World Biological Therapy: Cirrhosis - Pipeline Review, H2 2011

• Publication date: October 2011

This report provides information on the therapeutic development for 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 Cirrhosis. '' is built using data and information sourced from Global Industries Direct’s proprietary databases, Firms /University websites, SEC filings, investor presentations and featured press releases ...

This report provides information on the therapeutic development for 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 Cirrhosis. '' is built using data and information sourced from Global Industries Direct’s proprietary databases, Firms /University websites, SEC filings, investor presentations and featured press releases from firm /university sites and market -specific third party sources, put together by Global Industries 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 of the Research

- A snapshot of the global therapeutic scenario for Cirrhosis.
- A review of the Cirrhosis products under development by industry players and universities/research institutes based on information derived from industry player and market -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 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.

Why Should You Get This Report?

- Identify and understand important and diverse types of therapeutics under development for Cirrhosis.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and take over s effectively by identifying players with the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Cirrhosis pipeline depth and focus of Cirrhosis therapeutics.
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and grow business potential and scope.
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.

Global Biological Therapy Industry

Table of Contents
Table of Contents 2
List of Tables 7
List of Figures 8
Introduction 9
Global March kets Direct Report Coverage 9
Cirrhosis Overview 10
Therapeutics Development 11
An Overview of Pipeline Products for Cirrhosis 11
Cirrhosis Therapeutics under Development by Firms 13
Cirrhosis Therapeutics under Investigation by Universities/Institutes 15
Late Stage Products 18
Comparative Analysis 18
Mid Clinical Stage Products 19
Comparative Analysis 19
Early Clinical Stage Products 20
Comparative Analysis 20
Discovery and Pre-Clinical Stage Products 21
Comparative Analysis 21
Cirrhosis Therapeutics - Products under Development by Firms 22
Cirrhosis Therapeutics - Products under Investigation by Universities/Institutes 23
Companies Involved in Cirrhosis Therapeutics Development 26
Johnson & Johnson 26
F. Hoffmann-La Roche Ltd. 26
ARQULE, INC 27
Amsterdam Molecular Therapeutics BV 27
Ocera Therapeutics, Inc. 28
November Immune SA 28
Intercept Pharmaceuticals, Inc. 29
PharmaEssentia Corporation 29
Stelic Institute & Co. 30
Dr. Falk Pharma GmbH 30
Stempeutics Research Private Limited 31
Cirrhosis - Therapeutics Assessment 32
Assessment by Monotherapy Products 32
Assessment by Combination Products 33
Assessment by Route of Administration 34
Assessment by Molecule Type 36
Drug Profiles 39
NI-0801 - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
RG964 + Pegasys - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
Stelara - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
P1104 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
OCR-002 - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
STNM04 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
INT-747 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
ARQ 197 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
AMT-070 - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
Samsca - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
Xifaxan - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
Sorafenib - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
Autologous CD133 + Stem Cells - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
Torisel - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
Terlipressin - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
Budesonide + Ursodeoxycholic acid - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
Terlipressin - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
Oltipraz - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
Pegylated Interferon Alfa-2a + Ribavirin - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
Adefovir + Glycyrrhizin - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
Adefovir + Lamivudine - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
Adefovir - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Lenograstim + Haematopoietic Stem Cells - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
Nobelzin - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
Terlipressin + Dopamine + Norepinephrine - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Fenofibrate + Ursodeoxycholic Acid - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
CD133 - Drug Profile 70
Product Description 70
Mechanism of Action 70
R&D Progress 70
Modafinil - Drug Profile 71
Product Description 71
Mechanism of Action 71
R&D Progress 71
Umbilical Cord Mesenchymal Stem Cells - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
Allogenic Bone March row Stem Cells Transplant - Drug Profile 73
Product Description 73
Mechanism of Action 73
R&D Progress 73
Autologous Bone March row Mesenchymal Stem Cells Transplant - Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
Ursodiol + Methotrexate - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
Umbilical Cord Mesenchymal Stem Cells - Drug Profile 76
Product Description 76
Mechanism of Action 76
R&D Progress 76
Triglide - Drug Profile 78
Product Description 78
Mechanism of Action 78
R&D Progress 78
Umbilical Cord Mesenchymal Stem Cells - Drug Profile 79
Product Description 79
Mechanism of Action 79
R&D Progress 79
Mono Nuclear Cells - Drug Profile 80
Product Description 80
Mechanism of Action 80
R&D Progress 80
Pentoxifylline - Drug Profile 81
Product Description 81
Mechanism of Action 81
R&D Progress 81
Autograft Mesenchymal Stem Cells - Drug Profile 82
Product Description 82
Mechanism of Action 82
R&D Progress 82
INT 747 + Ursodeoxycholic Acid - Drug Profile 83
Product Description 83
Mechanism of Action 83
R&D Progress 83
Olmesartan Medoxomil - Drug Profile 84
Product Description 84
Mechanism of Action 84
R&D Progress 84
Dexamethasone - Drug Profile 85
Product Description 85
Mechanism of Action 85
R&D Progress 85
Autologous Bone March row-Derived Endothelial Progenitor Cells - Drug Profile 86
Product Description 86
Mechanism of Action 86
R&D Progress 86
Cyclophosphamide + Fludarabine + Campath-1H + Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation - Drug Profile 87
Product Description 87
Mechanism of Action 87
R&D Progress 87
Autologous Mesenchymal Stem Cell Transplantation - Drug Profile 88
Product Description 88
Mechanism of Action 88
R&D Progress 88
Stempeucel- LC - Drug Profile 89
Product Description 89
Mechanism of Action 89
R&D Progress 89
Autologous Bone March row Mononuclear Cells - Drug Profile 90
Product Description 90
Mechanism of Action 90
R&D Progress 90
Bone March row Derived Stem Cells Transplantation + G-CSF - Drug Profile 92
Product Description 92
Mechanism of Action 92
R&D Progress 92
Cirrhosis Therapeutics – Drug Profile Updates 93
Cirrhosis Therapeutics - Discontinued Products 96
Cirrhosis - Featured News 97
September 22, 2011: November Immune Initiates Proof-of-Concept Study Of NI-0801 For Primary Biliary Cirrhosis 97
March 31, 2011: Intercept Announces Positive Phase II Results For Obeticholic Acid As Monotherapy In Primary Biliary Cirrhosis 97
October 27, 2010: Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment of Primary Biliary Cirrhosis 98
October 26, 2010: Chugai Pharmaceutical Filed For Additional Indication Of Compensated Liver Cirrhosis Related to Hepatitis C For Pegasys, And Antiviral Drug, Copegus, 98
October 29, 2009: LG Life Sciences Discovers Innovative Necrosis Inhibitors 99
November 27, 2007: Amsterdam Molecular Therapeutics Initiates Program For Late Stage Liver Cirrhosis 99
Appendix 101
Methodology 101
Coverage 101
Secondary Research 101
Primary Research 101
Expert Panel Validation 102
Contact Us 102
Disclaimer 102

List of Tables

Number of Products Under Development for Cirrhosis, H2 2011 11
Products under Development for Cirrhosis – Comparative Analysis, H2 2011 12
Number of Products under Development by Firms, H2 2011 14
Number of Products under Investigation by Universities/Institutes, H2 2011 16
Number of Products under Investigation by Universities/Institutes, H2 2011 17
Comparative Analysis by Late Stage Development, H2 2011 18
Comparative Analysis by Mid Clinical Stage Development, H2 2011 19
Comparative Analysis by Early Clinical Stage Development, H2 2011 20
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H2 2011 21
Products under Development by Firms, H2 2011 22
Products under Investigation by Universities/Institutes, H2 2011 23
Products under Investigation by Universities/Institutes, H2 2011 24
Products under Investigation by Universities/Institutes, H2 2011 25
Johnson & Johnson, H2 2011 26
F. Hoffmann-La Roche Ltd., H2 2011 26
ARQULE, INC, H2 2011 27
Amsterdam Molecular Therapeutics BV, H2 2011 27
Ocera Therapeutics, Inc., H2 2011 28
November Immune SA, H2 2011 28
Intercept Pharmaceuticals, Inc., H2 2011 29
PharmaEssentia Corporation, H2 2011 29
Stelic Institute & Co., H2 2011 30
Dr. Falk Pharma GmbH, H2 2011 30
Stempeutics Research Private Limited, H2 2011 31
Assessment by Monotherapy Products, H2 2011 32
Assessment by Combination Products 33
Assessment by Stage and Route of Administration, H2 2011 35
Assessment by Molecule Type, H2 2011 38
Cirrhosis Therapeutics – Drug Profile Updates 93
Discontinued Products 96

List of Figures

Number of Products under Development for Cirrhosis, H2 2011 11
Products under Development for Cirrhosis – Comparative Analysis, H2 2011 12
Products under Development by Firms, H2 2011 13
Products under Investigation by Universities/Institutes, H2 2011 15
Late Stage Products, H2 2011 18
Mid Clinical Stage Products, H2 2011 19
Early Clinical Stage Products, H2 2011 20
Discovery and Pre-Clinical Stage Products, H2 2011 21
Assessment by Monotherapy Products, H2 2011 32
Assessment by Combination Products, H2 2011 33
Assessment by Route of Administration, H2 2011 34
Assessment by Stage and Route of Administration, H2 2011 35
Assessment by Molecule Type, H2 2011 36
Assessment by Stage and Molecule Type, H2 2011 37