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Pipeline and Commercial Insight: Neuropathic Pain - UCB's Vimpat set to compete with major players

Published by: Datamonitor

Published: Jun. 16, 2008 - 239 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Central Nervous System pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the Neuropathic pain market
Key metrics
Datamonitor pipeline assessment summary
Related reports
CHAPTER 2 NEUROPATHIC PAIN - MARKET OVERVIEW AND POTENTIAL
Definition of neuropathic pain
Segmentation of neuropathic pain
Segmentation of neuropathic pain differs depending on the geographic market
General neuropathic pain provides a broader customer base in the EU
US approval requires evidence in each neuropathic pain subtype
Major neuropathic pain subtypes
Diabetic neuropathic pain
Post-herpetic neuralgia
HIV neuropathic pain
Neuropathic low-back pain
Other subtypes
Epidemiology
Diabetic neuropathic pain
Post-herpetic neuralgia
HIV neuropathic pain
Post-operative pain
Current market overview
Five treatments are currently marketed for neuropathic pain
Off-label prescribing
US dominated market
Unmet need in neuropathic pain
Clinical unmet need
1. Improved efficacy
2. Improved side-effect profile
3. Reduced time to onset of action
4. Fewer drug-drug interactions
5. Pill burden
Clinical trial design in neuropathic pain
Choice of endpoint is the key clinical trial design factor in neuropathic pain
Head-to-head trials of increasing importance
Lyrica is the ideal choice of comparator drug for head-to-head clinical trials
Length of trial should indicate titration period for physician ease of use
The Initiative on Methods, Measurements and Pain Assessments in Clinical trials (IMMPACT)
European Federation of Neurological Societies assessment
Clinical trial endpoints in neuropathic pain
50% reduction in pain is a primary measure of efficacy
Multiple pain and quality of life assessment questionnaires should be used in trials
Clinical trial drop-out as an endpoint
CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
Marketed brands overview
Lyrica (pregabalin)
Drug overview
Forecasts to 2017
SWOT
Datamonitor drug assessment summary
Clinical trial data
Lyrica clinical trial 1
Lyrica clinical trial 2
Lyrica clinical trial 3
Neurontin (gabapentin)
Drug overview
Forecasts to 2017
SWOT
Clinical trial data
Lidoderm (lidocaine)
Drug overview
Forecasts to 2017
Clinical trial data
Lidoderm clinical trial 1
Lidoderm clinical trial 2
Cymbalta (duloxetine)
Drug overview
Forecasts to 2017
SWOT
Clinical trial data
Tegretol (carbamazepine)
Drug overview
SWOT
CHAPTER 4 FORECAST ANALYSIS
Key events
New product launches
Product launches in Japan
Patent expiries
Cymbalta
Lidoderm
Data definitions, limitations and assumptions
Standard units
Japanese market data
Derivation of sales forecasts and pricing trends
Forecast methodology
CHAPTER 5 STRATEGIES FOR SUCCESS
Key R&D company strategies
Reformulation strategies: Gabapentin
Gabapentin GR
XP13512
Patient subgroups
CHAPTER 6 PIPELINE OVERVIEW AND DYNAMICS
Pipeline overview
Classification of pipeline products
Glutamate receptor modulators
NMDA
AMPA
Kainate
Ion channel modulators
Sodium channels
Calcium channels
GABA modulators
Others
SNRIs
Dopamine modulators
Cannabinoid agonists
Vanilloid receptor agonists
Substance P release modulators
ACh receptor agonists
NGF modulators
TNF alpha antagonists
Adrenoceptor modulation
Adenosine A2 agonists
Free radicals
Phase II and above
Key companies involved in the neuropathic pain pipeline
Pfizer
Neurontin
Lyrica
Eli Lilly
Cymbalta
UCB
Vimpat
Brivaracetam
Discontinued and suspended projects
Projects recently suspended or discontinued
ACV-1
Pristiq
Radafaxine (353162)
Lamictal XR
Namenda (memantine)
Traxoprodil
AZD-4282
CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS
Glutamate receptor modulators
Pipeline summary
Comparative forecasts
Definition of current comparator therapy
Pfizer's Lyrica is Datamonitor's comparator therapy
Lidoderm is the topical comparator therapy
Zenvia (dextromethorphan & quinidine sulfate)
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Patient potential
Marketing factors
Satisfaction of unmet needs
Clinical trial data
NP-1 (ketamine & amitriptyline)
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Patient potential
Marketing factors
Satisfaction of unmet needs
Clinical trial data
Other glutamate receptor modulators
CNS-5161
V3381
RGH-896
EVT 101
NS-1209
NGX-426
Ion channel modulators
Pipeline summary
Comparative forecasts
Definition of current comparator therapy
Vimpat (lacosamide)
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Patient potential
Marketing factors
Satisfaction of unmet needs
Clinical trial data
Ralfinamide
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Patient potential
Marketing factors
Satisfaction of unmet needs
Clinical trial data
Other ion channel modulators
Retigabine
Bupivacaine (Eladur)
Lidocaine patch KN-48
Brivaracetam
GABA receptor modulators
Pipeline summary
Comparative forecasts
Definition of current comparator therapy
XP13512
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Marketing factors - improved duration of action
Patient potential
Satisfaction of unmet needs
Clinical trial data
Gabapentin GR
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Clinical trial data
Other therapies
Pipeline summary
Comparative forecasts
Transacin (NGX-4010)
Drug overview
Forecasts to 2017
Datamonitor drug assessment summary
Patient potential
Marketing factors
Satisfaction of unmet needs
Clinical trial data
Other drugs
Sativex (GW-1000)
Fentora (fentanyl buccal transmucosal)
BVT.115959
Bicifadine
NSD-644
Reboxetine (+)-(S,S)
F13640
AS-3201
KD7040
Ibudilast (AV411)
IP 751/CT-3 (ajulemic acid)
ADL5859
KDS-2000
AGN 203818
681323
Liposomal galantamine
TAK-583
Botulinum toxin type A-hemagglutinin complex (Dysport)
Zucapsaicin
2PX
CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS
Key Phase I and preclinical compounds in neuropathic pain
Selective sodium channel blockers
Vanilloid TRPV1 antagonists
Preclinical trial data
NGX-1998
GRC-6211
SAR-115740
N-type calcium channel blockers
Spinal cord and peripheral nerve stimulation
BIBLIOGRAPHY
Journals
Websites
Datamonitor reports
APPENDIX A
Methodology
Datamonitor forecast methodology
ICD-10 codes
Product forecasts
Definition of a standard unit
Datamonitor drug assessment summary
Contributing experts
Biographies
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare's therapy area capabilities
About the Disease analysis team
Disclaimer
List of Tables
Table 1: Neuropathic pain market size across the seven major markets ($m), 2007 and 2017
Table 2: Sales forecasts ($m) of key pipeline products in neuropathic pain, 2007-2017
Table 3: Abbreviations for neuropathic pain subtypes
Table 4: Diabetic neuropathic pain patient populations across the seven major markets, 2008
Table 5: Post-herpetic neuralgia patient population across the seven major markets, 2008
Table 6: HIV neuropathic pain patient population across the seven major markets, 2008
Table 7: Recommended core outcomes measures for clinical trials of chronic pain treatment efficacy
Table 8: Forecast launch dates for neuropathic pain drugs in the US and 5EU, 2008-2012
Table 9: Forecast launch dates for neuropathic pain drugs in Japan, 2010-2012
Table 10: Pivotal patent expiries for key marketed neuropathic pain drugs in the US and 5EU, 2012-16
Table 11: Neuropathic pain market sub-type definition by ICD-10 codes
Table 12: Number of key neuropathic pain drugs by class and phase of development, 2008
Table 13: Phase II & III R&D pipeline for neuropathic pain, 2008
Table 14: Key glutamate receptor modulators in the late-stage R&D pipeline for neuropathic pain, 2008
Table 15: Lyrica: key facts
Table 16: Estimated key events, approvals and launch dates impacting Zenvia's revenue forecast, 2008-2017
Table 17: Estimated key events, approvals and launch dates impacting NP-1's revenue forecast, 2008-2017
Table 18: Key ion channel modulators in the late-stage R&D pipeline for neuropathic pain, 2008
Table 19: Estimated key events, approvals and launch dates impacting Vimpat's revenue forecast, 2008-2017
Table 20: Estimated key events, approvals and launch dates impacting ralfinamide's revenue forecast, 2008-2017
Table 21: Key GABA modulators in the late-stage R&D pipeline for neuropathic pain, 2008
Table 22: Estimated key events, approvals and launch dates impacting XP13512's revenue forecast, 2008-2017
Table 23: Other drugs in late-stage R&D pipeline for neuropathic pain, 2008
Table 24: Estimated key events, approvals and launch dates impacting Transacin's revenue forecast, 2008-2017
Table 25: Key drugs in Phase I development for neuropathic pain, 2008
Table 26: Key drugs in preclinical development for neuropathic pain, 2008
Table 27: Neuropathic pain market definition by ICD-10 codes
Table 28: Datamonitor drug assessment parameters
List of Figures
Figure 1: Forecast of the neuropathic pain market value across the seven major markets, 2008-2017
Figure 2: Key neuropathic pain pipeline drug historical sales and forecasts, 2004-2017
Figure 3: Datamonitor drug assessment summary of pipeline therapies in development for neuropathic pain, 2008
Figure 4: Sales of molecules for neuropathic pain ($m), 2007
Figure 5: Total neuropathic pain sales across the seven major markets by region, 2004-07
Figure 6: Total neuropathic pain sales in the six major markets($m), 2007
Figure 7: Key unmet needs in neuropathic pain, 2008
Figure 8: Historical and forecast neuropathic pain-specific sales revenue for key brand and pipeline drugs across the seven major markets, 2004-2017
Figure 9: Sales forecast for Lyrica in neuropathic pain across the seven major markets to 2017
Figure 10: Lyrica SWOT analysis
Figure 11: Datamonitor's competitive positioning analysis of Lyrica, 2008
Figure 12: Historical and forecast sales for Neurontin in neuropathic pain across the seven major markets, 2004-2017
Figure 13: Neurontin SWOT analysis
Figure 14: Historical and forecast sales for Lidoderm in neuropathic pain across the seven major markets, 2004-2017
Figure 15: Lidoderm SWOT analysis
Figure 16: Sales forecast for Cymbalta in neuropathic pain across the seven major markets, 2004-2017
Figure 17: Cymbalta SWOT analysis
Figure 18: Tegretol SWOT analysis
Figure 19: Impact of each key event on the neuropathic pain market across the seven major markets, 2008-2017
Figure 20: Population of neuropathic pain subtypes in the seven major markets, 2008
Figure 21: Percentage neuropathic pain sales by subtype, 2008
Figure 22: Drugs in development for neuropathic pain by class and development stage, 2008
Figure 23: Pfizer sales by therapeutic area 2006
Figure 24: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain ($m), 2003-07
Figure 25: Historical sales of Lyrica, Neurontin, Cymbalta and generic gabapentin, 2003-07
Figure 26: Pfizer's Lyrica and CNS sales 2004-07 ($ billion)
Figure 27: Eli Lilly sales by therapeutic area, 2006
Figure 28: Cymbalta neuropathic pain specific sales in the seven major markets, 2003-07 ($m)
Figure 29: UCB sales by therapeutic area, 2007
Figure 30: Datamonitor drug assessment summary of key glutamate receptor modulators in development for neuropathic pain, 2008
Figure 31: Sales forecasts for glutamate receptor modulators in neuropathic pain across the seven major markets, 2008-2017
Figure 32: Sales forecast for Zenvia in neuropathic pain across the seven major markets, 2009-2017
Figure 33: Datamonitor's competitive positioning analysis of Zenvia, 2008
Figure 34: Sales forecast for NP-1 in neuropathic pain across the seven major markets, 2008-2017
Figure 35: Datamonitor's competitive positioning analysis of NP-1, 2008
Figure 36: Datamonitor drug assessment summary of pipeline ion channel modulators in development for neuropathic pain, 2008
Figure 37: Sales forecasts for ion channel modulators in neuropathic pain across the seven major markets, 2008-2017
Figure 38: Sales forecast for Vimpat in neuropathic pain across the seven major markets, 2008-2017
Figure 39: Datamonitor's competitive positioning analysis of Vimpat in neuropathic pain, 2008
Figure 40: Sales forecast for ralfinamide in neuropathic pain across the seven major markets, 2010-2017
Figure 41: Datamonitor's competitive positioning analysis of ralfinamide in neuropathic pain, 2008
Figure 42: Datamonitor drug assessment summary of pipeline GABA receptor modulators in development for neuropathic pain, 2008
Figure 43: Sales forecasts for GABA modulators in neuropathic pain across the seven major markets, 2008-2017
Figure 44: Sales forecast for XP13512 in neuropathic pain across the seven major markets, 2008-2017
Figure 45: Datamonitor's competitive positioning analysis of XP13512, 2008
Figure 46: Sales forecast for Gabapentin GR in neuropathic pain across the seven major markets, 2009-2017
Figure 47: Datamonitor's competitive positioning analysis of Gabapentin GR, 2008
Figure 48: Datamonitor drug assessment summary other therapies in development for neuropathic pain, 2008
Figure 49: Sales forecasts for 'Other' drugs in neuropathic pain across the seven major markets, 2008-2017
Figure 50: Sales forecast for Transacin in neuropathic pain across the seven major markets, 2008-2017
Figure 51: Datamonitor's competitive positioning analysis of Transacin in neuropathic pain, 2008
Figure 52: Datamonitor drug assessment summary of neuropathic pain treatments, 2007


Abstract

Introduction

The neuropathic pain market is forecast to almost triple to over $6.3 billion by the end of the forecast period in 2017. The growth in the market is spurred on by the uptake of Pfizer's Lyrica (pregabalin), forecast to reach almost $3 billion in sales by 2017. Vimpat is the most promising pipeline drug, forecast to take some $480m by 2017.

Scope
  • Analysis of patient potential, unmet needs and clinical trial design in the neuropathic pain market.
  • Overview of key marketed brands, late- and early-stage pipeline drugs.
  • Country-specific sales volume and value forecasts to 2017 of marketed brands, generics, and key late-stage pipeline drugs.
  • Identification of future market events that are expected to affect neuropathic pain revenues.
Highlights

UCB's Vimpat (lacosamide) demonstrates the most potential in the pipeline and is well suited to compete in this market. Datamonitor has forecast Vimpat to generate over $480m, over a third of the total pipeline sales by 2017.

Neuropathic pain offers diverse market opportunities, with niche underserved neuropathic pain indications (e.g. HIV associated neuropathic pain) offering a good market entry point.

Following the recent negative FDA advice on Cephalon's Fentora, Datamonitor has forecast that the drug will not launch for neuropathic pain. This is a blow to the development of a niche breakthrough neuropathic pain market.

Reasons to Purchase
  • Benchmark key late-stage pipeline neuropathic pain drugs against current market leading brands.
  • Assess country-specific (US, Japan, France, Germany, Italy, Spain and the UK) sales forecasts of key late-stage pipeline drugs and marketed brands.
  • Understand unmet needs and opportunities in the neuropathic pain market based on key opinion leader comments.
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