Nabi Biopharmaceuticals Completes Enrollment of Second NicVAX Phase III Clinical Trial
Final Data Expected in Early 2012 on Vaccine to Treat Nicotine Addiction and Prevent Smoking Relapse
ROCKVILLE, Md., Nov 9, 2010 (GlobeNewswire via COMTEX) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX(R) (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."
How NicVAX Works
Nicotine is a small molecule that, upon inhalation into the lungs, quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, resulting in the release of stimulants, such as dopamine, a chemical linked to pleasure and to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine, creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these receptors in the brain, fewer stimulants are released, and the pleasurable, highly-addictive effects of nicotine are diminished, thereby making it easier to quit smoking. Pre-clinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse and support long-term abstinence. This is potentially a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers; with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com.
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SOURCE: Nabi Biopharmaceuticals
CONTACT: Nabi Biopharmaceuticals Investor Relations 301-770-3099 www.nabi.com