Market Report Source

Overview

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

Table of 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