GSK Enters Into Licensing Agreement With Nabi For NicVAX

GlaxoSmithKline (GSK) and Nabi Biopharmaceuticals (Nabi) have reported a licensing agreement for a nicotine conjugate candidate vaccine (NicVAX), and for the development of a second generation nicotine vaccine. NicVAX is an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse.

Under the terms of the agreement GSK will pay Nabi an upfront non-refundable fee of $40m 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.

Together with the upfront payment, Nabi is eligible to receive over $500m 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.

Reportedly, 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 successful completion of the Phase III studies, if GSK exercises its option, GSK will take responsibility for further development and commercialisation of NicVAX.

In parallel with the Phase III studies, and independent of whether it exercises its option to in-license NicVAX, GSK will be developing a next-generation nicotine vaccine based on Nabi’s intellectual property together with GSK’s technology.

The company said that pre-clinical and clinical data show 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.

Jean Stephenne, president of GSK Biologicals, said: “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.”

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.”