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Published: Jan, 2015 | Pages:
71 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
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
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