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Cholestasis - Pipeline Review, H2 2014

  • December 2014
  • -
  • Global Markets Direct
  • -
  • 38 pages

Cholestasis - Pipeline Review, H2 2014

Summary

Global Markets Direct’s, ‘Cholestasis - Pipeline Review, H2 2014’, provides an overview of the Cholestasis’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Cholestasis, 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 Cholestasis 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 Cholestasis
- 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 Cholestasis and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects
- A review of the Cholestasis 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 Cholestasis 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 Cholestasis
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding Cholestasis 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

Cholestasis - Pipeline Review, H2 2014
Table of Contents
Introduction 5
Global Markets Direct Report Coverage 5
Cholestasis Overview 6
Therapeutics Development 7
Pipeline Products for Cholestasis - Overview 7
Pipeline Products for Cholestasis - Comparative Analysis 8
Cholestasis - Therapeutics under Development by Companies 9
Cholestasis - Therapeutics under Investigation by Universities/Institutes 10
Cholestasis - Pipeline Products Glance 11
Clinical Stage Products 11
Early Stage Products 12
Cholestasis - Products under Development by Companies 13
Cholestasis - Products under Investigation by Universities/Institutes 14
Cholestasis - Companies Involved in Therapeutics Development 15
AlbireoPharma 15
NGM Biopharmaceuticals, Inc. 16
Shire Plc 17
Cholestasis - Therapeutics Assessment 18
Assessment by Monotherapy Products 18
Assessment by Target 19
Assessment by Mechanism of Action 20
Assessment by Route of Administration 22
Assessment by Molecule Type 23
Drug Profiles 25
A-4250 - Drug Profile 25
Product Description 25
Mechanism of Action 25
RandD Progress 25
Gene Therapy for Infectious Disease, Gastrointestinal and Metabolic Disorders - Drug Profile 26
Product Description 26
Mechanism of Action 26
RandD Progress 26
NGM-282 - Drug Profile 27
Product Description 27
Mechanism of Action 27
RandD Progress 27
SC-435 - Drug Profile 28
Product Description 28
Mechanism of Action 28
RandD Progress 28
SHP-625 - Drug Profile 29
Product Description 29
Mechanism of Action 29
RandD Progress 29
Cholestasis - Recent Pipeline Updates 30
Cholestasis - Product Development Milestones 33
Featured News and Press Releases 33
May 09, 2014: Lumena Pharmaceuticals Now Dosing Patients in the INDIGO Phase 2 Clinical Trial of LUM001 in Pediatric Patients with Progressive Familial Intrahepatic Cholestasis 33
Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 34
Sep 26, 2013: Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food and Drug Administration for LUM001 in Four Rare Liver Diseases 34
Nov 08, 2012: Albireo Receives Orphan Drug Designation For A4250 From FDA For Treatment Of Progressive Familial Intrahepatic Cholestasis And For Primary Biliary Cirrhosis 35
Jul 24, 2012: Albireo Receives Positive Opinion From EMA For Orphan Drug Designation For A4250 For Severe Liver Diseases 36
Appendix 37
Methodology 37
Coverage 37
Secondary Research 37
Primary Research 37
Expert Panel Validation 37
Contact Us 38
Disclaimer 38

List of Tables

Number of Products under Development for Cholestasis, H2 2014 7
Number of Products under Development for Cholestasis - Comparative Analysis, H2 2014 8
Number of Products under Development by Companies, H2 2014 9
Number of Products under Investigation by Universities/Institutes, H2 2014 10
Comparative Analysis by Clinical Stage Development, H2 2014 11
Comparative Analysis by Early Stage Development, H2 2014 12
Products under Development by Companies, H2 2014 13
Products under Investigation by Universities/Institutes, H2 2014 14
Cholestasis - Pipeline by AlbireoPharma, H2 2014 15
Cholestasis - Pipeline by NGM Biopharmaceuticals, Inc., H2 2014 16
Cholestasis - Pipeline by Shire Plc, H2 2014 17
Assessment by Monotherapy Products, H2 2014 18
Number of Products by Stage and Target, H2 2014 19
Number of Products by Stage and Mechanism of Action, H2 2014 21
Number of Products by Stage and Route of Administration, H2 2014 22
Number of Products by Stage and Molecule Type, H2 2014 24
Cholestasis Therapeutics - Recent Pipeline Updates, H2 2014 30

List of Figures

Number of Products under Development for Cholestasis, H2 2014 7
Number of Products under Development for Cholestasis - Comparative Analysis, H2 2014 8
Number of Products under Development by Companies, H2 2014 9
Comparative Analysis by Clinical Stage Development, H2 2014 11
Comparative Analysis by Early Stage Products, H2 2014 12
Assessment by Monotherapy Products, H2 2014 18
Number of Products by Top 10 Mechanism of Actions, H2 2014 20
Number of Products by Stage and Top 10 Mechanism of Actions, H2 2014 20
Number of Products by Stage and Top 10 Routes of Administration, H2 2014 22
Number of Products by Top 10 Molecule Types, H2 2014 23
Number of Products by Stage and Top 10 Molecule Types, H2 2014 23

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