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Primary Biliary Cirrhosis-Pipeline Review, H1 2015

Primary Biliary Cirrhosis-Pipeline Review, H1 2015


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Executive Summary

Primary Biliary Cirrhosis-Pipeline Review, H1 2015

Summary

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.

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 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

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 Tables

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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AlbireoPharma

Dr. Falk Pharma GmbH

GlaxoSmithKline plc

Intercept Pharmaceuticals, Inc.

Johnson & Johnson

MediGene AG

NGM Biopharmaceuticals, Inc.

Shire Plc

Virobay Inc.

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


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