Stakeholder Opinions: Targeting Nerve Growth Factor for Pain Therapy

Published by: Datamonitor

Published: Mar. 3, 2010

Table of Contents

Overview

Catalyst

Summary

ABOUT DATAMONITOR HEALTHCARE

About the central nervous system pharmaceutical analysis team

Executive Summary

Scope of the analysis

Datamonitor insight into the potential of nerve growth factor (NGF) for pain therapy

Related reports

Upcoming reports

Table of Contents

1. Pain - Market Potential

Key findings

Definition

Epidemiology

Chronic pain prevalence represents a substantial population

Back pain and arthritic conditions are the most prevalent chronic pain indications

Current treatment options

Management of chronic pain severity

Consequences of inadequately treated chronic pain

Current market overview

Unmet needs in pain management

Unmet need 1: improved efficacy in difficult-to-treat pain conditions

Unmet need 2: abuse deterrent and abuse resistant approaches

Unmet need 3: safer pain management treatments

Unmet need 4: reduction in adverse effects

Target product profile versus current level of attainment

2. Class development

Key findings

Nerve growth factor has a key role in pain

Therapies targeting nerve growth factor (NGF) in pain

NGF antagonists

TrkA inhibitors

NGF trap molecules that compete with TrkA receptors

Pipeline overview

Strong presence of Big Pharma in NGF pipeline

Key Nerve growth factor projects in development

Overview of NGF antagonists and Overview of TrkA inhibitors

Tanezumab (RN624; Pfizer)

Drug profile

Development overview

First Phase III studies to yield results in

Promising Phase II data

Peripheral neuropathy and paresthesia documented in Phase II studies

Product positioning

Pfizer will obtain arthritis approval first

Tanezumab will be priced equivalent to existing biologics

SWOT analysis

REGN475 (SAR-164877, Sanofi-Aventis/Regeneron)

Drug profile

Development overview

JNJ-42160443 (formerly AMG403, Ortho-McNeil-Janssen Pharmaceuticals/Amgen)

Drug profile

Development overview

PG110 (hu-alphaD11, Abbott)

Drug profile

Development overview

Overview of TrkA inhibitors

BXL1H5 (huMNAC-13; BioXell/Cosmo Pharmaceutical SpA)

Drug profile

Development overview

3. Commercial considerations

Key findings

Key drivers to commercial success of the nerve growth factor (NGF) class

Driver 1: increased efficacy and long duration for NGF antagonists

Anti-NGF therapies exhibit stronger efficacy than NSAIDs

Long half-life represents more convenient dosing regimen

Driver 2: novel target in pain management

First novel class to enter pain management in decades

Validation of NGF pathway will increase development of small molecule inhibitors

Driver 3: strong investment in anti-NGF technologies

Entrance of Big Pharma into the NGF pipeline will act as strong driver for R&D

Driver 4: limited abuse potential

Anti-NGF therapies offer no euphoric effects that could lead to misuse

Driver 5: innovation in technology

Improvement in monoclonal antibody technology will limit immunological response

Specificity of anti-NGF will limit adverse drug-drug interactions

Key resistors to commercial success of the nerve growth factor (NGF) class

Resistor 1: safety issues of chronic use unknown

Reproductive toxicology issues

Long-term safety profile unknown

Resistor 2: high pricing will affect reimbursement and positioning

NGF therapies will be priced at a premium

Insurance companies are likely to insist on last-line usage

Set up costs will limit coverage and increase costs

High price will restrict usage to last-line

Resistor 3: does not treat all pain indications

Efficacy is strong in inflammatory disorders compared to neuropathic indications

4. Case Study

Key findings

Will anti-NGFs mirror the impact of anti-TNFs?

Similar to anti-TNFs, anti-NGFs will become the first biological drugs in chronic pain

Unlike anti-TNF, anti-NGFs will remain the last-line therapeutic choice if cost remains high

Less unmet need in chronic pain will result in lower anti-NGF uptake

Anti-NGFs will be priced the same as anti-TNFs

Proof of concept will open doors to increased competition

Anti-NGF usage will also spread to other indications

Bibliography

Journals

Websites

Datamonitor reports

Presentations

Appendix A

Data definitions, limitations and assumptions

Standard units

Appendix B

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Central Nervous System analysis team

Disclaimer

List of Tables

Table 1: Epidemiology surveys of chronic pain, published between 1998 and

Table 2: Estimates for the prevalence of chronic pain in the seven major markets,

Table 3: Estimated prevalence of key chronic pain indications across the seven major markets,

Table 4: The pain market split by drug class across the seven major markets , 2007-08 ($m)

Table 5: Safety issues in pain management therapies

Table 6: Leading brands in the treatment of chronic pain,

Table 7: Target product profile versus current comparator therapy,

Table 8: Nerve growth factor (NGF) modulators pipeline,

Table 9: Tanezumab (RN624, Sanofi-Aventis/Regeneron) - drug profile,

Table 10: Ongoing tanezumab pain studies,

Table 11: REGN475 (SAR-164877, Sanofi-Aventis/Regeneron) - drug profile,

Table 12: Ongoing REGN475 studies for the treatment of pain,

Table 13: JNJ-42160443 (AMG403, ) - drug profile,

Table 14: Ongoing JNJ-421604443 studies,

Table 15: PG110 (Hu-alphaD11, Abbott) - drug profile,

Table 16: Ongoing PG110 studies,

Table 17: BXL-1H5 (huMNAC-13, BioXell/Cosmo Pharmaceutical SpA) - drug profile,

Table 18: Summary of drivers and resistors for the nerve growth factor (NGF) class across the seven major markets,

Table 19: Yearly price for leading chronic treatments in the US

Table 20: Biological treatments available beyond anti-tumor necrosis factors (TNFs)for rheumatoid arthritis ,

List of Figures

Figure 1: Factors involved in pain sensation

Figure 2: World Health Organization pain relief treatment ladder

Figure 3: Sales value performance of the pain market in the seven major markets by class ($m), 2005-

Figure 4: Key unmet needs for pain,

Figure 5: The role of nerve growth factor (NGF) in pain signal transduction

Figure 6: Datamonitor's classification of nerve growth factor (NGF) therapies in pain

Figure 7: Anti-nerve growth factor (NGF) treatment provides effective pain control in an animal model of chronic arthritic pain

Figure 8: Pipeline nerve growth factor (NGF) therapies by development phase,

Figure 9: Prevention of nerve growth factor (NGF) antagonists,

Figure 10: Phase II effect of tanezumab in osteoarthritis patients,

Figure 11: Phase II effect of tanezumab in chronic lower back patients (CLBP),

Figure 12: Tanezumab SWOT analysis,

Figure 13: TrkA inhibitors in development to block nerve growth factor (NGF) signal transduction pathway,

Figure 14: Pharmacokinetic profile of BXL-1H

Figure 15: Development of anti-TNF therapy and potential development of anti-NGFs

Figure 16: Rheumatoid arthritis (RA) patient care path,

Figure 17: Nerve growth factor to become potential last-line setting in pain market

Figure 18: Rheumatoid arthritis-specific sales in the seven major markets, split by drug class ($ billion), 2004-

Abstract

• Overview of the current chronic pain market including epidemiology and key unmet needs.
• In depth analysis of the NGF class in development and proposed positioning in the treatment algorithm.
• Insights from interviews with five leading US and European key opinion leaders about the potential impact of NGF therapies.
• Identification of drivers and resistors to the commercial success of NGF therapies.

• Understand the development of the NGF class and quantify pipeline.
• Identify where the NGF class will be positioned in the market as determined by interviewed key opinion leaders.
• Evaluation of the commercial considerations which will drive or inhibit the success and impact of the anti-NGFs.

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