Forecast Insight: Migraine - Generic incursion inhibits market growth

Published by: Datamonitor

Published: Dec. 17, 2008 - 80 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current seven major market assessment

The seven major market migraine market grew to over $4.1 billion in 2007

Migraine market prescription volume has plateaued over 2004-07

Impact of genericization behind declining values in the German and UK markets over 2006-07

Low volume yet highly priced triptans continue to generate the largest sales value

Rest of the World snapshot

Rest of the world migraine market was larger than the 5EU market in 2007

Treatment choice and associated price differ greatly between the rest of the world and seven major markets

Older and cheaper non-narcotic analgesics and other antimigraine preparations are prescribed more often in rest of the world regions

Canada is by far the largest rest of the world migraine market

Canada is already a well established region for migraine therapies

Despite patent expiry Imitrex leads the way in the rest of the world migraine market

Future seven major market assessment

Comparison with previous forecast

Similar market dynamics between the two forecasts with phases of decline to offset phases of growth

Top-line events driving future market dynamics

Four distinct phases will determine the migraine market dynamics over the next 10 years

CHAPTER 3 BRAND DYNAMICS

Overview of competitive landscape

Current brand dynamics

Treximet becomes the first approved major migraine therapy for 3 years

GlaxoSmithKline's Imitrex remained the top-selling migraine therapy in 2007

Key migraine prophylaxis brands accrue revenues almost exclusively from the US

Imitrex remains dominant in the US whereas Zomig excels in the 5EU

Future market forecast by brand

All key marketed brands to post a negative CAGR over the 10-year forecast period

Merck & Co's telcagepant and GlaxoSmithKline's recently launched Treximet to become migraine market leading brands

Marketed triptans

Frova (frovatriptan; Vernalis, Endo and Menarini)

Frova fails to gain menstrual migraine indication in the US

Forecasts downgraded as Frova struggles to gain significant market share

Marketed anticonvulsants

FDA agrees that anticonvulsants pose a suicidality risk but require no Black-Box warning

Topamax (topiramate; Johnson & Johnson)

Topamax market exclusivity extended by 6 months following pediatric grant

Topamax's impending patent expiry continues to represent a significant problem for Johnson & Johnson

Depakote (valproate semisodium; Abbott)

FDA approves the first generic versions of valproate semisodium in August 2008

Forecast upgraded based on higher historical sales and greater appreciation of different product formulations

Recently launched products

Treximet (sumatriptan + naproxen; GlaxoSmithKline and Pozen)

Treximet finally gains FDA approval after a much troubled regulatory pathway

Post-marketing studies focus on probable migraine and short-acting triptan non-responders

Launch date correctly predicted yet delays to direct to consumer advertising campaign sees forecast slightly downgraded

Patent challenges came soon after launch

Forecasted late-stage pipeline products

Telcagepant (MK-0974, Merck & Co)

Positive Phase III clinical trial results announced after Datamonitor's previous migraine market report

New trial looks to assess the efficacy of telcagepant in treating more than one migraine headache

Telcagepant forecast upgraded after new clinical data and growing key opinion leader enthusiasm

Botox (botulinum toxin type-A, Allergan)

New Phase III data suggest Botox may decrease the number of headache days suffered

Botox forecast upgraded as Ipsen is not expected to seek migraine label for Dysport

EU market expected to be unreceptive to Botox approach to treating migraine

Sumatriptan DosePro (sumatriptan needleless; Zogenix)

Zogenix announces new clinical trial data at the 50th Annual American Headache Society Meeting in June 2008

European rights to sumatriptan DosePro licensed out to Destin Pharmaceuticals

5EU launch to span only Germany and less rapid uptake projected in updated forecast

NVD-201 (sumatriptan oral spray; NovaDel)

Revised development plan delays potential launch by an estimated 2 years

Pilot efficacy study data announced in September 2008 shows the potential to treat migraine with a lower dose compared to sumatriptan tablets

Forecast downgraded following development delays and no presumed EU launch

PRO-513 (diclofenac potassium powder; Kowa Pharmaceuticals America)

PDUFA date passes without announcement

Kowa Company acquires ProEthic and refocuses late-stage pipeline

Forecast downgraded due to later US launch

MAP0004 (dihydroergotamine, orally inhaled; MAP Pharma)

Positive Phase II clinical program trial results announced in March 2007

First Phase III study initiated in July 2008 under Special Protocol Assessment

MAP0004 is expected to become a useful alternative dihydroergotamine formulation

Unforecasted migraine pipeline candidates

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

Other sources

APPENDIX A - MARKET ASSUMPTIONS

New product launches

Patent expiries

ATC classes included in 'others' to define the migraine market

Migraine Diagnostic Values for key migraine brands

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Sales calculations

Forecast methodology

APPENDIX B

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the central nervous system analysis team

Disclaimer

List of Tables

Table 1: Comparison of leading branded drug sales ($m) for migraine in the seven major markets and the rest of the world (ROW), 2007

Table 2: Migraine market sales forecasts in the seven major markets ($m), 2007-2017

Table 3: Leading migraine-specific branded drug sales ($m) in the seven major markets, 2004-07

Table 4: Leading migraine-specific branded drug sales ($m) in the seven major markets, 2007-2017

Table 5: Forecast for key recently launched and late-stage R&D pipeline products for migraine, 2008

Table 6: Key clinical trial data points for telcagepant (MK-0974; Merck & Co) in a placebo-controlled acute migraine study announced in September 2008

Table 7: Key clinical trial data points for telcagepant (MK-0974; Merck & Co) in a placebo-controlled comparative acute migraine study announced in June 2008

Table 8: Unforecasted pipeline drugs in Phase II or higher development for migraine, 2008

Table 9: Datamonitor's launch date estimation for migraine products in the US, 5EU and Japan, 2009-2017

Table 10: Patent expiry dates for key migraine brands in the seven major markets, 2009-2017

Table 11: Other ATC classes included for migraine market definition, 2008

Table 12: Migraine Diagnostic values for key migraine brands in the seven major markets, 2007

List of Figures

Figure 1: Migraine market sales value ($m) in the US, 5EU and Japan, 2004-07

Figure 2: Migraine market volume (standard units, million) in the US, 5EU and Japan, 2004-07

Figure 3: Migraine market sales value ($m) growth dynamics by country in the seven major markets, 2004-07

Figure 4: Migraine market volume (standard units, million) and value ($m) by class in the seven major markets, 2004-07

Figure 5: Rest of the world versus seven major market sales ($m) split in the migraine market, 2007

Figure 6: Global migraine market annual sales value and volume ($), 2004-07

Figure 7: Regional migraine market sales volume (standard units, SUs) prescriptions by class, 2007

Figure 8: Migraine market sales value ($m) in the 10 highest value ex-seven major markets, 2004-07

Figure 9: Comparison of Datamonitor's updated seven major market migraine market forecast to 2017 with the previous market forecast to 2016

Figure 10: Migraine market sales ($) by seven major market region, 2007 and 2017 forecast

Figure 11: Migraine market sales forecasts ($m) in the seven major markets by class, 2007-2017

Figure 12: Impact of key events on the migraine market, 2008-2017

Figure 13: Timeline: launch dates of key migraine therapies, 1992-2008

Figure 14: Proportion of the leading nine migraine brand sales value originating from the US, 5EU/Japan combined, and the rest of the world, 2007

Figure 15: Migraine-specific triptan sales revenues across the seven major markets by brand (%), 2007

Figure 16: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Vernalis and Endo's Frova (frovatriptan) in the seven major markets, 2007-2017

Figure 17: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Johnson & Johnson's Topamax (topiramate) in the seven major markets, 2007-2017

Figure 18: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Abbot's Depakote (valproate semisodium) in the US, 2007-2017

Figure 19: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for GlaxoSmithKline's Treximet (sumatriptan 85mg + naproxen 500mg) in the US, 2007-2017

Figure 20: Assigned interventions for Merck & Co's Phase III study of telcagepant (MK-0974) in treating multiple migraine attacks

Figure 21: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Merck & Co's telcagepant (MK-0974) in the seven major markets, 2008-2017

Figure 22: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Allergan's Botox (botulinum toxin type-A) in the seven major markets, 2008-2017

Figure 23: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Zogenix's sumatriptan DosePro in the seven major markets, 2008-2017

Figure 24: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for NovaDel's NVD-201 (sumatriptan oral spray) in the US, 2008-2017

Figure 25: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for NovaDel's NVD-201 (sumatriptan oral spray) in the US, 2008-2017

Figure 26: Datamonitor's migraine-specific sales ($m) forecast for MAP Pharmaceuticals's MAP0004 (orally inhaled dihydroergotamine) in the US, 2008-2017

Abstract

• This report gives a strategic analysis of the likely impact that recent events will have on the future migraine market



• Includes migraine-specific sales forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2017



• Provides a global market snapshot by including migraine-specific sales analysis for leading brands outside the seven major markets



• Key conclusions are supported by key opinion leader comment

• Understand when late-stage pipeline products will launch and what impact these will have on the market during the forecast period 2008 to 2017



• Quantify the current size of the seven major markets and the trends in the rest of the world



• Assess the impact of events, such as patent expiries and new product launches, on the migraine-specific sales of key brand name products

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