Kicking the habit: Nicotine Dependence - where are we now and where are we going?

Although the dangers of tobacco use have been recognized for almost half a century, nicotine dependence continues to represent a serious global health problem. According to the World Health Organization (WHO), there are currently an estimated 1.3 billion smokers in the world and at the current rate; this figure is expected to rise to 1.7 billion by 2025.

The current nicotine dependence market consists of a wide range of over-the-counter products including various formulations of nicotine replacement therapies, yet only two specific prescription drugs are approved for this indication— Chantix/Champix and bupropion.

The unmet needs and commercial potential surrounding the smoking cessation market are reflected in a new report featured by LeadDiscovery: Pipeline and Commercial Insight: Nicotine Dependence - Chantix issues overshadow vaccine potential

Other recent products:

• Smoking Cessation and Addiction Treatments: A World Market Analysis
• The Global Anti-Addiction Market, 2008-2023
• UpdatesPlus Nicotinic Receptors - Current Research and Development
• Smoking Cessation Report, 2009-2024

Approximately 150 million people in the seven major markets are estimated to be current tobacco smokers. As a result of numerous anti-smoking campaigns and strict public bans, smoking prevalence rates in the US and UK have decreased steadily over the past decade. In contrast, with smoking remaining less stigmatized and far less regulated in Germany and Japan, rates have notably remained higher.

Chantix/Champix was launched in the US and Europe in 2006 and appeared to be not only revolutionizing the smoking cessation market but also fast growing into one of Pfizer's most successful products. Recent problems have however emerged with reports of suicidal ideation leading to a label modification reflecting this risk. In addition Chantix/Champix has been related to various and diverse accidents resulting in the FAA banning the use of Chantix by airline pilots. Overall US sales figures have fallen by approximately 50%. Combating negative publicity, Pfizer has been attempting to reinstate prescriber and patient confidence in Chantix by establishing a favourable risk-benefit ratio and emphasizing the requirement for improved patient screening and follow-up. While these efforts may reverse US sales trends, there remains a massive opportunity in the developing world. Remarkably, 60% of Russian and Chinese men smoke compared to 23% in the US and UK.

Those smoking cessation products that have been launched have succeeded because marketing efforts have paralleled government initiatives. This will continue to be the case and of note a new antismoking drive has been launched in India and this should offer an environment that companies such as Pfizer and GSK could harness. In addition Pfizer, in particular, has made a point of identifying those individuals most likely to want to stop smoking and targeting marketing towards this group. Of interest a study has recently opened in Asia aimed at identifying the characteristics of individuals seeking help in the cessation of smoking. Studies such as these should help break into emerging markets.

While Champix/Chantix and bupropion are both relatively successful in the short term, only a minority of individuals achieve permanent abstinence after an initial quit attempt. This represents one of the major unmet needs of currently available treatments. This problem exists in part because of sub-optimal treatments and also because the duration of existing therapies may be too short. This in turn relates at least in part to cost. Improving overall reimbursement/cost barriers should therefore have a significant impact on the success of future quit attempts;

So what is the future? Two relatively advanced smoking cessation vaccines are in the pipeline and both are being positioned as maintenance treatments. In other words they will hopefully be able to prevent relapse and should therefore stand side by side with current options that aid cessation. The smoking cessation market has grown 84.5% from 2004 to reach $1.35 billion in 2008 across the 7 major markets. If vaccines enter the market, the authors of Pipeline and Commercial Insight: Nicotine Dependence - Chantix issues overshadow vaccine potential anticipate the market growing to over $3.81 billion in 2018.

Nabi Biopharmaceuticals’ NicVAX is in line to become the first nicotine vaccine to enter the market. Assuming Nabi will secure a suitable development partner, NicVAX is expected to generate yearly 7 major market sales of almost $1.1 billion by 2018. Development of Cytos and Novartis’s nicotine vaccine NIC-002 is behind NicVAX’s. However, Novartis’ sales and marketing experience in the central nervous system and vaccines sectors bodes well for the launch of NIC-002 and yearly sales could reach $1.0 billion in the 7 major markets by 2018.

Whether a vaccine enters the market remains to be seen as both candidates have suffered development problems (for further analysis of these issues see LeadDiscovery’s recent issues of UpdatesPlus Nicotinic Receptors).