Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Nov 10 2010

Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational candidate vaccine being developed to treat nicotine addiction and prevent smoking relapse. Nabi initiated this clinical trial in March 2010 and expects to have final data in early 2012. The first clinical trial was initiated in November 2009 and we announced completion of enrollment in July 2010 with final data expected in the fourth quarter of 2011.

Both Phase III studies for NicVAX are double-blinded, placebo-controlled studies enrolling approximately 1,000 patients each. The primary endpoint of each study is long-term abstinence from smoking at 12 months. Abstinence will be evaluated by several measures, including self-reported cigarette consumption and exhaled carbon monoxide. Secondary endpoints include the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency. The U.S. Food and Drug Administration agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency on the trial protocol.

Nabi closed an exclusive world-wide option and license agreement for the development and commercialization of NicVAX with GlaxoSmithKline Biologicals SA in March 2010, for a total potential consideration of over $500 million, including a nonrefundable $40 million upfront payment. In addition Nabi may also receive royalties on global sales of NicVAX and next-generation nicotine vaccines. 

Nabi also recently received a grant of $244,479 for development of NicVAX from the Internal Revenue Service (IRS) through the Therapeutic Discovery Project Credit Program. Under this program, recipients may receive tax credits or cash grants to cover up to 50% of eligible R&D expenditures incurred in tax years 2009 or 2010.    

"We are very pleased to complete enrollment of both of these trials on schedule," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "Both Phase III trials are on track to deliver final results by the dates we originally expected. We believe that we have taken all the steps needed to maximize the likelihood of success in Phase III including optimizing the dose regimen, aligning the target quit date with peak antibody levels and defining the study design, trial protocol and end points through the SPA. If successful, NicVAX is on track to be the first-to-market nicotine vaccine for smoking cessation."