Pipeline Insight: Substance Dependence - Part II: Alcohol

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the CNS pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the alcohol dependence market
  • Key metrics
  • Datamonitor pipeline assessment summary
  • Contributing experts
  • Related reports
• CHAPTER 2 ALCOHOL DEPENDENCE - MARKET POTENTIAL
  • Definition of alcohol dependence
    • Both genetic and environmental factors play a role in the etiology of alcohol dependence
    • Screening and diagnosis of alcohol dependence
      • Verbal assessment
      • Self-report instruments
      • Alcohol dependence is often under-diagnosed and under-treated
  • Epidemiology of alcohol dependence
    • Alcohol dependence is estimated to affect 19.8 million people in the seven major markets
      • The prevalence of alcohol dependence is in decline in the US
      • However, key opinion leaders believe the prevalence of alcohol dependence is on the rise in developing nations
    • Alcohol dependence is more common in men than women
    • The prevalence of alcoholism declines with increasing age
    • Psychiatric co-morbidity is prevalent in alcohol-dependent patients
    • Alcohol dependence carries considerable adverse health and social consequences
      • Alcohol dependence is a major determinant of ill-health
      • Alcohol dependence carries a high socioeconomic impact
  • Current market overview
    • Although small, the alcohol dependence market demonstrates consistently strong growth
      • The EU dominates sales revenue of the alcohol dependence market
      • Only one alcohol dependence product is currently available in Japan
      • France is the largest alcohol dependence market in the 5EU
    • There are a limited number of drugs available to treat alcohol dependence
      • Merck KGaA and Forest' s Campral dominates the market with a 65% market share
      • Pharmacological treatment is commonly delivered in conjunction with non-pharmacologic treatment
  • Unmet need in alcohol dependence
    • Environmental unmet need: Greater resources and funding for treatments
    • Clinical unmet need: Greater efficacy
    • Clinical unmet need: Improved compliance
• CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS
  • Pipeline overview
    • Opioid antagonists are the most prevalent drug class in the current pipeline
      • A paradigm shift is required to expand the alcohol dependence market
  • Definition of current comparator therapy
    • Vivitrol is Datamonitor' s comparator therapy
    • Forecasts to 2016
    • Clinical trials
      • Phase III 6-month study
    • Vivitrol' s major competitor and key strengths and weaknesses
  • Classification of pipeline products
  • Recently discontinued or failed projects
    • Neramexane
  • Clinical trial design
    • There is a need for agreed research standards in alcohol dependence
      • Patient populations
      • Primary and secondary endpoints
• CHAPTER 4 OPIOID ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS
  • Overview for opioid antagonist class
    • Pipeline summary
  • Nalmefene (CPH-101)
    • Drug overview
    • Forecasts to 2016
    • Datamonitor drug assessment summary
    • Marketing factors
      • Nalmefene will benefit from the marketing resources of Lundbeck and Britannia
      • Gaining additional indications will serve to expand patient potential
      • Efficacy in the absence of formal psychosocial support provides a differentiating factor
    • Patient potential
      • Nalmefene set to be indicated for non-abstinent patients on an ' as-needed' basis
      • Nalmefene will be aimed at reducing heavy drinking days rather than total abstinence
    • Satisfaction of unmet needs
      • Nalmefene does not match Vivitrol' s ability to improve compliance
    • Clinical trial data
      • Phase III data (Finland)
      • Phase III data (UK)
  • Naltrel (naltrexone depot)
    • Drug overview
    • Forecasts to 2016
    • Datamonitor drug assessment summary
    • Marketing factors
      • Naltrel will experience competition from Vivitrol
      • Elbion would benefit from seeking a marketing partner for Naltrel
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
      • Phase III trial data
  • Depotrex (naltrexone)
    • Drug overview
• CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS
  • Overview for other drugs in late-stage development
    • Pipeline summary
  • ALKS-29
    • Drug overview
  • LY-686017
    • Drug overview
    • Ongoing clinical trials
• BIBLIOGRAPHY
  • Journal papers
  • Books
  • 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 alcohol 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 alcohol dependence
    • Table 2: Results of epidemiology studies of alcohol dependence across the seven major markets
    • Table 3: Prevalence of alcohol dependence in the seven major markets, 2007
    • Table 4: Key players in the alcohol dependence market in 2007
    • Table 5: Sales, growth and market share of marketed alcohol dependence products, 2005-06
    • Table 6: R&D pipeline for alcohol dependence, 2007
    • Table 7: Vivitrol: key facts
    • Table 8: Key opioid receptor antagonists in the late-stage R&D pipeline for alcohol dependence, 2007
    • Table 9: Factors impacting on the revenues of nalmefene, 2007-2016
    • Table 10: Factors impacting on the revenues of Naltrel, 2007-2016
    • Table 11: Other drugs in the late-stage R&D pipeline for alcohol dependence, 2007
    • Table 12: Datamonitor drug assessment parameters
    • Table 13: ICD-10 codes used to size the alcohol dependence market
  • List of Figures
    • Figure 1: Datamonitor' s alcohol dependence market summary, 7MM, 2007-2016
    • Figure 2: Drug assessment summary for alcohol dependence treatments, 7MM, 2007-2016
    • Figure 3: Past-year prevalence of alcohol dependence in the US, 2000-2001
    • Figure 4: 12-month prevalence of DSM-IV independent mood and anxiety disorders among respondents to the NESARC study with a 12-month DSM-IV alcohol dependence disorder
    • Figure 5: Total sales of the alcohol dependence prescription drugs by region of the 7MM ($m), 2003-06
    • Figure 6: Performance of the 5EU alcohol dependence markets ($m), 2005-06
    • Figure 7: Common reasons for patient non-adherence
    • Figure 8: Datamonitor' s forecast sales of Vivitrol across the 7MM for alcohol dependence ($m), 2007-2016
    • Figure 9: Datamonitor' s forecast sales of nalmefene across the 7MM for alcohol dependence ($m), 2007-2016
    • Figure 10: Drug assessment summary for nalmefene, 2007-2016
    • Figure 11: Datamonitor' s forecast sales of Naltrel across the 7MM for alcohol dependence ($m), 2007-2016
    • Figure 12: Drug assessment summary for Naltrel