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Biliary Cirrhosis - Pipeline Review, H2 2015

Published: Jul-2015 | Format: PDF | Global Markets Direct | Number of pages: 82 | Code: MRS - 31594

Biliary Cirrhosis - Pipeline Review, H2 2015

Summary

Global Markets Direct’s, ‘Biliary Cirrhosis - Pipeline Review, H2 2015’, provides an overview of the Biliary Cirrhosis’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Biliary Cirrhosis, 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 Biliary Cirrhosis 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 Biliary Cirrhosis
- 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 Biliary Cirrhosis and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects 
- A review of the Biliary Cirrhosis 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 Biliary Cirrhosis 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 Biliary Cirrhosis
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding 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
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Biliary Cirrhosis Overview 7
Therapeutics Development 8
Pipeline Products for Biliary Cirrhosis - Overview 8
Pipeline Products for Biliary Cirrhosis - Comparative Analysis 9
Biliary Cirrhosis - Therapeutics under Development by Companies 10
Biliary Cirrhosis - Pipeline Products Glance 11
Late Stage Products 11
Clinical Stage Products 12
Early Stage Products 13
Biliary Cirrhosis - Products under Development by Companies 14
Biliary Cirrhosis - Companies Involved in Therapeutics Development 15
AlbireoPharma 15
CymaBay Therapeutics, Inc. 16
Dr. Falk Pharma GmbH 17
Enanta Pharmaceuticals, Inc. 18
GlaxoSmithKline Plc 19
Intercept Pharmaceuticals, Inc. 20
Johnson & Johnson 21
MediGene AG 22
NGM Biopharmaceuticals, Inc. 23
Shire Plc 24
Virobay Inc. 25
Biliary Cirrhosis - 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
A-4250 - Drug Profile 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
budesonide - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
FFP-104 - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
GSK-2330672 - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
MBX-8025 - Drug Profile 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
NGM-282 - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
obeticholic acid - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
RhuDex - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
SHP-625 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
Small Molecules to Agonize Farnesoid X Receptor for Non-alcoholic Steatohepatitis and Primary Biliary Cirrhosis - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
ustekinumab - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
VBY-825 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
Biliary Cirrhosis - Recent Pipeline Updates 55
Biliary Cirrhosis - Dormant Projects 69
Biliary Cirrhosis - Product Development Milestones 70
Featured News & Press Releases 70
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 70
Apr 13, 2015: Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015 70
Mar 24, 2015: NGM Biopharmaceuticals Announces Positive Phase 2 Clinical Data in Primary Biliary Cirrhosis Patients for NGM282, a First-in-Class Investigational Medicine 72
Feb 05, 2015: Initiation of a Phase II Trial for A4250, the Company’s Lead Compound for Cholestatic Liver Diseases and NASH 73
Nov 08, 2014: Intercept Announces Additional Data for OCA in Primary Biliary Cirrhosis 74
May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 75
Apr 12, 2014: Intercept Reports Additional Positive Data From POISE Trial at EASL Late-Breaker Session 75
Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 77
Apr 04, 2014: Data From Intercept's Pivotal Phase 3 POISE Trial of Its FXR Agonist Obeticholic Acid to Treat Primary Biliary Cirrhosis and Other Key Obeticholic Acid Data to be Presented at EASL 2014 77
Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 79
Appendix 81
Methodology 81
Coverage 81
Secondary Research 81
Primary Research 81
Expert Panel Validation 81
Contact Us 81
Disclaimer 82

List of Tables
Number of Products under Development for Biliary Cirrhosis, H2 2015 8
Number of Products under Development for Biliary Cirrhosis - Comparative Analysis, H2 2015 9
Number of Products under Development by Companies, H2 2015 10
Comparative Analysis by Late Stage Development, H2 2015 11
Comparative Analysis by Clinical Stage Development, H2 2015 12
Comparative Analysis by Early Stage Development, H2 2015 13
Products under Development by Companies, H2 2015 14
Biliary Cirrhosis - Pipeline by AlbireoPharma, H2 2015 15
Biliary Cirrhosis - Pipeline by CymaBay Therapeutics, Inc., H2 2015 16
Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H2 2015 17
Biliary Cirrhosis - Pipeline by Enanta Pharmaceuticals, Inc., H2 2015 18
Biliary Cirrhosis - Pipeline by GlaxoSmithKline Plc, H2 2015 19
Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H2 2015 20
Biliary Cirrhosis - Pipeline by Johnson & Johnson, H2 2015 21
Biliary Cirrhosis - Pipeline by MediGene AG, H2 2015 22
Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H2 2015 23
Biliary Cirrhosis - Pipeline by Shire Plc, H2 2015 24
Biliary Cirrhosis - Pipeline by Virobay Inc., H2 2015 25
Assessment by Monotherapy Products, H2 2015 26
Number of Products by Stage and Target, H2 2015 28
Number of Products by Stage and Mechanism of Action, H2 2015 30
Number of Products by Stage and Route of Administration, H2 2015 32
Number of Products by Stage and Molecule Type, H2 2015 34
Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H2 2015 55
Biliary Cirrhosis - Dormant Projects, H2 2015 69

List of Figures
Number of Products under Development for Biliary Cirrhosis, H2 2015 8
Number of Products under Development for Biliary Cirrhosis - Comparative Analysis, H2 2015 9
Number of Products under Development by Companies, H2 2015 10
Comparative Analysis by Late Stage Development, H2 2015 11
Comparative Analysis by Clinical Stage Development, H2 2015 12
Assessment by Monotherapy Products, H2 2015 26
Number of Products by Top 10 Targets, H2 2015 27
Number of Products by Stage and Top 10 Targets, H2 2015 27
Number of Products by Top 10 Mechanism of Actions, H2 2015 29
Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 29
Number of Products by Top 10 Routes of Administration, H2 2015 31
Number of Products by Stage and Top 10 Routes of Administration, H2 2015 31
Number of Products by Top 10 Molecule Types, H2 2015 33
Number of Products by Stage and Top 10 Molecule Types, H2 2015 33

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