Vaxart Inc (VXRT)

[harry74nrw]

Previously five Phase I/II clinical studies completed to date involved more than 475 subjects and demonstrated that NicVAX was well-tolerated, highly immunogenic, gave a dose-dependent increase in antibody concentrations, and showed a clinical proof-of-concept for efficacy in smoking cessation in that clinical response rates were highly correlated with antibody concentration. Significantly, the data in the Phase IIb proof-of-concept study showed a correlation between antibody concentration and the ability of subjects not only to quit smoking but also to remain abstinent up to 12 months.
GSK acquired the worldwide marketing rights in 2010 for NicVax in a deal valued at $ 500 million for Nabi. GSK paid upfront payment of $ 40 million and will pay predetermined amounts on reaching milestones and royalties on sales. Nabi has completed enrollment for the 2 Phase III studies, received US patent for treatment and prevention of nicotine addiction with NicVax and implemented plans for commercial manufacture and launch of the vaccine in late 2012. Results of the first Phase III studies expected in 4Q2011, BLA/MAA filings planned for 2012.
http://nicvax.wordpress.com/2012/02/24/review/