Primary Biliary Cirrhosis - Pipeline Review, H2 2014

Published: Dec, 2014 | Pages: 73 | Publisher: Global Markets Direct
Industry: Healthcare | Report Format: Electronic (PDF)

Primary Biliary Cirrhosis - Pipeline Review, H2 2014

Summary

Global Markets Direct's, 'Primary Biliary Cirrhosis - Pipeline Review, H2 2014', provides an overview of the Primary Biliary Cirrhosis's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Primary 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 Primary 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 Primary 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 Primary Biliary Cirrhosis and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects 
- A review of the Primary 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 Primary 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 Primary Biliary Cirrhosis
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- 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
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Primary Biliary Cirrhosis Overview 7
Therapeutics Development 8
Pipeline Products for Primary Biliary Cirrhosis - Overview 8
Pipeline Products for Primary Biliary Cirrhosis - Comparative Analysis 9
Primary Biliary Cirrhosis - Therapeutics under Development by Companies 10
Primary Biliary Cirrhosis - Pipeline Products Glance 12
Late Stage Products 12
Clinical Stage Products 13
Early Stage Products 14
Primary Biliary Cirrhosis - Products under Development by Companies 15
Primary Biliary Cirrhosis - Companies Involved in Therapeutics Development 16
AlbireoPharma 16
Dr. Falk Pharma GmbH 17
GlaxoSmithKline plc 18
Intercept Pharmaceuticals, Inc. 19
Johnson & Johnson 20
MediGene AG 21
NGM Biopharmaceuticals, Inc. 22
Shire Plc 23
Virobay Inc. 24
Primary 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
R&D Progress 34
budesonide - Drug Profile 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
FFP-104 - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
GSK-2330672 - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
NGM-282 - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
obeticholic acid - Drug Profile 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
RhuDex - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
SHP-625 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
ustekinumab - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
VBY-825 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
Primary Biliary Cirrhosis - Recent Pipeline Updates 50
Primary Biliary Cirrhosis - Dormant Projects 61
Primary Biliary Cirrhosis - Product Development Milestones 62
Featured News & Press Releases 62
May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 62
Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 62
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 63
Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 64
Jan 09, 2014: Intercept Provides 2013 Year-End Update and 2014 Anticipated Milestones 65
Dec 13, 2013: Medigene Granted Additional Patent for RhuDex for the Treatment of Autoimmune Diseases 68
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 68
Oct 29, 2013: Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis 69
Sep 26, 2013: Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases 70
May 20, 2013: Intercept Pharma Announces Positive Initial Results From Ongoing Phase IIa Trial In Chronic Bile Acid Diarrhea 71
Appendix 72
Methodology 72
Coverage 72
Secondary Research 72
Primary Research 72
Expert Panel Validation 72
Contact Us 73
Disclaimer 73

List of Tables
Number of Products under Development for Primary Biliary Cirrhosis, H2 2014 8
Number of Products under Development for Primary Biliary Cirrhosis - Comparative Analysis, H2 2014 9
Number of Products under Development by Companies, H2 2014 11
Comparative Analysis by Late Stage Development, H2 2014 12
Comparative Analysis by Clinical Stage Development, H2 2014 13
Comparative Analysis by Early Stage Development, H2 2014 14
Products under Development by Companies, H2 2014 15
Primary Biliary Cirrhosis - Pipeline by AlbireoPharma, H2 2014 16
Primary Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H2 2014 17
Primary Biliary Cirrhosis - Pipeline by GlaxoSmithKline plc, H2 2014 18
Primary Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H2 2014 19
Primary Biliary Cirrhosis - Pipeline by Johnson & Johnson, H2 2014 20
Primary Biliary Cirrhosis - Pipeline by MediGene AG, H2 2014 21
Primary Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H2 2014 22
Primary Biliary Cirrhosis - Pipeline by Shire Plc, H2 2014 23
Primary Biliary Cirrhosis - Pipeline by Virobay Inc., H2 2014 24
Assessment by Monotherapy Products, H2 2014 25
Number of Products by Stage and Target, H2 2014 27
Number of Products by Stage and Mechanism of Action, H2 2014 29
Number of Products by Stage and Route of Administration, H2 2014 31
Number of Products by Stage and Molecule Type, H2 2014 33
Primary Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H2 2014 50
Primary Biliary Cirrhosis - Dormant Projects, H2 2014 61