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Glaxo and Nabi Team Up for Nicotine Vaccine

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They are the newest effort in a long battle to snuff out the addiction.

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For the tobacco industry, there's a lot of money to be made by getting people hooked on cigarettes and keeping them as customers for life. But smoking cessation products are increasingly sending a good portion of those revenues up in smoke.

In theory, anyway.

Products made by pharmaceutical companies to help smokers quit have had limited success penetrating the captive audience Big Tobacco has garnered from its incredibly brand-loyal customers. But Big Pharma hasn't given up trying to find that miracle drug that will cure addiction.

The industry's latest attempt at snuffing out peoples' nicotine habit comes from GlaxoSmithKline (GSK) and its newest partner Nabi Biopharmaceuticals (NABI). The two companies announced on Monday that they're partnering on a nicotine vaccine called NicVAX.

The compound is currently in the first of two phase 3 clinical studies. Glaxo is paying Nabi $40 million upfront for an option to license the drug and could pay as much as $500 million if certain regulatory and sales milestones are reached.

The vaccine is designed to boost the immune system response within the body, causing antibodies to form that would bind to the nicotine molecules preventing them from reaching the pleasure receptors in the brain. In other words, it would take away the enjoyment smokers get from puffing on a cigarette.

Smoking cessation is potentially a big market; there are still more than 1.2 billion smokers worldwide and plenty of those smokers make multiple attempts to quit. According to the American Cancer Society, only 4% to 7% of smokers are able to quit on any given attempt without the help of a program.

There are plenty of methods available to help people kick the habit. Glaxo is already immersed in the market -- its nicotine replacement therapies pulled in $383 million for the consumer health unit in the first nine months of 2009. The British drug company markets Nicorette gum, Commit lozenges, and the Nicoderm CQ patch. It also makes the drug Zyban, a repackaged version of the antidepressant Wellbutrin.

The US Food and Drug Administration gave Zyban and Pfizer's (PFE) Chantix a black box, the most severe warning, in July 2009 when Chantix, a pill that acts on the nicotine receptors in the brain by occupying those receptors, came under fire for its psychological side effects.

In 2008, reports surfaced that showed Chantix was linked to suicidal thoughts and intense feelings of depression. During the first year and a half that Chantix was on the market, the FDA received 227 domestic reports of suicidal acts, thoughts, or behaviors, 397 cases of possible psychosis, and 525 reports of hostility or aggression with many of the patients reporting hallucinations and thoughts of killing people. This also included 28 suicides.

The bad press for Chantix had troubling effects for Glaxo's smoking cessation products. Revenues for the gum, patch, and lozenges all started to slip after the news broke and a survey by the company showed that 67% of smokers who had heard the news attributed the problem to Glaxo's products. The company fired back with a rigorous ad campaign.

"The problems with Chantix do leave the market open for other products," said Miller Tabak analyst Les Funtleyder. "Yet, we still have plenty of addictive drugs because the pharmaceutical companies have not yet been able to crack the code on curing addiction."

Neither Glaxo nor Pfizer responded to a request for comment. The Glaxo/Nabi vaccine would not be ready for approval from the FDA before 2012, said a spokesperson from Nabi. The vaccine is given as a once-monthly injection for six months.
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