Nov 17, 2009 (Datamonitor via COMTEX) -- In securing GlaxoSmithKline's signature, Nabi Biopharmaceuticals has gained the perfect Big Pharma partner to support its NicVAX program. Although Phase III development remains Nabi's responsibility, it provides a timely boost to the validity of the approach, following the recent set-back experienced by Novartis and Cytos with their own nicotine vaccine, NIC-002.

Under a global option and licensing agreement, GlaxoSmithKline has agreed to pay Nabi an upfront non-refundable fee of $40m for NicVAX, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, while also receiving an option to develop a second-generation nicotine vaccine using Nabi's intellectual property. Nabi will continue to be responsible for the costs of the Phase III development, while upon successful completion, GSK will take responsibility for further development and commercialization of NicVAX.

In a move away from traditional nicotine replacement and agonist therapies, nicotine vaccines are the most prevalent drug class in the late-stage nicotine dependence pipeline. A vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine. The vaccines then act by blocking nicotine from crossing the blood-brain barrier and reaching receptors in the brain, thereby preventing the highly-addictive pleasure sensation experienced by smokers and users of nicotine products.

In April 2007, Novartis became the first Big Pharma player to license access to a nicotine vaccine by acquiring the worldwide rights to NIC-002 (formerly called CYT-002-NicQb) from Cytos Biotechnology. Although Novartis has taken over responsibilities for late-stage clinical development, in October 2009 it announced that an interim analysis of a Phase II study of NIC002 showed that the primary endpoint was not achieved. This cast fresh doubt on the potential of the whole vaccine approach.

Datamonitor estimates that approximately 150 million people in the seven major markets are current tobacco smokers. Nicotine dependence is a chronically relapsing condition, with only a minority of patients achieving permanent abstinence after an initial attempt to quit. Therefore, a reduction in the relapse rate of treated patients represents a major unmet need in the treatment of nicotine dependence. With Phase III trials already underway, NicVAX is in line to become the first nicotine vaccine to enter the market. With GlaxoSmithKline fulfilling Datamonitor's previous expectation of Nabi gaining a Big Pharma partner, NicVAX is forecast to achieve sales in excess of $1 billion across the seven major markets by 2018.

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