Biliary Cirrhosis – Pipeline Review, H2 2012

Biliary Cirrhosis – Pipeline Review, H2 2012

Summary

Global Markets Direct’s, 'Biliary Cirrhosis - Pipeline Review, H2 2012', provides an overview of the Biliary Cirrhosis therapeutic pipeline. This report provides information on the therapeutic development for Biliary Cirrhosis, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Biliary Cirrhosis. 'Biliary Cirrhosis - Pipeline Review, H2 2012' 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.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

- A snapshot of the global therapeutic scenario for Biliary Cirrhosis.
- 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.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Biliary Cirrhosis pipeline on the basis of route of administration and molecule type.
- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Biliary Cirrhosis.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying players with the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Biliary Cirrhosis pipeline depth and focus of Biliary Cirrhosis 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 4
List of Figures 4
Introduction 5
Global Markets Direct Report Coverage 5
Biliary Cirrhosis Overview 6
Therapeutics Development 7
An Overview of Pipeline Products for Biliary Cirrhosis 7
Biliary Cirrhosis Therapeutics under Development by Companies 9
Biliary Cirrhosis Therapeutics under Investigation by Universities/Institutes 10
Late Stage Products 12
Comparative Analysis 12
Mid Clinical Stage Products 13
Comparative Analysis 13
Early Clinical Stage Products 14
Comparative Analysis 14
Pre-Clinical Stage Products 15
Comparative Analysis 15
Biliary Cirrhosis Therapeutics – Products under Development by Companies 16
Biliary Cirrhosis Therapeutics – Products under Investigation by Universities/Institutes 17
Companies Involved in Biliary Cirrhosis Therapeutics Development 18
NovImmune SA 18
Intercept Pharmaceuticals, Inc. 19
Dr. Falk Pharma GmbH 20
Centocor Ortho Biotech, Inc. 21
Biliary Cirrhosis – Therapeutics Assessment 22
Assessment by Monotherapy Products 22
Assessment by Combination Products 23
Assessment by Route of Administration 24
Assessment by Molecule Type 26
Biliary Cirrhosis Therapeutics – Discontinued Products 28
Biliary Cirrhosis Therapeutics - Dormant Products 29
Biliary Cirrhosis – Product Development Milestones 30
Featured News & Press Releases 30
Jul 24, 2012: Albireo Receives Positive Opinion From EMA For Orphan Drug Designation For A4250 For Severe Liver Diseases 30
Jun 21, 2012: Medigene Achieves Positive Formulation Study Results For RhuDex For Treatment Of Autoimmune Diseases 30
Sep 22, 2011: NovImmune Initiates Proof-of-Concept Study Of NI-0801 For Primary Biliary Cirrhosis 31
Mar 31, 2011: Intercept Announces Positive Phase II Results For Obeticholic Acid As Monotherapy In Primary Biliary Cirrhosis 32
Oct 27, 2010: Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment of Primary Biliary Cirrhosis 32
Apr 13, 2010: Intercept Pharmaceuticals Presents Positive Phase II Results from Study of INT-747 Therapy in Primary Biliary Cirrhosis at EASL 33
Nov 02, 2004: Axcan Launches URSO Forte in the U.S 33
Jul 26, 2004: URSO 500 mg Tablets Approved in the U.S. for the Treatment of Primary Biliary Cirrhosis 34
Sep 24, 2003: Axcan Submitted A Supplemental New Drug Application For Approval Of URSO 500 mg Tablets 34
Dec 11, 1997: Axcan Received FDA Approval for Urso 34
Appendix 35
Methodology 35
Coverage 35
Secondary Research 35
Primary Research 35
Expert Panel Validation 35
Contact Us 36
Disclaimer 36

List of Tables
Number of Products Under Development for Biliary Cirrhosis, H2 2012 7
Products under Development for Biliary Cirrhosis – Comparative Analysis, H2 2012 8
Number of Products under Development by Companies, H2 2012 9
Number of Products under Investigation by Universities/Institutes, H2 2012 11
Comparative Analysis by Late Stage Development, H2 2012 12
Comparative Analysis by Mid Clinical Stage Development, H2 2012 13
Comparative Analysis by Early Clinical Stage Development, H2 2012 14
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 15
Products under Development by Companies, H2 2012 16
Products under Investigation by Universities/Institutes, H2 2012 17
NovImmune SA, H2 2012 18
Intercept Pharmaceuticals, Inc., H2 2012 19
Dr. Falk Pharma GmbH, H2 2012 20
Centocor Ortho Biotech, Inc., H2 2012 21
Assessment by Monotherapy Products, H2 2012 22
Assessment by Combination Products, H2 2012 23
Assessment by Stage and Route of Administration, H2 2012 25
Assessment by Stage and Molecule Type, H2 2012 27
Biliary Cirrhosis Therapeutics – Discontinued Products 28
Biliary Cirrhosis Therapeutics – Dormant Products 29

List of Figures
Number of Products under Development for Biliary Cirrhosis, H2 2012 7
Products under Development for Biliary Cirrhosis – Comparative Analysis, H2 2012 8
Products under Development by Companies, H2 2012 9
Products under Investigation by Universities/Institutes, H2 2012 10
Late Stage Products, H2 2012 12
Mid Clinical Stage Products, H2 2012 13
Early Clinical Stage Products, H2 2012 14
Pre-Clinical Stage Products, H2 2012 15
Assessment by Monotherapy Products, H2 2012 22
Assessment by Combination Products, H2 2012 23
Assessment by Route of Administration, H2 2012 24
Assessment by Stage and Route of Administration, H2 2012 25
Assessment by Molecule Type, H2 2012 26
Assessment by Stage and Molecule Type, H2 2012 27