Commercial Insight: Migraine - Opportunities will exist in the wake of generic attack

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.



Report 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.


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ABOUT DATAMONITOR HEALTHCARE 2
About the Migraine pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the migraine market 3
Market forecast summary 5
Contributing experts 5
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Current market situation 9
Seven major migraine market growth shows signs of slowing 9
Sales in the US dominate the total seven major migraine market 9
France is the largest migraine market in the 5EU 11
Triptans remain gold-standard class for the acute treatment of migraine 12
Imitrex maintains leadership of acute treatment market 12
Zomig outdoes Imitrex to become 5EU treatment of choice 13
Rapid Topamax uptake into immature prophylaxis market represents key growth driver 14
Strategic scoping and focus 17
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 18
Summary of environmental issues affecting migraine market size 18
Seven major market opportunities and threats 20
Opportunities 20
Substantial revenue exists in the prophylactic migraine market 20
Patient and physician education will expand patient pool and improve the quality of migraine management 26
Niche indications represent opportunities to increase revenue 27
Desire for improved patient acceptability promotes the development of different delivery methods 31
OTC availability substantially widens customer base 33
Threats 34
Generics 34
Cost-containment measures impact treatment choice and duration 36
OTC medications continue to provide strong competition to prescription drugs 38
Triptan safety issues limit their use 40
US: opportunities and threats 42
Opportunities 43
Advocacy and DTC campaigns drive public awareness of migraine 43
Comparatively high price of branded drugs possible in US market 45
Direct access to specialist physicians helps patients receive optimal treatment quicker 46
Threats 47
Insurance companies limit access to migraine medications 47
High drug prices increases the threatening impact of genericization 49
New migraine treatments will suffer as a result of restricted DTC advertising 49
Japan: opportunities and threats 51
Opportunities 51
Japanese migraine market shows scope for greater development 51
Plans to improve the drug approval review system in Japan 53
Governmental funding for clinical trials could benefit research into migraine 53
Threats 54
Public education greatly needed to raise poor awareness of migraine in Japan 54
Government plans to double the use of generics by the end of 2012 54
France: opportunities and threats 55
Opportunities 55
Large and well-treated French market is an attractive region to launch new therapies 55
Innovative drug development encouraged by price premium and high-level reimbursement 57
France currently has low generic incursion 57
High prescriptions of triptans for cluster headaches in France make it a target additional indication 58
Threats 59
After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future 59
Germany: opportunities and threats 61
Opportunities 62
German government initiative to boost biopharma R&D 62
OTC availability increases presence of brand availability 63
Threats 64
Pharmaceutical-Prescribing-Efficiency-Act - bonus-malus encourages generic prescribing 64
Italy: opportunities and threats 66
Opportunities 67
National migraine campaigns drive public awareness 67
Threats 67
Italy forces drug firms to give licenses for generics rivals 67
Spain: opportunities and threats 69
Opportunities 69
Low brand prices reduce the threat of genericization 69
Primary care interest in migraine is high 70
Threats 71
R&D activity expected to decline 71
UK: opportunities and threats 72
Opportunities 73
Highest 5EU price point achievable in the UK 73
New BASH guidelines clarify treatment algorithm and promote the use of triptans 73
Threats 76
Genericization is a big threat in the UK market 76
UK government looks to renegotiate the Pharmaceutical Price Regulation Scheme 77
Slow Topamax uptake shows that prophylactic treatment is restricted in the UK 78
CHAPTER 4 FORECAST ANALYSIS 81
Key events 81
New product launches 82
Frova launches in France 82
Trexima (sumatriptan +naproxen sodium combination) 83
PRO-513 85
Sumatriptan Intraject 86
Sumatriptan oral spray 88
MK-0974 89
Botox (botulinum toxin type-A) 91
Dysport (botulinum toxin type-A) 94
New product launches in Japan 95
Botox (botulinum toxin type-A) 95
MK-0974 96
Additional indications 96
Frova gains menstrual migraine indication approval 96
Patent expiries 97
Imitrex (sumatriptan) 97
Amerge (naratriptan) 99
Maxalt (rizatriptan) 99
Zomig (zolmitriptan) 100
Relpax (eletriptan) 100
Axert (almotriptan) 100
Frova (frovatriptan) 100
Depakote (valproate semisodium) 101
Topamax (Topiramate) 101
Data definitions, limitations and assumptions 102
Standard units 102
Japanese market data 102
Derivation of sales forecasts and pricing trends 102
Sales calculations 103
Generic erosion and pricing assumptions 103
Definition of the migraine prophylaxis market - assumptions and caveats 103
Forecasts 104
Forecast methodology 104
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 105
Introduction 105
Portfolio management strategies to increase revenue and offset triptan genericization 105
Case study 1: GSK's migraine franchise lifecycle management strategies 106
GSK's migraine franchise will suffer as Trexima will only partially offset sumatriptan genericization 106
Understanding Imitrex's path to success 107
Plan complementary product launches carefully - GSK failed to substantially bolster its portfolio with Amerge 110
Overcoming Imitrex's US patent expiry poses a daunting challenge for GSK 111
OTC switch looks to continue the UK Imigran brand sales long after patent expiry of the prescription molecule 112
Trexima is key to the future of GSK's US migraine franchise 115
Trexima scenario forecast 117
Significant opportunity remains in the largely underserved prophylactic market 119
Case study 2: Topamax indication expansion into migraine prophylaxis proves highly successful 120
Topamax's weight loss effect increases acceptance among patients 123
Topamax's migraine website provides patients with extensive information 123
Topamax 360 targets educating healthcare professionals 124
New anticonvulsants may offer superior efficacy and tolerability profiles 125
Lyrica shows potential in migraine prophylaxis 125
Non-significant results of zonisamide (Zonegran) hinder potential future in migraine 126
Keppra has been shown to benefit patients with chronic migraine 127
High price-point means triptans are unlikely to enter the prophylactic market 127
Naratriptan has shown promise in patients with chronic migraine 127
Therapies with migraine prevention as the primary indication would offer a better defined treatment approach 128
Minster's tonabersat is the most promising late-stage migraine-specific preventive therapy 128
Menstrual migraine represents an unknown yet potentially attractive niche market 129
Case study 3: Frova targets approval for the short-term prevention of menstrual migraine 130
FDA delays indication expansion decision for a second time 130
European indication expansion planned under the mutual recognition procedure 131
Positive results from pivotal menstrual migraine studies led to 2006 filing 131
Frova scenario forecast 132
Four triptans have been studied for either acute or preventive therapy of menstrual migraine 133
Randomized controlled evaluations show sumatriptan and zolmitriptan are effective acute therapies 134
Triptan evaluations as intermittent preventive therapy show those with a longer half-life may be better equipped 134
Proposed algorithm for the use of triptans in menstrual migraine shows where opportunities exist for each triptan 135
Longer, post-treatment trials will show if attacks are truly prevented or merely delayed 137
BIBLIOGRAPHY 139
Journal papers 139
Websites 144
Newspaper articles 151
Datamonitor reports 151
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 152
ATC classes included in 'others' to define the migraine market 152
Menstrual migraine market sizing calculations 154
Summary migraine market data 157
Triptan market data 158
Anticonvulsant market data 165
APPENDIX B - MARKET FORECAST DATA 167
Seven major markets 167
5EU market forecasts 168
US market forecasts 169
Japan market forecasts 170
France market forecasts 171
Germany market forecasts 172
Italy market forecasts 173
Spain market forecasts 174
UK market forecasts 175
APPENDIX C 176
Contributing experts 176
Report methodology 177
About Datamonitor 177
About Datamonitor Healthcare 177
About the CNS analysis team 178
Disclaimer 179

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Table 1: Key players in the migraine market, 2007 15
Table 2: Summary of environmental issues in the migraine market across the seven major markets, 2007 18
Table 3: Summary of environmental issues in the seven individual major migraine markets, 2007 19
Table 4: Average standard unit prices ($) of the drug classes prescribed for migraine prophylaxis in the seven major markets, 2003-06 23
Table 5: Summary of over-the-counter triptan drug availability, 2007 33
Table 6: Estimated launch dates for migraine products in the 5EU and US, 2007-2016 82
Table 7: Japan launch dates for migraine pipeline products, 2007-2016 95
Table 8: Key patent expiries of migraine brands across the seven major markets, 2007-2016 97
Table 9: Summary of Frova Phase III results in menstrual migraine 132
Table 10: Other ATC classes included for migraine market definition 152
Table 11: Projected menstrually-related migraine patient potential across the seven major markets, 2010 154
Table 12: Projected pure menstrual migraine patient potential across the seven major markets, 2010 155
Table 13: Migraine summary market data, 2006 157
Table 14: Imitrex: key facts 158
Table 15: Amerge: key facts 159
Table 16: Zomig: key facts 160
Table 17: Maxalt: key facts 161
Table 18: Axert: key facts 162
Table 19: Relpax: key facts 163
Table 20: Frova: key facts 164
Table 21: Topamax: key facts 165
Table 22: Depakote: key facts 166
Table 23: Seven major market migraine drug sales forecasts ($m), 2007-2016 167
Table 24: 5EU migraine drug sales forecasts ($m), 2007-2016 168
Table 25: US migraine drug sales forecasts ($m), 2007-2016 169
Table 26: Japan migraine drug sales forecasts ($m), 2007-2016 170
Table 27: France migraine drug sales forecasts ($m), 2007-2016 171
Table 28: Germany migraine drug sales forecasts ($m), 2007-2016 172
Table 29: Italy migraine drug sales forecasts ($m), 2007-2016 173
Table 30: Spain migraine drug sales forecasts ($m), 2007-2016 174
Table 31: UK migraine drug sales forecasts ($m), 2007-2016 175


Figure 1: Datamonitor's migraine market forecast across the seven major markets, 2007-2016 5
Figure 2: Migraine-specific sales revenue across the seven major markets ($m), 2003-06 9
Figure 3: Performance of the seven major migraine markets ($m), 2005-06 10
Figure 4: Migraine-specific sales volume across the seven major markets (SUs), 2003-06 11
Figure 5: Migraine-specific sales revenue in the 5EU ($m), 2003-06 12
Figure 6: Performance of the nine key migraine therapies across the seven major markets ($m), 2005-06 13
Figure 7: Total triptan migraine-specific sales revenues across the seven major markets by brand (%), 2006 14
Figure 8: Value of the seven major migraine prophylactic market vs. the acute migraine market, 2003-06 21
Figure 9: Migraine-specific sales in the seven major markets for the four leading migraine prophylaxis drug classes ($m), 2003-06 22
Figure 10: Migraine-specific standard units prescribed in the seven major markets for the four leading migraine prophylaxis drug classes, 2003-06 23
Figure 11: Total Topamax brand sales ($m) by indication in the US, 2003-06 24
Figure 12: Percentage of Imitrex sales attributable to cluster headache across the seven major markets, 2006 28
Figure 13: Maxalt 5EU migraine-specific sales by delivery method ($m), 2003-06 32
Figure 14: Generic sumatriptan's impact in the German, Spanish and UK migraine markets ($m and SUs), 2006 35
Figure 15: Forecasted impact of Imitrex and Topamax patent expiry on the US migraine market ($ billion), 2006-2016 36
Figure 16: Performance of the key migraine therapies in the US ($m), 2005-06 42
Figure 17: Screenshot of the purple Granger in GSK's Imitrex advert 44
Figure 18: Average triptan standard unit price across the seven major markets ($), 2003-06 46
Figure 19: Performance of the key migraine therapies in Japan ($m), 2005-06 51
Figure 20: Japan migraine-specific triptan sales ($m), 2003-06 52
Figure 21: Performance of the key migraine therapies in France ($m), 2005-06 55
Figure 22: 5EU migraine market by triptan standard units, 2003-06 56
Figure 23: The French cluster headache market ($m), 2004-06 59
Figure 24: Average triptan standard unit price in the 5EU countries ($), 2003-06 60
Figure 25: Performance of the key migraine therapies in Germany ($m), 2005-06 61
Figure 26: Migraine-specific Amerge sales in Germany ($m and SUs), 2003-06 64
Figure 27: Performance of the key migraine therapies in Italy ($m), 2005-06 66
Figure 28: Performance of the key migraine therapies in Spain ($m), 2005-06 69
Figure 29: Migraine-specific quarterly impact of Imitrex genericization in Spain ($m), 2006 70
Figure 30: Performance of the key migraine therapies in the UK ($m), 2005-06 72
Figure 31: Migraine-specific impact of Imitrex genericization in the UK, Germany and Spain ($m), 2005-06 77
Figure 32: Quarterly 5EU migraine-specific Topamax sales ($000s), 2005-06 79
Figure 33: UK migraine-specific anticonvulsant sales, ($m), 2003-06 80
Figure 34: Key events and their impact on the migraine market, 2007-2016 81
Figure 35: Forecasted GSK migraine franchise ($m), 2007-2016 106
Figure 36: SWOT analysis of Imitrex, 2007 107
Figure 37: Migraine-specific seven major market Imitrex sales split by formulation ($m), 2003-06 109
Figure 38: Migraine-specific sales of Imitrex and generic sumatriptan in Germany, Spain and the UK ($m), 2006-07 111
Figure 39: The 2007 Imigran recovery commercial image and strapline 113
Figure 40: Impact of Trexima scenario forecast on GSK's US migraine franchise ($m), 2006-2016 118
Figure 41: Forecasted seven major market migraine-specific Topamax sales ($m), 2007-2016 121
Figure 42: Seven major market migraine-specific Topamax prescriptions and sales, 2003-06 122
Figure 43: Ortho-McNeil Neurologics Topamax patient website 123
Figure 44: Frova scenario forecast for US and 5EU migraine-specific sales ($m), 2006-2016 133
Figure 45: Proposed algorithm for the use of triptans in menstrual migraine 136

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