Stakeholder Opinions: Targeting Nerve Growth Factor for Pain Therapy - Groundbreaking class to breathe new life into saturated market

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.

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 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
Datamonitor insight into the potential of nerve growth factor (NGF) for pain therapy 3
Related reports 5
Upcoming reports 5
Table of Contents 6
1. Pain - Market Potential 7
Key findings 7
Definition 8
Epidemiology 9
Chronic pain prevalence represents a substantial population 9
Back pain and arthritic conditions are the most prevalent chronic pain indications 12
Current treatment options 14
Management of chronic pain severity 16
Consequences of inadequately treated chronic pain 16
Current market overview 17
Unmet needs in pain management 18
Unmet need 1: improved efficacy in difficult-to-treat pain conditions 19
Unmet need 2: abuse deterrent and abuse resistant approaches 20
Unmet need 3: safer pain management treatments 21
Unmet need 4: reduction in adverse effects 22
Target product profile versus current level of attainment 26
2. Class development 27
Key findings 27
Nerve growth factor has a key role in pain 28
Therapies targeting nerve growth factor (NGF) in pain 29
NGF antagonists 30
TrkA inhibitors 31
NGF trap molecules that compete with TrkA receptors 32
Pipeline overview 33
Strong presence of Big Pharma in NGF pipeline 33
Key Nerve growth factor projects in development 34
Overview of NGF antagonists and Overview of TrkA inhibitors 34
Tanezumab (RN624; Pfizer) 35
Drug profile 35
Development overview 36
First Phase III studies to yield results in 2011 36
Promising Phase II data 38
Peripheral neuropathy and paresthesia documented in Phase II studies 41
Product positioning 41
Pfizer will obtain arthritis approval first 41
Tanezumab will be priced equivalent to existing biologics 42
SWOT analysis 43
REGN475 (SAR-164877, Sanofi-Aventis/Regeneron) 43
Drug profile 43
Development overview 44
JNJ-42160443 (formerly AMG403, Ortho-McNeil-Janssen Pharmaceuticals/Amgen) 45
Drug profile 45
Development overview 46
PG110 (hu-alphaD11, Abbott) 47
Drug profile 47
Development overview 48
Overview of TrkA inhibitors 48
BXL1H5 (huMNAC-13; BioXell/Cosmo Pharmaceutical SpA) 49
Drug profile 49
Development overview 50
3. Commercial considerations 51
Key findings 51
Key drivers to commercial success of the nerve growth factor (NGF) class 52
Driver 1: increased efficacy and long duration for NGF antagonists 52
Anti-NGF therapies exhibit stronger efficacy than NSAIDs 52
Long half-life represents more convenient dosing regimen 53
Driver 2: novel target in pain management 53
First novel class to enter pain management in decades 53
Validation of NGF pathway will increase development of small molecule inhibitors 54
Driver 3: strong investment in anti-NGF technologies 54
Entrance of Big Pharma into the NGF pipeline will act as strong driver for R&D 54
Driver 4: limited abuse potential 55
Anti-NGF therapies offer no euphoric effects that could lead to misuse 55
Driver 5: innovation in technology 56
Improvement in monoclonal antibody technology will limit immunological response 56
Specificity of anti-NGF will limit adverse drug-drug interactions 56
Key resistors to commercial success of the nerve growth factor (NGF) class 57
Resistor 1: safety issues of chronic use unknown 57
Reproductive toxicology issues 57
Long-term safety profile unknown 58
Resistor 2: high pricing will affect reimbursement and positioning 59
NGF therapies will be priced at a premium 59
Insurance companies are likely to insist on last-line usage 60
Set up costs will limit coverage and increase costs 61
High price will restrict usage to last-line 62
Resistor 3: does not treat all pain indications 62
Efficacy is strong in inflammatory disorders compared to neuropathic indications 62
4. Case Study 64
Key findings 64
Will anti-NGFs mirror the impact of anti-TNFs? 65
Similar to anti-TNFs, anti-NGFs will become the first biological drugs in chronic pain 65
Unlike anti-TNF, anti-NGFs will remain the last-line therapeutic choice if cost remains high 66
Less unmet need in chronic pain will result in lower anti-NGF uptake 69
Anti-NGFs will be priced the same as anti-TNFs 71
Proof of concept will open doors to increased competition 71
Anti-NGF usage will also spread to other indications 72
Bibliography 74
Journals 74
Websites 77
Datamonitor reports 79
Presentations 79
Appendix A 80
Data definitions, limitations and assumptions 80
Standard units 80
Appendix B 81
Contributing experts 81
Report methodology 81
About Datamonitor 82
About Datamonitor Healthcare 82
About the Central Nervous System analysis team 83
Disclaimer 85
List of Tables
Table 1: Epidemiology surveys of chronic pain, published between 1998 and 2009 11
Table 2: Estimates for the prevalence of chronic pain in the seven major markets, 2010 12
Table 3: Estimated prevalence of key chronic pain indications across the seven major markets, 2009 13
Table 4: The pain market split by drug class across the seven major markets , 2007-08 ($m) 17
Table 5: Safety issues in pain management therapies 22
Table 6: Leading brands in the treatment of chronic pain, 2010 24
Table 7: Target product profile versus current comparator therapy, 2010 26
Table 8: Nerve growth factor (NGF) modulators pipeline, 2009 34
Table 9: Tanezumab (RN624, Sanofi-Aventis/Regeneron) - drug profile, 2010 35
Table 10: Ongoing tanezumab pain studies, 2010 36
Table 11: REGN475 (SAR-164877, Sanofi-Aventis/Regeneron) - drug profile, 2010 44
Table 12: Ongoing REGN475 studies for the treatment of pain, 2010 44
Table 13: JNJ-42160443 (AMG403, ) - drug profile, 2010 46
Table 14: Ongoing JNJ-421604443 studies, 2010 46
Table 15: PG110 (Hu-alphaD11, Abbott) - drug profile, 2010 47
Table 16: Ongoing PG110 studies, 2010 48
Table 17: BXL-1H5 (huMNAC-13, BioXell/Cosmo Pharmaceutical SpA) - drug profile, 2010 49
Table 18: Summary of drivers and resistors for the nerve growth factor (NGF) class across the seven major markets, 2010 52
Table 19: Yearly price for leading chronic treatments in the US 60
Table 20: Biological treatments available beyond anti-tumor necrosis factors (TNFs)for rheumatoid arthritis , 2010 72
List of Figures
Figure 1: Factors involved in pain sensation 9
Figure 2: World Health Organization pain relief treatment ladder 16
Figure 3: Sales value performance of the pain market in the seven major markets by class ($m), 2005-08 18
Figure 4: Key unmet needs for pain, 2010 19
Figure 5: The role of nerve growth factor (NGF) in pain signal transduction 29
Figure 6: Datamonitor's classification of nerve growth factor (NGF) therapies in pain 30
Figure 7: Anti-nerve growth factor (NGF) treatment provides effective pain control in an animal model of chronic arthritic pain 31
Figure 8: Pipeline nerve growth factor (NGF) therapies by development phase, 2010 33
Figure 9: Prevention of nerve growth factor (NGF) antagonists, 2010 35
Figure 10: Phase II effect of tanezumab in osteoarthritis patients, 2010 39
Figure 11: Phase II effect of tanezumab in chronic lower back patients (CLBP), 2010 40
Figure 12: Tanezumab SWOT analysis, 2010 43
Figure 13: TrkA inhibitors in development to block nerve growth factor (NGF) signal transduction pathway, 2010 49
Figure 14: Pharmacokinetic profile of BXL-1H5 50
Figure 15: Development of anti-TNF therapy and potential development of anti-NGFs 66
Figure 16: Rheumatoid arthritis (RA) patient care path, 2010 68
Figure 17: Nerve growth factor to become potential last-line setting in pain market 69
Figure 18: Rheumatoid arthritis-specific sales in the seven major markets, split by drug class ($ billion), 2004-08 70

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