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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About Cardiovascular Disease Market

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.

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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?

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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.

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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

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