Pipeline Insight: Substance Dependence - Nicotine
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the nicotine dependence market - page 4
- Key metrics - page 5
- Datamonitor Pipeline Assessment Summary - page 5
- Contributing experts - page 6
- Upcoming reports - page 6
- CHAPTER 2 NICOTINE DEPENDENCE - MARKET POTENTIAL - page 8
- Definition of nicotine dependence - page 9
- Epidemiology of nicotine dependence - page 10
- Nicotine dependence is estimated to affect over 115 million people in the seven major markets - page 10
- Prevalence is expected to slowly decrease over time - page 12
- Few nicotine dependent individuals seek help with quitting from their primary care physician - page 13
- Diagnostic criteria for nicotine dependence are rarely used in clinical practice - page 14
- Nicotine dependence is estimated to affect over 115 million people in the seven major markets - page 10
- Current market overview - page 16
- Nicotine dependence market demonstrates sharp growth after a period of decline - page 16
- The US dominates sales revenue of the nicotine dependence market - page 17
- These is an absence of prescription nicotine dependence products in Japan - page 17
- The UK has overtaken France as the largest nicotine dependence market in the 5EU - page 18
- Only two prescription treatments are currently marketed for nicotine dependence - page 18
- Over-the-counter products represent barrier to prescription market growth - page 19
- Nicotine dependence market demonstrates sharp growth after a period of decline - page 16
- Unmet need in nicotine dependence - page 21
- Reduction in relapse rate - page 21
- CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS - page 23
- Pipeline overview - page 24
- Vaccines are the most prevalent drug class in the current pipeline - page 24
- Definition of current comparator therapy - page 26
- Pfizer's Chantix is Datamonitor's comparator therapy - page 26
- Forecasts to 2016 - page 28
- Clinical trials - page 29
- Phase II study - page 29
- Phase III comparative trials: Chantix versus bupropion - page 30
- Long-term abstinence - page 30
- Chantix's major competitors and key strengths and weaknesses - page 31
- Classification of pipeline products - page 33
- Recently discontinued or failed projects - page 33
- ADX10061 - page 33
- Rimonabant - page 34
- Taranabant - page 34
- NC-001 - page 34
- Clinical trial design - page 35
- Primary and secondary endpoints - page 35
- Patient populations - page 36
- Inclusion criteria require participants to smoke ten or more cigarettes per day - page 36
- Opinion leaders recommend inclusion of more heterogeneous participant samples - page 36
- Pipeline overview - page 24
- CHAPTER 4 VACCINE LATE-STAGE DRUG ANALYSIS & FORECASTS - page 38
- Overview for vaccine class - page 39
- Pipeline summary - page 39
- NicVAX (nicotine conjugate vaccine) - page 40
- Drug overview - page 40
- Forecasts to 2016 - page 40
- Datamonitor drug assessment summary - page 42
- Marketing factors - page 42
- Nabi will benefit from the expertise of the commercialization partner it is seeking - page 42
- Novel mechanism of action will generate strong interest among physicians - page 43
- Patient potential - page 44
- Individual variability in immunological response - page 44
- NicVAX has potential for prophylactic use - page 44
- Satisfaction of unmet needs - page 45
- NicVAX demonstrates comparable efficacy to Chantix - page 45
- Convenient dosing regimen will increase compliance - page 45
- Long-term irreversibility of NicVAX will reduce relapse rate - page 46
- Favorable side-effect and safety profile - page 46
- Clinical trial data - page 46
- Phase IIb data at 12 months - page 46
- Phase IIb data at 9 months - page 48
- NIC-002 - page 50
- Drug overview - page 50
- Forecasts to 2016 - page 50
- Datamonitor drug assessment summary - page 51
- Marketing factors - page 52
- Novartis's marketing and sales experience bodes well for the launch of NIC-002 - page 52
- Second-to-market vaccine for nicotine dependence - page 53
- Patient potential - page 53
- High immunological response will lead to high patient potential - page 53
- NIC-002 has potential for prophylactic use - page 53
- Satisfaction of unmet needs - page 53
- NIC-002 demonstrates strong efficacy - page 53
- Convenient dosing regimen will increase compliance - page 54
- Long-term irreversibility of NIC-002 will reduce relapse rate - page 54
- Favorable side-effect profile - page 54
- Clinical trial data - page 55
- Clinical dose-optimization study - page 55
- Phase II trial - 6 month and 12 month follow-up - page 56
- TA-NIC - page 58
- Drug overview - page 58
- Overview for vaccine class - page 39
- CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 59
- Overview for other pipeline nicotine dependence drugs - page 60
- Pipeline summary - page 60
- Dianicline - page 60
- Drug overview - page 61
- Forecasts to 2016 - page 61
- Datamonitor drug assessment summary - page 63
- Marketing factors - page 63
- Seven week treatment course is a strong competitive advantage - page 63
- Sanofi-Aventis has established relations with key prescribers - page 64
- Dianicline will experience fierce competition from established brands - page 64
- Patient potential - page 65
- Satisfaction of unmet needs - page 65
- Dosing regimen - page 65
- Dianicline does not satisfy the need for a reduction in relapse rates - page 65
- Side-effect and safety profile - page 65
- Clinical trial data - page 66
- Ongoing clinical trials - page 67
- Nalmefene - page 67
- Drug overview: opioid antagonist - page 68
- GW-468816 - page 69
- Drug overview: glycine receptor antagonist - page 69
- Ongoing clinical trials - page 69
- Drug overview: glycine receptor antagonist - page 69
- Surinabant - page 70
- Drug overview: cannabinoid receptor antagonist - page 70
- Ongoing clinical trials - page 71
- Drug overview: cannabinoid receptor antagonist - page 70
- Overview for other pipeline nicotine dependence drugs - page 60
- BIBLIOGRAPHY - page 72
- Journal papers - page 72
- Datamonitor reports - page 73
- Websites - page 73
- APPENDIX A - page 79
- Methodology - page 79
- Datamonitor forecast methodology - page 79
- Epidemiology forecasts - page 79
- Product forecasts - page 79
- Definition of a standard unit - page 79
- Datamonitor forecast methodology - page 79
- Contributing experts - page 81
- Methodology - page 79
- APPENDIX B - page 82
- Methodology - page 82
- Definition of nicotine dependence market - page 82
- About Datamonitor - page 83
- About Datamonitor Healthcare - page 83
- Datamonitor Healthcare's therapy area capabilities - page 84
- About the Disease analysis team - page 85
- Disclaimer - page 86
- Methodology - page 82
- List of Tables
- Table 1: DSM-IV criteria for nicotine dependence - page 10
- Table 2: Results of epidemiology studies of nicotine dependence across the seven major markets - page 11
- Table 3: Prevalence of nicotine dependence in the seven major markets, 2007 - page 12
- Table 4: Fagerström Test for Nicotine Dependence - page 15
- Table 5: Sales, growth and market share of Zyban and Chantix, 2005-06 - page 19
- Table 6: Key OTC nicotine replacement products - page 19
- Table 7: R&D pipeline in nicotine dependence, 2007 - page 25
- Table 8: Chantix: key facts - page 27
- Table 9: Percentage of continuous abstinence from cigarette smoking at weeks 9 through to 12 across three key clinical trials - page 30
- Table 10: Percentage of continuous abstinence from cigarette smoking at weeks 9 through to 52 across three key clinical trials - page 31
- Table 11: Key vaccines in the late-stage R&D pipeline for nicotine dependence, 2007 - page 39
- Table 12: Factors impacting on the revenues of NicVAX, 2007-2016 - page 41
- Table 13: Factors impacting on the revenues of NIC-002, 2007-2016 - page 51
- Table 14: Continuous abstinence levels with NIC-002 at 6 and 12 months after start of treatment - page 57
- Table 15: Other key drugs in the late-stage R&D pipeline for nicotine dependence, 2007 - page 60
- Table 16: Factors impacting on the revenues of dianicline, 2007-2016 - page 62
- Table 17: Datamonitor drug assessment parameters - page 80
- Table 18: ICD-10 codes used to size the nicotine dependence market - page 82
- List of Figures
- Figure 1: Datamonitor's nicotine dependence market summary, 2007-16 - page 5
- Figure 2: Drug assessment summary for nicotine dependence treatments - page 6
- Figure 3: Total sales of the key prescription nicotine dependence products by region ($m), 2003-06 - page 17
- Figure 4: Sales revenue of OTC nicotine replacement therapies across the 7MM ($m), 2003-06 - page 20
- Figure 5: Datamonitor's forecast sales of Chantix across the 7MM for nicotine dependence ($m), 2007-16 - page 29
- Figure 6: Datamonitor's forecast sales of NicVAX across the 7MM for nicotine dependence ($m), 2007-16 - page 41
- Figure 7: Drug assessment summary for NicVAX - page 42
- Figure 8: Datamonitor's forecast sales of NIC-002 across the 7MM for nicotine dependence ($m), 2007-16 - page 51
- Figure 9: Drug assessment summary for NIC-002 - page 52
- Figure 10: Datamonitor's forecast sales of dianicline across the 7MM for nicotine dependence ($m), 2007-16 - page 62
- Figure 11: Drug assessment summary for dianicline - page 63
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