ROCKVILLE, Md., Dec. 23, 2008 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of NicVAX(r) (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine to treat nicotine addiction and prevent smoking relapse. The SPA is a process by which sponsors and the FDA reach agreement on the design and size of clinical trials. It is intended to form the basic foundation to support approval of a New Drug Application.
"We are very pleased to reach agreement with the FDA on this very important and pivotal trial protocol. This SPA provides us with a clear, well-defined path to support approval of NicVAX and further strengthens our leadership position to bring the first smoking cessation vaccine to market," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "Ideally, we would prefer to initiate Phase 3 testing with a strategic partner and we continue to pursue all options through our strategic alternatives process. The SPA further reduces the regulatory risks associated with the NicVAX program for both Nabi and its potential partners. Smoking cessation represents a critical unmet medical need and a significant market opportunity for a safe and effective vaccine product."
About NicVAX
NicVAX(r) is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX(r) is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX(r) blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and previous clinical data, as well as the study reported here, show that NicVAX(r)'s ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes NicVAX(r) also could be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers and, 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, and PentaStaph(tm) (Pentavalent S. aureus Vaccine), a vaccine designed to protect against the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site: http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements including statements about the development of our product candidates, and clinical trials and studies. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, anticipations or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: obtain successful clinical trial results; successfully develop product candidates; successfully pursue strategic and other alternatives; receive PhosLo milestone and royalty proceeds; successfully partner with third parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; realize anticipated cost saving; attract and maintain the human and financial resources to bring to market products in development; depend upon third parties to manufacture our products; achieve approval and market acceptance of our products; enter into and maintain arrangements with third parties to market and sell our products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 filed with the Securities and Exchange Commission.