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Published: Sep, 2014 | Pages:
153 | Publisher: Global Markets Direct
Industry: Healthcare | Report Format: Electronic (PDF)
Hypercholesterolemia - Pipeline Review, H2 2014 Summary Global Markets Direct's, 'Hypercholesterolemia - Pipeline Review, H2 2014', provides an overview of the Hypercholesterolemia's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Hypercholesterolemia, 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 Hypercholesterolemia 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 Hypercholesterolemia - 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 Hypercholesterolemia and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Hypercholesterolemia 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 Hypercholesterolemia 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 Hypercholesterolemia - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Hypercholesterolemia 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 8 List of Figures 9 Introduction 10 Global Markets Direct Report Coverage 10 Hypercholesterolemia Overview 11 Therapeutics Development 12 Pipeline Products for Hypercholesterolemia - Overview 12 Pipeline Products for Hypercholesterolemia - Comparative Analysis 13 Hypercholesterolemia - Therapeutics under Development by Companies 14 Hypercholesterolemia - Therapeutics under Investigation by Universities/Institutes 17 Hypercholesterolemia - Pipeline Products Glance 19 Late Stage Products 19 Clinical Stage Products 20 Early Stage Products 21 Hypercholesterolemia - Products under Development by Companies 22 Hypercholesterolemia - Products under Investigation by Universities/Institutes 24 Hypercholesterolemia - Companies Involved in Therapeutics Development 25 Bristol-Myers Squibb Company 25 Johnson & Johnson 26 Amgen Inc. 27 Eli Lilly and Company 28 Merck & Co., Inc. 29 Pfizer Inc. 30 Santaris Pharma A/S 31 SoluBest Ltd. 32 Alnylam Pharmaceuticals, Inc. 33 Regeneron Pharmaceuticals, Inc. 34 CrystalGenomics, Inc. 35 Catabasis Pharmaceuticals, Inc. 36 Planet Biotechnology Inc. 37 Zhejiang Hisun Pharmaceutical Co., Ltd. 38 Esperion Therapeutics, Inc. 39 Progenra, Inc. 40 Serometrix, LLC 41 Hanmi Pharmaceuticals, Co. Ltd. 42 AtheroNova Inc. 43 Immune Response BioPharma, Inc. 44 Agilvax, Inc. 45 Michigan Life Therapeutics, LLC 46 LondonPharma Ltd 47 Dybly AG 48 Hypercholesterolemia - Therapeutics Assessment 49 Assessment by Monotherapy Products 49 Assessment by Combination Products 50 Assessment by Target 51 Assessment by Mechanism of Action 54 Assessment by Route of Administration 57 Assessment by Molecule Type 59 Drug Profiles 61 anacetrapib - Drug Profile 61 Product Description 61 Mechanism of Action 61 R&D Progress 61 alirocumab - Drug Profile 63 Product Description 63 Mechanism of Action 63 R&D Progress 63 (aspirin + lisinopril + lovastatin) - Drug Profile 67 Product Description 67 Mechanism of Action 67 R&D Progress 67 HCP-1306 - Drug Profile 68 Product Description 68 Mechanism of Action 68 R&D Progress 68 ETC-1002 - Drug Profile 69 Product Description 69 Mechanism of Action 69 R&D Progress 69 Small Molecule to Inhibit LDL-C for Hypercholesterolemia - Drug Profile 71 Product Description 71 Mechanism of Action 71 R&D Progress 71 evolocumab - Drug Profile 72 Product Description 72 Mechanism of Action 72 R&D Progress 72 bococizumab - Drug Profile 74 Product Description 74 Mechanism of Action 74 R&D Progress 74 LY-3015014 - Drug Profile 75 Product Description 75 Mechanism of Action 75 R&D Progress 75 HS-25 - Drug Profile 76 Product Description 76 Mechanism of Action 76 R&D Progress 76 CAT-2003 - Drug Profile 77 Product Description 77 Mechanism of Action 77 R&D Progress 77 AEM-28 - Drug Profile 78 Product Description 78 Mechanism of Action 78 R&D Progress 78 MGL-3196 - Drug Profile 79 Product Description 79 Mechanism of Action 79 R&D Progress 79 ALN-PCS02 - Drug Profile 81 Product Description 81 Mechanism of Action 81 R&D Progress 81 BMS-962476 - Drug Profile 82 Product Description 82 Mechanism of Action 82 R&D Progress 82 AHRO-001 - Drug Profile 83 Product Description 83 Mechanism of Action 83 R&D Progress 83 simvastatin - Drug Profile 85 Product Description 85 Mechanism of Action 85 R&D Progress 85 fluvastatin sodium - Drug Profile 86 Product Description 86 Mechanism of Action 86 R&D Progress 86 pravastatin sodium - Drug Profile 87 Product Description 87 Mechanism of Action 87 R&D Progress 87 PF-06678552 - Drug Profile 88 Product Description 88 Mechanism of Action 88 R&D Progress 88 fenofibrate - Drug Profile 89 Product Description 89 Mechanism of Action 89 R&D Progress 89 ALN-PCSsc - Drug Profile 91 Product Description 91 Mechanism of Action 91 R&D Progress 91 1D05-Fab - Drug Profile 93 Product Description 93 Mechanism of Action 93 R&D Progress 93 IR-1002 - Drug Profile 94 Product Description 94 Mechanism of Action 94 R&D Progress 94 gemcabene calcium - Drug Profile 95 Product Description 95 Mechanism of Action 95 R&D Progress 95 aplexone - Drug Profile 96 Product Description 96 Mechanism of Action 96 R&D Progress 96 DYB-186 - Drug Profile 97 Product Description 97 Mechanism of Action 97 R&D Progress 97 Small Molecule to Inhibit Endothelial Lipase for Hypercholesterolemia - Drug Profile 98 Product Description 98 Mechanism of Action 98 R&D Progress 98 Antisense Oligonucleotide to Target miR-33 for Cardiovascular Diseases - Drug Profile 99 Product Description 99 Mechanism of Action 99 R&D Progress 99 EP-80317 - Drug Profile 100 Product Description 100 Mechanism of Action 100 R&D Progress 100 Vaccine for Metabolic Disorders - Drug Profile 101 Product Description 101 Mechanism of Action 101 R&D Progress 101 Small Molecules for Ophthalmology, Cardiovascular, CNS and Metabolic Disorders - Drug Profile 102 Product Description 102 Mechanism of Action 102 R&D Progress 102 Synthetic Peptide for Hypercholesterolemia - Drug Profile 104 Product Description 104 Mechanism of Action 104 R&D Progress 104 SX-PCK9 - Drug Profile 105 Product Description 105 Mechanism of Action 105 R&D Progress 105 Small Molecules to Inhibit IDOL for Hypercholesterolemia - Drug Profile 106 Product Description 106 Mechanism of Action 106 R&D Progress 106 EGF-AB Fc Variants to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 107 Product Description 107 Mechanism of Action 107 R&D Progress 107 Drugs to Inhibit Sortilin for Hypercholesterolemia - Drug Profile 109 Product Description 109 Mechanism of Action 109 R&D Progress 109 Small Molecules to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 110 Product Description 110 Mechanism of Action 110 R&D Progress 110 Drugs for Hypercholesterolemia - Drug Profile 111 Product Description 111 Mechanism of Action 111 R&D Progress 111 Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 112 Product Description 112 Mechanism of Action 112 R&D Progress 112 Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 113 Product Description 113 Mechanism of Action 113 R&D Progress 113 Hypercholesterolemia - Recent Pipeline Updates 114 Hypercholesterolemia - Dormant Projects 139 Hypercholesterolemia - Discontinued Products 140 Hypercholesterolemia - Product Development Milestones 141 Featured News & Press Releases 141 Sep 02, 2014: Amgen Submits Marketing Authorization Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The European Medicines Agency 141 Aug 31, 2014: Regeneron and Sanofi Announce Presentation of Detailed Positive Results from Four Pivotal Alirocumab Trials at ESC Congress 2014 142 Aug 28, 2014: Amgen Announces Positive Top-Line Results From Phase 3 YUKAWA-2 Trial Of Evolocumab In Combination With Statins In Japanese Patients With High Cardiovascular Risk And High Cholesterol 144 Aug 28, 2014: Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA 145 Aug 25, 2014: Regeneron and Sanofi to Present Results from Four Phase 3 Alirocumab Trials in Hot Line Session at ESC Congress 2014 146 Aug 12, 2014: Esperion Therapeutics Provides ETC-1002 Development Program Update 147 Jul 30, 2014: Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 147 Jul 30, 2014: Sanofi and Regeneron Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 148 Jul 24, 2014: Esperion Therapeutics Announces Initiation of a Phase 2 Clinical Study of ETC-1002 in Patients with Hypercholesterolemia and Hypertension 149 Jun 11, 2014: Capstone Therapeutics Announces Initiation of Dosing for AEM-28 Phase 1b/2a Human Clinical Trial in Refractory Hypercholesterolemic Subjects 150 Appendix 152 Methodology 152 Coverage 152 Secondary Research 152 Primary Research 152 Expert Panel Validation 152 Contact Us 153 Disclaimer 153
List of Tables Number of Products under Development for Hypercholesterolemia, H2 2014 12 Number of Products under Development for Hypercholesterolemia - Comparative Analysis, H2 2014 13 Number of Products under Development by Companies, H2 2014 15 Number of Products under Development by Companies, H2 2014 (Contd..1) 16 Number of Products under Investigation by Universities/Institutes, H2 2014 18 Comparative Analysis by Late Stage Development, H2 2014 19 Comparative Analysis by Clinical Stage Development, H2 2014 20 Comparative Analysis by Early Stage Development, H2 2014 21 Products under Development by Companies, H2 2014 22 Products under Development by Companies, H2 2014 (Contd..1) 23 Products under Investigation by Universities/Institutes, H2 2014 24 Hypercholesterolemia - Pipeline by Bristol-Myers Squibb Company, H2 2014 25 Hypercholesterolemia - Pipeline by Johnson & Johnson, H2 2014 26 Hypercholesterolemia - Pipeline by Amgen Inc., H2 2014 27 Hypercholesterolemia - Pipeline by Eli Lilly and Company, H2 2014 28 Hypercholesterolemia - Pipeline by Merck & Co., Inc., H2 2014 29 Hypercholesterolemia - Pipeline by Pfizer Inc., H2 2014 30 Hypercholesterolemia - Pipeline by Santaris Pharma A/S, H2 2014 31 Hypercholesterolemia - Pipeline by SoluBest Ltd., H2 2014 32 Hypercholesterolemia - Pipeline by Alnylam Pharmaceuticals, Inc., H2 2014 33 Hypercholesterolemia - Pipeline by Regeneron Pharmaceuticals, Inc., H2 2014 34 Hypercholesterolemia - Pipeline by CrystalGenomics, Inc., H2 2014 35 Hypercholesterolemia - Pipeline by Catabasis Pharmaceuticals, Inc., H2 2014 36 Hypercholesterolemia - Pipeline by Planet Biotechnology Inc., H2 2014 37 Hypercholesterolemia - Pipeline by Zhejiang Hisun Pharmaceutical Co., Ltd., H2 2014 38 Hypercholesterolemia - Pipeline by Esperion Therapeutics, Inc., H2 2014 39 Hypercholesterolemia - Pipeline by Progenra, Inc., H2 2014 40 Hypercholesterolemia - Pipeline by Serometrix, LLC, H2 2014 41 Hypercholesterolemia - Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H2 2014 42 Hypercholesterolemia - Pipeline by AtheroNova Inc., H2 2014 43 Hypercholesterolemia - Pipeline by Immune Response BioPharma, Inc., H2 2014 44 Hypercholesterolemia - Pipeline by Agilvax, Inc., H2 2014 45 Hypercholesterolemia - Pipeline by Michigan Life Therapeutics, LLC, H2 2014 46 Hypercholesterolemia - Pipeline by LondonPharma Ltd, H2 2014 47 Hypercholesterolemia - Pipeline by Dybly AG, H2 2014 48 Assessment by Monotherapy Products, H2 2014 49 Assessment by Combination Products, H2 2014 50 Number of Products by Stage and Target, H2 2014 53 Number of Products by Stage and Mechanism of Action, H2 2014 56 Number of Products by Stage and Route of Administration, H2 2014 58 Number of Products by Stage and Molecule Type, H2 2014 60 Hypercholesterolemia Therapeutics - Recent Pipeline Updates, H2 2014 114 Hypercholesterolemia - Dormant Projects, H2 2014 139 Hypercholesterolemia - Discontinued Products, H2 2014 140
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