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Primary Biliary Cirrhosis - Pipeline Review, H1 2015

Published By :

Global Markets Direct

Published Date : Jan 2015

Category :

Pharmaceutical

No. of Pages : 71 Pages


Global Markets Direct’s, ‘Primary Biliary Cirrhosis Pipeline Review, H1 2015’, 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.

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 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 11
Late Stage Products 11
Clinical Stage Products 12
Primary Biliary Cirrhosis Products under Development by Companies 13
Primary Biliary Cirrhosis Companies Involved in Therapeutics Development 14
AlbireoPharma 14
Dr. Falk Pharma GmbH 15
GlaxoSmithKline plc 16
Intercept Pharmaceuticals, Inc. 17
Johnson & Johnson 18
MediGene AG 19
NGM Biopharmaceuticals, Inc. 20
Shire Plc 21
Virobay Inc. 22
Primary Biliary Cirrhosis Therapeutics Assessment 23
Assessment by Monotherapy Products 23
Assessment by Target 24
Assessment by Mechanism of Action 26
Assessment by Route of Administration 28
Assessment by Molecule Type 30
Drug Profiles 32
A-4250 - Drug Profile 32
Product Description 32
Mechanism of Action 32
R&D Progress 32
budesonide - Drug Profile 33
Product Description 33
Mechanism of Action 33
R&D Progress 33
FFP-104 - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
GSK-2330672 - Drug Profile 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
NGM-282 - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
obeticholic acid - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
RhuDex - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
SHP-625 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
ustekinumab - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
VBY-825 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
Primary Biliary Cirrhosis Recent Pipeline Updates 48
Primary Biliary Cirrhosis Dormant Projects 59
Primary Biliary Cirrhosis Product Development Milestones 60
Featured News & Press Releases 60
May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 60
Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 60
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 61
Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 62
Jan 09, 2014: Intercept Provides 2013 Year-End Update and 2014 Anticipated Milestones 63
Dec 13, 2013: Medigene Granted Additional Patent for RhuDex for the Treatment of Autoimmune Diseases 66
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 66
Oct 29, 2013: Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis 67
Sep 26, 2013: Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases 68
May 20, 2013: Intercept Pharma Announces Positive Initial Results From Ongoing Phase IIa Trial In Chronic Bile Acid Diarrhea 68

Appendix 70
Methodology 70
Coverage 70
Secondary Research 70
Primary Research 70
Expert Panel Validation 70
Contact Us 71
Disclaimer 71

List of Table


Number of Products under Development for Primary Biliary Cirrhosis, H1 2015 8
Number of Products under Development for Primary Biliary Cirrhosis Comparative Analysis, H1 2015 9
Number of Products under Development by Companies, H1 2014 10
Comparative Analysis by Late Stage Development, H1 2015 11
Comparative Analysis by Clinical Stage Development, H1 2015 12
Products under Development by Companies, H1 2015 13
Primary Biliary Cirrhosis Pipeline by AlbireoPharma, H1 2015 14
Primary Biliary Cirrhosis Pipeline by Dr. Falk Pharma GmbH, H1 2015 15
Primary Biliary Cirrhosis Pipeline by GlaxoSmithKline plc, H1 2015 16
Primary Biliary Cirrhosis Pipeline by Intercept Pharmaceuticals, Inc., H1 2015 17
Primary Biliary Cirrhosis Pipeline by Johnson & Johnson, H1 2015 18
Primary Biliary Cirrhosis Pipeline by MediGene AG, H1 2015 19
Primary Biliary Cirrhosis Pipeline by NGM Biopharmaceuticals, Inc., H1 2015 20
Primary Biliary Cirrhosis Pipeline by Shire Plc, H1 2015 21
Primary Biliary Cirrhosis Pipeline by Virobay Inc., H1 2015 22
Assessment by Monotherapy Products, H1 2015 23
Number of Products by Stage and Target, H1 2015 25
Number of Products by Stage and Mechanism of Action, H1 2015 27
Number of Products by Stage and Route of Administration, H1 2015 29
Number of Products by Stage and Molecule Type, H1 2015 31
Primary Biliary Cirrhosis Therapeutics Recent Pipeline Updates, H1 2015 48
Primary Biliary Cirrhosis Dormant Projects, H1 2015 59

List of Figures
Number of Products under Development for Primary Biliary Cirrhosis, H1 2015 8
Number of Products under Development for Primary Biliary Cirrhosis Comparative Analysis, H1 2015 9
Number of Products under Development by Companies, H1 2015 10
Comparative Analysis by Clinical Stage Development, H1 2015 12
Assessment by Monotherapy Products, H1 2015 23
Number of Products by Top 10 Targets, H1 2015 24
Number of Products by Stage and Top 10 Targets, H1 2015 24
Number of Products by Top 10 Mechanism of Actions, H1 2015 26
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 26
Number of Products by Top 10 Routes of Administration, H1 2015 28
Number of Products by Stage and Top 10 Routes of Administration, H1 2015 28
Number of Products by Top 10 Molecule Types, H1 2015 30
Number of Products by Stage and Top 10 Molecule Types, H1 2015 30

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