Vaccine To Treat Nicotine Addiction Steps Closer To Market As Companies Agree Option Deal

Featured Article
Main Category: Smoking / Quit Smoking
Also Included In: Immune System / Vaccines;  Pharma Industry / Biotech Industry
Article Date: 18 Nov 2009 - 2:00 PST

email to a friend   printer friendly   view / write opinions

An experimental vaccine called NicVAX, designed to treat nicotine addiction that works by stopping the drug from reaching the brain, moved a step closer to the market when the vaccine developer Nabi Biopharmaceuticals (Nabi), based in Rockville, Maryland, US agreed an option and licensing deal with GlaxoSmithKline Biologicals SA (GSK), based in Brussels, Belgium.

The deal also covers the development of a second generation nicotine vaccine, so that even if GSK does not go ahead with its option to sell the current version of NicVAX, they get the right to develop the next generation themselves using Nabi's research and development knowledge.

The announcement, made in London and Rockville on Monday, also appears on the websites of both companies and states that the companies have agreed a worldwide option and licensing agreement for NicVAX, an investigational vaccine for treating nicotine addiction and to prevent smoking relapse.

Under the terms of the agreement, in return for paying an up-front non-returnable fee of 40 million US dollars to Nabi, GSK will receive an option to exclusively in-license NicVAX worldwide and a license to develop the next generation of follow on vaccines using Nabi's intellectual property.

The deal will only go ahead if NicVAX successfully completes both of its phase III trials (the first has just started), and GSK exercises its option. If it goes ahead, GSK will take over further development and commercialization of the vaccine. However, in parallel with the phase III trials, and independently of whether it exercises the option to in-license the vaccine, GSK will be going ahead with the next generation vaccine using Nabi's intellectual property and GSK's own technology.

As well as the up-front payment, Nabi is eligible to receive over 500 million dollars in "option fees and regulatory, development and sales milestones for NicVAX and follow-on nicotine vaccines", plus "double-digit" royalties on global sales if GSK goes ahead with its option, plus royalties on gobal sales of next generation vaccines, said the announcement.

Jean Stephenne, President of GSK Biologicals, told the press that:

"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; a habit that is well documented to be very hard to stop permanently."

"This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio," said Stephenne.

Dr Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals, said:

"We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialise NicVAX."

"We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives," added Fahim.

NicVAX works by stimulating the immune system to make antibodies that bind to nicotine molecules, making them too big to cross the blood-brain barrier and preventing them from reaching nicotine receptors and triggering the pleasure sensation that smokers and users of nicotine experience and become addicted to.

Data from pre-clinical trials suggest that the injectable vaccine would be effective not only in helping people quit smoking but also from relapsing back into the habit because the nicotine antibodies last a long time.

Relapse is a significant problem for people trying to quit, and some figures on smoking cessation suggest 90 per cent of quitters relapse in the first year after quitting.

Nabi shareholders will vote on whether to approve the deal early next year.

Sources: Nabi, GSK.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today