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Published: Oct, 2017 | Pages:
95 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Pipeline Review, H2 2017 Summary Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) pipeline Target constitutes close to 28 molecules. Out of which approximately 26 molecules are developed by companies and remaining by the universities/institutes. The latest report Proprotein Convertase SubtilisinKexin Type 9 - Pipeline Review, H2 2017, outlays comprehensive information on the Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme encoded by the PCSK9 gene. It is a crucial player in the regulation of plasma cholesterol homeostasis. It binds to low-density lipid receptor family members. It acts via a non-proteolytic mechanism to enhance the degradation of the hepatic LDLR through a clathrin LDLRAP1/ARH-mediated pathway. It prevents the recycling of LDLR from endosomes to the cell surface or directs it to lysosomes for degradation. It induces ubiquitination of LDLR leading to its subsequent degradation. It inhibits intracellular degradation of APOB via the autophagosome/lysosome pathway in a LDLR-independent manner. The molecules developed by companies in Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical, Discovery and Unknown stages are 1, 3, 4, 3, 8, 6 and 1 respectively. Similarly, the universities portfolio in Preclinical and Discovery stages comprises 1 and 1 molecules, respectively. Report covers products from therapy areas Metabolic Disorders, Cardiovascular, Gastrointestinal, Immunology, Infectious Disease and Oncology which include indications Hypercholesterolemia, Hyperlipidemia, Atherosclerosis, Cardiovascular Disease, Homozygous Familial Hypercholesterolemia (HoFH), Non-Alcoholic Steatohepatitis (NASH), Type 2 Diabetes, Bacterial Sepsis, Hypertriglyceridemia, Inflammation, Liver Diseases, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease (NAFLD) and Peripheral Arterial Disease (PAD)/ Peripheral Vascular Disease (PVD). Furthermore, this report also reviews key players involved in Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics development with respective active and dormant or discontinued projects. Driven by data and information sourced from 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. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Scope - The report provides a snapshot of the global therapeutic landscape for Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - The report reviews Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics under development 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 in Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics and enlists all their major and minor projects - The report assesses Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics based on 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 and deals related to Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) targeted therapeutics 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 the targeted therapy areas and indications for Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Identify the use of drugs for target identification and drug repurposing - 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 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) development landscape - 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.
Table of Contents
Table of Contents 2 List of Tables 6 List of Figures 6 Introduction 7 Global Markets Direct Report Coverage 7 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Overview 8 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Therapeutics Development 9 Products under Development by Stage of Development 9 Products under Development by Therapy Area 10 Products under Development by Indication 11 Products under Development by Companies 12 Products under Development by Universities/Institutes 17 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Therapeutics Assessment 19 Assessment by Mechanism of Action 19 Assessment by Route of Administration 20 Assessment by Molecule Type 22 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Companies Involved in Therapeutics Development 24 AFFiRiS AG 24 Betagenon AB 24 Bioleaders Corp 25 BioLingus AG 25 Catabasis Pharmaceuticals Inc 25 Dicerna Pharmaceuticals Inc 26 Eli Lilly and Co 26 Ensemble Therapeutics Corp 27 Kowa Co Ltd 27 Novartis AG 27 Pfizer Inc 28 Regeneron Pharmaceuticals Inc 28 Serometrix LLC 29 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd 29 The Medicines Company 30 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Drug Profiles 31 AK-102 - Drug Profile 31 Product Description 31 Mechanism Of Action 31 R&D Progress 31 alirocumab - Drug Profile 32 Product Description 32 Mechanism Of Action 32 R&D Progress 32 Antisense Oligonucleotide to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 44 Product Description 44 Mechanism Of Action 44 R&D Progress 44 Antisense RNAi Oligonucleotide to Inhibit PCSK-9 for Hypercholesterolemia - Drug Profile 45 Product Description 45 Mechanism Of Action 45 R&D Progress 45 AT-04A - Drug Profile 46 Product Description 46 Mechanism Of Action 46 R&D Progress 46 AT-06A - Drug Profile 47 Product Description 47 Mechanism Of Action 47 R&D Progress 47 BLSM-201 - Drug Profile 48 Product Description 48 Mechanism Of Action 48 R&D Progress 48 CAT-2000 Series - Drug Profile 49 Product Description 49 Mechanism Of Action 49 R&D Progress 49 CVI-LM001 - Drug Profile 50 Product Description 50 Mechanism Of Action 50 R&D Progress 50 DCRPCSK-9 - Drug Profile 51 Product Description 51 Mechanism Of Action 51 R&D Progress 51 Gene Therapy to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 52 Product Description 52 Mechanism Of Action 52 R&D Progress 52 inclisiran - Drug Profile 53 Product Description 53 Mechanism Of Action 53 R&D Progress 53 JS-002 - Drug Profile 59 Product Description 59 Mechanism Of Action 59 R&D Progress 59 K-312 - Drug Profile 60 Product Description 60 Mechanism Of Action 60 R&D Progress 60 lodelcizumab - Drug Profile 61 Product Description 61 Mechanism Of Action 61 R&D Progress 61 LY-3015014 - Drug Profile 62 Product Description 62 Mechanism Of Action 62 R&D Progress 62 Monoclonal Antibodies to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 63 Product Description 63 Mechanism Of Action 63 R&D Progress 63 Monoclonal Antibody to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 64 Product Description 64 Mechanism Of Action 64 R&D Progress 64 O-304 - Drug Profile 65 Product Description 65 Mechanism Of Action 65 R&D Progress 65 PF-06446846 - Drug Profile 67 Product Description 67 Mechanism Of Action 67 R&D Progress 67 Recombinant Protein to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 68 Product Description 68 Mechanism Of Action 68 R&D Progress 68 Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 70 Product Description 70 Mechanism Of Action 70 R&D Progress 70 Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 71 Product Description 71 Mechanism Of Action 71 R&D Progress 71 Small Molecules to Inhibit PCSK9 for Cardiovascular Disease - Drug Profile 72 Product Description 72 Mechanism Of Action 72 R&D Progress 72 Small Molecules to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 73 Product Description 73 Mechanism Of Action 73 R&D Progress 73 SX-PCK9 - Drug Profile 74 Product Description 74 Mechanism Of Action 74 R&D Progress 74 Synthetic Peptide to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 75 Product Description 75 Mechanism Of Action 75 R&D Progress 75 Vaccine to Target PCSK9 for Hypercholesterolemia - Drug Profile 76 Product Description 76 Mechanism Of Action 76 R&D Progress 76 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Dormant Products 77 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Discontinued Products 79 Proprotein Convertase Subtilisin/Kexin Type 9 (Proprotein Convertase 9 or Neural Apoptosis Regulated Convertase 1 or Subtilisin/Kexin Like Protease PC9 or PCSK9 or EC 3.4.21.) - Product Development Milestones 80 Featured News & Press Releases 80 Aug 28, 2017: New, One-Year Data from ORION-1 Phase II Study of Inclisiran Extends Excellent Long-Term Efficacy and Safety Profile, Affirming Dose for Phase III Trials 80 Aug 25, 2017: Regeneron and Sanofi to Present New Analyses from Praluent Injection Trials at the ESC Congress 2017 82 Jun 11, 2017: Medication That Inhibits PCSK9 Safely Reduces Cardiovascular Risk in Patients with Type 2 Diabetes 82 Jun 11, 2017: Sanofi and Regeneron Announce Positive Results from First Dedicated Studies Evaluating Praluent (alirocumab) in Individuals with Diabetes and Hypercholesterolemia 84 Apr 26, 2017: The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran 86 Apr 25, 2017: Regeneron And Sanofi Announce FDA Approval Of A New Once-Monthly Dosing Option For Praluent (Alirocumab) Injection 87 Mar 17, 2017: The Medicines Company and Alnylam Pharmaceuticals Report Positive Final Results from ORION-1 Phase II Study of Inclisiran 88 Mar 14, 2017: The Medicines Company to Webcast Presentation of ORION-1 Phase II Study of Inclisiran at ACC.17 89 Mar 07, 2017: Regeneron and Sanofi to Present New Phase 3 Praluent (alirocumab) Injection Clinical Trial Analyses at ACC.17 Scientific Sessions 89 Feb 08, 2017: Appeals Court Grants Stay of Permanent Injunction for Praluent (alirocumab) During Appeals Process 91 Jan 25, 2017: The Medicines Company to Present Results from ORION-1 Phase 2 Study of Inclisiran at the American College of Cardiology's 66th Annual Scientific Session 91 Jan 13, 2017: Sanofi and Regeneron File Notice of Appeal and Motion to Stay (Suspend) Injunction with Federal Circuit Court of Appeals in Patent Case Regarding Praluent (alirocumab) Injection 92 Jan 09, 2017: Amgen Statement on January 9, 2017, U.S. District Court Decision 92 Jan 08, 2017: The Medicines Company Announces Positive Top-Line Results from Day 180 Interim Analysis in Ongoing ORION-1 Phase 2 Study of Inclisiran 92 Jan 05, 2017: Regeneron and Sanofi to Appeal U.S. District Court Rulings in Ongoing Patent Litigation Regarding Praluent (alirocumab) Injection 93 Appendix 94 Methodology 94 Coverage 94 Secondary Research 94 Primary Research 94 Expert Panel Validation 94 Contact Us 94 Disclaimer 95
List of Tables
Number of Products under Development by Stage of Development, H2 2017 9 Number of Products under Development by Therapy Areas, H2 2017 10 Number of Products under Development by Indication, H2 2017 11 Number of Products under Development by Companies, H2 2017 12 Number of Products under Development by Companies, H2 2017 (Contd..1) 13 Products under Development by Companies, H2 2017 14 Products under Development by Companies, H2 2017 (Contd..1), H2 2017 15 Products under Development by Companies, H2 2017 (Contd..2), H2 2017 16 Number of Products under Investigation by Universities/Institutes, H2 2017 17 Products under Investigation by Universities/Institutes, H2 2017 18 Number of Products by Stage and Mechanism of Actions, H2 2017 19 Number of Products by Stage and Route of Administration, H2 2017 21 Number of Products by Stage and Molecule Type, H2 2017 23 Pipeline by AFFiRiS AG, H2 2017 24 Pipeline by Betagenon AB, H2 2017 24 Pipeline by Bioleaders Corp, H2 2017 25 Pipeline by BioLingus AG, H2 2017 25 Pipeline by Catabasis Pharmaceuticals Inc, H2 2017 26 Pipeline by Dicerna Pharmaceuticals Inc, H2 2017 26 Pipeline by Eli Lilly and Co, H2 2017 27 Pipeline by Ensemble Therapeutics Corp, H2 2017 27 Pipeline by Kowa Co Ltd, H2 2017 27 Pipeline by Novartis AG, H2 2017 28 Pipeline by Pfizer Inc, H2 2017 28 Pipeline by Regeneron Pharmaceuticals Inc, H2 2017 29 Pipeline by Serometrix LLC, H2 2017 29 Pipeline by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd, H2 2017 30 Pipeline by The Medicines Company, H2 2017 30 Dormant Products, H2 2017 77 Dormant Products, H2 2017 (Contd..1), H2 2017 78 Discontinued Products, H2 2017 79
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