Primary Sclerosing Cholangitis - Pipeline Review, H1 2014

Primary Sclerosing Cholangitis - Pipeline Review, H1 2014

Summary

Global Markets Direct’s, ‘Primary Sclerosing Cholangitis - Pipeline Review, H1 2014’, provides an overview of the Primary Sclerosing Cholangitis’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Primary Sclerosing Cholangitis, 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 Sclerosing Cholangitis 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 Sclerosing Cholangitis
- 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 Sclerosing Cholangitis and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects
- A review of the Primary Sclerosing Cholangitis 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 Sclerosing Cholangitis 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 Sclerosing Cholangitis
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding Primary Sclerosing Cholangitis 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 4
Introduction 5
Global Markets Direct Report Coverage 5
Primary Sclerosing Cholangitis Overview 6
Therapeutics Development 7
Pipeline Products for Primary Sclerosing Cholangitis - Overview 7
Pipeline Products for Primary Sclerosing Cholangitis - Comparative Analysis 8
Primary Sclerosing Cholangitis - Therapeutics under Development by Companies 9
Primary Sclerosing Cholangitis - Therapeutics under Investigation by Universities/Institutes 10
Primary Sclerosing Cholangitis - Pipeline Products Glance 11
Clinical Stage Products 11
Early Stage Products 12
Primary Sclerosing Cholangitis - Products under Development by Companies 13
Primary Sclerosing Cholangitis - Products under Investigation by Universities/Institutes 14
Primary Sclerosing Cholangitis - Companies Involved in Therapeutics Development 15
Gilead Sciences, Inc. 15
Intercept Pharmaceuticals, Inc. 16
Dr. Falk Pharma GmbH 17
Lumena Pharmaceuticals, Inc. 18
Primary Sclerosing Cholangitis - Therapeutics Assessment 19
Assessment by Monotherapy Products 19
Assessment by Target 20
Assessment by Mechanism of Action 22
Assessment by Route of Administration 24
Assessment by Molecule Type 26
Drug Profiles 28
simtuzumab - Drug Profile 28
Product Description 28
Mechanism of Action 28
R&D Progress 28
norursodeoxycholic acid - Drug Profile 30
Product Description 30
Mechanism of Action 30
R&D Progress 30
mitomycin - Drug Profile 31
Product Description 31
Mechanism of Action 31
R&D Progress 31
LUM-001 - Drug Profile 32
Product Description 32
Mechanism of Action 32
R&D Progress 32
ursodiol - Drug Profile 33
Product Description 33
Mechanism of Action 33
R&D Progress 33
INT-767 - Drug Profile 34
Product Description 34
Mechanism of Action 34
R&D Progress 34
Primary Sclerosing Cholangitis - Recent Pipeline Updates 36
Primary Sclerosing Cholangitis - Dormant Projects 38
Primary Sclerosing Cholangitis - Product Development Milestones 39
Featured News & Press Releases 39
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 39
Sep 26, 2013: Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases 39
Appendix 41
Methodology 41
Coverage 41
Secondary Research 41
Primary Research 41
Expert Panel Validation 41
Contact Us 42
Disclaimer 42

List of Tables
Number of Products under Development for Primary Sclerosing Cholangitis, H1 2014 7
Number of Products under Development for Primary Sclerosing Cholangitis - Comparative Analysis, H1 2014 8
Number of Products under Development by Companies, H1 2014 9
Number of Products under Investigation by Universities/Institutes, H1 2014 10
Comparative Analysis by Clinical Stage Development, H1 2014 11
Comparative Analysis by Early Stage Development, H1 2014 12
Products under Development by Companies, H1 2014 13
Products under Investigation by Universities/Institutes, H1 2014 14
Primary Sclerosing Cholangitis - Pipeline by Gilead Sciences, Inc., H1 2014 15
Primary Sclerosing Cholangitis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2014 16
Primary Sclerosing Cholangitis - Pipeline by Dr. Falk Pharma GmbH, H1 2014 17
Primary Sclerosing Cholangitis - Pipeline by Lumena Pharmaceuticals, Inc., H1 2014 18
Assessment by Monotherapy Products, H1 2014 19
Number of Products by Stage and Target, H1 2014 21
Number of Products by Stage and Mechanism of Action, H1 2014 23
Number of Products by Stage and Route of Administration, H1 2014 25
Number of Products by Stage and Molecule Type, H1 2014 27
Primary Sclerosing Cholangitis Therapeutics - Recent Pipeline Updates, H1 2014 36
Primary Sclerosing Cholangitis - Dormant Projects, H1 2014 38

List of Figures
Number of Products under Development for Primary Sclerosing Cholangitis, H1 2014 7
Number of Products under Development for Primary Sclerosing Cholangitis - Comparative Analysis, H1 2014 8
Number of Products under Development by Companies, H1 2014 9
Number of Products under Investigation by Universities/Institutes, H1 2014 10
Comparative Analysis by Clinical Stage Development, H1 2014 11
Assessment by Monotherapy Products, H1 2014 19
Number of Products by Top 10 Target, H1 2014 20
Number of Products by Stage and Top 10 Target, H1 2014 21
Number of Products by Top 10 Mechanism of Action, H1 2014 22
Number of Products by Stage and Top 10 Mechanism of Action, H1 2014 23
Number of Products by Top 10 Route of Administration, H1 2014 24
Number of Products by Stage and Top 10 Route of Administration, H1 2014 25
Number of Products by Top 10 Molecule Type, H1 2014 26
Number of Products by Stage and Top 10 Molecule Type, H1 2014 27