片頭痛（偏頭痛）治療薬動向

Abstract

Overview

Introduction

After the launch of Trexima in 2007, triptan genericization coupled with a weak late-stage pipeline will result in a major shift in market dynamics, and will result in the migraine market value decreasing to $3.2 billion in 2015. The market remains receptive to superior prophylactics however, with innovation being essential for the progression of the acute market, post-triptan era.

Scope

• Analysis of patient potential, unmet needs and clinical trial design in migraine
• Overview of drugs in preregistration, Phase III, II and I; with analysis of key companies involved in the R&D pipeline
• Detailed profiles of key compounds in development for use in migraine, with forecasts of drug revenues to 2015
• Discussion of GSK and Pozen' s strategies and insight from key industry opinion leaders

Report Highlights

Due to Imitrex' s commercial success, GSK is the current migraine market leader. Trexima, co-developed by GSK and Pozen represents GSK' s product line extension for its migraine franchise, but approval delays and the impending US sumatriptan patent expiry will limit its success.

The next big thing in the prophylactic market will be the label expansion of Allergan' s Botox and Ipsen' s Dysport. Seven major market Botox and Dysport combined sales for migraine are forecast to grow to over $170m in 2015.

The presence of glutamatergic receptor inhibitors, NOS inhibitors and CGRP antagonists, amongst others in early stage clinical trials, indicate companies are developing innovative drugs for the post triptan future. With all identified to play a role in the biological mechanisms of migraine, there holds great potential in such novel drug targets.

Reasons to Purchase

• Understand unmet needs in the migraine market based on key opinion leader comments
• Benchmark key late-stage migraine compounds against current market leaders
• Assess the combined US, Japan, five major EU sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

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
      • Menstrual migraine
  • 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
      • Sumatriptan
    • NSAIDs
      • NSAID pipeline drugs
    • 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
      • Lidocaine and Zonisamide
    • 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
      • Menstrual migraine
    • 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
    • Pipeline summary
  • 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
    • Pipeline Summary
  • 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
    • Pipeline Summary
  • 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
    • Pipeline Summary
  • 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
    • Pipeline Summary
  • E-2007
    • Profile
      • Drug overview
    • 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
    • Pipeline Summary
  • 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
    • Pipeline Summary
  • 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
    • Pipeline Summary
  • Lido-PAIN-HM
    • Drug overview
      • Drug evaluation
  • Zonisamide
    • Profile
      • Drug overview
      • Clinical trial data
      • Drug evaluation
• CHAPTER 13 OTHER LATE-STAGE DRUG ANALYSIS
  • Overview
    • Pipeline Summary
  • 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