GSK, Nabi announce agreement for vaccine for nicotine addiction

LONDON and ROCKVILLE, Md. — GlaxoSmithKline Biologicals and Nabi Biopharmaceuticals have announced an exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second-generation nicotine vaccine.

Under the terms of the agreement announced Nov. 16, GSK will pay to Nabi an upfront non-refundable fee of $40 million at closing and will receive an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-generation nicotine vaccines using Nabi’s intellectual property.

“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” said Jean Stephenne, president of GSK Biologicals.

Together with the upfront payment, Nabi is eligible to receive more than $500 million in option fees and regulatory, development and sales milestones for NicVAX and follow-on nicotine vaccines. Nabi will also receive double-digit royalties on global sales of NicVAX should GSK exercise its option as well as royalties on global sales of next generation nicotine vaccines.

NicVAX has recently entered the first of two Phase III clinical trials. Nabi will be responsible at its cost for the Phase III development of this candidate vaccine. Upon completion of the Phase III studies, if GSK exercises its option, GSK will take responsibility for further development and commercialization of NicVAX. In parallel with the Phase III studies, and independent of whether it exercises its option to in-license NicVAX, GSK will develop a next-generation nicotine vaccine based on Nabi’s intellectual property together with GSK’s technology.

Tobacco use is the leading cause of preventable death in the world. Smoking is a global epidemic, affecting an estimated 1.2 billion smokers worldwide and is responsible for 5.4 million deaths per year worldwide. Nicotine dependence is a chronically relapsing condition with only a minority of smokers achieving permanent abstinence in the first attempt to quit. Tobacco has been recognised by the Royal College of Physicians as being on par, from an addictive standpoint, with heroin and cocaine and as such, many tobacco users need support to stop.

The vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products.

Pre-clinical and clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes the candidate vaccine could also be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers. Currently available smoking cessation therapies have relapse rates that can be as high as 90 percent in the first year after a smoker quits.

The transaction is subject to approval by Nabi shareholders and customary closing conditions, and is expected to be completed in the first quarter 2010.