Pipeline Insight: Migraine
Innovation essential as weak late-stage pipeline fails to hold off the impact of triptan patent expiries
Pages: 234
Publisher: Datamonitor
Date Published: December 2006
Format: PDF, Slide-Pack
Price: $11400
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
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
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
