Cardiovascular Disorders Drug Development Pipeline Review, 2017

Cardiovascular disease (CVD) covers a range of difference diseases and conditions affecting the heart and/or blood vessels. The most crucial risk factors for CVD are hypertension and dyslipidemia of which accelerate the development of atherosclerotic plaques building up within blood vessels. As atheroma develops its causes stenosis of the blood vessels which can restrict blood flow to the body, brain or heart depending on its locale. It is also possible for the fibrous cap of the plaque to break off, triggering the coagulation cascade and causing a thrombus to form locally which can completely occlude blood flow.

The treatments of CVD typically focus on prevention by controlling the risk factors of CVD. As such, the treatments usually fall within three categories: Anti-hypertensives aim to lower blood pressure; anti-dyslipidemia drugs aim to alter lipid levels to an acceptable range; and anti-thrombotic drugs aim to either prevent thrombus forming or work to mitigate the damage of a current thrombi, they do this by either interrupting the coagulation cascade or inhibiting platelet aggregation, both of which inhibit blood from clotting.

There are over 1,200 pipeline products within the CVD therapy area. Over 50% of these products are small molecules however there is also diversification with regards to molecule types within the pipeline. In addition, the molecular targets in the pipeline are considerably diverse with a high frequency of products acting on targets related to lipid metabolism and those which act on elements of the coagulation cascade.

Among those pipeline drugs expected for imminent release to market there is a mixture of first-in-class products, typically anti-dyslipidemia drugs aiming to provide alternatives to statin therapy, and drugs belonging to currently popular classes such as PCSK9 inhibitors and direct factor Xa inhibitors.

The report provides comprehensive information on the pipeline development landscape for Hypertension, Dyslipidemia, Venous thromboembolism and Heart failure, from Discovery through to the Pre-Registration stage. This includes an analysis of products by stage of development, molecular target, mechanism of action (MoA), route of administration (RoA) and molecule type. A list of all products in development is provided, including dormant and discontinued projects. Finally, the report provides an overview of key players involved in the development of products in this area, and outlines recent updates and press releases in the field.

Scope

– Which companies are the most active within the pipeline for CVD?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication, and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline, and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Table of Contents

Table of Contents

GBI Research Report Guidance 2

Executive Summary 3

Table of Contents 4

List of Tables 6

List of Figures 15

Introduction 18

Cardiovascular Disorders Report Coverage 18

Hypertension Overview 18

Dyslipidemia Overview 18

Thromboembolism Overview 18

Heart Failure Overview 18

Therapeutics Development 20

Hypertension 20

Dyslipidemia 22

Thromboembolism 24

Heart Failure 26

Therapeutics under Development by Companies 31

Hypertension 31

Dyslipidemia 35

Thromboembolism 39

Heart Failure 40

Therapeutics under Investigation by Universities/Institutes 47

Hypertension 47

Dyslipidemia 49

Thromboembolism 50

Heart Failure 50

Pipeline Products Glance 52

Hypertension 52

Dyslipidemia 55

Thromboembolism 58

Heart Failure 61

Products under Development by Companies 68

Hypertension 68

Dyslipidemia 75

Thromboembolism 79

Heart Failure 79

Products under Investigation by Universities/Institutes 86

Hypertension 86

Dyslipidemia 87

Thromboembolism 88

Heart Failure 88

Companies Involved in Therapeutics Development 90

Hypertension 90

Dyslipidemia 151

Thromboembolism 185

Heart Failure 192

Therapeutics Assessment 244

Hypertension 244

Dyslipidemia 265

Thromboembolism 281

Heart Failure 290

Dormant Projects 325

Hypertension 325

Dyslipidemia 335

Thromboembolism 343

Heart Failure 343

Discontinued Products 349

Hypertension 349

Dyslipidemia 351

Thromboembolism 353

Heart Failure 353

Product Development Milestones 356

Hypertension 356

Dyslipidemia 367

Thromboembolism 379

Heart Failure 396

Appendix 431

Methodology 431

Coverage 431

Secondary Research 431

Primary Research 431

Expert Panel Validation 431

Contact Us 432

Disclaimer 432

List of Tables

List of Tables

Number of Products under Development for Hypertension 20

Number of Products under Development for Hypertension – Comparative Analysis 21

Number of Products under Development for Dyslipidemia 22

Number of Products under Development for Dyslipidemia – Comparative Analysis 23

Number of Products under Development for Thromboembolism 24

Number of Products under Development for Thromboembolism – Comparative Analysis 25

Number of Products under Development for Acute Heart Failure 26

Number of Products under Development for Congestive Heart Failure (Heart Failure) 27

Number of Products under Development for Congestive Heart Failure (Heart Failure) – Comparative Analysis 28

Number of Products under Development for Chronic Heart Failure 29

Number of Products under Development for Chronic Heart Failure – Comparative Analysis 30

Number of Products under Development by Companies, Hypertension 31

Number of Products under Development by Companies, Dyslipidemia 36

Number of Products under Development by Companies, Thromboembolism 39

Number of Products under Development by Companies, Acute Heart Failure 40

Number of Products under Development by Companies, Congestive Heart Failure (Heart Failure) 42

Number of Products under Development by Companies, Chronic Heart Failure 46

Number of Products under Investigation by Universities/Institutes, Hypertension 48

Number of Products under Investigation by Universities/Institutes, Dyslipidemia 49

Number of Products under Investigation by Universities/Institutes, Thromboembolism 50

Number of Products under Investigation by Universities/Institutes, Congestive Heart Failure (Heart Failure) 51

Number of Products under Investigation by Universities/Institutes, Chronic Heart Failure 51

Comparative Analysis by Late Stage Development, Hypertension 52

Comparative Analysis by Clinical Stage Development, Hypertension 53

Comparative Analysis by Early Stage Development, Hypertension 54

Comparative Analysis by Late Stage Development, Dyslipidemia 55

Comparative Analysis by Clinical Stage Development, Dyslipidemia 56

Comparative Analysis by Early Stage Development, Dyslipidemia 57

Comparative Analysis by Unknown Stage Development, Dyslipidemia 58

Comparative Analysis by Late Stage Development, Thromboembolism 58

Comparative Analysis by Clinical Stage Development, Thromboembolism 59

Comparative Analysis by Early Stage Development, Thromboembolism 60

Comparative Analysis by Late Stage Development, Acute Heart Failure 61

Comparative Analysis by Clinical Stage Development, Acute Heart Failure 61

Comparative Analysis by Early Stage Development, Acute Heart Failure 62

Comparative Analysis by Late Stage Development, Congestive Heart Failure (Heart Failure) 62

Comparative Analysis by Clinical Stage Development, Congestive Heart Failure (Heart Failure) 63

Comparative Analysis by Early Stage Development, Congestive Heart Failure (Heart Failure) 64

Comparative Analysis by Unknown Stage Development, Congestive Heart Failure (Heart Failure) 65

Comparative Analysis by Late Stage Development, Chronic Heart Failure 65

Comparative Analysis by Clinical Stage Development, Chronic Heart Failure 66

Comparative Analysis by Early Stage Development, Chronic Heart Failure 67

Products under Development by Companies, Hypertension 68

Products under Development by Companies, Dyslipidemia 75

Products under Development by Companies, Thromboembolism 79

Products under Development by Companies, Acute Heart Failure 79

Products under Development by Companies, Congestive Heart Failure (Heart Failure) 80

Products under Development by Companies, Chronic Heart Failure 85

Products under Investigation by Universities/Institutes, Hypertension 86

Products under Investigation by Universities/Institutes, Dyslipidemia 87

Products under Investigation by Universities/Institutes, Thromboembolism 88

Products under Investigation by Universities/Institutes, Congestive Heart Failure (Heart Failure) 88

Products under Investigation by Universities/Institutes, Chronic Heart Failure 89

Hypertension – Pipeline by A1M Pharma AB 90

Hypertension – Pipeline by AbbVie Inc 90

Hypertension – Pipeline by Actelion Ltd 91

Hypertension – Pipeline by Afferent Pharmaceuticals Inc 91

Hypertension – Pipeline by Alnylam Pharmaceuticals Inc 92

Hypertension – Pipeline by Anacor Pharmaceuticals Inc 93

Hypertension – Pipeline by AnGes MG Inc 94

Hypertension – Pipeline by APT Therapeutics Inc 94

Hypertension – Pipeline by Arena Pharmaceuticals Inc 95

Hypertension – Pipeline by Ascendis Pharma A/S 96

Hypertension – Pipeline by Asklepion Pharmaceuticals LLC 97

Hypertension – Pipeline by AVEO Pharmaceuticals Inc 97

Hypertension – Pipeline by Bayer AG 98

Hypertension – Pipeline by Bial – Portela & Ca SA 98

Hypertension – Pipeline by Biolab Farmaceutica Ltda 99

Hypertension – Pipeline by BioRestorative Therapies Inc 99

Hypertension – Pipeline by Boryung Pharmaceutical Co Ltd 100

Hypertension – Pipeline by Cellceutix Corp 100

Hypertension – Pipeline by Celsion Corp 101

Hypertension – Pipeline by Celtaxsys Inc 101

Hypertension – Pipeline by Chong Kun Dang Pharmaceutical Corp 102

Hypertension – Pipeline by CJ HealthCare Corp 102

Hypertension – Pipeline by Complexa Inc 103

Hypertension – Pipeline by Conatus Pharmaceuticals Inc 103

Hypertension – Pipeline by Corion Biotech Srl 104

Hypertension – Pipeline by Cumberland Pharmaceuticals Inc 104

Hypertension – Pipeline by Cytokinetics Inc 105

Hypertension – Pipeline by Daewoong Pharmaceutical Co Ltd 106

Hypertension – Pipeline by Daiichi Sankyo Company Ltd 107

Hypertension – Pipeline by DiaMedica Inc 107

Hypertension – Pipeline by Eli Lilly and Company 108

Hypertension – Pipeline by Esperion Therapeutics Inc 108

Hypertension – Pipeline by F. Hoffmann-La Roche Ltd 109

Hypertension – Pipeline by Ferring International Center SA 109

Hypertension – Pipeline by Galectin Therapeutics Inc 110

Hypertension – Pipeline by Genextra Spa 110

Hypertension – Pipeline by Gilead Sciences Inc 111

Hypertension – Pipeline by GlaxoSmithKline Plc 112

Hypertension – Pipeline by Glenveigh Medical LLC 112

Hypertension – Pipeline by HanAll Biopharma Co Ltd 113

Hypertension – Pipeline by Hanmi Pharmaceuticals Co Ltd 114

Hypertension – Pipeline by HitGen LTD 114

Hypertension – Pipeline by Innopharmax Inc 115

Hypertension – Pipeline by Insmed Inc 115

Hypertension – Pipeline by INVENT Pharmaceuticals Inc 116

Hypertension – Pipeline by Ionis Pharmaceuticals Inc 116

Hypertension – Pipeline by Ironwood Pharmaceuticals Inc 117

Hypertension – Pipeline by Jeil Pharmaceutical Co Ltd 118

Hypertension – Pipeline by Johnson & Johnson 119

Hypertension – Pipeline by JW Pharmaceutical Corp 120

Hypertension – Pipeline by Kowa Company Ltd 120

Hypertension – Pipeline by Leading BioSciences Inc 121

Hypertension – Pipeline by Lee’s Pharmaceutical Holdings Ltd 121

Hypertension – Pipeline by Les Laboratoires Servier SAS 122

Hypertension – Pipeline by LFB SA 122

Hypertension – Pipeline by LG Life Science LTD 123

Hypertension – Pipeline by LinXis BV 123

Hypertension – Pipeline by Liquidia Technologies Inc 124

Hypertension – Pipeline by Lotus Pharmaceutical Co Ltd 124

Hypertension – Pipeline by MannKind Corp 125

Hypertension – Pipeline by Mast Therapeutics Inc 125

Hypertension – Pipeline by Merck & Co Inc 126

Hypertension – Pipeline by Mezzion Pharma Co Ltd 126

Hypertension – Pipeline by miRagen Therapeutics Inc 127

Hypertension – Pipeline by Mitsubishi Tanabe Pharma Corp 127

Hypertension – Pipeline by Morphogen-IX Ltd 128

Hypertension – Pipeline by Neurim Pharmaceuticals Ltd 128

Hypertension – Pipeline by Nippon Kayaku Co Ltd 129

Hypertension – Pipeline by Nippon Shinyaku Co Ltd 130

Hypertension – Pipeline by Novartis AG 131

Hypertension – Pipeline by Noxamet Ltd 131

Hypertension – Pipeline by Omeros Corp 132

Hypertension – Pipeline by Peloton Therapeutics Inc 132

Hypertension – Pipeline by Pfizer Inc 133

Hypertension – Pipeline by PhaseBio Pharmaceuticals Inc 133

Hypertension – Pipeline by Pluristem Therapeutics Inc 134

Hypertension – Pipeline by Polyphor Ltd 134

Hypertension – Pipeline by Proteo Inc 135

Hypertension – Pipeline by Pulmokine Inc 135

Hypertension – Pipeline by Quantum Genomics SA 136

Hypertension – Pipeline by Reata Pharmaceuticals Inc 136

List of Figures

List of Figures

Number of Products under Development for Hypertension 20

Number of Products under Development for Hypertension – Comparative Analysis 21

Number of Products under Development for Dyslipidemia 22

Number of Products under Development for Dyslipidemia – Comparative Analysis 23

Number of Products under Development for Thromboembolism 24

Number of Products under Development for Thromboembolism – Comparative Analysis 25

Number of Products under Development for Acute Heart Failure 26

Number of Products under Development for Congestive Heart Failure (Heart Failure) 27

Number of Products under Development for Congestive Heart Failure (Heart Failure) – Comparative Analysis 28

Number of Products under Development for Chronic Heart Failure 29

Number of Products under Development for Chronic Heart Failure – Comparative Analysis 30

Number of Products under Development by Companies, Hypertension 31

Number of Products under Development by Companies, Dyslipidemia 35

Number of Products under Development by Companies, Thromboembolism 39

Number of Products under Development by Companies, Acute Heart Failure 40

Number of Products under Development by Companies, Congestive Heart Failure (Heart Failure) 41

Number of Products under Development by Companies, Chronic Heart Failure 45

Number of Products under Investigation by Universities/Institutes, Hypertension 47

Number of Products under Investigation by Universities/Institutes, Dyslipidemia 49

Number of Products under Investigation by Universities/Institutes, Congestive Heart Failure (Heart Failure) 50

Comparative Analysis by Late Stage Development, Hypertension 52

Comparative Analysis by Clinical Stage Development, Hypertension 53

Comparative Analysis by Early Stage Products, Hypertension 54

Comparative Analysis by Late Stage Development, Dyslipidemia 55

Comparative Analysis by Clinical Stage Development, Dyslipidemia 56

Comparative Analysis by Early Stage Products, Dyslipidemia 57

Comparative Analysis by Late Stage Development, Thromboembolism 58

Comparative Analysis by Clinical Stage Development, Thromboembolism 59

Comparative Analysis by Early Stage Products, Thromboembolism 60

Comparative Analysis by Clinical Stage Development, Acute Heart Failure 61

Comparative Analysis by Late Stage Development, Congestive Heart Failure (Heart Failure) 62

Comparative Analysis by Clinical Stage Development, Congestive Heart Failure (Heart Failure) 63

Comparative Analysis by Early Stage Products, Congestive Heart Failure (Heart Failure) 64

Comparative Analysis by Clinical Stage Development, Chronic Heart Failure 66

Comparative Analysis by Early Stage Products, Chronic Heart Failure 67

Assessment by Monotherapy Products, Hypertension 244

Assessment by Combination Products, Hypertension 245

Number of Products by Top 10 Targets, Hypertension 246

Number of Products by Stage and Top 10 Targets, Hypertension 246

Number of Products by Top 10 Mechanism of Actions, Hypertension 254

Number of Products by Stage and Top 10 Mechanism of Actions, Hypertension 254

Number of Products by Top 10 Routes of Administration, Hypertension 262

Number of Products by Stage and Top 10 Routes of Administration, Hypertension 262

Number of Products by Top 10 Molecule Types, Hypertension 264

Number of Products by Stage and Top 10 Molecule Types, Hypertension 264

Assessment by Monotherapy Products, Dyslipidemia 265

Assessment by Combination Products, Dyslipidemia 267

Number of Products by Top 10 Targets, Dyslipidemia 268

Number of Products by Stage and Top 10 Targets, Dyslipidemia 268

Number of Products by Top 10 Mechanism of Actions, Dyslipidemia 273

Number of Products by Stage and Top 10 Mechanism of Actions, Dyslipidemia 273

Number of Products by Routes of Administration, Dyslipidemia 278

Number of Products by Stage and Routes of Administration, Dyslipidemia 278

Number of Products by Molecule Types, Dyslipidemia 280

Number of Products by Stage and Molecule Types, Dyslipidemia 280

Assessment by Monotherapy Products, Thromboembolism 281

Number of Products by Targets, Thromboembolism 283

Number of Products by Stage and Targets, Thromboembolism 283

Number of Products by Mechanism of Actions, Thromboembolism 285

Number of Products by Stage and Mechanism of Actions, Thromboembolism 285

Number of Products by Routes of Administration, Thromboembolism 287

Number of Products by Stage and Routes of Administration, Thromboembolism 287

Number of Products by Molecule Types, Thromboembolism 289

Number of Products by Stage and Molecule Types, Thromboembolism 289

Assessment by Monotherapy Products, Acute Heart Failure 290

Number of Products by Top 10 Targets, Acute Heart Failure 292

Number of Products by Stage and Top 10 Targets, Acute Heart Failure 292

Number of Products by Top 10 Mechanism of Actions, Acute Heart Failure 294

Number of Products by Stage and Top 10 Mechanism of Actions, Acute Heart Failure 294

Number of Products by Routes of Administration, Acute Heart Failure 296

Number of Products by Stage and Routes of Administration, Acute Heart Failure 296

Number of Products by Molecule Types, Acute Heart Failure 298

Number of Products by Stage and Molecule Types, Acute Heart Failure 298

Assessment by Monotherapy Products, Congestive Heart Failure (Heart Failure) 299

Number of Products by Top 10 Targets, Congestive Heart Failure (Heart Failure) 300

Number of Products by Stage and Top 10 Targets, Congestive Heart Failure (Heart Failure) 301

Number of Products by Top 10 Mechanism of Actions, Congestive Heart Failure (Heart Failure) 307

Number of Products by Stage and Top 10 Mechanism of Actions, Congestive Heart Failure (Heart Failure) 307

Number of Products by Top 10 Routes of Administration, Congestive Heart Failure (Heart Failure) 313

Number of Products by Stage and Top 10 Routes of Administration, Congestive Heart Failure (Heart Failure) 313

Number of Products by Top 10 Molecule Types, Congestive Heart Failure (Heart Failure) 315

Number of Products by Stage and Top 10 Molecule Types, Congestive Heart Failure (Heart Failure) 315

Assessment by Monotherapy Products, Chronic Heart Failure 316

Number of Products by Top 10 Targets, Chronic Heart Failure 318

Number of Products by Stage and Top 10 Targets, Chronic Heart Failure 318

Number of Products by Top 10 Mechanism of Actions, Chronic Heart Failure 320

Number of Products by Stage and Top 10 Mechanism of Actions, Chronic Heart Failure 320

Number of Products by Routes of Administration, Chronic Heart Failure 322

Number of Products by Stage and Routes of Administration, Chronic Heart Failure 322

Number of Products by Molecule Types, Chronic Heart Failure 324

Number of Products by Stage and Molecule Types, Chronic Heart Failure 324

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