Pipeline Insight: Neuropathic Pain

Summary

Introduction

The neuropathic pain market is forecast to double from 2006 to reach over $7 billion by 2016. At this time, the current late-stage neuropathic pain pipeline is forecast to take only 18% of the total market share, highlighting an opportunity for better pipeline drugs that demonstrate improved pain management. The most promising and closest pipeline drug to market is UCB's Vimpat (lacosamide).

Scope

• Analysis of patient potential, unmet needs and clinical trial design in neuropathic pain
• Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the market
• Detailed profiles of key compounds in development for use in neuropathic pain, with indication-specific drug sales forecasts to 2016
• Discussion of Pfizer, Eli Lilly and UCB's market strategies and insight from key opinion leaders

Highlights

UCB's increasing CNS portfolio is further bolstered by the imminent arrival of Vimpat on the market. CNS is a key area of investigation for UCB, constituting 39% of their sales in 2006. UCB has further expanded its reach by trialling this anticonvulsant not just for epilepsy but also for neuropathic pain, fibromyalgia, migraine and osteoarthritis.

NeurogesX's Transacin (capsaicin) treatment is set to cause a stir in the topical market, currently dominated by Endo's Lidoderm (lidocaine 5% patch). The advantageous 3 monthly dosing regimen coupled with a strong efficacy and safety profile, will see Transacin draw favorable returns in its niche market.

Pfizer will continue to be a major contender in neuropathic pain, with the current market leader Lyrica predicted to be an even greater commercial success than its predecessor Neurontin (gabapentin). Pfizer's branded drugs are forecast to capture a substantial 41% of the neuropathic pain market share in 2016.

Reasons to Purchase

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

Contents

• 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 Pipeline Overview and Dynamics
  • Pipeline overview
  • Phase II and above
  • Discontinued and suspended projects
  • Projects recently suspended or discontinued
  • Pristiq
  • Lamictal XR
  • Gabapentin GR
  • ACV-1
  • Namenda (memantine)
  • Traxoprodil
  • AZD-4282
  • Key companies involved in the neuropathic pain pipeline
  • Pfizer
  • Neurontin
  • Lyrica
  • Eli Lilly
  • Cymbalta
  • UCB
  • Vimpat
  • Brivaracetam
  • Key R&D company strategies
  • Reformulation strategies: Gabapentin
  • Gabapentin GR
  • XP13512
  • Patient subgroups
• Chapter 3 Neuropathic Pain - Market Overview
  • 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
• Chapter 4 R&d Approach
  • Classification of pipeline products
  • Glutamate receptor modulators
  • NMDA
  • AMPA
  • Kainate
  • Ion channel modulators
  • Sodium channels
  • Calcium channels
  • GABA modulators
  • Monoamine modulators
  • SNRIs
  • Dopamine
  • Others
  • Cannabinoid agonists
  • Vanilloid receptor agonists
  • Substance P release modulators
  • ACh receptor agonists
  • NGF modulators
  • TNF alpha antagonists
  • Adrenoceptor modulation
  • Adenosine A2 agonist
  • Free radicals
  • 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 choice of ideal 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 5 Glutamate Receptor Modulators Late-Stage Drug Analysis & Forecasts
  • Overview of 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
  • Clinical trial data
  • Phase III trial
  • Patient potential
  • Marketing factors
  • Satisfaction of unmet needs
  • Improved efficacy
  • Improved side effect profile: potential to cause upset
  • Reduced pill burden
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • NP-1 (ketamine & amitriptyline)
  • Drug overview
  • Clinical trial data
  • Phase II trial
  • Patient potential
  • NP-1's topical use attracts a wide treatment range
  • Potential negative aspects
  • Marketing factors
  • Antidepressant topical mechanism of action
  • Satisfaction of unmet needs
  • Improved efficacy
  • Improved side effect profile
  • Reduced pill burden
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • CNS-5161
  • Drug overview
  • Clinical trial data
  • Phase IIa trial
  • Phase I trial
  • Satisfaction of unmet needs
  • Improved efficacy
  • Improved side effect profile
  • Reduced pill burden
  • Datamonitor comments
  • V3381
  • Clinical trial data
  • Phase IIa study
  • Phase I study
  • Preclinical studies:
  • Datamonitor comments
  • Other glutamate receptor modulators
  • RGH-896
  • EVT-101
  • NS-1209
  • NGX-426
  • Late-stage development compounds recently discontinued
  • AZD-9272
• Chapter 6 Ion Channel Modulators Late-Stage Drug Analysis and Forecasts
  • Overview of ion channel modulators
  • Pipeline summary
  • Comparative forecasts
  • Definition of current comparator therapy
  • Vimpat (lacosamide)
  • Drug overview
  • Clinical trial data
  • Phase III study
  • Phase II study
  • Patient potential
  • Sodium channels have potential to be lucrative market
  • Marketing factors
  • Vimpat is being investigated for epilepsy along with other indications like many neuropathic pain treatments
• Ucb Looks Set to Become A Big Player in The Cns Market
  • Satisfaction of unmet needs
  • Improved efficacy: data promising
  • Improved side-effect profile
  • Fewer drug-drug interactions: add to physician confidence in Vimpat
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Lamictal XR
  • Drug overview
  • Clinical trial data
  • Phase II Lamictal clinical trial
  • Phase III
  • Improved side effect profile: a big problem in neuropathic pain
  • Forecasts to 2016
  • Ralfinamide
  • Drug overview
  • Clinical trial data
  • Phase II study results
  • Phase IIa study
  • Patient potential
  • Multiple neuropathic pain indications indicate mechanistic approach
  • Marketing factors
  • Satisfaction of unmet needs
  • Improved efficacy
  • Reduced time to onset of action
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Other ion channel modulators
  • ABT-894
  • Bupivacaine (Eladur)
  • Lidocaine patch KN-48
  • Brivaracetam
  • Late-stage development compounds recently discontinued
  • ACV-1
• Chapter 7 Gaba Modulators Late-Stage Drug Analysis and Forecasts
  • Overview of GABA receptor modulators
  • Pipeline summary
  • Comparative forecasts
  • Definition of current comparator therapy
  • Gabapentin GR
  • Drug overview
  • Clinical trial data
  • Phase III study
  • Phase II study
  • A future for Gabapentin GR?
  • Forecasts to 2016
  • XP13512 gabapentin (Enacarbil)
  • Clinical trial data
  • Phase IIa
  • Phase I
  • Marketing factors - improved duration of action
  • Patient potential
  • Satisfaction of unmet needs
  • Improved efficacy
  • Reduced pill burden
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Other GABA modulators
  • Retigabine
• Chapter 8 Monoamine Modulators Late-Stage Analysis and Forecasts
  • Overview of monoamine receptor modulators
  • Pipeline summary
  • Definition of current comparator therapy
  • Pristiq (desvenlafaxine)
  • Drug overview
  • Clinical trial data
  • Ongoing trials: Phase III
  • Phase II Venlafaxine studies
  • Satisfaction of unmet needs
  • Forecasts to 2016
  • Other monoamine modulators
  • Bicifadine
  • Reboxetine (+)-(S,S)
  • F13640
  • Late-stage development compounds recently discontinued
  • Radafaxine (353162)
• Chapter 9 Other Late-Stage Drug Analysis and Forecasts
  • Overview of other therapies
  • Pipeline summary
  • Comparative forecasts
  • Definition of current comparator therapy
  • Fentora (fentanyl buccal transmucosal)
  • Drug overview
  • Clinical trial data
  • Phase III study
  • Patient potential
  • Marketing factors
  • Satisfaction of unmet needs
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Sativex (GW-1000)
  • Drug overview
  • Clinical trial data
  • Phase III DNP study
  • Phase III Allodynia study
  • Phase II study
  • Ongoing trials
  • Marketing potential
  • Potential for abuse is real but multiple indication use may offset this
  • Patient potential
  • Satisfaction of unmet needs
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Transacin (NGX-4010)
  • Drug overview
  • Clinical trial data
  • Ongoing trials
  • Phase III study
  • Phase III HIV-associated neuralgia
  • Phase II study
  • Patient potential
  • Marketing factors
  • Satisfaction of unmet needs
  • Reduced pill burden
  • Forecasts to 2016
  • Datamonitor drug assessment summary
  • Other drugs
  • AS-3201
  • Botulinum toxin type A-hemagglutinin complex (Dysport)
  • Zucapsaicin
  • AGN 203818
  • Ibudilast (AV411)
  • BVT.115959
  • 681323
  • KDS-2000
• Ip 751/Ct-3 (Ajulemic Acid)
  • Liposomal galantamine
  • TAK-583
• Chapter 10 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
  • 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: Size of the neuropathic pain market across the 7MM ($m), 2006-2016
  • Table 2: Sales forecasts ($m) of key pipeline products in neuropathic pain, 2007-2016
  • Table 3: Number of key neuropathic pain drugs by class and phase of development, 2007
  • Table 4: Phase II & III R&D pipeline for neuropathic pain, 2007
  • Table 5: Abbreviations for neuropathic pain subtypes
  • Table 6: The diabetic neuropathic pain patient populations across the 7MMs, 2007
  • Table 7: The post herpetic neuralgia patient population across the 7MMs, 2007
  • Table 8: The HIV neuropathic pain patient population across the 7MMs, 2007
  • Figure 16: Key unmet needs in neuropathic pain, 2007
  • Table 9: Recommended core outcomes measures for clinical trials of chronic pain treatment efficacy
  • Table 10: Key glutamate receptor modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  • Table 11: Lyrica; key facts
  • Table 12: Estimated key events, approvals and launch dates impacting Zenvia's revenue forecast, 2007-2016
  • Table 13: Estimated key events, approvals and launch dates impacting NP-1's revenue forecast, 2007-2016
  • Table 14: Key ion channel modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  • Table 15: Estimated key events, approvals and launch dates impacting Vimpat's revenue forecast, 2007-2016
  • Table 16: Estimated key events, approvals and launch dates impacting ralfinamide's revenue forecast, 2007-2016
  • Table 17: Key GABA modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  • Table 18: Estimated key events, approvals and launch dates impacting XP13512's revenue forecast, 2007-2016
  • Table 19: Monoamine modulator in late-stage R&D pipeline for neuropathic pain, 2007
  • Table 20: Other drugs in late-stage R&D pipeline for neuropathic pain, 2007
  • Table 21: Estimated key events, approvals and launch dates impacting Fentora's revenue forecast, 2007-2016
  • Table 22: Estimated key events, approvals and launch dates impacting Sativex's revenue forecast, 2007-2016
  • Table 23: Estimated key events, approvals and launch dates impacting Transacin's revenue forecast, 2007-2016
  • Table 24: Key drugs in Phase I development for neuropathic pain, 2007I
  • Table 25: Key drugs in preclinical development for neuropathic pain, 2007
  • Table 26: Neuropathic pain market definition by ICD-10 codes
  • Table 27: Datamonitor drug assessment parameters
• List of Figures
  • Figure 1: Forecast of the neuropathic pain market value across the 7MM, 2007-2016
  • Figure 2: Key pipeline drug sales forecasts, 2007- 2016
  • Figure 3: Datamonitor drug assessment summary of pipeline therapies in development for neuropathic pain, 2007
  • Figure 4: Drugs in development for neuropathic pain by class and development stage, 2007
  • Figure 5: Pfizer sales by therapeutic area, 2006
  • Figure 6: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain ($m), 2003-06
  • Figure 7: Historical sales of Lyrica, Neurontin, Cymbalta and generic gabapentin, 2003-06
  • Figure 8: Pfizer's Lyrica and CNS sales 2004-06 ($ billion)
  • Figure 9: Eli Lilly sales by therapeutic area, 2006
  • Figure 10: Cymbalta all indication sales in the 7MMs, 2003-06 ($m)
  • Figure 11: UCB sales by therapeutic area, 2006
  • Figure 12: Population of neuropathic pain subtypes in the 7MMs, 2007
  • Figure 13: Sales of marketed drugs for neuropathic pain, 2006 ($m)
  • Figure 14: Total neuropathic pain sales across the seven major pharmaceutical markets by region, 2003-06
  • Figure 15: Total neuropathic pain sales in the 5EU, 2006 ($m)
  • Figure 17: Datamonitor drug assessment summary of key glutamate receptor modulators in development for neuropathic pain, 2007
  • Figure 18: Sales forecasts for glutamate receptor modulators in neuropathic pain across the 7MMs, 2007-2016
  • Figure 19: Sales forecast for Zenvia in neuropathic pain across the 7MMs to 2016
  • Figure 20: Datamonitor's competitive positioning analysis of Zenvia, 2007
  • Figure 21: Sales forecast for NP-1 in neuropathic pain to 2016 across the 7MMs
  • Figure 22: Datamonitor's competitive positioning analysis of NP-1, 2007
  • Figure 23: Datamonitor drug assessment summary of pipeline ion channel modulators in development for neuropathic pain, 2007
  • Figure 24: Sales forecasts for ion channel modulators in neuropathic pain across the 7MMs, 2007-2016
  • Figure 25: Sales forecast for Vimpat in neuropathic pain to 2016 across the 7MMs
  • Figure 26: Datamonitor's competitive positioning analysis of Vimpat in neuropathic pain, 2007
  • Figure 27: Sales forecast for ralfinamide in neuropathic pain to 2016, in the 7MMs
  • Figure 28: Datamonitor's competitive positioning analysis of ralfinamide in neuropathic pain, 2007
  • Figure 29: Datamonitor drug assessment summary of pipeline GABA receptor modulators in development for neuropathic pain, 2007
  • Figure 30: Sales forecasts for GABA modulators in neuropathic pain to 2016 in the 7MMs
  • Figure 31: Sales forecast for XP13512 to 2016 in neuropathic pain across the 7MMs
  • Figure 32: Datamonitor's competitive positioning analysis of XP13512, 2007
  • Figure 33: Datamonitor drug assessment summary other therapies in development for neuropathic pain, 2007
  • Figure 34: Sales forecasts for 'Other' drugs in neuropathic pain to 2016 across the 7MMs
  • Figure 35: Sales forecast for Fentora in neuropathic pain to 2016 in the 7MMs
  • Figure 36: Datamonitor's competitive positioning analysis of Fentora in neuropathic pain, 2007
  • Figure 37: Sales forecast for Sativex in neuropathic pain to 2016 in the 7MMs
  • Figure 38: Datamonitor's competitive positioning analysis of Sativex for neuropathic pain, 2007
  • Figure 39: Sales forecast for Transacin in neuropathic pain to 2016 in the 7MMs
  • Figure 40: Datamonitor's competitive positioning analysis of Transacin in neuropathic pain, 2007
  • Figure 41: Datamonitor drug assessment summary of neuropathic pain treatments, 2007