Table of Contents

ABOUT DATAMONITOR HEALTHCARE 2
About the Central Nervous System pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 7
Market definition for this report 7
Current seven major market assessment 8
The seven major market migraine market grew to over $4.1 billion in 2007 8
Migraine market prescription volume has plateaued over 2004-07 9
Impact of genericization behind declining values in the German and UK markets over 2006-07 10
Low volume yet highly priced triptans continue to generate the largest sales value 11
Rest of the World snapshot 13
Rest of the world migraine market was larger than the 5EU market in 2007 13
Treatment choice and associated price differ greatly between the rest of the world and seven major markets 15
Older and cheaper non-narcotic analgesics and other antimigraine preparations are prescribed more often in rest of the world regions 16
Canada is by far the largest rest of the world migraine market 17
Canada is already a well established region for migraine therapies 17
Despite patent expiry Imitrex leads the way in the rest of the world migraine market 19
Future seven major market assessment 20
Comparison with previous forecast 20
Similar market dynamics between the two forecasts with phases of decline to offset phases of growth 20
Top-line events driving future market dynamics 21
Four distinct phases will determine the migraine market dynamics over the next 10 years 22
CHAPTER 3 BRAND DYNAMICS 28
Overview of competitive landscape 28
Current brand dynamics 28
Treximet becomes the first approved major migraine therapy for 3 years 28
GlaxoSmithKline's Imitrex remained the top-selling migraine therapy in 2007 29
Key migraine prophylaxis brands accrue revenues almost exclusively from the US 30
Imitrex remains dominant in the US whereas Zomig excels in the 5EU 31
Future market forecast by brand 32
All key marketed brands to post a negative CAGR over the 10-year forecast period 32
Merck & Co's telcagepant and GlaxoSmithKline's recently launched Treximet to become migraine market leading brands 33
Marketed triptans 34
Frova (frovatriptan; Vernalis, Endo and Menarini) 34
Frova fails to gain menstrual migraine indication in the US 35
Forecasts downgraded as Frova struggles to gain significant market share 36
Marketed anticonvulsants 37
FDA agrees that anticonvulsants pose a suicidality risk but require no Black-Box warning 37
Topamax (topiramate; Johnson & Johnson) 38
Topamax market exclusivity extended by 6 months following pediatric grant 38
Topamax's impending patent expiry continues to represent a significant problem for Johnson & Johnson 39
Depakote (valproate semisodium; Abbott) 40
FDA approves the first generic versions of valproate semisodium in August 2008 40
Forecast upgraded based on higher historical sales and greater appreciation of different product formulations 41
Recently launched products 42
Treximet (sumatriptan + naproxen; GlaxoSmithKline and Pozen) 42
Treximet finally gains FDA approval after a much troubled regulatory pathway 43
Post-marketing studies focus on probable migraine and short-acting triptan non-responders 43
Launch date correctly predicted yet delays to direct to consumer advertising campaign sees forecast slightly downgraded 44
Patent challenges came soon after launch 46
Forecasted late-stage pipeline products 47
Telcagepant (MK-0974, Merck & Co) 47
Positive Phase III clinical trial results announced after Datamonitor's previous migraine market report 47
New trial looks to assess the efficacy of telcagepant in treating more than one migraine headache 50
Telcagepant forecast upgraded after new clinical data and growing key opinion leader enthusiasm 51
Botox (botulinum toxin type-A, Allergan) 52
New Phase III data suggest Botox may decrease the number of headache days suffered 53
Botox forecast upgraded as Ipsen is not expected to seek migraine label for Dysport 54
EU market expected to be unreceptive to Botox approach to treating migraine 54
Sumatriptan DosePro (sumatriptan needleless; Zogenix) 56
Zogenix announces new clinical trial data at the 50th Annual American Headache Society Meeting in June 2008 57
European rights to sumatriptan DosePro licensed out to Destin Pharmaceuticals 57
5EU launch to span only Germany and less rapid uptake projected in updated forecast 58
NVD-201 (sumatriptan oral spray; NovaDel) 59
Revised development plan delays potential launch by an estimated 2 years 59
Pilot efficacy study data announced in September 2008 shows the potential to treat migraine with a lower dose compared to sumatriptan tablets 59
Forecast downgraded following development delays and no presumed EU launch 60
PRO-513 (diclofenac potassium powder; Kowa Pharmaceuticals America) 62
PDUFA date passes without announcement 62
Kowa Company acquires ProEthic and refocuses late-stage pipeline 62
Forecast downgraded due to later US launch 63
MAP0004 (dihydroergotamine, orally inhaled; MAP Pharma) 64
Positive Phase II clinical program trial results announced in March 2007 64
First Phase III study initiated in July 2008 under Special Protocol Assessment 64
MAP0004 is expected to become a useful alternative dihydroergotamine formulation 65
Unforecasted migraine pipeline candidates 67
BIBLIOGRAPHY 68
Journal papers 68
Websites 68
Datamonitor reports 71
Other sources 71
APPENDIX A - MARKET ASSUMPTIONS 73
New product launches 73
Patent expiries 73
ATC classes included in 'others' to define the migraine market 74
Migraine Diagnostic Values for key migraine brands 75
Data definitions, limitations and assumptions 75
Standard units 75
Japanese market data 75
Derivation of sales forecasts and pricing trends 76
Sales calculations 76
Forecast methodology 76
APPENDIX B 77
Contributing experts 77
Report methodology 78
About Datamonitor 78
About Datamonitor Healthcare 78
About the central nervous system analysis team 79
Disclaimer 80
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 19
Table 2: Migraine market sales forecasts in the seven major markets ($m), 2007-2017 25
Table 3: Leading migraine-specific branded drug sales ($m) in the seven major markets, 2004-07 29
Table 4: Leading migraine-specific branded drug sales ($m) in the seven major markets, 2007-2017 33
Table 5: Forecast for key recently launched and late-stage R&D pipeline products for migraine, 2008 34
Table 6: Key clinical trial data points for telcagepant (MK-0974; Merck & Co) in a placebo-controlled acute migraine study announced in September 2008 48
Table 7: Key clinical trial data points for telcagepant (MK-0974; Merck & Co) in a placebo-controlled comparative acute migraine study announced in June 2008 49
Table 8: Unforecasted pipeline drugs in Phase II or higher development for migraine, 2008 67
Table 9: Datamonitor's launch date estimation for migraine products in the US, 5EU and Japan, 2009-2017 73
Table 10: Patent expiry dates for key migraine brands in the seven major markets, 2009-2017 73
Table 11: Other ATC classes included for migraine market definition, 2008 74
Table 12: Migraine Diagnostic values for key migraine brands in the seven major markets, 2007 75
List of Figures
Figure 1: Migraine market sales value ($m) in the US, 5EU and Japan, 2004-07 9
Figure 2: Migraine market volume (standard units, million) in the US, 5EU and Japan, 2004-07 10
Figure 3: Migraine market sales value ($m) growth dynamics by country in the seven major markets, 2004-07 11
Figure 4: Migraine market volume (standard units, million) and value ($m) by class in the seven major markets, 2004-07 12
Figure 5: Rest of the world versus seven major market sales ($m) split in the migraine market, 2007 13
Figure 6: Global migraine market annual sales value and volume ($), 2004-07 15
Figure 7: Regional migraine market sales volume (standard units, SUs) prescriptions by class, 2007 16
Figure 8: Migraine market sales value ($m) in the 10 highest value ex-seven major markets, 2004-07 18
Figure 9: Comparison of Datamonitor's updated seven major market migraine market forecast to 2017 with the previous market forecast to 2016 21
Figure 10: Migraine market sales ($) by seven major market region, 2007 and 2017 forecast 22
Figure 11: Migraine market sales forecasts ($m) in the seven major markets by class, 2007-2017 24
Figure 12: Impact of key events on the migraine market, 2008-2017 27
Figure 13: Timeline: launch dates of key migraine therapies, 1992-2008 28
Figure 14: Proportion of the leading nine migraine brand sales value originating from the US, 5EU/Japan combined, and the rest of the world, 2007 30
Figure 15: Migraine-specific triptan sales revenues across the seven major markets by brand (%), 2007 32
Figure 16: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Vernalis and Endo's Frova (frovatriptan) in the seven major markets, 2007-2017 37
Figure 17: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Johnson & Johnson's Topamax (topiramate) in the seven major markets, 2007-2017 39
Figure 18: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Abbot's Depakote (valproate semisodium) in the US, 2007-2017 41
Figure 19: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for GlaxoSmithKline's Treximet (sumatriptan 85mg + naproxen 500mg) in the US, 2007-2017 45
Figure 20: Assigned interventions for Merck & Co's Phase III study of telcagepant (MK-0974) in treating multiple migraine attacks 51
Figure 21: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Merck & Co's telcagepant (MK-0974) in the seven major markets, 2008-2017 52
Figure 22: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Allergan's Botox (botulinum toxin type-A) in the seven major markets, 2008-2017 56
Figure 23: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for Zogenix's sumatriptan DosePro in the seven major markets, 2008-2017 58
Figure 24: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for NovaDel's NVD-201 (sumatriptan oral spray) in the US, 2008-2017 61
Figure 25: Datamonitor's 2007 and updated migraine-specific sales ($m) forecast for NovaDel's NVD-201 (sumatriptan oral spray) in the US, 2008-2017 63
Figure 26: Datamonitor's migraine-specific sales ($m) forecast for MAP Pharmaceuticals's MAP0004 (orally inhaled dihydroergotamine) in the US, 2008-2017 66