Frontier Pharma: Cardiovascular Disease - Diverse First-in-Class Molecular Targets to Bridge Unmet Needs in Pulmonary Hypertension, Heart Failure and Atherosclerosis

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Frontier Pharma: Cardiovascular Disease - Diverse First-in-Class Molecular Targets to Bridge Unmet Needs in Pulmonary Hypertension, Heart Failure and Atherosclerosis

Drug Pipeline, Drug Discovery, Pharma & Healthcare

Publication ID:

GBI0817007

Publication Date:

August 01, 2017

Pages:

113

Publisher:

GBI Research

Region:

Global

$6,995.00

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Description

Frontier Pharma: Cardiovascular Disease - Diverse First-in-Class Molecular Targets to Bridge Unmet Needs in Pulmonary Hypertension, Heart Failure and Atherosclerosis

Summary

The cardiovascular disease (CVD) therapy area encompasses a range of different diseases and conditions affecting the heart and/or blood vessels. The most crucial risk factors for CVD are hypertension and dyslipidemia, which accelerate the development of atherosclerotic plaque building up within blood vessels. As atheroma develops it causes the affected blood vessels to narrow, restricting blood flow to the body, brain or heart, depending on its location. It is also possible for the fibrous cap of this 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, which aim to alterblood pressure to within a normal range; anti-dyslipidemic drugs, which aim to modify lipid levels to a normal range; and anti-thrombotic drugs, which aim to either prevent a thrombus from formingby inhibiting the coagulation cascade or platelet aggregation.

There has been vast scientific innovation within the CVD therapeutics market over recent decades, particularly within the anti-dyslipidemia market, first with the introduction of statins such as Lipitor (atorvastatin), and more recently with the introduction of PCSK9 inhibitors. Innovation continues within the dyslipidemia pipeline, with a range of first-in-class molecular targets in the pipeline, including those that offer the promise of revolutionizing treatment by reversing the process of atherosclerosis.

Heart failure and pulmonary hypertension remain poorly treated, and are associated with poor prognosis. Heart failure in particular is associated with a five-year mortality rate of 50%. The large pipeline for heart failure includes a high proportion of first-in-class products relative to other CVD indications, and possesses the potential for breakthroughs in the treatment of this condition.

Scope

- With over 1,400 products in active development, the pipeline for CVD is extensive. Does current pipeline innovation hold the potential to change the CVD market in the near future?
- There are 320 first-in-class products in the CVD market that act on a novel molecular target thatis not present in an approved product across any indication in the pharmaceutical industry. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
- Analysis of the history of strategic consolidations revealed a modest level of deal activity in recent years, and a large number of first-in-class products not yet involved in any deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs that have not yet been involved in a licensing or co-development deal appear to be particularly promising?

Reasons to buy

- Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis and prognosis, and the treatment options available.
- Visualize the composition of the CVD market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
- Analyze the CVD pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating CVD to overcome the unmet need in the market.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.
- Identify commercial opportunities in the CVD deals landscape by analyzing trends in licensing and co-development deals, and analyzing a curated list of CVD therapies that have not yet been involved in deals, and may offer potential investment opportunities.

Table of Contents

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Executive Summary 6
2.1 Robust pipeline with attempts to meet unmet need 6
2.2 Drugs targeting apolipoproteins and elements of the reverse lipid transport pathway offer potential new therapies for the treatment of dyslipidemia and atherosclerosis 6
2.3 Cardiovascular disease pipeline emphasizes move away from conventional areas towards targets related to transmembrane and extracellular signaling 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 8
3.2 Diversification of Molecular Targets 8
3.3 Innovative First-in-Class Product Developments Remain Attractive 9
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9
3.5 Sustained Innovation in Cardiovascular Disease 10
3.6 GBI Research Report Guidance 10
4 Clinical and Commercial Landscape 11
4.1 Cardiovascular Disease Overview 11
4.2 Symptoms, Disease Staging and Prognosis 12
4.2.1 Symptoms 12
4.2.2 Prognosis 12
4.3 Diagnosis 13
4.3.1 Blood Pressure Test 13
4.3.2 Tests for Dyslipidemia 14
4.3.3 Imaging Tests 14
4.3.4 Stress Testing 15
4.4 Epidemiology 15
4.5 Etiology and Pathophysiology 15
4.5.1 Etiology 15
4.5.2 Pathophysiology 17
4.6 Management and Treatment of Cardiovascular Disease 20
4.6.1 Pharmacological Intervention 20
4.6.2 Non-pharmacological Intervention 25
4.6.3 Unmet Need 26
4.7 Overview of Marketed Products 27
5 Assessment of Pipeline Product Innovation 29
5.1 Overview 29
5.2 Pipeline by Stage of Development and Molecule Type 29
5.2.1 Cardiovascular Disease Overall 29
5.2.2 Key Cardiovascular Indications 31
5.3 Pipeline by Molecular Target 34
5.3.1 Cardiovascular Disease 34
5.3.2 Key Cardiovascular Indications 37
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 38
5.5 First-in-Class Programs Targeting Novel Molecular Targets 39
5.5.1 Cardiovascular Disease 39
6 Signaling Network and Innovation Alignment within Cardiovascular Disease 59
6.1 Complexity of Signaling Networks in Cardiovascular Disease 59
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 59
6.3 First-in-Class Matrix Assessment 60
7 First-in-Class Target and Pipeline Program Evaluation 66
7.1 Pipeline Programs Targeting Apelin Receptor 66
7.2 Pipeline Programs Targeting Apolipoproteins (Apolipoprotein E, Apolipoprotein C-III and Apolipoprotein A-I) 67
7.2.1 APOE 68
7.2.2 APOCIII 70
7.2.3 ApoA1 71
7.3 Pipeline Programs Targeting Scavenger Receptor Class B Member 1 (SRB1) 74
7.4 Pipeline Programs Targeting Cholesteryl Ester Transfer Protein (CETP) 77
7.5 Pipeline Programs Targeting Glutamyl Aminopeptidase 80
7.6 Pipeline Programs Targeting E-selectin 82
7.7 Pipeline Programs Targeting Platelet Glycoproteins (Platelet Glycoprotein VI and Platelet Glycoprotein Ib Alpha Chain) 85
7.7.1 Platelet Glycoprotein VI (GP6) 85
7.7.2 Platelet Glycoprotein Ib Alpha Chain (GP1ba) 87
7.8 Pipeline Programs Targeting Tissue Factor 88
7.9 Conclusion 90
8 Strategic Consolidations 91
8.1 Industry-Wide First-in-Class Deals 91
8.2 Licensing Deals 93
8.2.1 Deals by Region, Value and Year 93
8.2.2 Deals by Stage of Development and Value 94
8.2.3 Deals by Molecule Type, Molecular Target and Value 95
8.2.4 List of Deals with Disclosed Deal Values 97
8.3 Co-development Deals 98
8.3.1 Deals by Region, Value and Year 98
8.3.2 Deals by Region, Year and Value 98
8.3.3 Deals by Stage of Development and Value 99
8.3.4 Deals by Molecule Type, Molecular Target and Value 100
8.3.5 List of Deals with Disclosed Deal Values 102
8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals 102
9 Appendix 106
9.1 References 106
9.2 Abbreviations 110
9.3 Disease List 110
9.3.1 Hypertension 110
9.3.2 Dyslipidemia 110
9.3.3 Heart failure 111
9.3.4 Thrombosis 111
9.3.5 CVD events 111
9.3.6 Other 111
9.4 Research Methodology 111
9.4.1 Data integrity 111
9.4.2 Innovative and meaningful analytical techniques and frameworks: 111
9.4.3 Evidence based analysis and insight: 111
9.5 Secondary Research 112
9.5.1 Market Analysis 112
9.5.2 Pipeline Analysis 112
9.5.3 First-in-Class Matrix Assessment 112
9.5.4 First-in-Class Target Profiles 112
9.5.5 Licensing and Co-Development Deals 113
9.6 Contact Us 113
9.7 Disclaimer 113

List of Tables
1.1 List of Tables
Table 1: Cardiovascular Disease Therapeutics Market, Systolic and Diastolic Blood Pressure Level and Corresponding Category 13
Table 2: Cardiovascular Disease Therapeutics Market, Total Cholesterol, LDL and HDL Levels and Corresponding Category 14
Table 3: Cardiovascular Disease Therapeutics Market, Global, Epidemiology of Cardiovascular Disease, Forecast 2017 15
Table 4: Cardiovascular Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Apelin Receptor, 2017 66
Table 5: Cardiovascular Therapeutics Market, Global, Pipeline Programs Targeting Apelin Receptor ,2017 67
Table 6: Cardiovascular Disease Therapeutics Market, Global, Key Features of Apolipoprotein E, 2017 69
Table 7: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Apolipoprotein E, 2017 69
Table 8: Cardiovascular Disease Therapeutics Market, Global, Key Features of Apolipoprotein-CIII, 2017 70
Table 9: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Apolipoprotein-CIII, 2017 71
Table 10: Cardiovascular Disease Therapeutics Market, Global, Key Features of Apolipoprotein-A1, 2017 72
Table 11: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Apolipoportein-A1, 2017 73
Table 12: Cardiovascular Disease Therapeutics Market, Global, Key Features of SRB1, 2017 75
Table 13: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting SRB1, 2017 76
Table 14: Cardiovascular Therapeutics Market, Global, Key Features of CETP, 2017 78
Table 15: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting CETP, 2017 78
Table 16: Cardiovascular Disease Therapeutics Market, Global, Key Features of Glutamyl Aminopeptidase, 2017 81
Table 17: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Glutamyl Aminopeptidase, 2017 81
Table 18: Cardiovascular Disease Therapeutics Market, Global, Key Features and Pipeline Activity of E-selectin, 2017 82
Table 19: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting E-selectin, 2017 83
Table 20: Cardiovascular Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Platelet Glycoprotein VI, 2017 86
Table 21: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Platelet Glycoprotein VI, 2017 87
Table 22: Cardiovascular Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Platelet Glycoprotein Ib Alpha Chain, 2017 88
Table 23: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Platelet Glycoprotein Ib Alpha Chain, 2017 88
Table 24: Cardiovascular Disease Therapeutics Market, Global, Key Features of Tissue Factor, 2017 89
Table 25: Cardiovascular Disease Therapeutics Market, Global, Pipeline Programs Targeting Tissue Factor, 2017 90

List of Figures
1.2 List of Figures
Figure 1: Cardiovascular Disease and Associated Indications, Global, US, Innovation Trends in Product Approvals, 1987-2014 8
Figure 2: Cardiovascular Disease and Associated Indications, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 9
Figure 3: Cardiovascular Disease and Associated Indications, Global, Cardiovascular Disease Market by Molecular Target, 2017 28
Figure 4: Cardiovascular Disease and Associated Indications, Global, Pipeline by Therapy Area, 2017 29
Figure 5: Cardiovascular Disease, Global, Pipeline by Stage of Development and Molecule Type, 2017 30
Figure 6: Hypertension, Dyslipidemia, Thrombotic events, and Heart Failure, Global, Pipelines by Stage of Development, 2017 32
Figure 7: Hypertension, Dyslipidemia, Thrombotic Events, and Heart Failure, Global, Pipelines by Molecule Type, 2017 33
Figure 8: Cardiovascular Disease, Global, Pipeline by Molecular Target, 2017 35
Figure 9: Cardiovascular Disease, Global, Pipeline by Molecular Target Breakdown, 2017 36
Figure 10: Hypertension, Dyslipidemia, Thrombotic Events, Heart Failure, Global, Pipelines by Molecular Target, 2017 38
Figure 11: Cardiovascular Disease, Global, Pipeline and Marketed Products by Molecular Target Class, 2017 39
Figure 12: Cardiovascular Disease, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2017 40
Figure 13: Cardiovascular Disease Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development and Molecular Target (%), 2017 41
Figure 14: Cardiovascular Disease Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target, 2017 42
Figure 15: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 1 44
Figure 16: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 2 45
Figure 17: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 3 46
Figure 18: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 4 47
Figure 19: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 5 48
Figure 20: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 6 49
Figure 21: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 7 50
Figure 22: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 8 51
Figure 23: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 9 52
Figure 24: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 10 53
Figure 25: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 11 54
Figure 26: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 12 55
Figure 27: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 13 56
Figure 28: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 14 57
Figure 29: Cardiovascular Disease Therapeutics, Global, List of All First-in-Class Pipeline Programs, 2017 Part 15 58
Figure 30: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix for Hypertension, 2017 61
Figure 31: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix for Heart Failure, 2017 62
Figure 32: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix for Dyslipidemia, 2017 63
Figure 33: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix for Thrombosis, 2017 64
Figure 34: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix for Other Atherosclerotic Cardiovascular Disease Indications, 2017 65
Figure 35: Cardiovascular Disease Therapeutics Market, Global, Industry-Wide Deals by Stage of Development and First-in-Class Status, 2006-2017 91
Figure 36: Cardiovascular Disease Therapeutics Market, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status, 2006-2017 92
Figure 37: Cardiovascular Disease Therapeutics, Global, Licensing Deals by Region, Value and Year, 2006-2017 94
Figure 38: Cardiovascular Disease Therapeutics, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017 95
Figure 39: Cardiovascular Disease Therapeutics, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target, 2006-2017 96
Figure 40: Cardiovascular Disease Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 97
Figure 41: Cardiovascular Disease Therapeutics, Global, Co-development Deals by Region, Value and Year, 2006-2017 99
Figure 42: Cardiovascular Disease Therapeutics, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 100
Figure 43: Cardiovascular Disease Therapeutics, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target, 2006-2017 101
Figure 44: Cardiovascular Disease Therapeutics, Global, Co-development Deals with Disclosed Deal Values, 2006-2017 102
Figure 45: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017 Part 1 103
Figure 46: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017 Part 2 104
Figure 47: Cardiovascular Disease Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017 Part 3 105

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