Table of Contents
- ABOUT HEALTHCARE
- About the CNS pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the migraine market
- Summary
- CHAPTER 2 PATIENT POTENTIAL
- Definition of migraine
- Segmentation of migraine
- Migraine with aura
- Migraine without aura
- Epidemiology of migraine
- Unmet need in migraine
- Environmental unmet needs
- Clinical unmet needs
- Unmet need 1: Sustained pain relief and headache relapse
- Unmet need 2: Fewer side effects particularly for prophylactics
- Unmet need 3: Ability to use as acute and prophylactic treatment
- Unmet need 4: Improved delivery methods
- Unmet need 5: Faster onset of therapeutic action
- CHAPTER 3 R&D APPROACH
- Classification of pipeline products
- Triptans
- NSAIDs
- Botulinum toxin type-A
- Clinical trial data
- Botulinum toxin type-A in the pipeline
- Other 5-HT-1 receptor modulators
- Other 5-HT-1 receptor modulators pipeline drugs
- Glutamate receptor antagonists
- AMPA receptor antagonist
- Glutamate receptor antagonist pipeline drugs
- Hormone therapy
- Estrogen and Progesterone treatment
- Dexamethasone and 17-beta-estradiol
- Vanilloid VR1 Modulators
- Clinical trial data
- Zucapsaicin (VR1 agonist) and SB-705498 (VR1 antagonist)
- Sodium channel blockers
- Others
- Clinical trial design in migraine
- Guidelines
- Current clinical trial designs in migraine
- Single-attack clinical trial design (acute therapy)
- Prophylactic therapy
- Clinical endpoints in migraine
- Prophylactic therapy trial endpoints
- Acute therapy trial endpoints
- Patient perception
- Validated migraine evaluation instruments
- Future strategies for clinical trials
- Placebo-controlled design, or comparator design
- Trials for menstrual migraine
- CHAPTER 4 MIGRAINE PIPELINE ANALYSIS
- Pipeline overview
- Key companies involved in the migraine pipeline
- Focused effort in a crowded migraine development pipeline
- GSK committed to maintaining leader status in migraine market
- Trexima is the immediate key for Imigran/Imitrex franchise extension
- GSK look to diversity for the future
- GSK, no novice in the face of generic erosion
- Pozen: focused on penetrating migraine market
- MT-100 falls at last hurdle in the US
- Strategies for success
- Key drug delivery strategies in migraine pipeline
- Dissolving tablets
- Nasal delivery
- Novel oral delivery systems
- Injection
- Niche area research
- Over The Counter (OTC) migraine headache therapies
- Triptans available OTC in Germany and in the UK
- CHAPTER 5 TRIPTAN LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview
- Definition of current comparator therapy
- Comparative forecasts
- Trexima
- Profile
- Drug overview
- Phase II development prior to GSK & Pozen agreement
- Phase III clinical trial data
- Menstrual Migraine Treatment with Trexima
- Bioavailability Phase I study
- Regulatory information
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- Sumatriptan-needleless delivery, Intraject
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- Sumatriptan-sublingual spray
- Profile
- Drug Overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- CHAPTER 6 NSAID LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview
- Definition of current comparator therapy
- Comparative forecasts
- MT-100 (metoclopramide + naproxen)
- Profile
- Drug overview
- Approval issues
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- PRO-513 (diclofenac potassium)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- GW-406381
- Profile
- Drug overview
- Patient potential
- Marketing factors
- Drug evaluation
- Lornoxicam
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- CHAPTER 7 BOTULINUM TOXIN TYPE-A LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview
- Definition of current comparator therapy
- Comparative forecasts
- Botulinum Toxin Type-A (Botox)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- Botulinum Toxin Type-A (Dysport)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2015
- Datamonitor drug assessment summary
- CHAPTER 8 OTHER 5-HT-1 RECEPTOR MODULATOR LATE-STAGE DRUG ANALYSIS
- Overview
- MAP-0004
- Profile
- Drug Overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Tonabersat
- Profile
- Drug Overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- CHAPTER 9 GLUTAMATE RECEPTOR ANTAGONIST LATE-STAGE DRUG ANALYSIS
- Overview
- E-2007
- Profile
- Eisai E-2007 development
- Clinical trial data
- Migraine development discontinued
- Pharmacology Research Institute E-2007 development
- Clinical trial data
- Drug evaluation
- FP-0011
- ADX-10059
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- Tezampanel (NGX-424)
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- CHAPTER 10 HORMONE TREATMENT LATE-STAGE DRUG ANALYSIS
- Overview
- Dexamethasone
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- 17-beta-estradiol
- Profile
- Drug overview
- Patient potential
- Drug evaluation
- CHAPTER 11 VANILLOID VR1 MODULATOR LATE-STAGE DRUG ANALYSIS
- Overview
- Zucapsaicin
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- SB-705498
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- CHAPTER 12 SODIUM CHANNEL BLOCKERS LATE-STAGE DRUG ANALYSIS
- Overview
- Lido-PAIN-HM
- Zonisamide
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- CHAPTER 13 OTHER LATE-STAGE DRUG ANALYSIS
- Overview
- Carbon dioxide therapy
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- GW-274150
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- AST-726
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- MK-0974
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- RWJ-333369
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- AZ-001 (Staccato prochlorperazine)
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- MTR-106
- Profile
- Drug overview
- Clinical trial data
- Drug evaluation
- Donepezil
- LLL-2011
- CHAPTER 14 INNOVATIVE EARLY-STAGE PROJECTS
- Key Phase I compounds in migraine
- Glutamatergic receptor inhibitors
- Nitric oxide synthase (NOS) inhibitors
- Calcitonin gene-related peptide (CGRP) antagonists
- BIBLIOGRAPHY
- Journal articles and conference abstracts
- Websites
- Posters
- APPENDIX A
- Sales forecasts
- Competitive positioning analysis of pipeline migraine drugs
- APPENDIX B
- Report Methodology
- Definition of migraine market
- Product forecasts
- Estimation of launch dates
- Patent expiry and generic assumptions
- Sales calculations
- Definition of a standard unit
- Japanese market data
- Additional information
- List of Tables
- Table 1: Prevalence of migraine in the seven major markets, 2006
- Table 2: Triptan 24 hours sustained pain freedom rate
- Table 3: Pipeline drugs in Phase III to Registration for Migraine, 2006
- Table 4: Pipeline drugs in Phase II for Migraine, 2006
- Table 5: GSK' s pipeline migraine drugs, 2006
- Table 6: Pozen' s pipeline migraine drugs, 2006
- Table 7: Key triptan drugs in late-stage R&D pipeline for
migraine, 2006
- Table 8: Sumatriptan: key facts
- Table 9: Phase III trial Trexima 24-hour pain free response
- Table 10: Key approval and launch dates impacting Trexima' s revenue
forecast in the seven major markets, 2006-2015
- Table 11: Key approval and launch dates impacting sumatriptan
Intraject' s revenue forecast in the seven major markets, 2006-2015
- Table 12: Key approval and launch dates impacting sumatriptan
sublingual revenue forecast in the seven major markets, 2006-2015
- Table 13: Key products in late-stage R&D pipeline for NSAIDs, 2006
- Table 14: Key approval and launch dates impacting MT-100 revenue
forecast in the seven major markets, 2006-2015
- Table 15: Key approval and launch dates impacting PRO-513 revenue
forecast in the seven major markets, 2006-2015
- Table 16: Inhibition of COX-1 and COX-2 enzymes
- Table 17: Key products in late-stage R&D pipeline for botulinum
toxin type-A, 2006
- Table 18: Topiramate: key facts
- Table 19: Key approval and launch dates impacting Botox revenue
forecast in the seven major markets, 2006-2015
- Table 20: Key approval and launch dates impacting Dysport revenue
forecast in the seven major markets, 2006-2015
- Table 21: Key other 5-HT-1 receptor modulator drugs in late-stage
R&D pipeline for migraine, 2006
- Table 22: Key products in late-stage R&D pipeline for glutamate
receptor antagonists in the seven major markets, 2006
- Table 23: Key products in late-stage R&D pipeline for hormone
treatment, 2006
- Table 24: Key products in late-stage R&D pipeline for vanilloid
VR1 modulators, 2006
- Table 25: Key products in late-stage R&D pipeline for sodium
channel blockers, 2006
- Table 26: Key products in late-stage R&D pipeline for ' other'
migraine drugs, 2006
- Table 27: Pipeline drugs in Phase I for Migraine, 2006
- Table 28: Datamonitor' s forecast sales of pipeline migraine drugs and
the total migraine market across the seven major markets ($m), 2007-2015
- Table 29: Summary of commercial and research/clinical attractiveness
of comparator and forecasted late-stage drugs for migraine
- Table 30: Estimation of launch dates by phase of development
- Table 31: Estimated generic discounts by country, 2006
- Table 32: Estimation of brand erosion by following patent expiry by
country
- List of Figures
- Figure 1: Datamonitor' s migraine forecast market across the seven
major markets ($m), 2006-2015
- Figure 2: Datamonitor' s migraine drug assessment summary for the seven
major markets ($m), 2006-2015
- Figure 3: Clinical unmet needs in migraine, 2006
- Figure 4: The IHS migraine headache pain scale
- Figure 5: Breakdown of the late-stage pipeline by molecule, 2006
- Figure 6: Migraine drug pipeline by development phase and class (Phase
II and onwards), 2006
- Figure 7: Development stage of GSK' s migraine products, 2006
- Figure 8: Difference in pain free rates between Imitrex tablet of 50mg
and the respective placebo
- Figure 9: Difference in pain free rates between Imitrex injection of
6mg and 4mg and the respective placebos
- Figure 10: Difference in pain free rates between Imitrex nasal spray
of 20mg and the respective placebo
- Figure 11: Datamonitor' s comparative forecast of sales for late-stage
triptan products across the seven major markets ($m), 2006-2015
- Figure 12: Datamonitor' s forecast of sales for Trexima across the
seven major markets ($m), 2006-2015
- Figure 13: Datamonitor' s competitive positioning analysis for Trexima
in the seven major markets, 2006-2015
- Figure 14: Datamonitor' s forecast of sales for sumatriptan Intraject
across the seven major markets ($m), 2006-2015
- Figure 15: Datamonitor' s competitive positioning analysis for
Sumatriptan Intraject in the seven major markets, 2006-2015
- Figure 16: Datamonitor' s forecast of sales for sumatriptan sublingual
across the seven major markets ($m), 2006-2015
- Figure 17: Datamonitor' s competitive positioning analysis for
sumatriptan sublingual in the seven major markets, 2006-2015
- Figure 18: Datamonitor' s comparative forecast of sales for late-stage
NSAID products across the seven major markets ($m), 2006-2015
- Figure 19: Datamonitor' s forecast of sales for MT-100 across the seven
major markets ($m), 2006-2015
- Figure 20: Datamonitor' s competitive positioning analysis for MT-100
in the seven major markets, 2006-2015
- Figure 21: Datamonitor' s forecast of sales for PRO-513 across the
seven major markets ($m), 2006-2015
- Figure 22: Datamonitor' s competitive positioning analysis for PRO-513
in the seven major markets, 2006-2015
- Figure 23: The effectiveness of Topamax at reducing the number of
migraines suffered
- Figure 24: Datamonitor' s comparative forecast of sales for botulinum
toxin type-A products across the seven major markets ($m), 2006-2015
- Figure 25: Datamonitor' s forecast of sales for Botox across the seven
major markets ($m), 2006-2015
- Figure 26: Datamonitor' s competitive positioning analysis for Botox in
the seven major markets, 2006-2015
- Figure 27: Datamonitor' s forecast of sales for Dysport across the
seven major markets ($m), 2006-2015
- Figure 28: Datamonitor' s competitive positioning analysis for Dysport
in the seven major markets, 2006-2015
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