Abstract
Overview
Introduction
The high prevalence of nicotine dependence, strong uptake of Pfizer' s Chantix
(varenicline), and the launch of new innovative therapies will cause the
nicotine dependence prescription drug market to grow to $4.6 billion across
the seven major markets by 2016. Innovative therapies are set to offer
patients a convenient dosing regimen and thereby carrying the potential for
improved compliance.
Scope
- Analysis of patient potential, unmet needs and clinical trial design in
nicotine dependence
- Overview of the current nicotine dependence market, covering both
prescription and OTC products
- Overview of drugs in late stage clinical development for nicotine
dependence
- Profiles of key compounds in development for use in nicotine dependence,
with forecasts of drug revenues to 2016 and insight from key opinion leaders
Highlights
Nicotine vaccines are the most prevalent drug class in the late-stage
pipeline. This represents a move away from nicotine replacement and nicotine
agonist therapies, which have historically dominated the market. Datamonitor
predicts nicotine vaccine companies will be important players in the market by
2016, led by Novartis' s NIC-002.
Nicotine vaccines are designed to prevent nicotine from entering the brain and
thus reduce the pleasurable effect of smoking. The utility of vaccines in
nicotine dependence lies in the long-term protection they provide along with
minimal patient compliance and carry the potential for prophylactic use.
With two compounds in late-stage development for the treatment of nicotine
dependence, it is evident that Sanofi-Aventis is keen to penetrate this
market. Although possessing a similar mechanism of action to Chantix,
Datamonitor believes that the drug' s shorter treatment course than the market
leader represents a strong competitive advantage.
Reasons to Purchase
- Understand unmet needs and opportunities in this market based on the
comments of interviewed key opinion leaders.
- Benchmark key late-stage nicotine dependence compounds against the current
market leader.
- Assess the seven major market total sales forecasts of key late-stage
pipeline drugs; and examine their clinical and commercial potential
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the nicotine dependence market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Contributing experts
- Upcoming reports
- CHAPTER 2 NICOTINE DEPENDENCE - MARKET POTENTIAL
- Definition of nicotine dependence
- Epidemiology of nicotine dependence
- Nicotine dependence is estimated to affect over 115 million people in
the seven major markets
- Prevalence is expected to slowly decrease over time
- Few nicotine dependent individuals seek help with quitting from
their primary care physician
- Diagnostic criteria for nicotine dependence are rarely used in
clinical practice
- Current market overview
- Nicotine dependence market demonstrates sharp growth after a period of
decline
- The US dominates sales revenue of the nicotine dependence market
- These is an absence of prescription nicotine dependence products in
Japan
- The UK has overtaken France as the largest nicotine dependence
market in the 5EU
- Only two prescription treatments are currently marketed for nicotine
dependence
- Over-the-counter products represent barrier to prescription market
growth
- Unmet need in nicotine dependence
- Reduction in relapse rate
- CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Vaccines are the most prevalent drug class in the current pipeline
- Definition of current comparator therapy
- Pfizer' s Chantix is Datamonitor' s comparator therapy
- Forecasts to 2016
- Clinical trials
- Phase II study
- Phase III comparative trials: Chantix versus bupropion
- Long-term abstinence
- Chantix' s major competitors and key strengths and weaknesses
- Classification of pipeline products
- Recently discontinued or failed projects
- ADX10061
- Rimonabant
- Taranabant
- NC-001
- Clinical trial design
- Primary and secondary endpoints
- Patient populations
- Inclusion criteria require participants to smoke ten or more
cigarettes per day
- Opinion leaders recommend inclusion of more heterogeneous
participant samples
- CHAPTER 4 VACCINE LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for vaccine class
- NicVAX (nicotine conjugate vaccine)
- Drug overview
- Forecasts to 2016
- Datamonitor drug assessment summary
- Marketing factors
- Nabi will benefit from the expertise of the commercialization
partner it is seeking
- Novel mechanism of action will generate strong interest among
physicians
- Patient potential
- Individual variability in immunological response
- NicVAX has potential for prophylactic use
- Satisfaction of unmet needs
- NicVAX demonstrates comparable efficacy to Chantix
- Convenient dosing regimen will increase compliance
- Long-term irreversibility of NicVAX will reduce relapse rate
- Favorable side-effect and safety profile
- Clinical trial data
- Phase IIb data at 12 months
- Phase IIb data at 9 months
- NIC-002
- Drug overview
- Forecasts to 2016
- Datamonitor drug assessment summary
- Marketing factors
- Novartis' s marketing and sales experience bodes well for the launch
of NIC-002
- Second-to-market vaccine for nicotine dependence
- Patient potential
- High immunological response will lead to high patient potential
- NIC-002 has potential for prophylactic use
- Satisfaction of unmet needs
- NIC-002 demonstrates strong efficacy
- Convenient dosing regimen will increase compliance
- Long-term irreversibility of NIC-002 will reduce relapse rate
- Favorable side-effect profile
- Clinical trial data
- Clinical dose-optimization study
- Phase II trial - 6 month and 12 month follow-up
- TA-NIC
- CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for other pipeline nicotine dependence drugs
- Dianicline
- Drug overview
- Forecasts to 2016
- Datamonitor drug assessment summary
- Marketing factors
- Seven week treatment course is a strong competitive advantage
- Sanofi-Aventis has established relations with key prescribers
- Dianicline will experience fierce competition from established brands
- Patient potential
- Satisfaction of unmet needs
- Dosing regimen
- Dianicline does not satisfy the need for a reduction in relapse rates
- Side-effect and safety profile
- Clinical trial data
- Ongoing clinical trials
- Nalmefene
- Drug overview: opioid antagonist
- GW-468816
- Drug overview: glycine receptor antagonist
- Surinabant
- Drug overview: cannabinoid receptor antagonist
- BIBLIOGRAPHY
- Journal papers
- Datamonitor reports
- Websites
- APPENDIX A
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Definition of a standard unit
- Contributing experts
- APPENDIX B
- Methodology
- Definition of nicotine dependence market
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: DSM-IV criteria for nicotine dependence
- Table 2: Results of epidemiology studies of nicotine dependence across
the seven major markets
- Table 3: Prevalence of nicotine dependence in the seven major markets,
2007
- Table 4: Fagerström Test for Nicotine Dependence
- Table 5: Sales, growth and market share of Zyban and Chantix, 2005-06
- Table 6: Key OTC nicotine replacement products
- Table 7: R&D pipeline in nicotine dependence, 2007
- Table 8: Chantix: key facts
- Table 9: Percentage of continuous abstinence from cigarette smoking at
weeks 9 through to 12 across three key clinical trials
- Table 10: Percentage of continuous abstinence from cigarette smoking
at weeks 9 through to 52 across three key clinical trials
- Table 11: Key vaccines in the late-stage R&D pipeline for nicotine
dependence, 2007
- Table 12: Factors impacting on the revenues of NicVAX, 2007-2016
- Table 13: Factors impacting on the revenues of NIC-002, 2007-2016
- Table 14: Continuous abstinence levels with NIC-002 at 6 and 12 months
after start of treatment
- Table 15: Other key drugs in the late-stage R&D pipeline for
nicotine dependence, 2007
- Table 16: Factors impacting on the revenues of dianicline, 2007-2016
- Table 17: Datamonitor drug assessment parameters
- Table 18: ICD-10 codes used to size the nicotine dependence market
- List of Figures
- Figure 1: Datamonitor' s nicotine dependence market summary, 2007-16
- Figure 2: Drug assessment summary for nicotine dependence treatments
- Figure 3: Total sales of the key prescription nicotine dependence
products by region ($m), 2003-06
- Figure 4: Sales revenue of OTC nicotine replacement therapies across
the 7MM ($m), 2003-06
- Figure 5: Datamonitor' s forecast sales of Chantix across the 7MM for
nicotine dependence ($m), 2007-16
- Figure 6: Datamonitor' s forecast sales of NicVAX across the 7MM for
nicotine dependence ($m), 2007-16
- Figure 7: Drug assessment summary for NicVAX
- Figure 8: Datamonitor' s forecast sales of NIC-002 across the 7MM for
nicotine dependence ($m), 2007-16
- Figure 9: Drug assessment summary for NIC-002
- Figure 10: Datamonitor' s forecast sales of dianicline across the 7MM
for nicotine dependence ($m), 2007-16
- Figure 11: Drug assessment summary for dianicline
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