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Published: Jul, 2014 | Pages:
63 | Publisher: Global Markets Direct
Industry: Healthcare | Report Format: Electronic (PDF)
Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline Review, H2 2014 Summary Global Markets Direct's, 'Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline Review, H2 2014', provides an overview of the Familial Hypercholesterolemia (Type II Hyperlipoproteinemia)'s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia), 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) 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 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Overview 6 Therapeutics Development 7 Pipeline Products for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Overview 7 Pipeline Products for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Comparative Analysis 8 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Therapeutics under Development by Companies 9 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Therapeutics under Investigation by Universities/Institutes 10 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline Products Glance 11 Late Stage Products 11 Clinical Stage Products 12 Early Stage Products 13 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Products under Development by Companies 14 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Products under Investigation by Universities/Institutes 15 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Companies Involved in Therapeutics Development 16 Amgen Inc. 16 ReGenX Biosciences, LLC 17 Cerenis Therapeutics SA 18 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - 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 evolocumab - Drug Profile 28 Product Description 28 Mechanism of Action 28 R&D Progress 28 CER-001 - Drug Profile 30 Product Description 30 Mechanism of Action 30 R&D Progress 30 Gene Therapy To Activate LDL Receptor For Familial Hypercholesterolemia - Drug Profile 32 Product Description 32 Mechanism of Action 32 R&D Progress 32 Antisense Oligonucleotides to Inhibit ApoB100 for Familial Hypercholesterolemia - Drug Profile 33 Product Description 33 Mechanism of Action 33 R&D Progress 33 BSN-272 - Drug Profile 34 Product Description 34 Mechanism of Action 34 R&D Progress 34 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Recent Pipeline Updates 35 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Dormant Projects 44 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Discontinued Products 45 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Product Development Milestones 46 Featured News & Press Releases 46 Jun 02, 2014: Cerenis Reports Two Positive Phase II Studies for HDL Mimetic CER-001 at EAS 46 Mar 30, 2014: Data From Phase 3 Pivotal Studies Show Amgen's Novel Investigational Cholesterol-Lowering Medication Evolocumab Significantly Reduced LDL Cholesterol In Statin Intolerant Patients And In Patients On Statins 47 Mar 27, 2014: Sanofi and Regeneron To Present Alirocumab Clinical Data at the American College of Cardiology's 63rd Annual Scientific Session 50 Mar 27, 2014: Bococizumab (RN316) Significantly Reduced LDL Cholesterol In Statin-Treated Adults With High Cholesterol In A Phase 2b Study 52 Mar 24, 2014: Phase 3 Pivotal Data On Amgen's Novel Investigational Cholesterol-Lowering Medicine To Be Featured At The American College of Cardiology's 63rd Annual Scientific Session 53 Mar 17, 2014: Amgen Announces Positive Top-Line Results From Phase 3 TESLA Trial Of Evolocumab (AMG 145) In Patients With Homozygous Familial Hypercholesterolemia 54 Jan 28, 2014: Amgen Announces Positive Top-Line Results From Phase 3 LAPLACE-2 Trial Of Evolocumab (AMG 145) In Combination With Statins In Patients With High Cholesterol 55 Jan 23, 2014: Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-2 Trial Of Evolocumab (AMG 145) In Statin Intolerant Patients With High Cholesterol 57 Jan 02, 2014: Cerenis Reports Top-Line Phase II Results for its HDL Mimetic CER-001 59 Dec 19, 2013: Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study Of Evolocumab In Patients With High Cholesterol 60 Appendix 62 Methodology 62 Coverage 62 Secondary Research 62 Primary Research 62 Expert Panel Validation 62 Contact Us 63 Disclaimer 63
List of Tables Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia), H2 2014 7 Number of Products under Development for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - 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 Late Stage Development, H2 2014 11 Comparative Analysis by Clinical Stage Development, H2 2014 12 Comparative Analysis by Early Stage Development, H2 2014 13 Products under Development by Companies, H2 2014 14 Products under Investigation by Universities/Institutes, H2 2014 15 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline by Amgen Inc., H2 2014 16 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline by ReGenX Biosciences, LLC, H2 2014 17 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Pipeline by Cerenis Therapeutics SA, H2 2014 18 Assessment by Monotherapy Products, H2 2014 19 Number of Products by Stage and Target, H2 2014 21 Number of Products by Stage and Mechanism of Action, H2 2014 23 Number of Products by Stage and Route of Administration, H2 2014 25 Number of Products by Stage and Molecule Type, H2 2014 27 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) Therapeutics - Recent Pipeline Updates, H2 2014 35 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Dormant Projects, H2 2014 44 Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Discontinued Products, H2 2014 45
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