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Primary Biliary Cirrhosis - Pipeline Review, H1 2016

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

Primary Biliary Cirrhosis - Pipeline Review, H1 2016

Summary

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

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

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 Biliary Cirrhosis
- 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 Biliary Cirrhosis 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 Biliary Cirrhosis - Pipeline Review, H1 2016
Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Primary Biliary Cirrhosis Overview 8
Therapeutics Development 9
Pipeline Products for Primary Biliary Cirrhosis - Overview 9
Primary Biliary Cirrhosis - Therapeutics under Development by Companies 10
Primary Biliary Cirrhosis - Pipeline Products Glance 11
Late Stage Products 11
Clinical Stage Products 12
Early Stage Products 13
Unknown Stage Products 14
Primary Biliary Cirrhosis - Products under Development by Companies 15
Primary Biliary Cirrhosis - Companies Involved in Therapeutics Development 16
AlbireoPharma 16
CymaBay Therapeutics, Inc. 17
Dr. Falk Pharma GmbH 18
Enanta Pharmaceuticals, Inc. 19
GenKyoTex S.A. 20
GlaxoSmithKline Plc 21
Intercept Pharmaceuticals, Inc. 22
MediGene AG 23
NGM Biopharmaceuticals, Inc. 24
Novartis AG 25
Shire Plc 26
TGV-Laboratories 27
Virobay Inc. 28
Primary Biliary Cirrhosis - Therapeutics Assessment 29
Assessment by Monotherapy Products 29
Assessment by Target 30
Assessment by Mechanism of Action 32
Assessment by Route of Administration 34
Assessment by Molecule Type 36
Drug Profiles 38
A-4250 - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
budesonide - Drug Profile 39
Product Description 39
Mechanism of Action 39
RandD Progress 39
EDP-305 - Drug Profile 42
Product Description 42
Mechanism of Action 42
RandD Progress 42
FFP-104 - Drug Profile 43
Product Description 43
Mechanism of Action 43
RandD Progress 43
GKT-831 - Drug Profile 44
Product Description 44
Mechanism of Action 44
RandD Progress 44
GSK-2330672 - Drug Profile 46
Product Description 46
Mechanism of Action 46
RandD Progress 46
Hep-114 - Drug Profile 47
Product Description 47
Mechanism of Action 47
RandD Progress 47
LJN-452 - Drug Profile 48
Product Description 48
Mechanism of Action 48
RandD Progress 48
MBX-8025 - Drug Profile 49
Product Description 49
Mechanism of Action 49
RandD Progress 49
NGM-282 - Drug Profile 51
Product Description 51
Mechanism of Action 51
RandD Progress 51
obeticholic acid - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
RhuDex - Drug Profile 56
Product Description 56
Mechanism of Action 56
RandD Progress 56
SHP-625 - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
VBY-825 - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
Primary Biliary Cirrhosis - Recent Pipeline Updates 60
Primary Biliary Cirrhosis - Dormant Projects 77
Primary Biliary Cirrhosis - Product Development Milestones 78
Featured News and Press Releases 78
Feb 03, 2016: Fast Forward Pharmaceuticals Initiates Phase II Pilot Studies in Primary Biliary Cirrhosis and Crohn's Disease with anti-CD40 Monoclonal Antibody 78
Dec 17, 2015: FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC 78
Nov 14, 2015: Intercept Presents New PBC Data at AASLD 2015 79
Nov 10, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Primary Biliary Cholangitis/Cirrhosis 80
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 81
Nov 03, 2015: Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting 82
Aug 31, 2015: FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis 84
Jun 29, 2015: Intercept Pharmaceuticals Submits Applications in the U.S. and Europe for Marketing Approval of Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis 85
Apr 13, 2015: Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015 85
Mar 24, 2015: NGM Biopharmaceuticals Announces Positive Phase 2 Clinical Data in Primary Biliary Cirrhosis Patients for NGM282, a First-in-Class Investigational Medicine 87
Appendix 89
Methodology 89
Coverage 89
Secondary Research 89
Primary Research 89
Expert Panel Validation 89
Contact Us 89
Disclaimer 90

List of Tables
Number of Products under Development for Primary Biliary Cirrhosis, H1 2016 9
Number of Products under Development by Companies, H1 2016 10
Comparative Analysis by Late Stage Development, H1 2016 11
Comparative Analysis by Clinical Stage Development, H1 2016 12
Comparative Analysis by Early Stage Development, H1 2016 13
Comparative Analysis by Unknown Stage Development, H1 2016 14
Products under Development by Companies, H1 2016 15
Primary Biliary Cirrhosis - Pipeline by AlbireoPharma, H1 2016 16
Primary Biliary Cirrhosis - Pipeline by CymaBay Therapeutics, Inc., H1 2016 17
Primary Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H1 2016 18
Primary Biliary Cirrhosis - Pipeline by Enanta Pharmaceuticals, Inc., H1 2016 19
Primary Biliary Cirrhosis - Pipeline by GenKyoTex S.A., H1 2016 20
Primary Biliary Cirrhosis - Pipeline by GlaxoSmithKline Plc, H1 2016 21
Primary Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2016 22
Primary Biliary Cirrhosis - Pipeline by MediGene AG, H1 2016 23
Primary Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H1 2016 24
Primary Biliary Cirrhosis - Pipeline by Novartis AG, H1 2016 25
Primary Biliary Cirrhosis - Pipeline by Shire Plc, H1 2016 26
Primary Biliary Cirrhosis - Pipeline by TGV-Laboratories, H1 2016 27
Primary Biliary Cirrhosis - Pipeline by Virobay Inc., H1 2016 28
Assessment by Monotherapy Products, H1 2016 29
Number of Products by Stage and Target, H1 2016 31
Number of Products by Stage and Mechanism of Action, H1 2016 33
Number of Products by Stage and Route of Administration, H1 2016 35
Number of Products by Stage and Molecule Type, H1 2016 37
Primary Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H1 2016 60
Primary Biliary Cirrhosis - Dormant Projects, H1 2016 77

List of Figures
Number of Products under Development for Primary Biliary Cirrhosis, H1 2016 9
Number of Products under Development by Companies, H1 2016 10
Comparative Analysis by Late Stage Development, H1 2016 11
Comparative Analysis by Clinical Stage Development, H1 2016 12
Assessment by Monotherapy Products, H1 2016 29
Number of Products by Top 10 Targets, H1 2016 30
Number of Products by Stage and Top 10 Targets, H1 2016 30
Number of Products by Mechanism of Actions, H1 2016 32
Number of Products by Stage and Mechanism of Actions, H1 2016 32
Number of Products by Routes of Administration, H1 2016 34
Number of Products by Stage and Routes of Administration, H1 2016 34
Number of Products by Molecule Types, H1 2016 36
Number of Products by Stage and Molecule Types, H1 2016 36

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