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 2016

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 2016’, 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 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. 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.

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

BioLingus AG

Catabasis Pharmaceuticals, Inc.

Daiichi Sankyo Company, Limited

Dicerna Pharmaceuticals, Inc.

Eli Lilly and Company

Ensemble Therapeutics Corporation

HitGen LTD

Kowa Company, Ltd.

Kymab Limited

MedImmune, LLC

Novartis AG

Pfizer Inc.

Planet Biotechnology Inc.

Regeneron Pharmaceuticals Inc

Serometrix, LLC

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

The Medicines Company

Thetis Pharmaceuticals LLC

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

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 10

Therapeutics Development 11

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.) - Products under Development by Stage of Development 11

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.) - Products under Development by Therapy Area 12

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.) - Products under Development by Indication 13

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 Products Glance 15

Late Stage Products 15

Early Stage Products 16

Unknown Stage Products 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.) - Products under Development by Companies 18

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.) - Products under Development by Universities/Institutes 21

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 23

Assessment by Monotherapy/Combination Products 23

Assessment by Mechanism of Action 24

Assessment by Route of Administration 25

Assessment by Molecule Type 27

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 29

AFFiRiS AG 29

Betagenon AB 30

BioLingus AG 31

Catabasis Pharmaceuticals, Inc. 32

Daiichi Sankyo Company, Limited 33

Dicerna Pharmaceuticals, Inc. 34

Eli Lilly and Company 35

Ensemble Therapeutics Corporation 36

HitGen LTD 37

Kowa Company, Ltd. 38

Kymab Limited 39

MedImmune, LLC 40

Novartis AG 41

Pfizer Inc. 42

Planet Biotechnology Inc. 43

Regeneron Pharmaceuticals Inc 44

Serometrix, LLC 45

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. 46

The Medicines Company 47

Thetis Pharmaceuticals LLC 48

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 49

(atorvastatin calcium + TP-452) - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

alirocumab - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

ALN-PCSsc - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Antisense Oligonucleotide to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

ATH-04 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

ATH-06 - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

bococizumab - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

CAT-2000 Series - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

DCRPCSK-9 - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

DS-9001 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Gene Therapy to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

JS-002 - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

K-312 - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

KY-1020 - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

lodelcizumab - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

LY-3015014 - Drug Profile 79

Product Description 79

Mechanism Of Action 79

R&D Progress 79

MEDI-4166 - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

Monoclonal Antibodies to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

Monoclonal Antibody to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

O-304 - Drug Profile 83

Product Description 83

Mechanism Of Action 83

R&D Progress 83

Recombinant Protein to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

Small Molecule to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

Small Molecules to Inhibit PCSK9 for Acute Coronary Syndrome and Atherosclerosis - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

Small Molecules to Inhibit PCSK9 for Cardiovascular Disease - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

Small Molecules to Inhibit PCSK9 for Coronary Artery Disease and Metabolic Disorders - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

Small Molecules to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

SX-PCK9 - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

Synthetic Peptide to Inhibit PCSK9 for Hypercholesterolemia - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

TP-452 - Drug Profile 95

Product Description 95

Mechanism Of Action 95

R&D Progress 95

Vaccine to Target PCSK9 for Hypercholesterolemia - Drug Profile 96

Product Description 96

Mechanism Of Action 96

R&D Progress 96

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 Projects 97

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 99

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.) - Featured News & Press Releases 100

Oct 18, 2016: The Medicines Company Announces Positive Top-Line Results from Day 90 Interim Analysis in Ongoing ORION-1 Phase 2 Study of PCSK9si 100

Oct 05, 2016: The Medicines Company Provides Progress Update on Ongoing ORION-1 Study of PCSK9si 101

Aug 30, 2016: Betagenon: Start of Phase IIa Proof-of-Concept Clinical Trial of AMPK Activator O304 in Type 2 Diabetics 102

Aug 30, 2016: The Medicines Company Provides Update on PCSK9si (PCSK9 synthesis inhibitor) 102

Aug 29, 2016: Regeneron and Sanofi Present Positive Phase 3 Investigational Data for Praluent (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016 103

Jul 05, 2016: Regeneron and Sanofi Announce Approval of Praluent (alirocumab) for the Treatment of Hypercholesterolemia in Japan 104

Jun 28, 2016: Two Additional Phase 3 Lipid-Lowering Studies of Bococizumab Deliver Positive Topline Results 105

Jun 22, 2016: NICE Green Lights Cholesterol-Lowering Treatment Praluent (alirocumab) For NHS Funding 107

Jun 02, 2016: The Medicines Company Completes Patient Enrollment for ORION-1 Study of PCSK9si 108

May 24, 2016: New Cholesterol Treatment Now Available for Canadians 109

May 16, 2016: ICON and Pfizer Honoured as Clinical Research Team of the Year at the Clinical and Research Excellence Awards 110

May 11, 2016: Cigna’s New Value-Based Contract with Sanofi/Regeneron for Praluent 111

May 06, 2016: Innovative cholesterol-lowering treatment, Praluent (alirocumab), approved by NICE for people with raised cholesterol levels who are at significantly high risk of a heart attack or stroke 112

Apr 26, 2016: Bococizumab SPIRE-2 Cardiovascular Outcome Study Fully Enrolled 113

Apr 01, 2016: Pfizer Announces Positive Topline Results From Second Phase 3 Lipid-Lowering Study Evaluating Bococizumab 114

Appendix 116

Methodology 116

Coverage 116

Secondary Research 116

Primary Research 116

Expert Panel Validation 116

Contact Us 116

Disclaimer 117

List of Tables

List of Tables

Number of Products under Development for, H2 2016 11

Number of Products under Development by Therapy Area, H2 2016 12

Number of Products under Development by Indication, H2 2016 14

Comparative Analysis by Late Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Comparative Analysis by Unknown Stage Development, H2 2016 17

Number of Products under Development by Companies, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Development by Companies, H2 2016 (Contd..1) 20

Number of Products under Investigation by Universities/Institutes, H2 2016 21

Products under Investigation by Universities/Institutes, H2 2016 22

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 24

Number of Products by Stage and Route of Administration, H2 2016 26

Number of Products by Stage and Molecule Type, H2 2016 28

Pipeline by AFFiRiS AG, H2 2016 29

Pipeline by Betagenon AB, H2 2016 30

Pipeline by BioLingus AG, H2 2016 31

Pipeline by Catabasis Pharmaceuticals, Inc., H2 2016 32

Pipeline by Daiichi Sankyo Company, Limited, H2 2016 33

Pipeline by Dicerna Pharmaceuticals, Inc., H2 2016 34

Pipeline by Eli Lilly and Company, H2 2016 35

Pipeline by Ensemble Therapeutics Corporation, H2 2016 36

Pipeline by HitGen LTD, H2 2016 37

Pipeline by Kowa Company, Ltd., H2 2016 38

Pipeline by Kymab Limited, H2 2016 39

Pipeline by MedImmune, LLC, H2 2016 40

Pipeline by Novartis AG, H2 2016 41

Pipeline by Pfizer Inc., H2 2016 42

Pipeline by Planet Biotechnology Inc., H2 2016 43

Pipeline by Regeneron Pharmaceuticals Inc, H2 2016 44

Pipeline by Serometrix, LLC, H2 2016 45

Pipeline by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., H2 2016 46

Pipeline by The Medicines Company, H2 2016 47

Pipeline by Thetis Pharmaceuticals LLC, H2 2016 48

Dormant Projects, H2 2016 97

Dormant Projects (Contd..1), H2 2016 98

Discontinued Products, H2 2016 99

List of Figures

List of Figures

Number of Products under Development for, H2 2016 11

Number of Products under Development by Therapy Area, H2 2016 12

Number of Products under Development by Top 10 Indication, H2 2016 13

Comparative Analysis by Late Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Stage and Mechanism of Actions, H2 2016 24

Number of Products by Routes of Administration, H2 2016 25

Number of Products by Stage and Routes of Administration, H2 2016 25

Number of Products by Molecule Types, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 27

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