Table of Contents

TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the nicotine dependence market 4
Key metrics 5
Datamonitor Pipeline Assessment Summary 5
Contributing experts 6
Upcoming reports 6
CHAPTER 2 NICOTINE DEPENDENCE – MARKET POTENTIAL 13
Definition of nicotine dependence 14
Epidemiology of nicotine dependence 15
Nicotine dependence is estimated to affect over 115 million people in the seven major markets 15
Prevalence is expected to slowly decrease over time 17
Few nicotine dependent individuals seek help with quitting from their primary care physician 18
Diagnostic criteria for nicotine dependence are rarely used in clinical practice 19
Current market overview 21
Nicotine dependence market demonstrates sharp growth after a period of decline 21
The US dominates sales revenue of the nicotine dependence market 22
These is an absence of prescription nicotine dependence products in Japan 22
The UK has overtaken France as the largest nicotine dependence market in the 5EU 23
Only two prescription treatments are currently marketed for nicotine dependence 23
Over-the-counter products represent barrier to prescription market growth 24
Unmet need in nicotine dependence 26
Reduction in relapse rate 26
CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS 28
Pipeline overview 29
Vaccines are the most prevalent drug class in the current pipeline 29
Definition of current comparator therapy 31
Pfizer’s Chantix is Datamonitor’s comparator therapy 31
Forecasts to 2016 33
Clinical trials 34
Phase II study 34
Phase III comparative trials: Chantix versus bupropion 35
Long-term abstinence 35
Chantix’s major competitors and key strengths and weaknesses 36
Classification of pipeline products 38
Recently discontinued or failed projects 38
ADX10061 38
Rimonabant 39
Taranabant 39
NC-001 39
Clinical trial design 40
Primary and secondary endpoints 40
Patient populations 41
Inclusion criteria require participants to smoke ten or more cigarettes per day 41
Opinion leaders recommend inclusion of more heterogeneous participant samples 41
CHAPTER 4 VACCINE LATE-STAGE DRUG ANALYSIS & FORECASTS 43
Overview for vaccine class 44
Pipeline summary 44
NicVAX (nicotine conjugate vaccine) 45
Drug overview 45
Forecasts to 2016 45
Datamonitor drug assessment summary 47
Marketing factors 47
Nabi will benefit from the expertise of the commercialization partner it is seeking 47
Novel mechanism of action will generate strong interest among physicians 48
Patient potential 49
Individual variability in immunological response 49
NicVAX has potential for prophylactic use 49
Satisfaction of unmet needs 50
NicVAX demonstrates comparable efficacy to Chantix 50
Convenient dosing regimen will increase compliance 50
Long-term irreversibility of NicVAX will reduce relapse rate 51
Favorable side-effect and safety profile 51
Clinical trial data 51
Phase IIb data at 12 months 51
Phase IIb data at 9 months 53
NIC-002 55
Drug overview 55
Forecasts to 2016 55
Datamonitor drug assessment summary 56
Marketing factors 57
Novartis’s marketing and sales experience bodes well for the launch of NIC-002 57
Second-to-market vaccine for nicotine dependence 58
Patient potential 58
High immunological response will lead to high patient potential 58
NIC-002 has potential for prophylactic use 58
Satisfaction of unmet needs 58
NIC-002 demonstrates strong efficacy 58
Convenient dosing regimen will increase compliance 59
Long-term irreversibility of NIC-002 will reduce relapse rate 59
Favorable side-effect profile 59
Clinical trial data 60
Clinical dose-optimization study 60
Phase II trial — 6 month and 12 month follow-up 61
TA-NIC 63
Drug overview 63
CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS 64
Overview for other pipeline nicotine dependence drugs 65
Pipeline summary 65
Dianicline 65
Drug overview 66
Forecasts to 2016 66
Datamonitor drug assessment summary 68
Marketing factors 68
Seven week treatment course is a strong competitive advantage 68
Sanofi-Aventis has established relations with key prescribers 69
Dianicline will experience fierce competition from established brands 69
Patient potential 70
Satisfaction of unmet needs 70
Dosing regimen 70
Dianicline does not satisfy the need for a reduction in relapse rates 70
Side-effect and safety profile 70
Clinical trial data 71
Ongoing clinical trials 72
Nalmefene 72
Drug overview: opioid antagonist 73
GW-468816 74
Drug overview: glycine receptor antagonist 74
Ongoing clinical trials 74
Surinabant 75
Drug overview: cannabinoid receptor antagonist 75
Ongoing clinical trials 76
BIBLIOGRAPHY 77
APPENDIX A 84
Methodology 84
Datamonitor forecast methodology 84
Epidemiology forecasts 84
Product forecasts 84
Definition of a standard unit 84
Contributing experts 86
APPENDIX B 87
Methodology 87
Definition of nicotine dependence market 87
About Datamonitor 88
About Datamonitor Healthcare 88
Datamonitor Healthcare’s therapy area capabilities 89
About the Disease analysis team 90
Disclaimer 91