Primary Biliary Cirrhosis - Pipeline Review, H2 2016

 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
Primary Biliary Cirrhosis - Therapeutics under Development by Companies 9
Primary Biliary Cirrhosis - Pipeline Products Glance 10
Late Stage Products 10
Clinical Stage Products 11
Early Stage Products 12
Unknown Stage Products 13
Primary Biliary Cirrhosis - Products under Development by Companies 14
Primary Biliary Cirrhosis - Companies Involved in Therapeutics Development 15
AlbireoPharma 15
CymaBay Therapeutics, Inc. 16
Dr. Falk Pharma GmbH 17
Enanta Pharmaceuticals, Inc. 18
Genextra S.p.a. 19
GenKyoTex S.A. 20
GlaxoSmithKline Plc 21
MediGene AG 22
NGM Biopharmaceuticals, Inc. 23
Novartis AG 24
Shire Plc 25
TGV-Laboratories 26
Virobay Inc. 27
Primary Biliary Cirrhosis - Therapeutics Assessment 28
Assessment by Monotherapy Products 28
Assessment by Target 29
Assessment by Mechanism of Action 31
Assessment by Route of Administration 33
Assessment by Molecule Type 35
Drug Profiles 37
A-4250 - Drug Profile 37
Product Description 37
Mechanism Of Action 37
R&D Progress 37
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 47
Product Description 47
Mechanism Of Action 47
R&D Progress 47
Hep-114 - Drug Profile 48
Product Description 48
Mechanism Of Action 48
R&D Progress 48
LJN-452 - Drug Profile 49
Product Description 49
Mechanism Of Action 49
R&D Progress 49
maralixibat chloride - Drug Profile 50
Product Description 50
Mechanism Of Action 50
R&D Progress 50
MBX-8025 - Drug Profile 53
Product Description 53
Mechanism Of Action 53
R&D Progress 53
NGM-282 - Drug Profile 56
Product Description 56
Mechanism Of Action 56
R&D Progress 56
obeticholic acid - Drug Profile 58
Product Description 58
Mechanism Of Action 58
R&D Progress 58
RhuDex - Drug Profile 67
Product Description 67
Mechanism Of Action 67
R&D Progress 67
VBY-825 - Drug Profile 69
Product Description 69
Mechanism Of Action 69
R&D Progress 69
Primary Biliary Cirrhosis - Dormant Projects 70
Primary Biliary Cirrhosis - Product Development Milestones 71
Featured News & Press Releases 71
May 31, 2016: CymaBay Therapeutics Announces Top Line Efficacy and Safety Data From Its Phase 2 Study of Mbx-8025 in Patients With Primary Biliary Cholangitis (PBC) 71
May 27, 2016: FDA Grants Accelerated Approval to Ocaliva (Obeticholic Acid) for the Treatment of Patients with PBC 72
May 18, 2016: Intercept Announces Ocaliva (Obeticholic Acid) Data in PBC to be Presented at DDW 2016 73
Apr 14, 2016: New Analyses of the Phase 3 POISE Trial of Ocaliva (Obeticholic Acid) for the Treatment of PBC Presented at EASL 75
Apr 07, 2016: FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of PBC 76
Mar 30, 2016: Intercept Announces New OCA Data in PBC and NASH to be Presented at EASL 2016 77
Feb 03, 2016: Fast Forward Pharmaceuticals Initiates Phase II Pilot Studies in Primary Biliary Cirrhosis and Crohn's Disease with anti-CD40 Monoclonal Antibody 79
Dec 17, 2015: FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC 80
Nov 14, 2015: Intercept Presents New PBC Data at AASLD 2015 80
Nov 10, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Primary Biliary Cholangitis/Cirrhosis 81
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 82
Nov 03, 2015: Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting 83
Aug 31, 2015: FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis 85
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 86
Apr 13, 2015: Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015 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, H2 2016 8
Number of Products under Development by Companies, H2 2016 9
Comparative Analysis by Late Stage Development, H2 2016 10
Comparative Analysis by Clinical Stage Development, H2 2016 11
Comparative Analysis by Early Stage Development, H2 2016 12
Comparative Analysis by Unknown Stage Development, H2 2016 13
Products under Development by Companies, H2 2016 14
Primary Biliary Cirrhosis - Pipeline by AlbireoPharma, H2 2016 15
Primary Biliary Cirrhosis - Pipeline by CymaBay Therapeutics, Inc., H2 2016 16
Primary Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H2 2016 17
Primary Biliary Cirrhosis - Pipeline by Enanta Pharmaceuticals, Inc., H2 2016 18
Primary Biliary Cirrhosis - Pipeline by Genextra S.p.a., H2 2016 19
Primary Biliary Cirrhosis - Pipeline by GenKyoTex S.A., H2 2016 20
Primary Biliary Cirrhosis - Pipeline by GlaxoSmithKline Plc, H2 2016 21
Primary Biliary Cirrhosis - Pipeline by MediGene AG, H2 2016 22
Primary Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H2 2016 23
Primary Biliary Cirrhosis - Pipeline by Novartis AG, H2 2016 24
Primary Biliary Cirrhosis - Pipeline by Shire Plc, H2 2016 25
Primary Biliary Cirrhosis - Pipeline by TGV-Laboratories, H2 2016 26
Primary Biliary Cirrhosis - Pipeline by Virobay Inc., H2 2016 27
Assessment by Monotherapy Products, H2 2016 28
Number of Products by Stage and Target, H2 2016 30
Number of Products by Stage and Mechanism of Action, H2 2016 32
Number of Products by Stage and Route of Administration, H2 2016 34
Number of Products by Stage and Molecule Type, H2 2016 36
Primary Biliary Cirrhosis - Dormant Projects, H2 2016 70 

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