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Pfizer's smoking-cessation drug a step closer to European approval

Published on 03/08/06 at 12:29pm

Pfizer's potential blockbuster smoking cessation drug Champix has been recommended for European approval by a key EMEA committee.

The first-in-class treatment is designed to activate the brain's nicotonic receptor to reduce the severity of smokers' cravings as well as their withdrawal symptoms.

Dr Joseph Feczko, Pfizer's chief medical officer, said: "Globally, it is expected that half a billion people alive today will die from smoking-related causes. Champix represents a significant new discovery in the arena of smoking cessation research.

"Pfizer is pleased that the European Committee for Medicinal Products for Human Use has recognised the potential therapeutic benefit of Champix in addressing this serious public health issue."

In Europe alone, more than 1.2 million people die each year from a smoking related disease, and by 2010, the World Health Organisation estimates the annual global cost of tobacco-related illness to be approximately $500 billion.

A final decision on Champix (varenicline) from the EMEA is now expected within the next few months, and follows FDA approval in the US in May. Following European approval, analysts expect the product to achieve peak year sales of more than $1 billion.

Unlike the nicotine replacement therapy (NRT) products that currently dominate the smoking cessation market, Champix is non-nicotine based and works by partially stimulating and binding to the receptors that channel the habit-forming properties of nicotine.

GlaxoSmithKline's Zyban (bupropion) was the first non-nicotine based smoking cessation drug when it was launched in 2000, but it failed miserably, with concerns about serious side-effects its biggest handicap. It has also now come off patent.

Last year, two clinical trials, involving about 2,000 smokers, showed that patients taking Champix were more likely to quit after 12 weeks than those patients receiving Zyban or placebo. In both trials, the results showed that, at 12 weeks, 44% of smokers receiving Champix had quit, compared with 30% of smokers receiving Zyban and 18% receiving placebo.

Champix is still likely to face a number of future competitors - GSK now has a new smoking cessation drug in phase II development, while a number of companies, including biotechs Cytos and Xenova, are developing nicotine vaccines that could also challenge Champix.

Coming up fast behind is Sanofi-Aventis' Acomplia. The drug has now been approved for cardiovascular disease  but the company is also investigating its efficacy in smoking cessation and it is expected that a licence for this indication will be submitted within the next few months.

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