Pipeline Insight: Substance Dependence - Part I: Nicotine

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
    • Pipeline summary
  • 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
    • Drug overview
• CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS
  • Overview for other pipeline nicotine dependence drugs
    • Pipeline summary
  • 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
      • Ongoing clinical trials
  • Surinabant
    • Drug overview: cannabinoid receptor antagonist
      • Ongoing clinical trials
• 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