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JSB Market Research: MK-1602 (Migraine) - Forecast
and Market Analysis to 2023
On 9
th
July 2014

Summary

The migraine market is saturated with generic drugs, and the remaining branded
products already on the market are expected to lose exclusivity during the next
few years, with the exception of Botox for chronic migraine, which is expected to
maintain its leading position in terms of sales. However, reformulations of mature
products as well as new classes of therapies are anticipated to launch during the
forecast period and these will contribute to the market growth. By 2023, the
migraine market will grow to $3.7 billion at a compound annual growth rate
(CAGR) of 3.6%, with the US continuing to dominate the market as a result of
higher drug prices and a large migraine population. Some of the new treatments
are expected to target the key unmet needs but opportunities will remain for
further treatment choices especially drugs that will offer an improved safety and
side-effects profile.

MK-1602, under development by Merck, is a calcitonin gene-related peptide
(CGRP) receptor antagonist. It is a member of a new class of therapy for the acute

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treatment of migraine, called the gepants. CGRP is a vasoactive neuropeptide
whose receptors are widely distributed in the peripheral and central nervous
systems such as the trigeminovascular complex, thalamus, hypothalamus and
trigeminal ganglion (Hoffmann and Goadsby, 2012). CGRP has been indicated as a
key mediator of migraine pathology by several lines of evidence.

Scope

- Overview of Migraine, including epidemiology, etiology, symptoms, diagnosis,
pathology and treatment guidelines as well as an overview on the competitive
landscape.

- Detailed information on MK-1602 including product description, safety and
efficacy profiles as well as a SWOT analysis.

- Sales forecast for MK-1602 for the top seven countries from 2012 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 Migraine

- 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
MK-1602 performance


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- Obtain sales forecast for MK-1602 from 2012-2023 in the top seven countries
(the US, France, Germany, Italy, Spain, the UK and Japan).

Table of Contents:
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 15
3.1.3 Prognosis 16
3.2 Symptoms 16
3.2.1 Premonitory Phase 16
3.2.2 Aura Phase 17
3.2.3 Headache Phase 18
3.2.4 Postdrome Phase 18
4 Disease Management 19
4.1 Treatment Overview 19
4.1.1 Acute Migraine Treatment 22

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4.1.2 Preventive Migraine Treatment 23
5 Competitive Assessment 24
5.1 Overview 24
5.2 Strategic Competitor Assessment 25
6 Opportunity and Unmet Need 26
6.1 Overview 26
6.1.1 A Lack of Acute Therapies for Patients with or at Risk of Cardiovascular
Disorders 27
6.1.2 Lack of Acute Therapies for Patients Unresponsive to Triptan Medication 27
6.1.3 Lack of Diagnostic Tools Causes Misdiagnosis 28
6.1.4 Physician Education 28
6.1.5 Effective and Well-Tolerated Prophylactic Therapies 29
6.2 Unmet Needs Gap Analysis 29
6.2.1 Acute Therapies for Patients with or at Risk of Cardiovascular Disorders and
for Patients Unresponsive to Triptan Medication 30
6.2.2 Effective and Well-Tolerated (Migraine-Specific) Preventive Therapies 31
6.2.3 Physician Education 31
6.2.4 Diagnostic Tools 32
7 Pipeline Assessment 33
7.1 Overview 33

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7.2 Promising drugs in clinical development 34
8 MK-1602 37
8.1 Overview 37
8.2 Efficacy 38
8.3 Safety 39
8.4 Dosing and Formulation 40
8.5 Potential Clinical Positioning 40
8.6 Potential Commercial Positioning 40
8.7 Pricing and Reimbursement 40
8.8 SWOT Analysis 41
8.9 Forecast 42
9 Appendix 43
9.1 Bibliography 43
9.2 Abbreviations 46
9.3 Methodology 48
9.4 Forecasting Methodology 48
9.4.1 Diagnosed Migraine Patients 48
9.4.2 Percent Drug-treated Patients 48
9.4.3 General Pricing Assumptions 49

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9.4.4 Generic Erosion 50
9.4.5 Pricing of Pipeline agents 50
9.5 Physicians and Specialists Included in this Study 51
9.6 Survey of Prescribing Physicians 52
9.7 About the Authors 53
9.7.1 Author 53
9.7.2 Reviewer 53
9.7.3 Global Head of Healthcare 53
9.8 About GlobalData 55
9.9 Disclaimer 55

List of Tables
Table 1: Classification of Migraine Subtypes 13
Table 2: Diagnostic Criteria for Migraine with Aura 17
Table 3: Diagnostic Criteria for Migraine without Aura 18
Table 4: Treatment Guidelines for Migraine 20
Table 5: Most Prescribed Drugs for Migraine by Class in the Major Markets, 2013
21
Table 6: Overall Unmet Needs - Current Level of Attainment 26

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Table 7: Clinical Unmet Needs - Gap Analysis, 2013 30
Table 8: Migraine - Promising Late-Stage Pipeline, 2013 34
Table 9: Comparison of Therapeutic Classes in Development for Migraine, 2013 36
Table 10: Product Profile - MK-1602 38
Table 11: MK-1602 SWOT Analysis, 2013 41
Table 12: Global Sales Forecasts ($m) for MK-1602, 2012-2023 42
Table 13: Physicians Surveyed, By Country 52

List of Figures
Figure 1: Migraine Treatment Algorithm in the 7MM 21
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Migraine,
2012-2023 35








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