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Biliary Cirrhosis-Pipeline Review, H1 2015

Biliary Cirrhosis-Pipeline Review, H1 2015


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Executive Summary

Biliary Cirrhosis-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Biliary Cirrhosis-Pipeline Review, H1 2015', provides an overview of the Biliary Cirrhosis's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for 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 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.

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

Scope

The report provides a snapshot of the global therapeutic landscape of 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 Biliary Cirrhosis and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

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

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 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 Biliary Cirrhosis

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding 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

Table of Contents 2

List of Tables 4

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Biliary Cirrhosis Overview 7

Therapeutics Development 8

Pipeline Products for Biliary Cirrhosis-Overview 8

Pipeline Products for Biliary Cirrhosis-Comparative Analysis 9

Biliary Cirrhosis-Therapeutics under Development by Companies 10

Biliary Cirrhosis-Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Biliary Cirrhosis-Products under Development by Companies 15

Biliary Cirrhosis-Companies Involved in Therapeutics Development 16

AlbireoPharma 16

Dr. Falk Pharma GmbH 17

GlaxoSmithKline plc 18

Intercept Pharmaceuticals, Inc. 19

Johnson & Johnson 20

MediGene AG 21

NGM Biopharmaceuticals, Inc. 22

Shire Plc 23

Virobay Inc. 24

Biliary Cirrhosis-Therapeutics Assessment 25

Assessment by Monotherapy Products 25

Assessment by Target 26

Assessment by Mechanism of Action 28

Assessment by Route of Administration 30

Assessment by Molecule Type 32

Drug Profiles 34

A-4250-Drug Profile 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

budesonide-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

FFP-104-Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

GSK-2330672-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

Leukothera-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

NGM-282-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

obeticholic acid-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

RhuDex-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

SHP-625-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

ustekinumab-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

VBY-825-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

Biliary Cirrhosis-Recent Pipeline Updates 51

Biliary Cirrhosis-Dormant Projects 62

Biliary Cirrhosis-Product Development Milestones 63

Featured News & Press Releases 63

Nov 08, 2014: Intercept Announces Additional Data for OCA in Primary Biliary Cirrhosis 63

May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 64

Apr 12, 2014: Intercept Reports Additional Positive Data From POISE Trial at EASL Late-Breaker Session 64

Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 66

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 67

Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 68

Jan 09, 2014: Intercept Provides 2013 Year-End Update and 2014 Anticipated Milestones 69

Dec 13, 2013: Medigene Granted Additional Patent for RhuDex for the Treatment of Autoimmune Diseases 71

Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 72

Oct 29, 2013: Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis 73

Appendix 74

Methodology 74

Coverage 74

Secondary Research 74

Primary Research 74

Expert Panel Validation 74

Contact Us 75

Disclaimer 75

List of Tables

Number of Products under Development for Biliary Cirrhosis, H1 2015 8

Number of Products under Development for Biliary Cirrhosis-Comparative Analysis, H1 2015 9

Number of Products under Development by Companies, H1 2015 11

Comparative Analysis by Late Stage Development, H1 2015 12

Comparative Analysis by Clinical Stage Development, H1 2015 13

Comparative Analysis by Early Stage Development, H1 2015 14

Products under Development by Companies, H1 2015 15

Biliary Cirrhosis-Pipeline by AlbireoPharma, H1 2015 16

Biliary Cirrhosis-Pipeline by Dr. Falk Pharma GmbH, H1 2015 17

Biliary Cirrhosis-Pipeline by GlaxoSmithKline plc, H1 2015 18

Biliary Cirrhosis-Pipeline by Intercept Pharmaceuticals, Inc., H1 2015 19

Biliary Cirrhosis-Pipeline by Johnson & Johnson, H1 2015 20

Biliary Cirrhosis-Pipeline by MediGene AG, H1 2015 21

Biliary Cirrhosis-Pipeline by NGM Biopharmaceuticals, Inc., H1 2015 22

Biliary Cirrhosis-Pipeline by Shire Plc, H1 2015 23

Biliary Cirrhosis-Pipeline by Virobay Inc., H1 2015 24

Assessment by Monotherapy Products, H1 2015 25

Number of Products by Stage and Target, H1 2015 27

Number of Products by Stage and Mechanism of Action, H1 2015 29

Number of Products by Stage and Route of Administration, H1 2015 31

Number of Products by Stage and Molecule Type, H1 2015 33

Biliary Cirrhosis Therapeutics-Recent Pipeline Updates, H1 2015 51

Biliary Cirrhosis-Dormant Projects, H1 2015 62

List of Figures

Number of Products under Development for Biliary Cirrhosis, H1 2015 8

Number of Products under Development for 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 13

Assessment by Monotherapy Products, H1 2015 25

Number of Products by Top 10 Targets, H1 2015 26

Number of Products by Stage and Top 10 Targets, H1 2015 26

Number of Products by Top 10 Mechanism of Actions, H1 2015 28

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 28

Number of Products by Top 10 Routes of Administration, H1 2015 30

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 31

Number of Products by Top 10 Molecule Types, H1 2015 32

Number of Products by Stage and Top 10 Molecule Types, H1 2015 33

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AlbireoPharma

Dr. Falk Pharma GmbH

GlaxoSmithKline plc

Intercept Pharmaceuticals, Inc.

Johnson & Johnson

MediGene AG

NGM Biopharmaceuticals, Inc.

Shire Plc

Virobay Inc.

Biliary Cirrhosis Therapeutic Products under Development, Key Players in Biliary Cirrhosis Therapeutics, Biliary Cirrhosis Pipeline Overview, Biliary Cirrhosis Pipeline, Biliary Cirrhosis Pipeline Assessment


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