind Showed Minimal to No Transfer of Drug from Mother’s Plasma to Breast Milk 81

Nov 11, 2016: UCB Presents Data on Cimzia (certolizumab pegol) at 2016 ACR/ARHP Annual Meeting 82

Oct 25, 2016: Certolizumab pegol (Cimzia) AutoClicks Prefilled Pen - a New Self-injection Device Designed in Collaboration With Patients and Good Grips - is Now Available in the UK on the NHS 86

Jun 08, 2016: UCB commitment to addressing real world patient needs on display at the Annual European Congress of Rheumatology (EULAR 2016) 86

Nov 06, 2015: UCB Presents Latest Research from Immunology Portfolio at American College of Rheumatology Annual Meeting 89

Nov 14, 2014: UCB Shows Strong Scientific Presence On Certolizumab pegol (CIMZIA) At Leading Rheumatology Meeting 94

Sep 20, 2013: UCB receives CHMP positive opinion for Cimzia in severe active axial spondyloarthritis 97

Jul 24, 2013: U.S. FDA Arthritis Advisory Committee Votes On Cimzia For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis 98

Jun 14, 2013: UCB's Certolizumab Pegol Rapidly Improves Pain, Fatigue And Physical Function In axSpA Patients In Phase III Study 99

Feb 20, 2013: UCB Announces Regulatory Filings For Cimzia To Treat Psoriatic Arthritis And Axial Spondyloarthritis 101

Appendix 103

Methodology 103

Coverage 103

Secondary Research 103

Primary Research 103

Expert Panel Validation 103

Contact Us 103

Disclaimer 104

List of Tables

List of Tables

Number of Products under Development for Axial Spondyloarthritis, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Products under Development by Companies, H2 2017 9

Number of Products by Stage and Target, H2 2017 11

Number of Products by Stage and Mechanism of Action, H2 2017 13

Number of Products by Stage and Route of Administration, H2 2017 15

Number of Products by Stage and Molecule Type, H2 2017 17

Axial Spondyloarthritis – Pipeline by AstraZeneca Plc, H2 2017 18

Axial Spondyloarthritis – Pipeline by Eli Lilly and Co, H2 2017 19

Axial Spondyloarthritis – Pipeline by Novartis AG, H2 2017 19

Axial Spondyloarthritis – Pipeline by Sandoz International GmbH, H2 2017 20

Axial Spondyloarthritis – Pipeline by Sun Pharma Advanced Research Company Ltd, H2 2017 20

Axial Spondyloarthritis – Pipeline by UCB SA, H2 2017 21

Axial Spondyloarthritis – Dormant Projects, H2 2017 76

List of Figures

List of Figures

Number of Products under Development for Axial Spondyloarthritis, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Number of Products by Targets, H2 2017 10

Number of Products by Stage and Targets, H2 2017 10

Number of Products by Mechanism of Actions, H2 2017 12

Number of Products by Stage and Mechanism of Actions, H2 2017 12

Number of Products by Routes of Administration, H2 2017 14

Number of Products by Stage and Routes of Administration, H2 2017 14

Number of Products by Molecule Types, H2 2017 16

Number of Products by Stage and Molecule Types, H2 2017 16

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