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Drug Discovery

Migraine

A market focus

Publication Date   August 2004
Publisher   Scrip Reports
Product Type   Report
Pages   109
ISBN Number   BS1252
Product Code   SCR009
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Summary


Migraine is a serious neurological disorder characterised by recurrent headaches, varying in severity and frequency. Accounting for the loss of over 100 million working days in the US alone, the economic cost and social impact of migraine is significant. Furthermore, the people most susceptible to migraine are those within their most productive years (22-55), causing both personal and professional disruptions and a significant burden on healthcare services.

Milder forms of migraine can be offset through the use of OTC therapies. However, for more severe symptoms, OTC therapies prove ineffective, creating a need for more specific, effective agents. The advent of the triptans in the 1990s met these requirements head-on and are now the drugs of choice for the treatment of migraine.
Exemplified by the success of GlaxoSmithKline's blockbuster sumatriptan (Imitrex), there are substantial rewards for products in this market. In 2003, sumatriptan (Imitrex) achieved sales in excess of $1 billion, and gained over 50% of the triptan market. However, late market arrivals such as zolmitriptan (Zomig) and eletriptan (Relpax) are set to challenge this dominance.

Pushed by the launch of more convenient and faster-acting triptan formulations (nasal, injectable and rapid-melt) the migraine market is set to breach $3 billion by 2009. This will also be backed by an expansion in the Japanese migraine market and select approvals in treating menstrually associated migraine (MAM), which is thought to effect up to 60% of all women.
Migraine therapy can either be acute or prophylactic. For more frequent sufferers of migraine (>2 episodes per week) long-term use of acute therapies are not suitable - preventative therapies are deemed more appropriate. However, there still lacks any real noteworthy candidates for this treatment requirement.

This report takes a detailed market-focused approach to the migraine market, with a review of the use of anticonvulsants as effective prophylactic therapy for migraine and an examination of the next generation of products serving millions of migraine sufferers.

An introduction to the action of migraine is provided in Chapter 1, looking at the prevalence and economic cost of migraine, its symptoms and methods of diagnosis. What is known of migraine's genetic foundations is also discussed.
Chapter 2 looks at the current treatments available, both preventative and acute. This primarily focuses on the triptans but also details Merck & Co's recently approved COX-2 inhibitor, rofecoxib (Vioxx). Each product is categorised by pharmacological class and is accompanied by a concise product profile, detailing marketing agreements and clinical data supporting them.

The need for improved migraine therapies is a key driver for this market - up to 80% of patients are unhappy with their current therapies. Products and targets currently in development are detailed in Chapter 3. Pozen's portfolio of antimigraine products has attracted considerable attention, as has Boehringer Ingelheim's BIBN-4096, which offers a novel mechanism of action. This chapter also examines the use of anticonvulsants as prophylactic therapy and those targets currently in preclinical investigation.

Chapter 4 examines the dynamics of the migraine market, with sales forecasts to 2009. The strength of the OTC antimigraine market is discussed, as is the growth of migraine therapies in Japan. Shifts in the market share of leading products are also examined.

A selection of the most significant companies involved in the migraine market are featured in Chapter 5, from the established market players AstraZeneca and GlaxoSmithKline to companies developing new, innovative therapies such as Boehringer Ingelheim and Nastech. The chapter provides market share data by company, followed by profiles with a break down of financial performance to 2003 and details on the most significant clinical data and marketing agreements.

Content


  • Chapter 1 Introduction To Migraine
    • 1.1 Migraine as a disorder
    • 1.2 What are the types of headache?
    • 1.3 Phases of the migraine attack
    • What is an aura?
    • 1.4 Pathophysiology of migraine
    • Genetic links
    • Other theories
    • 1.5 Trigger factors
    • 1.6 Symptoms of migraine
    • 1.7 The migraine attack
    • 1.8 The diagnosis and management of migraine
    • Migraine diagnosis
    • Diagnosis by gender
    • 1.9 Prevalence of migraine
    • Age and gender
    • Race
    • 1.10 Economic cost of migraine
    • 1.11 Migraine in adolescents
    • 1.12 Menstrual migraine
  • Chapter 2 Migraine Therapies On The Market
    • 2.1 Introduction
    • Current options
    • 2.2 Acute therapy for migraine
    • 2.3 5-HT agonists
    • 2.4 An introduction to triptans
    • 2.5 5-HT1D agonists
    • 2.5.1 Sumatriptan
    • Clinical trial data
    • Marketing
    • 2.5.2 Naratriptan
    • Clinical trial data
    • Marketing
    • 2.5.3 Almotriptan
    • Clinical trial data
    • Marketing
    • 2.6 5-HT1B/1D agonists
    • 2.6.1 Zolmitriptan
    • Clinical trial data
    • Zomig-ZMT
    • Zomig nasal spray
    • Marketing
    • 2.6.2 Rizatriptan
    • Clinical trial data
    • Marketing
    • 2.6.3 Eletriptan
    • Clinical trial data
    • Marketing
    • 2.6.4 Frovatriptan
    • Clinical trial data
    • Marketing
    • 2.7 Comparative data between currently launched triptans
    • Comparative studies vs sumatriptan
    • Comparative study data for triptan products
    • 2.8 Ergot derivatives
    • 2.8.1 Ergotamine
    • 2.8.2 Dihydroergotamine
    • Marketing
    • 2.9 Cyclo-oxygenase 2 inhibitors (COX-2)
    • 2.9.1 Rofecoxib
    • Clinical trial data
    • Marketing
    • 2.10 Prophylactic treatments of migraine
    • 2.10.1 Beta blockers
    • 2.10.2 Calcium channel blockers
    • 2.10.3 Anti-depressants
    • 2.10.4 Anticonvulsants
    • 2.10.5 Sodium antagonists/GABA agonists
    • Valproate semisodium
    • Depakote ER
    • Sales and marketing
  • Chapter 3 Migraine Therapies In Development
    • 3.1 Introduction
    • What must new therapies achieve?
    • Migraine treatments by development status
    • R&D by pharmacology
    • 3.2 5-HT1B/1D agonists
    • 3.2.1 MT-300
    • Clinical trial data
    • Opportunities
    • Marketing
    • 3.2.2 MT-400
    • Clinical trial data
    • Marketing
    • 3.2.3 Donitriptan
    • Clinical trial data
    • 3.2.4 Sumatriptan (GSK)
    • 3.2.5 ALX-0646
    • Clinical trial data
    • 3.2.6 Sumatripan (Lyfjathroun)
    • Clinical trial data
    • 3.2.7 Sumatriptan (Nastech)
    • Clinical trial data
    • 3.2.8 ALGRX-2872
    • 3.3 Calcitonin gene-related peptide antagonists
    • 3.3.1 BIBN-4096
    • Clinical trial data
    • 3.4 Dopamine D2 antagonists
    • 3.4.1 MT-100
    • Clinical trial data
    • Marketing
    • 3.5 Cyclo-oxygenase 2 (COX-2) inhibitors
    • 3.5.1 GW-406381
    • 3.6 Sodium channel antagonists/GABA receptor agonists
    • 3.6.1 GABA agonists
    • 3.6.2 Topiramate
    • Clinical trial data
    • Marketing
    • 3.6.3 Zonisamide
    • Clinical trial data
    • 3.6.4 SPD-421 (DP-VPA)
    • 3.7 Potassium and sodium channel antagonists/membrane integrity antagonists
    • 3.7.1 Lidocaine
    • 3.8 Neurokinin 1 antagonists
    • 3.8.1 L-758298
    • 3.8.2 Nolpitantium chloride
    • 3.9 Acetylcholinesterase inhibitors
    • 3.9.1 Donepezil hydrochloride
    • Clinical trial data
    • 3.10 ?eta adrenoreceptor antagonists
    • 3.10.1 Propranolol
    • 3.11 Miscellaneous
    • 3.11.1 Isovaleramide
    • 3.11.2 Carabersat
    • 3.11.3 FHPC 01/ PW-4146
    • 3.11.4 Levetiracetam
    • 3.12 Compounds in preclinical development
  • Chapter 4 The Migraine Market And Strategic Forecast
    • 4.1 Introduction
    • 4.2 The global pharmaceutical market
    • The leading pharmaceutical countries
    • Leading therapeutic markets
    • The CNS market
    • The migraine market
    • The migraine market by region
    • The US migraine market
    • The Japanese migraine market
    • 4.3 The current migraine market
    • 4.4 The migraine market and its growth to 2008
    • Peak sales of products for migraine
    • The prophylactic migraine market
    • 4.5 Company strategies to capitalise on the migraine market
  • Chapter 5 Company Profiles
    • 5.1 Introduction
    • 5.1.1 Company's market share of the migraine market
    • 5.2 AstraZeneca
    • 5.2.1 Introduction
    • 5.2.2 Financial summary
    • 5.3 Boehringer Ingelheim
    • 5.3.1 Introduction
    • 5.3.2 Financial summary
    • 5.3.3 Boehringer Ingelheim's pipeline
    • 5.4 GlaxoSmithKline
    • 5.4.1 Introduction
    • 5.4.2 Financial summary
    • 5.4.3 GlaxoSmithKline's pipeline
    • Products on the market
    • Products in development
    • 5.4.4 Collaborations and agreements
    • 5.5 Lyfjathroun
    • 5.5.1 Introduction
    • 5.5.2 Financial summary
    • 5.5.3 Lyfjathroun's pipeline
    • 5.6 NPS Pharmaceuticals
    • 5.6.1 Introduction
    • 5.6.2 Financial summary
    • 5.6.3 NPS Pharmaceuticals pipeline
    • 5.7 Nastech Pharmaceuticals
    • 5.7.1 Introduction
    • 5.7.2 Financial summary
    • 5.7.3 Nastech's pipeline
    • 5.8 Pozen Inc
    • 5.8.1 Introduction
    • 5.8.2 Financial summary
    • 5.8.3 Pozen's pipeline
    • 5.9 Xcel Pharmaceuticals
    • 5.9.1 Introduction
    • 5.9.2 Financial summary
    • 5.9.3 Xcel Pharmaceuticals pipeline
    • REFERENCES
  • List Of Tables
    • Table 1.1 Definitions of primary headaches
    • Table 1.2 Symptoms of the four phases of migraine
    • Table 1.3 Genetic mutations associated with migraine
    • Table 1.4 The most common migraine symptoms reported in 29,727 migraine sufferers
    • Table 1.5 The MIDAS scoring system
    • Table 1.6 Results of migraine prevalence studies
    • Table 1.7 Annual costs associated with migraine attacks by treatment setting
    • Table 2.1 Distribution of migraine severity
    • Table 2.2 Drugs used in the treatment of migraine
    • Table 2.3 Actions of the triptans
    • Table 2.4 5-HT1D agonists for the acute treatment of migraine
    • Table 2.5 Clinical efficacy of naratriptan vs sumatriptan
    • Table 2.6 5-HT1B/1D agonists licensed for the treatment of migraine
    • Table 2.7 Potency of the currently marketed triptans
    • Table 2.8 Ranking of triptans based on set criteria
    • Table 2.9 Details of the seven triptan therapies currently on the market
    • Table 2.10 Efficacy of current prophylactic treatments
    • Table 3.1 Goals of effective acute and preventative therapies
    • Table 3.2 5-HT1B/1D agonists in development
    • Table 3.3 Pharmacokinetics of Lyfjathroun sumatriptan vs sumatriptan (Imitrex) oral and injectables
    • Table 3.4 Pharmacokinetic results of Nastech's sumatriptan
    • Table 3.5 Clinical properties of MT-100
    • Table 3.6 MT-100 vs placebo and sumatriptan in sustained response levels
    • Table 3.7 Common adverse events reported with migraine drugs
    • Table 3.8 GABA receptor agonists for the treatment of migraine
    • Table 3.9 NK-1 antagonists under development for the treatment of migraine
    • Table 3.10 Clinical efficacy profile of donepezil
    • Table 3.11 Antimigraine products currently in preclinical development
    • Table 4.1 Peak sales of leading acute migraine therapies
    • Table 5.1 Top ten companies involved in the migraine market in 2003 ($ millions)
    • Table 5.2 AstraZeneca's financial summary, 2001-2003 ( millions)
    • Table 5.3 AstraZeneca's leading therapeutic areas ($ millions)
    • Table 5.4 Boehringer Ingelheim's financial summary, 2001-2003 (€ millions)
    • Table 5.5 GSK's financial summary, 2001-2003 ( millions)
    • Table 5.6 GSK's leading therapeutic areas ($ millions)
    • Table 5.7 Lyfjathroun's financial summary, 2002-2003 ($ millions)
    • Table 5.8 Selected financial details of NPS Pharmaceuticals between 2001-2003 ($ millions)
    • Table 5.9 Nastech's financial summary, 2001-2003 ($ millions, except EPS)
    • Table 5.10 Pozen's financial summary, 2001-2003 ($ millions, except EPS)
    • Table 5.11 Pozen's migraine pipeline
  • List Of Figures
    • Figure 1.1 The prevalence of migraine by age
    • Figure 1.2 The distribution of bedridden days amongst migraine sufferers (in millions)
    • Figure 2.1 Sales performance of naratriptan in relation to sumatriptan ( millions)
    • Figure 2.2 Zomig-ZMT response rate to headache at one and two hour intervals
    • Figure 3.1 Migraine therapies in development by clinical phase
    • Figure 3.2 Pharmacological targets under investigation for the treatment of migraine
    • Figure 3.3 Sustained pain response of patients administered MT-300 vs placebo
    • Figure 3.4 MT-400 vs sumatriptan monotherapy
    • Figure 3.5 MT-400 vs triptan monotherapy in providing therapeutic response
    • Figure 3.6 The onset of Lyfjathroun's intranasal sumatriptan formulation
    • Figure 3.7 Response rates at two hours of BIBN-4096 (1-10mg) vs placebo
    • Figure 3.8 Sustained pain relief of MT-100 vs placebo
    • Figure 3.9 MT-100 vs sumatriptan (Imitrex) (efficacy comparison)
    • Figure 3.10 Effect of topiramate on migraine frequency over a period of 26 weeks
    • Figure 4.1 Global pharmaceutical sales by region, in 2003 ($ millions)
    • Figure 4.2 Pharmaceutical sales in the twelve leading markets, in 2003 ($ millions)
    • Figure 4.3 Top ten therapeutic areas in 2003($ millions)
    • Figure 4.4 The distribution of OTC and prescription usage amongst migraine sufferers
    • Figure 4.5 The distribution of prescription and OTC usage, 1989-1999
    • Figure 4.6 The regional distribution of sales in the migraine market (%)
    • Figure 4.7 Sales of selective acute therapies for migraine, in 2003 ($ millions)
    • Figure 4.8 The market share of the triptan market in 2003 (%)
    • Figure 4.9 Sales in the acute migraine therapy market 2003-2009 ($ millions)
    • Figure 4.10 Product dominance in the acute migraine therapy market from 2004-2006 (%)