Migraine - Innovation essential as weak late-stage pipeline fails to hold off the impact of triptan patent expiries
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the migraine market - page 4
- Summary - page 6
- CHAPTER 2 PATIENT POTENTIAL - page 23
- Definition of migraine - page 24
- Segmentation of migraine - page 25
- Migraine with aura - page 25
- Migraine without aura - page 27
- Menstrual migraine - page 27
- Epidemiology of migraine - page 28
- Unmet need in migraine - page 30
- Environmental unmet needs - page 30
- Clinical unmet needs - page 31
- Unmet need 1: Sustained pain relief and headache relapse - page 32
- Unmet need 2: Fewer side effects particularly for prophylactics - page 34
- Unmet need 3: Ability to use as acute and prophylactic treatment - page 35
- Unmet need 4: Improved delivery methods - page 37
- Unmet need 5: Faster onset of therapeutic action - page 38
- CHAPTER 3 R&D APPROACH - page 40
- Classification of pipeline products - page 41
- Triptans - page 41
- Sumatriptan - page 42
- NSAIDs - page 45
- NSAID pipeline drugs - page 46
- Botulinum toxin type-A - page 46
- Clinical trial data - page 47
- Botulinum toxin type-A in the pipeline - page 47
- Other 5-HT-1 receptor modulators - page 48
- Other 5-HT-1 receptor modulators pipeline drugs - page 48
- Glutamate receptor antagonists - page 49
- AMPA receptor antagonist - page 49
- Glutamate receptor antagonist pipeline drugs - page 49
- Hormone therapy - page 50
- Estrogen and Progesterone treatment - page 50
- Dexamethasone and 17-beta-estradiol - page 50
- Vanilloid VR1 Modulators - page 50
- Clinical trial data - page 51
- Zucapsaicin (VR1 agonist) and SB-705498 (VR1 antagonist) - page 51
- Sodium channel blockers - page 51
- Lidocaine and Zonisamide - page 52
- Others - page 52
- Triptans - page 41
- Clinical trial design in migraine - page 53
- Guidelines - page 53
- Current clinical trial designs in migraine - page 54
- Single-attack clinical trial design (acute therapy) - page 54
- Prophylactic therapy - page 55
- Clinical endpoints in migraine - page 56
- Prophylactic therapy trial endpoints - page 56
- Acute therapy trial endpoints - page 56
- Patient perception - page 58
- Validated migraine evaluation instruments - page 58
- Future strategies for clinical trials - page 60
- Placebo-controlled design, or comparator design - page 61
- Trials for menstrual migraine - page 61
- Classification of pipeline products - page 41
- CHAPTER 4 MIGRAINE PIPELINE ANALYSIS - page 63
- Pipeline overview - page 64
- Key companies involved in the migraine pipeline - page 69
- Focused effort in a crowded migraine development pipeline - page 69
- GSK committed to maintaining leader status in migraine market - page 69
- Trexima is the immediate key for Imigran/Imitrex franchise extension - page 69
- GSK look to diversity for the future - page 71
- GSK, no novice in the face of generic erosion - page 72
- Pozen: focused on penetrating migraine market - page 73
- MT-100 falls at last hurdle in the US - page 74
- Strategies for success - page 75
- Key drug delivery strategies in migraine pipeline - page 75
- Dissolving tablets - page 75
- Nasal delivery - page 75
- Novel oral delivery systems - page 76
- Injection - page 76
- Niche area research - page 76
- Menstrual migraine - page 77
- Over The Counter (OTC) migraine headache therapies - page 78
- Triptans available OTC in Germany and in the UK - page 79
- Key drug delivery strategies in migraine pipeline - page 75
- CHAPTER 5 TRIPTAN LATE-STAGE DRUG ANALYSIS & FORECASTS - page 81
- Overview - page 82
- Pipeline summary - page 82
- Definition of current comparator therapy - page 82
- Comparative forecasts - page 86
- Trexima - page 87
- Profile - page 87
- Drug overview - page 87
- Phase II development prior to GSK & Pozen agreement - page 87
- Phase III clinical trial data - page 88
- Menstrual Migraine Treatment with Trexima - page 90
- Bioavailability Phase I study - page 91
- Regulatory information - page 92
- Patient potential - page 92
- Marketing factors - page 93
- Satisfaction of unmet needs - page 94
- Forecasts to 2015 - page 97
- Datamonitor drug assessment summary - page 99
- Profile - page 87
- Sumatriptan-needleless delivery, Intraject - page 100
- Profile - page 100
- Drug overview - page 100
- Clinical trial data - page 101
- Patient potential - page 101
- Marketing factors - page 103
- Satisfaction of unmet needs - page 103
- Forecasts to 2015 - page 105
- Datamonitor drug assessment summary - page 107
- Profile - page 100
- Sumatriptan-sublingual spray - page 108
- Profile - page 108
- Drug Overview - page 108
- Clinical trial data - page 108
- Patient potential - page 110
- Marketing factors - page 111
- Satisfaction of unmet needs - page 112
- Forecasts to 2015 - page 113
- Datamonitor drug assessment summary - page 115
- Profile - page 108
- Overview - page 82
- CHAPTER 6 NSAID LATE-STAGE DRUG ANALYSIS & FORECASTS - page 116
- Overview - page 117
- Pipeline Summary - page 117
- Definition of current comparator therapy - page 117
- Comparative forecasts - page 118
- MT-100 (metoclopramide + naproxen) - page 119
- Profile - page 119
- Drug overview - page 119
- Approval issues - page 119
- Clinical trial data - page 120
- Patient potential - page 121
- Marketing factors - page 122
- Satisfaction of unmet needs - page 123
- Forecasts to 2015 - page 124
- Datamonitor drug assessment summary - page 126
- Profile - page 119
- PRO-513 (diclofenac potassium) - page 127
- Profile - page 127
- Drug overview - page 127
- Clinical trial data - page 127
- Patient potential - page 129
- Marketing factors - page 130
- Satisfaction of unmet needs - page 130
- Forecasts to 2015 - page 132
- Datamonitor drug assessment summary - page 134
- Profile - page 127
- GW-406381 - page 135
- Profile - page 135
- Drug overview - page 135
- Patient potential - page 135
- Marketing factors - page 136
- Drug evaluation - page 137
- Profile - page 135
- Lornoxicam - page 137
- Profile - page 137
- Drug overview - page 137
- Clinical trial data - page 138
- Drug evaluation - page 139
- Profile - page 137
- Overview - page 117
- CHAPTER 7 BOTULINUM TOXIN TYPE-A LATE-STAGE DRUG ANALYSIS & FORECASTS - page 140
- Overview - page 141
- Pipeline Summary - page 141
- Definition of current comparator therapy - page 141
- Comparative forecasts - page 144
- Botulinum Toxin Type-A (Botox) - page 145
- Profile - page 145
- Drug overview - page 145
- Clinical trial data - page 145
- Patient potential - page 148
- Marketing factors - page 150
- Satisfaction of unmet needs - page 151
- Forecasts to 2015 - page 154
- Datamonitor drug assessment summary - page 156
- Profile - page 145
- Botulinum Toxin Type-A (Dysport) - page 157
- Profile - page 157
- Drug overview - page 157
- Clinical trial data - page 157
- Patient potential - page 159
- Marketing factors - page 159
- Satisfaction of unmet needs - page 160
- Forecasts to 2015 - page 160
- Datamonitor drug assessment summary - page 162
- Profile - page 157
- Overview - page 141
- CHAPTER 8 OTHER 5-HT-1 RECEPTOR MODULATOR LATE-STAGE DRUG ANALYSIS - page 163
- Overview - page 164
- Pipeline Summary - page 164
- MAP-0004 - page 164
- Profile - page 164
- Drug Overview - page 164
- Clinical trial data - page 165
- Patient potential - page 166
- Marketing factors - page 166
- Satisfaction of unmet needs - page 166
- Profile - page 164
- Tonabersat - page 167
- Profile - page 167
- Drug Overview - page 167
- Clinical trial data - page 167
- Patient potential - page 170
- Marketing factors - page 171
- Satisfaction of unmet needs - page 171
- Profile - page 167
- Overview - page 164
- CHAPTER 9 GLUTAMATE RECEPTOR ANTAGONIST LATE-STAGE DRUG ANALYSIS - page 172
- Overview - page 173
- Pipeline Summary - page 173
- E-2007 - page 173
- Profile - page 173
- Drug overview - page 173
- Eisai E-2007 development - page 174
- Clinical trial data - page 174
- Migraine development discontinued - page 175
- Pharmacology Research Institute E-2007 development - page 175
- Clinical trial data - page 175
- Drug evaluation - page 176
- Profile - page 173
- FP-0011 - page 176
- ADX-10059 - page 177
- Profile - page 177
- Drug overview - page 177
- Clinical trial data - page 177
- Drug evaluation - page 178
- Profile - page 177
- Tezampanel (NGX-424) - page 178
- Profile - page 178
- Drug overview - page 178
- Clinical trial data - page 179
- Drug evaluation - page 180
- Profile - page 178
- Overview - page 173
- CHAPTER 10 HORMONE TREATMENT LATE-STAGE DRUG ANALYSIS - page 181
- Overview - page 182
- Pipeline Summary - page 182
- Dexamethasone - page 182
- Profile - page 182
- Drug overview - page 182
- Clinical trial data - page 183
- Patient potential - page 184
- Marketing factors - page 185
- Satisfaction of unmet needs - page 185
- Profile - page 182
- 17-beta-estradiol - page 186
- Profile - page 186
- Drug overview - page 186
- Patient potential - page 187
- Drug evaluation - page 188
- Profile - page 186
- Overview - page 182
- CHAPTER 11 VANILLOID VR1 MODULATOR LATE-STAGE DRUG ANALYSIS - page 189
- Overview - page 190
- Pipeline Summary - page 190
- Zucapsaicin - page 190
- Profile - page 190
- Drug overview - page 190
- Clinical trial data - page 190
- Drug evaluation - page 191
- Profile - page 190
- SB-705498 - page 191
- Profile - page 191
- Drug overview - page 191
- Clinical trial data - page 192
- Drug evaluation - page 192
- Profile - page 191
- Overview - page 190
- CHAPTER 12 SODIUM CHANNEL BLOCKERS LATE-STAGE DRUG ANALYSIS - page 194
- Overview - page 195
- Pipeline Summary - page 195
- Lido-PAIN-HM - page 195
- Drug overview - page 195
- Drug evaluation - page 196
- Drug overview - page 195
- Zonisamide - page 196
- Profile - page 196
- Drug overview - page 196
- Clinical trial data - page 197
- Drug evaluation - page 197
- Profile - page 196
- Overview - page 195
- CHAPTER 13 OTHER LATE-STAGE DRUG ANALYSIS - page 198
- Overview - page 199
- Pipeline Summary - page 199
- Carbon dioxide therapy - page 199
- Profile - page 199
- Drug overview - page 199
- Clinical trial data - page 200
- Drug evaluation - page 200
- Profile - page 199
- GW-274150 - page 201
- Profile - page 201
- Drug overview - page 201
- Clinical trial data - page 201
- Drug evaluation - page 203
- Profile - page 201
- AST-726 - page 203
- Profile - page 203
- Drug overview - page 203
- Clinical trial data - page 203
- Drug evaluation - page 204
- Profile - page 203
- MK-0974 - page 205
- Profile - page 205
- Drug overview - page 205
- Clinical trial data - page 205
- Drug evaluation - page 205
- Profile - page 205
- RWJ-333369 - page 206
- Profile - page 206
- Drug overview - page 206
- Clinical trial data - page 206
- Drug evaluation - page 207
- Profile - page 206
- AZ-001 (Staccato prochlorperazine) - page 207
- Profile - page 207
- Drug overview - page 207
- Clinical trial data - page 208
- Drug evaluation - page 209
- Profile - page 207
- MTR-106 - page 210
- Profile - page 210
- Drug overview - page 210
- Clinical trial data - page 210
- Drug evaluation - page 210
- Profile - page 210
- Donepezil - page 211
- LLL-2011 - page 211
- Overview - page 199
- CHAPTER 14 INNOVATIVE EARLY-STAGE PROJECTS - page 212
- Key Phase I compounds in migraine - page 213
- Glutamatergic receptor inhibitors - page 214
- Nitric oxide synthase (NOS) inhibitors - page 215
- Calcitonin gene-related peptide (CGRP) antagonists - page 215
- BIBLIOGRAPHY - page 217
- Journal articles and conference abstracts - page 217
- Websites - page 222
- Posters - page 225
- APPENDIX A - page 226
- Sales forecasts - page 226
- Competitive positioning analysis of pipeline migraine drugs - page 227
- APPENDIX B - page 228
- Report Methodology - page 228
- Definition of migraine market - page 228
- Datamonitor forecast methodology and assumptions - page 228
- Product forecasts - page 228
- Estimation of launch dates - page 228
- Patent expiry and generic assumptions - page 229
- Sales calculations - page 230
- Definition of a standard unit - page 230
- Japanese market data - page 230
- Additional information - page 231
- About Datamonitor - page 231
- About Datamonitor Healthcare - page 231
- Datamonitor Healthcare's therapy area capabilities - page 232
- About the CNS analysis team - page 233
- Disclaimer - page 234
- Report Methodology - page 228
- List of Tables
- Table 1: Prevalence of migraine in the seven major markets, 2006 - page 28
- Table 2: Triptan 24 hours sustained pain freedom rate - page 33
- Table 3: Pipeline drugs in Phase III to Registration for Migraine, 2006 - page 64
- Table 4: Pipeline drugs in Phase II for Migraine, 2006 - page 65
- Table 5: GSK's pipeline migraine drugs, 2006 - page 72
- Table 6: Pozen's pipeline migraine drugs, 2006 - page 73
- Table 7: Key triptan drugs in late-stage R&D pipeline for migraine, 2006 - page 82
- Table 8: Sumatriptan: key facts - page 85
- Table 9: Phase III trial Trexima 24-hour pain free response - page 94
- Table 10: Key approval and launch dates impacting Trexima's revenue forecast in the seven major markets, 2006-2015 - page 97
- Table 11: Key approval and launch dates impacting sumatriptan Intraject's revenue forecast in the seven major markets, 2006-2015 - page 105
- Table 12: Key approval and launch dates impacting sumatriptan sublingual revenue forecast in the seven major markets, 2006-2015 - page 113
- Table 13: Key products in late-stage R&D pipeline for NSAIDs, 2006 - page 117
- Table 14: Key approval and launch dates impacting MT-100 revenue forecast in the seven major markets, 2006-2015 - page 124
- Table 15: Key approval and launch dates impacting PRO-513 revenue forecast in the seven major markets, 2006-2015 - page 132
- Table 16: Inhibition of COX-1 and COX-2 enzymes - page 138
- Table 17: Key products in late-stage R&D pipeline for botulinum toxin type-A, 2006 - page 141
- Table 18: Topiramate: key facts - page 143
- Table 19: Key approval and launch dates impacting Botox revenue forecast in the seven major markets, 2006-2015 - page 154
- Table 20: Key approval and launch dates impacting Dysport revenue forecast in the seven major markets, 2006-2015 - page 160
- Table 21: Key other 5-HT-1 receptor modulator drugs in late-stage R&D pipeline for migraine, 2006 - page 164
- Table 22: Key products in late-stage R&D pipeline for glutamate receptor antagonists in the seven major markets, 2006 - page 173
- Table 23: Key products in late-stage R&D pipeline for hormone treatment, 2006 - page 182
- Table 24: Key products in late-stage R&D pipeline for vanilloid VR1 modulators, 2006 - page 190
- Table 25: Key products in late-stage R&D pipeline for sodium channel blockers, 2006 - page 195
- Table 26: Key products in late-stage R&D pipeline for 'other' migraine drugs, 2006 - page 199
- Table 27: Pipeline drugs in Phase I for Migraine, 2006 - page 213
- Table 28: Datamonitor's forecast sales of pipeline migraine drugs and the total migraine market across the seven major markets ($m), 2007-2015 - page 226
- Table 29: Summary of commercial and research/clinical attractiveness of comparator and forecasted late-stage drugs for migraine - page 227
- Table 30: Estimation of launch dates by phase of development - page 228
- Table 31: Estimated generic discounts by country, 2006 - page 229
- Table 32: Estimation of brand erosion by following patent expiry by country - page 230
- List of Figures
- Figure 1: Datamonitor's migraine forecast market across the seven major markets ($m), 2006-2015 - page 6
- Figure 2: Datamonitor's migraine drug assessment summary for the seven major markets ($m), 2006-2015 - page 7
- Figure 3: Clinical unmet needs in migraine, 2006 - page 32
- Figure 4: The IHS migraine headache pain scale - page 57
- Figure 5: Breakdown of the late-stage pipeline by molecule, 2006 - page 67
- Figure 6: Migraine drug pipeline by development phase and class (Phase II and onwards), 2006 - page 68
- Figure 7: Development stage of GSK's migraine products, 2006 - page 70
- Figure 8: % of patients with headache response (no or mild pain) for 50mg Imitrex tablet and the respective placebo - page 83
- Figure 9: % of patients with headache response (no or mild pain) for Imitrex injection of 6mg and 4mg and the respective placebo - page 84
- Figure 10: % of patients with headache response (no or mild pain) for 20mg Imitrex nasal spray and the respective placebo - page 84
- Figure 11: Datamonitor's comparative forecast of sales for late-stage triptan products across the seven major markets ($m), 2006-2015 - page 86
- Figure 12: Datamonitor's forecast of sales for Trexima across the seven major markets ($m), 2006-2015 - page 98
- Figure 13: Datamonitor's competitive positioning analysis for Trexima in the seven major markets, 2006-2015 - page 99
- Figure 14: Datamonitor's forecast of sales for sumatriptan Intraject across the seven major markets ($m), 2006-2015 - page 106
- Figure 15: Datamonitor's competitive positioning analysis for Sumatriptan Intraject in the seven major markets, 2006-2015 - page 107
- Figure 16: Datamonitor's forecast of sales for sumatriptan sublingual across the seven major markets ($m), 2006-2015 - page 114
- Figure 17: Datamonitor's competitive positioning analysis for sumatriptan sublingual in the seven major markets, 2006-2015 - page 115
- Figure 18: Datamonitor's comparative forecast of sales for late-stage NSAID products across the seven major markets ($m), 2006-2015 - page 118
- Figure 19: Datamonitor's forecast of sales for MT-100 across the seven major markets ($m), 2006-2015 - page 125
- Figure 20: Datamonitor's competitive positioning analysis for MT-100 in the seven major markets, 2006-2015 - page 126
- Figure 21: Datamonitor's forecast of sales for PRO-513 across the seven major markets ($m), 2006-2015 - page 133
- Figure 22: Datamonitor's competitive positioning analysis for PRO-513 in the seven major markets, 2006-2015 - page 134
- Figure 23: The effectiveness of Topamax at reducing the number of migraines suffered - page 142
- Figure 24: Datamonitor's comparative forecast of sales for botulinum toxin type-A products across the seven major markets ($m), 2006-2015 - page 144
- Figure 25: Datamonitor's forecast of sales for Botox across the seven major markets ($m), 2006-2015 - page 155
- Figure 26: Datamonitor's competitive positioning analysis for Botox in the seven major markets, 2006-2015 - page 156
- Figure 27: Datamonitor's forecast of sales for Dysport across the seven major markets ($m), 2006-2015 - page 161
- Figure 28: Datamonitor's competitive positioning analysis for Dysport in the seven major markets, 2006-2015 - page 162
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