Primary Biliary Cirrhosis - Pipeline Review, H1 2016

 Table of Contents

Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Primary Biliary Cirrhosis Overview 8
Therapeutics Development 9
Pipeline Products for Primary Biliary Cirrhosis - Overview 9
Primary Biliary Cirrhosis - Therapeutics under Development by Companies 10
Primary Biliary Cirrhosis - Pipeline Products Glance 11
Late Stage Products 11
Clinical Stage Products 12
Early Stage Products 13
Unknown Stage Products 14
Primary Biliary Cirrhosis - Products under Development by Companies 15
Primary Biliary Cirrhosis - Companies Involved in Therapeutics Development 16
AlbireoPharma 16
CymaBay Therapeutics, Inc. 17
Dr. Falk Pharma GmbH 18
Enanta Pharmaceuticals, Inc. 19
GenKyoTex S.A. 20
GlaxoSmithKline Plc 21
Intercept Pharmaceuticals, Inc. 22
MediGene AG 23
NGM Biopharmaceuticals, Inc. 24
Novartis AG 25
Shire Plc 26
TGV-Laboratories 27
Virobay Inc. 28
Primary Biliary Cirrhosis - Therapeutics Assessment 29
Assessment by Monotherapy Products 29
Assessment by Target 30
Assessment by Mechanism of Action 32
Assessment by Route of Administration 34
Assessment by Molecule Type 36
Drug Profiles 38
A-4250 - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
budesonide - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
EDP-305 - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
FFP-104 - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
GKT-831 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
GSK-2330672 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
Hep-114 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
LJN-452 - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
MBX-8025 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
NGM-282 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
obeticholic acid - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
RhuDex - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
SHP-625 - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
VBY-825 - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
Primary Biliary Cirrhosis - Recent Pipeline Updates 60
Primary Biliary Cirrhosis - Dormant Projects 77
Primary Biliary Cirrhosis - Product Development Milestones 78
Featured News & Press Releases 78
Feb 03, 2016: Fast Forward Pharmaceuticals Initiates Phase II Pilot Studies in Primary Biliary Cirrhosis and Crohn's Disease with anti-CD40 Monoclonal Antibody 78
Dec 17, 2015: FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC 78
Nov 14, 2015: Intercept Presents New PBC Data at AASLD 2015 79
Nov 10, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Primary Biliary Cholangitis/Cirrhosis 80
Nov 09, 2015: NGM Bio to Present Data Highlighting the Therapeutic Potential of NGM282 in Cholestatic Liver Diseases at AASLD's The Liver Meeting 2015 81
Nov 03, 2015: Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting 82
Aug 31, 2015: FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis 84
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 85
Apr 13, 2015: Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015 85
Mar 24, 2015: NGM Biopharmaceuticals Announces Positive Phase 2 Clinical Data in Primary Biliary Cirrhosis Patients for NGM282, a First-in-Class Investigational Medicine 87
Appendix 89
Methodology 89
Coverage 89
Secondary Research 89
Primary Research 89
Expert Panel Validation 89
Contact Us 89
Disclaimer 90

List of Tables

Number of Products under Development for Primary Biliary Cirrhosis, H1 2016 9
Number of Products under Development by Companies, H1 2016 10
Comparative Analysis by Late Stage Development, H1 2016 11
Comparative Analysis by Clinical Stage Development, H1 2016 12
Comparative Analysis by Early Stage Development, H1 2016 13
Comparative Analysis by Unknown Stage Development, H1 2016 14
Products under Development by Companies, H1 2016 15
Primary Biliary Cirrhosis - Pipeline by AlbireoPharma, H1 2016 16
Primary Biliary Cirrhosis - Pipeline by CymaBay Therapeutics, Inc., H1 2016 17
Primary Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H1 2016 18
Primary Biliary Cirrhosis - Pipeline by Enanta Pharmaceuticals, Inc., H1 2016 19
Primary Biliary Cirrhosis - Pipeline by GenKyoTex S.A., H1 2016 20
Primary Biliary Cirrhosis - Pipeline by GlaxoSmithKline Plc, H1 2016 21
Primary Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2016 22
Primary Biliary Cirrhosis - Pipeline by MediGene AG, H1 2016 23
Primary Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H1 2016 24
Primary Biliary Cirrhosis - Pipeline by Novartis AG, H1 2016 25
Primary Biliary Cirrhosis - Pipeline by Shire Plc, H1 2016 26
Primary Biliary Cirrhosis - Pipeline by TGV-Laboratories, H1 2016 27
Primary Biliary Cirrhosis - Pipeline by Virobay Inc., H1 2016 28
Assessment by Monotherapy Products, H1 2016 29
Number of Products by Stage and Target, H1 2016 31
Number of Products by Stage and Mechanism of Action, H1 2016 33
Number of Products by Stage and Route of Administration, H1 2016 35
Number of Products by Stage and Molecule Type, H1 2016 37
Primary Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H1 2016 60
Primary Biliary Cirrhosis - Dormant Projects, H1 2016 77 

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