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RHB-103 (Migraine) - Forecast and Market Analysis to 2023

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.

RedHill Biopharma (RedHill) is co-developing rizatriptan film (RHB-103) with IntelGenx, using the latter’s VersaFilm propriety thin film technology. Rizatriptan belongs to the triptan class of drugs which target the 5-HT1B and 5-HT1D receptor subtypes. These are located on the extracerebral, intracranial blood vessels, which dilate during the migraine attack, and also located on the nerve terminals of the trigeminal system. Inhibition of these receptors constricts cranial vessels, blocks neuropeptide release and reduces neurotransmission in the trigeminal pain pathways.

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 RHB-103 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for RHB-103 for the top six countries from 2012 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain and the UK.

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 RHB-103 performance
- Obtain sales forecast for RHB-103 from 2012-2023 in the top six countries (the US, France, Germany, Italy, Spain and the UK.).

Table Of Contents

RHB-103 (Migraine) - Forecast and Market Analysis to 2023
1 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 17
3.2.4 Postdrome Phase 18
4 Disease Management 19
4.1 Treatment Overview 19
4.1.1 Acute Migraine Treatment 22
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
7.2 Promising drugs in clinical development 34
8 RHB-103 37
8.1 Overview 37
8.2 Efficacy 38
8.3 Safety 38
8.4 Dosing and Formulation 39
8.5 Potential Clinical Positioning 39
8.6 Potential Commercial Positioning 39
8.7 Pricing and Reimbursement 39
8.8 SWOT Analysis 40
8.9 Forecast 41
9 Appendix 42
9.1 Bibliography 42
9.2 Abbreviations 44
9.3 Methodology 46
9.4 Forecasting Methodology 46
9.4.1 Diagnosed Migraine Patients 46
9.4.2 Percent Drug-treated Patients 46
9.4.3 General Pricing Assumptions 47
9.4.4 Generic Erosion 48
9.4.5 Pricing of Pipeline agents 48
9.5 Physicians and Specialists Included in this Study 49
9.6 Survey of Prescribing Physicians 50
9.7 About the Authors 51
9.7.1 Author 51
9.7.2 Reviewer 51
9.7.3 Global Head of Healthcare 51
9.8 About GlobalData 53
9.9 Disclaimer 53

1.1 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
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 - RHB-103 38
Table 11: RHB-103 SWOT Analysis, 2013 40
Table 12: Global Sales Forecasts ($m) for RHB-103, 2012-2023 41
Table 13: Physicians Surveyed, By Country 50

1.2 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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