Table of Contents

Table of Contents
ABOUT DATAMONITOR HEALTHCARE 2
About the CNS pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the alcohol dependence market 4
Key metrics 5
Datamonitor pipeline assessment summary 6
Contributing experts 6
Related reports 7
CHAPTER 2 ALCOHOL DEPENDENCE - MARKET POTENTIAL 9
Definition of alcohol dependence 10
Both genetic and environmental factors play a role in the etiology of alcohol dependence 11
Screening and diagnosis of alcohol dependence 13
Verbal assessment 13
Self-report instruments 14
Alcohol dependence is often under-diagnosed and under-treated 16
Epidemiology of alcohol dependence 17
Alcohol dependence is estimated to affect 19.8 million people in the seven major markets 17
The prevalence of alcohol dependence is in decline in the US 19
However, key opinion leaders believe the prevalence of alcohol dependence is on the rise in developing nations 21
Alcohol dependence is more common in men than women 21
The prevalence of alcoholism declines with increasing age 22
Psychiatric co-morbidity is prevalent in alcohol-dependent patients 23
Alcohol dependence carries considerable adverse health and social consequences 25
Alcohol dependence is a major determinant of ill-health 25
Alcohol dependence carries a high socioeconomic impact 26
Current market overview 26
Although small, the alcohol dependence market demonstrates consistently strong growth 26
The EU dominates sales revenue of the alcohol dependence market 28
Only one alcohol dependence product is currently available in Japan 29
France is the largest alcohol dependence market in the 5EU 29
There are a limited number of drugs available to treat alcohol dependence 30
Merck KGaA and Forest's Campral dominates the market with a 65% market share 32
Pharmacological treatment is commonly delivered in conjunction with non-pharmacologic treatment 33
Unmet need in alcohol dependence 33
Environmental unmet need: Greater resources and funding for treatments 34
Clinical unmet need: Greater efficacy 35
Clinical unmet need: Improved compliance 36
CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS 38
Pipeline overview 39
Opioid antagonists are the most prevalent drug class in the current pipeline 39
A paradigm shift is required to expand the alcohol dependence market 41
Definition of current comparator therapy 41
Vivitrol is Datamonitor's comparator therapy 41
Forecasts to 2016 43
Clinical trials 44
Phase III 6-month study 44
Vivitrol's major competitor and key strengths and weaknesses 45
Classification of pipeline products 46
Recently discontinued or failed projects 46
Neramexane 47
Clinical trial design 47
There is a need for agreed research standards in alcohol dependence 47
Patient populations 47
Primary and secondary endpoints 48
CHAPTER 4 OPIOID ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS 50
Overview for opioid antagonist class 51
Pipeline summary 51
Nalmefene (CPH-101) 51
Drug overview 51
Forecasts to 2016 52
Datamonitor drug assessment summary 53
Marketing factors 54
Nalmefene will benefit from the marketing resources of Lundbeck and Britannia 54
Gaining additional indications will serve to expand patient potential 55
Efficacy in the absence of formal psychosocial support provides a differentiating factor 56
Patient potential 56
Nalmefene set to be indicated for non-abstinent patients on an 'as-needed' basis 56
Nalmefene will be aimed at reducing heavy drinking days rather than total abstinence 57
Satisfaction of unmet needs 57
Nalmefene does not match Vivitrol's ability to improve compliance 57
Clinical trial data 58
Phase III data (Finland) 58
Phase III data (UK) 59
Naltrel (naltrexone depot) 59
Drug overview 59
Forecasts to 2016 60
Datamonitor drug assessment summary 61
Marketing factors 62
Naltrel will experience competition from Vivitrol 62
Elbion would benefit from seeking a marketing partner for Naltrel 63
Patient potential 63
Satisfaction of unmet needs 63
Clinical trial data 63
Phase III trial data 63
Depotrex (naltrexone) 65
Drug overview 65
CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS 66
Overview for other drugs in late-stage development 67
Pipeline summary 67
ALKS-29 67
Drug overview 67
LY-686017 68
Drug overview 68
Ongoing clinical trials 69
BIBLIOGRAPHY 70
Journal papers 70
Books 74
Datamonitor reports 75
Websites 75
APPENDIX A 81
Methodology 81
Datamonitor forecast methodology 81
Epidemiology forecasts 81
Product forecasts 81
Definition of a standard unit 81
Contributing experts 83
APPENDIX B 84
Methodology 84
Definition of alcohol dependence market 84
About Datamonitor 85
About Datamonitor Healthcare 85
Datamonitor Healthcare's therapy area capabilities 86
About the Disease analysis team 86
Disclaimer 88
List of Tables
Table 1: DSM-IV criteria for alcohol dependence 11
Table 2: Results of epidemiology studies of alcohol dependence across the seven major markets 18
Table 3: Prevalence of alcohol dependence in the seven major markets, 2007 19
Table 4: Key players in the alcohol dependence market in 2007 31
Table 5: Sales, growth and market share of marketed alcohol dependence products, 2005-06 32
Table 6: R&D pipeline for alcohol dependence, 2007 40
Table 7: Vivitrol: key facts 42
Table 8: Key opioid receptor antagonists in the late-stage R&D pipeline for alcohol dependence, 2007 51
Table 9: Factors impacting on the revenues of nalmefene, 2007-2016 53
Table 10: Factors impacting on the revenues of Naltrel, 2007-2016 61
Table 11: Other drugs in the late-stage R&D pipeline for alcohol dependence, 2007 67
Table 12: Datamonitor drug assessment parameters 82
Table 13: ICD-10 codes used to size the alcohol dependence market 84
List of Figures
Figure 1: Datamonitor's alcohol dependence market summary, 7MM, 2007-2016 5
Figure 2: Drug assessment summary for alcohol dependence treatments, 7MM, 2007-2016 6
Figure 3: Past-year prevalence of alcohol dependence in the US, 2000-2001 22
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 24
Figure 5: Total sales of the alcohol dependence prescription drugs by region of the 7MM ($m), 2003-06 27
Figure 6: Performance of the 5EU alcohol dependence markets ($m), 2005-06 30
Figure 7: Common reasons for patient non-adherence 37
Figure 8: Datamonitor's forecast sales of Vivitrol across the 7MM for alcohol dependence ($m), 2007-2016 43
Figure 9: Datamonitor's forecast sales of nalmefene across the 7MM for alcohol dependence ($m), 2007-2016 53
Figure 10: Drug assessment summary for nalmefene, 2007-2016 54
Figure 11: Datamonitor's forecast sales of Naltrel across the 7MM for alcohol dependence ($m), 2007-2016 60
Figure 12: Drug assessment summary for Naltrel 61