Market Report Source

Overview

Introduction
With the seven triptan brands continuing to dominate acute migraine treatment and Ortho-McNeil’s Topamax (topiramate) driving sales in the prophylactic market, 7MM revenues of anti-migraine drugs increased by 8.1% from 2005 to $3.7 billion in 2006. The US accounted for 80% of the 7MM total in 2006, Whilst in the 5EU, France is the largest market for migraine-specific drug sales.

Scope

• This report focuses on acute and prophylactic drugs used to treat migraine, with indication- and country-specific sales and volume forecasts to 2016
• Assessment of current and future opportunities and threats in the migraine market across the 7MMs and in individual regions
• Analysis and quantification of future market events expected to impact anti-migraine drug revenues over the next decade
• Case study analysis of successful lifecycle management strategies and scenario forecasts provide further market insight and key recommendations

Highlights
GSK has executed a number of well-timed lifecycle management strategies that have ensured Imitrex’s market leadership. However, Imitrex’s impending patent expiry will result in generic sumatriptan flooding the US market in late 2008, and crucial delays to Trexima’s launch will signal the end of GSK’s dominance of the migraine market. There remains substantial opportunity in the migraine prophylaxis market. In spite of US Topamax patent expiry in 2008, the large number of untreated patients and poor tolerability profiles of existing treatments means the prophylactic market will remain highly attractive over the forecast period. Menstrual migraine (MM) represents an unknown, yet potentially rewarding market opportunity. Endo and Vernalis’s Frova (frovatriptan) awaits the FDA’s decision on its application for the short-term prevention of MM. This outcome will be crucial to the drug’s future and will also influence other triptan manufacturers’ decision to pursue MM.

Reasons to Purchase

• Quantify the future size of the migraine market, in terms of prescription volume and value, in each of the seven major markets
• Assess the impact of future events such as patent expiries, indication expansions, and new product launches on the sales of key marketed brands
• Identify key lifecycle management strategies and market opportunities that can ensure growth in the competitive anti-migraine pharmaceutical arena

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the migraine market

Market forecast summary

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

Seven major migraine market growth shows signs of slowing

Sales in the US dominate the total seven major migraine market

France is the largest migraine market in the 5EU

Triptans remain gold-standard class for the acute treatment of migraine

Imitrex maintains leadership of acute treatment market

Zomig outdoes Imitrex to become 5EU treatment of choice

Rapid Topamax uptake into immature prophylaxis market represents key growth driver

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting migraine market size

Seven major market opportunities and threats

Opportunities

Substantial revenue exists in the prophylactic migraine market

Patient and physician education will expand patient pool and improve the quality of migraine management

Niche indications represent opportunities to increase revenue

Desire for improved patient acceptability promotes the development of different delivery methods

OTC availability substantially widens customer base

Threats

Generics

Cost-containment measures impact treatment choice and duration

OTC medications continue to provide strong competition to prescription drugs

Triptan safety issues limit their use

US: opportunities and threats

Opportunities

Advocacy and DTC campaigns drive public awareness of migraine

Comparatively high price of branded drugs possible in US market

Direct access to specialist physicians helps patients receive optimal treatment quicker

Threats

Insurance companies limit access to migraine medications

High drug prices increases the threatening impact of genericization

New migraine treatments will suffer as a result of restricted DTC advertising

Japan: opportunities and threats

Opportunities

Japanese migraine market shows scope for greater development

Plans to improve the drug approval review system in Japan

Governmental funding for clinical trials could benefit research into migraine

Threats

Public education greatly needed to raise poor awareness of migraine in Japan

Government plans to double the use of generics by the end of 2012

France: opportunities and threats

Opportunities

Large and well-treated French market is an attractive region to launch new therapies

Innovative drug development encouraged by price premium and high-level reimbursement

France currently has low generic incursion

High prescriptions of triptans for cluster headaches in France make it a target additional indication

Threats

After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future

Germany: opportunities and threats

Opportunities

German government initiative to boost biopharma R&D

OTC availability increases presence of brand availability

Threats

Pharmaceutical-Prescribing-Efficiency-Act – bonus-malus encourages generic prescribing

Italy: opportunities and threats

Opportunities

National migraine campaigns drive public awareness

Threats

Italy forces drug firms to give licenses for generics rivals

Spain: opportunities and threats

Opportunities

Low brand prices reduce the threat of genericization

Primary care interest in migraine is high

Threats

R&D activity expected to decline

UK: opportunities and threats

Opportunities

Highest 5EU price point achievable in the UK

New BASH guidelines clarify treatment algorithm and promote the use of triptans

Threats

Genericization is a big threat in the UK market

UK government looks to renegotiate the Pharmaceutical Price Regulation Scheme

Slow Topamax uptake shows that prophylactic treatment is restricted in the UK

CHAPTER 4 FORECAST ANALYSIS

Key events

New product launches

Frova launches in France

Trexima (sumatriptan +naproxen sodium combination)

PRO-513

Sumatriptan Intraject

Sumatriptan oral spray

MK-0974

Botox (botulinum toxin type-A)

Dysport (botulinum toxin type-A)

New product launches in Japan

Botox (botulinum toxin type-A)

MK-0974

Additional indications

Frova gains menstrual migraine indication approval

Patent expiries

Imitrex (sumatriptan)

Amerge (naratriptan)

Maxalt (rizatriptan)

Zomig (zolmitriptan)

Relpax (eletriptan)

Axert (almotriptan)

Frova (frovatriptan)

Depakote (valproate semisodium)

Topamax (Topiramate)

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Sales calculations

Generic erosion and pricing assumptions

Definition of the migraine prophylaxis market – assumptions and caveats

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Portfolio management strategies to increase revenue and offset triptan genericization

Case study 1: GSK’s migraine franchise lifecycle management strategies

GSK’s migraine franchise will suffer as Trexima will only partially offset sumatriptan genericization

Understanding Imitrex’s path to success

Plan complementary product launches carefully – GSK failed to substantially bolster its portfolio with Amerge

Overcoming Imitrex’s US patent expiry poses a daunting challenge for GSK

OTC switch looks to continue the UK Imigran brand sales long after patent expiry of the prescription molecule

Trexima is key to the future of GSK’s US migraine franchise

Trexima scenario forecast

Significant opportunity remains in the largely underserved prophylactic market

Case study 2: Topamax indication expansion into migraine prophylaxis proves highly successful

Topamax’s weight loss effect increases acceptance among patients

Topamax’s migraine website provides patients with extensive information

Topamax 360 targets educating healthcare professionals

New anticonvulsants may offer superior efficacy and tolerability profiles

Lyrica shows potential in migraine prophylaxis

Non-significant results of zonisamide (Zonegran) hinder potential future in migraine

Keppra has been shown to benefit patients with chronic migraine

High price-point means triptans are unlikely to enter the prophylactic market

Naratriptan has shown promise in patients with chronic migraine

Therapies with migraine prevention as the primary indication would offer a better defined treatment approach

Minster’s tonabersat is the most promising late-stage migraine-specific preventive therapy

Menstrual migraine represents an unknown yet potentially attractive niche market

Case study 3: Frova targets approval for the short-term prevention of menstrual migraine

FDA delays indication expansion decision for a second time

European indication expansion planned under the mutual recognition procedure

Positive results from pivotal menstrual migraine studies led to 2006 filing

Frova scenario forecast

Four triptans have been studied for either acute or preventive therapy of menstrual migraine

Randomized controlled evaluations show sumatriptan and zolmitriptan are effective acute therapies

Triptan evaluations as intermittent preventive therapy show those with a longer half-life may be better equipped

Proposed algorithm for the use of triptans in menstrual migraine shows where opportunities exist for each triptan

Longer, post-treatment trials will show if attacks are truly prevented or merely delayed

BIBLIOGRAPHY

Journal papers

Websites

Newspaper articles

Datamonitor reports

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

ATC classes included in ‘others’ to define the migraine market

Menstrual migraine market sizing calculations

Summary migraine market data

Triptan market data

Anticonvulsant market data

APPENDIX B – MARKET FORECAST DATA

Seven major markets

5EU market forecasts

US market forecasts

Japan market forecasts

France market forecasts

Germany market forecasts

Italy market forecasts

Spain market forecasts

UK market forecasts

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Key players in the migraine market, 2007

Table 2: Summary of environmental issues in the migraine market across the seven major markets, 2007

Table 3: Summary of environmental issues in the seven individual major migraine markets, 2007

Table 4: Average standard unit prices ($) of the drug classes prescribed for migraine prophylaxis in the seven major markets, 2003-06

Table 5: Summary of over-the-counter triptan drug availability, 2007

Table 6: Estimated launch dates for migraine products in the 5EU and US, 2007-2016

Table 7: Japan launch dates for migraine pipeline products, 2007-2016

Table 8: Key patent expiries of migraine brands across the seven major markets, 2007-2016

Table 9: Summary of Frova Phase III results in menstrual migraine

Table 10: Other ATC classes included for migraine market definition

Table 11: Projected menstrually-related migraine patient potential across the seven major markets, 2010

Table 12: Projected pure menstrual migraine patient potential across the seven major markets, 2010

Table 13: Migraine summary market data, 2006

Table 14: Imitrex: key facts

Table 15: Amerge: key facts

Table 16: Zomig: key facts

Table 17: Maxalt: key facts

Table 18: Axert: key facts

Table 19: Relpax: key facts

Table 20: Frova: key facts

Table 21: Topamax: key facts

Table 22: Depakote: key facts

Table 23: Seven major market migraine drug sales forecasts ($m), 2007-2016

Table 24: 5EU migraine drug sales forecasts ($m), 2007-2016

Table 25: US migraine drug sales forecasts ($m), 2007-2016

Table 26: Japan migraine drug sales forecasts ($m), 2007-2016

Table 27: France migraine drug sales forecasts ($m), 2007-2016

Table 28: Germany migraine drug sales forecasts ($m), 2007-2016

Table 29: Italy migraine drug sales forecasts ($m), 2007-2016

Table 30: Spain migraine drug sales forecasts ($m), 2007-2016

Table 31: UK migraine drug sales forecasts ($m), 2007-2016

List of Figures

Figure 1: Datamonitor’s migraine market forecast across the seven major markets, 2007-2016

Figure 2: Migraine-specific sales revenue across the seven major markets ($m), 2003-06

Figure 3: Performance of the seven major migraine markets ($m), 2005-06

Figure 4: Migraine-specific sales volume across the seven major markets (SUs), 2003-06

Figure 5: Migraine-specific sales revenue in the 5EU ($m), 2003-06

Figure 6: Performance of the nine key migraine therapies across the seven major markets ($m), 2005-06

Figure 7: Total triptan migraine-specific sales revenues across the seven major markets by brand (%), 2006

Figure 8: Value of the seven major migraine prophylactic market vs. the acute migraine market, 2003-06

Figure 9: Migraine-specific sales in the seven major markets for the four leading migraine prophylaxis drug classes ($m), 2003-06

Figure 10: Migraine-specific standard units prescribed in the seven major markets for the four leading migraine prophylaxis drug classes, 2003-06

Figure 11: Total Topamax brand sales ($m) by indication in the US, 2003-06

Figure 12: Percentage of Imitrex sales attributable to cluster headache across the seven major markets, 2006

Figure 13: Maxalt 5EU migraine-specific sales by delivery method ($m), 2003-06

Figure 14: Generic sumatriptan’s impact in the German, Spanish and UK migraine markets ($m and SUs), 2006

Figure 15: Forecasted impact of Imitrex and Topamax patent expiry on the US migraine market ($ billion), 2006-2016

Figure 16: Performance of the key migraine therapies in the US ($m), 2005-06

Figure 17: Screenshot of the purple Granger in GSK’s Imitrex advert

Figure 18: Average triptan standard unit price across the seven major markets ($), 2003-06

Figure 19: Performance of the key migraine therapies in Japan ($m), 2005-06

Figure 20: Japan migraine-specific triptan sales ($m), 2003-06

Figure 21: Performance of the key migraine therapies in France ($m), 2005-06

Figure 22: 5EU migraine market by triptan standard units, 2003-06

Figure 23: The French cluster headache market ($m), 2004-06

Figure 24: Average triptan standard unit price in the 5EU countries ($), 2003-06

Figure 25: Performance of the key migraine therapies in Germany ($m), 2005-06

Figure 26: Migraine-specific Amerge sales in Germany ($m and SUs), 2003-06

Figure 27: Performance of the key migraine therapies in Italy ($m), 2005-06

Figure 28: Performance of the key migraine therapies in Spain ($m), 2005-06

Figure 29: Migraine-specific quarterly impact of Imitrex genericization in Spain ($m), 2006

Figure 30: Performance of the key migraine therapies in the UK ($m), 2005-06

Figure 31: Migraine-specific impact of Imitrex genericization in the UK, Germany and Spain ($m), 2005-06

Figure 32: Quarterly 5EU migraine-specific Topamax sales ($000s), 2005-06

Figure 33: UK migraine-specific anticonvulsant sales, ($m), 2003-06

Figure 34: Key events and their impact on the migraine market, 2007-2016

Figure 35: Forecasted GSK migraine franchise ($m), 2007-2016

Figure 36: SWOT analysis of Imitrex, 2007

Figure 37: Migraine-specific seven major market Imitrex sales split by formulation ($m), 2003-06

Figure 38: Migraine-specific sales of Imitrex and generic sumatriptan in Germany, Spain and the UK ($m), 2006-07

Figure 39: The 2007 Imigran recovery commercial image and strapline

Figure 40: Impact of Trexima scenario forecast on GSK’s US migraine franchise ($m), 2006-2016