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Primary Sclerosing Cholangitis - Pipeline Review, H1 2016

  • February 2016
  • -
  • Global Markets Direct
  • -
  • 85 pages

Primary Sclerosing Cholangitis - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Primary Sclerosing Cholangitis - Pipeline Review, H1 2016’, provides an overview of the Primary Sclerosing Cholangitis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Primary Sclerosing Cholangitis, 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 Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis
- The report reviews pipeline therapeutics for Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis therapeutics and enlists all their major and minor projects
- The report assesses Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis

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 Primary Sclerosing Cholangitis
- 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 Primary Sclerosing Cholangitis 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

Primary Sclerosing Cholangitis - Pipeline Review, H1 2016
Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Primary Sclerosing Cholangitis Overview 7
Therapeutics Development 8
Pipeline Products for Primary Sclerosing Cholangitis - Overview 8
Primary Sclerosing Cholangitis - Therapeutics under Development by Companies 9
Primary Sclerosing Cholangitis - Pipeline Products Glance 10
Clinical Stage Products 10
Early Stage Products 11
Unknown Stage Products 12
Primary Sclerosing Cholangitis - Products under Development by Companies 13
Primary Sclerosing Cholangitis - Companies Involved in Therapeutics Development 14
Biotie Therapies Corp. 14
ChemoCentryx, Inc. 15
Dr. Falk Pharma GmbH 16
Gilead Sciences, Inc. 17
Intercept Pharmaceuticals, Inc. 18
NGM Biopharmaceuticals, Inc. 19
Sancilio and Company, Inc. 20
Shire Plc 21
Takeda Pharmaceutical Company Limited 22
TGV-Laboratories 23
Tobira Therapeutics, Inc. 24
Primary Sclerosing Cholangitis - Therapeutics Assessment 25
Assessment by Monotherapy Products 25
Assessment by Target 26
Assessment by Mechanism of Action 28
Assessment by Route of Administration 30
Assessment by Molecule Type 32
Drug Profiles 34
bertilimumab - Drug Profile 34
Product Description 34
Mechanism of Action 34
RandD Progress 34
BTT-1023 - Drug Profile 36
Product Description 36
Mechanism of Action 36
RandD Progress 36
CCX-507 - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
cenicriviroc mesylate - Drug Profile 39
Product Description 39
Mechanism of Action 39
RandD Progress 39
Cyndacel-M - Drug Profile 41
Product Description 41
Mechanism of Action 41
RandD Progress 41
Hep-114 - Drug Profile 43
Product Description 43
Mechanism of Action 43
RandD Progress 43
NGM-282 - Drug Profile 44
Product Description 44
Mechanism of Action 44
RandD Progress 44
norursodeoxycholic acid - Drug Profile 46
Product Description 46
Mechanism of Action 46
RandD Progress 46
obeticholic acid - Drug Profile 47
Product Description 47
Mechanism of Action 47
RandD Progress 47
SC-404 - Drug Profile 50
Product Description 50
Mechanism of Action 50
RandD Progress 50
SHP-625 - Drug Profile 51
Product Description 51
Mechanism of Action 51
RandD Progress 51
simtuzumab - Drug Profile 52
Product Description 52
Mechanism of Action 52
RandD Progress 52
vedolizumab - Drug Profile 54
Product Description 54
Mechanism of Action 54
RandD Progress 54
Primary Sclerosing Cholangitis - Recent Pipeline Updates 56
Primary Sclerosing Cholangitis - Dormant Projects 76
Primary Sclerosing Cholangitis - Product Development Milestones 77
Featured News and Press Releases 77
Jan 07, 2016: Tobira Therapeutics Announces Initiation of Program to Evaluate Cenicriviroc for the Treatment of Primary Sclerosing Cholangitis 77
Nov 09, 2015: NGM Bio to Present Data Highlighting the Therapeutic Potential of NGM282 in Cholestatic Liver Diseases at AASLD's The Liver Meeting 2015 77
Nov 03, 2015: Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting 78
Mar 31, 2015: Biotie announces start of patient enrolment into Phase 2a clinical study with BTT1023 in primary sclerosing cholangitis 81
Feb 17, 2015: BTT1023 receives positive opinion for Orphan Drug Designation from COMP 81
Jul 24, 2014: Clinical study with Biotie's BTT1023 in primary sclerosing cholangitis awarded external grant funding 81
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 82
Sep 26, 2013: Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food and Drug Administration for LUM001 in Four Rare Liver Diseases 83
Appendix 84
Methodology 84
Coverage 84
Secondary Research 84
Primary Research 84
Expert Panel Validation 84
Contact Us 84
Disclaimer 85

List of Tables
Number of Products under Development for Primary Sclerosing Cholangitis, H1 2016 8
Number of Products under Development by Companies, H1 2016 9
Comparative Analysis by Clinical Stage Development, H1 2016 10
Comparative Analysis by Early Stage Development, H1 2016 11
Comparative Analysis by Unknown Stage Development, H1 2016 12
Products under Development by Companies, H1 2016 13
Primary Sclerosing Cholangitis - Pipeline by Biotie Therapies Corp., H1 2016 14
Primary Sclerosing Cholangitis - Pipeline by ChemoCentryx, Inc., H1 2016 15
Primary Sclerosing Cholangitis - Pipeline by Dr. Falk Pharma GmbH, H1 2016 16
Primary Sclerosing Cholangitis - Pipeline by Gilead Sciences, Inc., H1 2016 17
Primary Sclerosing Cholangitis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2016 18
Primary Sclerosing Cholangitis - Pipeline by NGM Biopharmaceuticals, Inc., H1 2016 19
Primary Sclerosing Cholangitis - Pipeline by Sancilio and Company, Inc., H1 2016 20
Primary Sclerosing Cholangitis - Pipeline by Shire Plc, H1 2016 21
Primary Sclerosing Cholangitis - Pipeline by Takeda Pharmaceutical Company Limited, H1 2016 22
Primary Sclerosing Cholangitis - Pipeline by TGV-Laboratories, H1 2016 23
Primary Sclerosing Cholangitis - Pipeline by Tobira Therapeutics, Inc., H1 2016 24
Assessment by Monotherapy Products, H1 2016 25
Number of Products by Stage and Target, H1 2016 27
Number of Products by Stage and Mechanism of Action, H1 2016 29
Number of Products by Stage and Route of Administration, H1 2016 31
Number of Products by Stage and Molecule Type, H1 2016 33
Primary Sclerosing Cholangitis Therapeutics - Recent Pipeline Updates, H1 2016 56
Primary Sclerosing Cholangitis - Dormant Projects, H1 2016 76

List of Figures
Number of Products under Development for Primary Sclerosing Cholangitis, H1 2016 8
Number of Products under Development by Companies, H1 2016 9
Comparative Analysis by Clinical Stage Development, H1 2016 10
Comparative Analysis by Early Stage Products, H1 2016 11
Assessment by Monotherapy Products, H1 2016 25
Number of Products by Top 10 Targets, H1 2016 26
Number of Products by Stage and Top 10 Targets, H1 2016 26
Number of Products by Top 10 Mechanism of Actions, H1 2016 28
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2016 28
Number of Products by Routes of Administration, H1 2016 30
Number of Products by Stage and Routes of Administration, H1 2016 30
Number of Products by Molecule Types, H1 2016 32
Number of Products by Stage and Molecule Types, H1 2016 32

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