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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