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Biliary Cirrhosis - Pipeline Review, H1 2015

  • January 2015
  • -
  • Global Markets Direct
  • -
  • 75 pages

Biliary Cirrhosis - Pipeline Review, H1 2015

Summary

Global Markets Direct’s, ‘Biliary Cirrhosis - Pipeline Review, H1 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

Biliary Cirrhosis - Pipeline Review, H1 2015
Table of Contents
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 12
Late Stage Products 12
Clinical Stage Products 13
Early Stage Products 14
Biliary Cirrhosis - Products under Development by Companies 15
Biliary Cirrhosis - Companies Involved in Therapeutics Development 16
AlbireoPharma 16
Dr. Falk Pharma GmbH 17
GlaxoSmithKline plc 18
Intercept Pharmaceuticals, Inc. 19
Johnson and Johnson 20
MediGene AG 21
NGM Biopharmaceuticals, Inc. 22
Shire Plc 23
Virobay Inc. 24
Biliary Cirrhosis - 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
A-4250 - Drug Profile 34
Product Description 34
Mechanism of Action 34
RandD Progress 34
budesonide - Drug Profile 35
Product Description 35
Mechanism of Action 35
RandD Progress 35
FFP-104 - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
GSK-2330672 - Drug Profile 39
Product Description 39
Mechanism of Action 39
RandD Progress 39
Leukothera - Drug Profile 40
Product Description 40
Mechanism of Action 40
RandD Progress 40
NGM-282 - Drug Profile 41
Product Description 41
Mechanism of Action 41
RandD Progress 41
obeticholic acid - Drug Profile 42
Product Description 42
Mechanism of Action 42
RandD Progress 42
RhuDex - Drug Profile 45
Product Description 45
Mechanism of Action 45
RandD Progress 45
SHP-625 - Drug Profile 47
Product Description 47
Mechanism of Action 47
RandD Progress 47
ustekinumab - Drug Profile 48
Product Description 48
Mechanism of Action 48
RandD Progress 48
VBY-825 - Drug Profile 50
Product Description 50
Mechanism of Action 50
RandD Progress 50
Biliary Cirrhosis - Recent Pipeline Updates 51
Biliary Cirrhosis - Dormant Projects 62
Biliary Cirrhosis - Product Development Milestones 63
Featured News and Press Releases 63
Nov 08, 2014: Intercept Announces Additional Data for OCA in Primary Biliary Cirrhosis 63
May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 64
Apr 12, 2014: Intercept Reports Additional Positive Data From POISE Trial at EASL Late-Breaker Session 64
Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 66
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 67
Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 68
Jan 09, 2014: Intercept Provides 2013 Year-End Update and 2014 Anticipated Milestones 69
Dec 13, 2013: Medigene Granted Additional Patent for RhuDex for the Treatment of Autoimmune Diseases 71
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 72
Oct 29, 2013: Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis 73
Appendix 74
Methodology 74
Coverage 74
Secondary Research 74
Primary Research 74
Expert Panel Validation 74
Contact Us 75
Disclaimer 75

List of Tables

Number of Products under Development for Biliary Cirrhosis, H1 2015 8
Number of Products under Development for Biliary Cirrhosis - Comparative Analysis, H1 2015 9
Number of Products under Development by Companies, H1 2015 11
Comparative Analysis by Late Stage Development, H1 2015 12
Comparative Analysis by Clinical Stage Development, H1 2015 13
Comparative Analysis by Early Stage Development, H1 2015 14
Products under Development by Companies, H1 2015 15
Biliary Cirrhosis - Pipeline by AlbireoPharma, H1 2015 16
Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H1 2015 17
Biliary Cirrhosis - Pipeline by GlaxoSmithKline plc, H1 2015 18
Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2015 19
Biliary Cirrhosis - Pipeline by Johnson and Johnson, H1 2015 20
Biliary Cirrhosis - Pipeline by MediGene AG, H1 2015 21
Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H1 2015 22
Biliary Cirrhosis - Pipeline by Shire Plc, H1 2015 23
Biliary Cirrhosis - Pipeline by Virobay Inc., H1 2015 24
Assessment by Monotherapy Products, H1 2015 25
Number of Products by Stage and Target, H1 2015 27
Number of Products by Stage and Mechanism of Action, H1 2015 29
Number of Products by Stage and Route of Administration, H1 2015 31
Number of Products by Stage and Molecule Type, H1 2015 33
Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H1 2015 51
Biliary Cirrhosis - Dormant Projects, H1 2015 62

List of Figures

Number of Products under Development for Biliary Cirrhosis, H1 2015 8
Number of Products under Development for Biliary Cirrhosis - Comparative Analysis, H1 2015 9
Number of Products under Development by Companies, H1 2015 10
Comparative Analysis by Clinical Stage Development, H1 2015 13
Assessment by Monotherapy Products, H1 2015 25
Number of Products by Top 10 Targets, H1 2015 26
Number of Products by Stage and Top 10 Targets, H1 2015 26
Number of Products by Top 10 Mechanism of Actions, H1 2015 28
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 28
Number of Products by Top 10 Routes of Administration, H1 2015 30
Number of Products by Stage and Top 10 Routes of Administration, H1 2015 31
Number of Products by Top 10 Molecule Types, H1 2015 32
Number of Products by Stage and Top 10 Molecule Types, H1 2015 33

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