Stakeholder Opinions: Targeting Nerve Growth Factor for Pain Therapy
Datamonitor
March 3, 2010 SKU: DFMN2613237
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Overview
Introduction
Pain treatment is a multibillion dollar market that is saturated with a wide variety of branded and generic drugs. The NGF class has potential to be first of an entirely new type of painkiller to enter the sector in decades. Nevertheless, high expectations need to be tempered once the long term side effects, safety and pharmacoeconomics have been established.
Scope
- 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.
Report Highlights
Clinical studies have shown inhibition of nerve growth factor (NGF) has a strong analgesic effect. Three classifications block or sequester the NGF signal transduction pathway; NGF antagonists, tropomyosin-related kinase A inhibitors and NGF trap molecules. The most advanced pipeline candidate is Pfizer's tanezumab with expected launch in 2012.
The safety of the NGF targeting therapies remains uncertain. Adverse effects shown in tanezumab trials indicate peripheral neuropathy, dysesthesia and paresthesia were the most frequent, however, no patient has taken tanezumab for longer than 6 months. Further long-term trials are required to establish the risk-benefit profile in chronic usage.
The involvement of Big Pharma will aid the successful long-term commercialization of NGF therapies. Not only do these companies have the resources necessary to conduct the large long-term clinical trials required for chronic pain therapy, but their activity and experience in licensing pain products will encourage higher uptake upon launch.
Reasons to Purchase
- 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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- 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-
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