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

Global Markets Direct’s, ‘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’, provides in depth analysis on 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 pipeline therapeutics. The report provides comprehensive information complete with analysis by indications, stage of development, 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 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 and features dormant and discontinued projects. The report analyses the pipeline products from therapy areas Metabolic Disorders, Cardiovascular, Gastrointestinal, Immunology, Infectious Disease and Oncology under development targeting 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.).

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.

*Updated report will be delivered in 48 hours of order confirmation.

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

Companies mentioned

AFFiRiS AG

Betagenon AB

Bioleaders Corp

BioLingus AG

Catabasis Pharmaceuticals Inc

Dicerna Pharmaceuticals Inc

Eli Lilly and Co

Ensemble Therapeutics Corp

Kowa Co Ltd

Novartis AG

Pfizer Inc

Regeneron Pharmaceuticals Inc

Serometrix LLC

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd

The Medicines Company

Table of Contents

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

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

List of Figures

List of Figures

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 Top 10 Indications, H2 2017 11

Number of Products by Stage and Mechanism of Actions, H2 2017 19

Number of Products by Routes of Administration, H2 2017 20

Number of Products by Stage and Routes of Administration, H2 2017 20

Number of Products by Molecule Types, H2 2017 22

Number of Products by Stage and Molecule Types, H2 2017 22

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