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Evolocumab (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Evolocumab (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023”. The current ACS market - primarily comprised of antithrombotics, antihypertensives, and statins - is flush with well-established standard-of-care therapies, many of which are generic. Therefore, the pipeline therapies that show the most promise exploit novel mechanisms of action and target orphan biochemical pathways. The ACS market will be driven by an aging population with a preponderance of lifestyle-based diseases, such as obesity, and the growing prevalence of metabolic disorders such as diabetes. The expansion of biologics into the ACS mainstream during the ten year forecast period is expected to significantly and fundamentally alter the ACS market, both medically and financially.

Evolocumab is a member of the emerging class of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, fully human monoclonal antibodies (mAbs) that prevent the degradation of LDL-C receptors in the liver. This novel mechanism of action increases the body’s ability to filter LDL-C from the circulation. Evolocumab is one of several PCSK9 inhibitors navigating critical Phase III clinical trials in a race to achieve regulatory approval.

Scope

- Overview of ACS, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Aricept including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Aricept for the top seven countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for ACS
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of Aricept performance
- Obtain sales forecast for Aricept from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)

Table Of Contents

Evolocumab (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 20
3.1.3 Prognosis 21
3.1.4 Quality of Life 22
3.2 Symptoms 22
4 Disease Management 24
4.1 Treatment Overview 24
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 31
6 Unmet Need and Opportunity 36
6.1 Overview 36
6.2 Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques 37
6.2.1 Unmet Need 37
6.2.2 Gap Analysis 38
6.2.3 Opportunity 38
6.3 Therapies that Treat Fibrotic Myocardium and Associated Comorbidities 39
6.3.1 Unmet Need 39
6.3.2 Gap Analysis 40
6.3.3 Opportunity 40
6.4 LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients 41
6.4.1 Unmet Need 41
6.4.2 Gap Analysis 43
6.4.3 Opportunity 45
6.5 Antidotes for New Oral Anticoagulants (NOACs) 45
6.5.1 Unmet Need 45
6.5.2 Gap Analysis 46
6.5.3 Opportunity 46
6.6 Blood-Thinning Agents with Significantly Reduced Bleeding Risks 47
6.6.1 Unmet Need 47
6.6.2 Gap Analysis 48
6.6.3 Opportunity 48
7 Pipeline Assessment 50
7.1 Overview 50
7.2 Clinical Trials by Phase and Trial Status 52
7.3 Promising Drugs in Clinical Development 54
8 Evolocumab (AMG 145) 59
8.1 Overview 59
8.2 Efficacy 61
8.3 Safety 65
8.4 Dosing and Formulation 65
8.5 Potential Clinical Positioning 66
8.6 Potential Commercial Positioning 66
8.7 Pricing and Reimbursement 66
8.8 SWOT Analysis 67
8.9 Forecast 67
9 Appendix 69
9.1 Bibliography 69
9.2 Abbreviations 75
9.3 Methodology 79
9.4 Forecasting Methodology 79
9.4.1 Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population 79
9.4.2 Diagnosed Acute Coronary Syndrome Patients 80
9.4.3 Percent Drug-Treated Patients 81
9.4.4 General Pricing Assumptions 81
9.4.5 Generic Erosion 83
9.4.6 Pricing of Pipeline Agents 83
9.5 Physicians and Specialists Included in this Study 84
9.6 About the Authors 87
9.6.1 Author 87
9.6.2 Reviewer 87
9.6.3 Global Head of Healthcare 88
9.7 About GlobalData 89
9.8 Disclaimer 89

1.1 List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation 18
Table 2: Anticoagulants that Inhibit the Coagulatory Cascade 18
Table 3: Symptoms of Acute Coronary Syndrome 23
Table 4: Treatment Guidelines for Acute Coronary Syndromes (UA, NSTEMI, and STEMI) 27
Table 5: Most Prescribed Drugs for ACS by Class in the Global Markets, 2014 29
Table 6: Leading Treatments for Acute Coronary Syndrome, 2014 35
Table 7: Unmet Need and Opportunity in Acute Coronary Syndrome 37
Table 8: Acute Coronary Syndrome - Clinical Trials by Phase and Status, 2014 53
Table 9: Acute Coronary Syndrome - Late-Stage Pipeline, 2014 56
Table 10: Comparison of Therapeutic Classes in Development for ACS, 2014 57
Table 11: Product Profile - Evolocumab (AMG 145) 61
Table 12: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013 - Q1 2014 63
Table 13: Evolocumab SWOT Analysis, 2013 67
Table 14: Global Sales Forecasts ($m) for Evolocumab, 2013-2023 68
Table 15: Price Sources and Calculations, by Country 82
Table 16: Physicians Surveyed, By Country 86

1.2 List of Figures

Figure 1: The ACS Timeline and the Scope of GlobalData's ACS Report and Forecast 16
Figure 2: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome 17
Figure 3: Platelet and Coagulatory Factors Implicated in Thrombosis 19
Figure 4: Electrocardiography in the Diagnosis of ACS 20
Figure 5: Acute Coronary Syndrome Therapeutics - Clinical Trials by Phase in the 7MM, 2014 54
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013-2023 58

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