Nabi Biopharmaceuticals (NABI) has initiated the second phase III clinical trial for NicVAX, an investigational vaccine being developed for the treatment of nicotine addiction and preventing smoking relapse. Results from the first phase III trial are expected at the end of 2010.
An agreement with the US Food and Drug Administration (FDA) has been reached on the study design, protocol and end points for the trial. Nabi has also received confirmation from the European Medicines Agency (EMEA) supporting the trial protocol. The double blind placebo controlled study would be conducted on 1,000 patients with results expected by early 2012.
In November 2009, Nabi and GlaxoSmithKline (GSK) signed a licensing agreement for NicVAX and development of a second generation nicotine vaccine. The agreement involved a $40 million upfront payment with the potential to receive more than $500 million (including upfront payment) as option fees and milestones for NicVAX and follow-on nicotine vaccines.
Nabi has the potential to receive double-digit royalties from sales if the product is commercialized. GlaxoSmithKline will have 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 its own technology.
Estimates put the worldwide number of smokers at about 1.2 billion and smoking causes approximately 5.4 million deaths every year. In view of the huge increase in the number of smokers, the global market for smoking cessation is expected to increase significantly.
Currently available smoking cessation therapies have relapse rates which can be as high as 90% in the first year after a smoker quits. Although NicVAX holds immense potential, we however remain concerned about its successful development. In October 2009, an anti-smoking vaccine developed by Cytos Biotechnology and Novartis (NVS) missed its main goal in a mid-stage study.
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