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Published: May, 2016 | Pages:
71 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline Review, H1 2016 Summary Global Markets Direct's, 'Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline Review, H1 2016', provides an overview of the Homozygous Familial Hypercholesterolemia (HoFH) pipeline landscape. The report provides comprehensive information on the therapeutics under development for Homozygous Familial Hypercholesterolemia (HoFH), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Homozygous Familial Hypercholesterolemia (HoFH) and features dormant 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, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data. Scope - The report provides a snapshot of the global therapeutic landscape of Homozygous Familial Hypercholesterolemia (HoFH) - The report reviews pipeline therapeutics for Homozygous Familial Hypercholesterolemia (HoFH) by companies and universities/research institutes based on information derived from company and industry-specific sources - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved Homozygous Familial Hypercholesterolemia (HoFH) therapeutics and enlists all their major and minor projects - The report assesses Homozygous Familial Hypercholesterolemia (HoFH) therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type - The report summarizes all the dormant and discontinued pipeline projects - The report reviews latest news related to pipeline therapeutics for Homozygous Familial Hypercholesterolemia (HoFH) Reasons To Buy - Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of therapeutics under development for Homozygous Familial Hypercholesterolemia (HoFH) - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies - Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Homozygous Familial Hypercholesterolemia (HoFH) 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 Homozygous Familial Hypercholesterolemia (HoFH) Overview 7 Therapeutics Development 8 Pipeline Products for Homozygous Familial Hypercholesterolemia (HoFH) - Overview 8 Homozygous Familial Hypercholesterolemia (HoFH) - Therapeutics under Development by Companies 9 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline Products Glance 10 Late Stage Products 10 Clinical Stage Products 11 Early Stage Products 12 Homozygous Familial Hypercholesterolemia (HoFH) - Products under Development by Companies 13 Homozygous Familial Hypercholesterolemia (HoFH) - Companies Involved in Therapeutics Development 14 Aegerion Pharmaceuticals, Inc. 14 CymaBay Therapeutics, Inc. 15 Kastle Therapeutics LLC 16 Regeneron Pharmaceuticals, Inc. 17 RegenxBio Inc. 18 Homozygous Familial Hypercholesterolemia (HoFH) - 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 AEM-28 - Drug Profile 28 Product Description 28 Mechanism of Action 28 R&D Progress 28 AEM-2802 - Drug Profile 29 Product Description 29 Mechanism of Action 29 R&D Progress 29 AEM-2814 - Drug Profile 30 Product Description 30 Mechanism of Action 30 R&D Progress 30 AM-0010 - Drug Profile 31 Product Description 31 Mechanism of Action 31 R&D Progress 31 evinacumab - Drug Profile 33 Product Description 33 Mechanism of Action 33 R&D Progress 33 gemcabene calcium - Drug Profile 34 Product Description 34 Mechanism of Action 34 R&D Progress 34 lomitapide mesylate - Drug Profile 35 Product Description 35 Mechanism of Action 35 R&D Progress 35 MBX-8025 - Drug Profile 38 Product Description 38 Mechanism of Action 38 R&D Progress 38 MGL-3196 - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 MGL-3745 - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 mipomersen sodium - Drug Profile 43 Product Description 43 Mechanism of Action 43 R&D Progress 43 RGX-501 - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 Homozygous Familial Hypercholesterolemia (HoFH) - Recent Pipeline Updates 47 Homozygous Familial Hypercholesterolemia (HoFH) - Dormant Projects 61 Homozygous Familial Hypercholesterolemia (HoFH) - Product Development Milestones 62 Featured News & Press Releases 62 Mar 17, 2016: CymaBay Therapeutics Announces Positive Results from its Pilot Phase 2 Clinical Study of MBX-8025 in Patients with Homozygous Familial Hypercholesterolemia 62 Nov 20, 2015: JUXTAPID (lomitapide) Capsules Available on the Regie de l'Assurance Maladie du Quebec (RAMQ) for the Treatment of Homozygous Familial Hypercholesterolemia (HoFH) 63 Nov 10, 2015: Aegerion Pharmaceuticals Announces Results From First Year of LOWER Study at AHA Scientific Sessions 2015 64 May 26, 2015: Aegerion Pharmaceuticals Achieves Primary Endpoint in Phase III Study of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) 64 Apr 30, 2015: AOP Orphan Launches Lojuxta (lomitapide) for Treatment of Homozygous Familial Hypercholesterolaemia to the Austrian Market 65 Apr 23, 2015: CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia 66 Mar 25, 2015: CymaBay Therapeutics Announces U.S. Orphan Drug Designation for MBX-8025 in Homozygous Familial Hypercholesterolemia 67 Jan 28, 2015: Aegerion Investigated by Former Louisiana Attorney General and Special Prosecutor Richard P. Ieyoub and the Firm of Ieyoub O'Bell & Myers 68 Aug 27, 2014: Aegerion Pharmaceuticals Announces Resolution of Warning Letter for JUXTAPID Capsules 68 Apr 09, 2014: Aegerion Pharmaceuticals Initiates Phase 3 Clinical Trial in Japan to Evaluate Lomitapide for Treatment of Homozygous Familial Hypercholesterolemia 68 Appendix 70 Methodology 70 Coverage 70 Secondary Research 70 Primary Research 70 Expert Panel Validation 70 Contact Us 70 Disclaimer 71
List of Tables
Number of Products under Development for Homozygous Familial Hypercholesterolemia (HoFH), H1 2016 8 Number of Products under Development by Companies, H1 2016 9 Comparative Analysis by Late Stage Development, H1 2016 10 Comparative Analysis by Clinical Stage Development, H1 2016 11 Comparative Analysis by Early Stage Development, H1 2016 12 Products under Development by Companies, H1 2016 13 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline by Aegerion Pharmaceuticals, Inc., H1 2016 14 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline by CymaBay Therapeutics, Inc., H1 2016 15 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline by Kastle Therapeutics LLC, H1 2016 16 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline by Regeneron Pharmaceuticals, Inc., H1 2016 17 Homozygous Familial Hypercholesterolemia (HoFH) - Pipeline by RegenxBio Inc., H1 2016 18 Assessment by Monotherapy Products, H1 2016 19 Number of Products by Stage and Target, H1 2016 21 Number of Products by Stage and Mechanism of Action, H1 2016 23 Number of Products by Stage and Route of Administration, H1 2016 25 Number of Products by Stage and Molecule Type, H1 2016 27 Homozygous Familial Hypercholesterolemia (HoFH) Therapeutics - Recent Pipeline Updates, H1 2016 47 Homozygous Familial Hypercholesterolemia (HoFH) - Dormant Projects, H1 2016 61
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