GSK licences smoking vaccine candidate
pharmafile | November 30, 2009 | News story | Research and Development |Â Â GSK, Nabi, smoking, vaccinesÂ
GlaxoSmithKline Biologicals has signed a licensing agreement for a nicotine vaccine candidate currently in the first of two phase III trials.
Nabi Biopharmaceuticals’ NicVAX aims to treat smokers for their addiction as well as helping them not to slip back into the habit. GSK will pay the Maryland-based firm $40 million up front, for which it gets exclusive options to licence NicVAX worldwide and develop follow-on products.
Nabi could receive more than $500 million in option fees and milestone payments, plus double-digit royalties, assuming NicVAX and any next-generation vaccines are successful.
Whatever happens, GSK will develop a new vaccine using its own technology and Nabi’s intellectual property.
Nabi chief executive Raafat Fahim said NicVAX would be “an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives”.
The vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine molecules, thus making them too large to reach receptors in the brain.
Nabi suggests that this blocks the addictive pleasure sensation experienced by smokers – and may prevent relapse since nicotine antibodies circulate for long periods.
Indeed, the company identifies this as the key point of difference between NicVAX and existing anti-smoking therapies.
Nabi will be responsible for funding phase III development, after which GSK will take over further development and commercialisation.
“If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent,” said Jean Stephenne, president of GSK Biologicals.
Relapse rates can be as high as 90% in the first year after a smoker quits, the companies point out.
“This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio,” Stephenne added.
GSK has led the field before, when its Zyban became the first non-nicotine-based product to hit markets nine years ago. But it stumbled over concerns about serious side effects.
More recently sales of Pfizer’s Chantix/Champix, a first-in-class treatment designed to reduce the severity of smokers’ cravings and withdrawal symptoms, fell in the last quarter after warnings about a risk of suicide with the drug.
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