Pipeline Insight: Migraine

Innovation essential as weak late-stage pipeline fails to hold off the impact of triptan patent expiries

Publication Date	December 2006
Publisher	Datamonitor
Product Type	Report
Pages	234
ISBN Number	not applicable
Product Code	DAT04412

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Summary

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

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

Content

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
- Datamonitor forecast methodology and assumptions
- Product forecasts
- Estimation of launch dates
- Patent expiry and generic assumptions
- Sales calculations
- Definition of a standard unit
- Japanese market data
- Additional information
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the CNS analysis team
- Disclaimer