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Nabi falls on NicVax miss

July 19, 2011 12:22 AM UTC

Nabi Biopharmaceuticals (NASDAQ:NABI) fell $3.74 (66%) to $1.89 on Monday after NicVax nicotine vaccine missed the primary endpoint in a Phase III trial to treat nicotine addiction and prevent smoking relapse. The vaccine did not significantly improve abstinence rate for 16 weeks ending at 12 months as measured by self-reported cigarette consumption and exhaled carbon dioxide vs. placebo. The double-blind, U.S. trial enrolled 1,000 patients. The trial is the first of two ongoing Phase III studies. Data from the second trial are expected by early 2012.

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has an option to license exclusive, worldwide rights to NicVax under a 2009 deal. Nabi said the pharma would have had 25 days from delivery of preliminary data from the first Phase III trial to exercise its option had the vaccine met undisclosed criteria. GSK said it will now wait for the full data set from the first Phase III trial before assessing its option. GSK did not provide a timeline for when it expects the additional data. ...