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Nabi Pharmaceuticals’ NicVAX Misses Goal of Late-Stage Study, Shares Fall 72 Percent

By Pharmaceutical Processing | July 19, 2011

Nabi Pharmaceuticals shares fell as much as 72 percent Monday after
the company announced data suggesting that its experimental nicotine
addiction vaccine NicVAX failed to meet the primary endpoint in the
first of two ongoing late-stage studies. “We are clearly surprised and
deeply disappointed with the results of this…trial,” said Nabi CEO
Raafat Fahim, adding that “we are in the process of assessing the
reasons for these unexpected data.”

The study randomised around 1000 patients to receive either NicVAX
or placebo. After 12 months, a preliminary analysis of the data showed
that approximately 11 percent of participants in the NicVAX arm had quit
smoking at least 16 weeks earlier, which was similar to smoking
cessation rates observed in the placebo arm.

Fahim noted that as the company awaits further data from the trial
along with results from the second study, “the board of directors is
actively evaluating any and all appropriate strategic alternative
actions to preserve shareholder value.”

Last year, GlaxoSmithKline and Nabi entered into an option and license agreement regarding NicVAX.

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