ROCKVILLE, Md., June 3, 2009 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced it has received scientific advice from the European Medicines Agency (EMEA) on NicVAX regarding the requirements for marketing authorization submission as it relates to the appropriate design of the pivotal phase III clinical studies and safety data base . This advice helps ensure the performance of appropriate clinical studies so that no major objections regarding the design of the studies are likely to be raised during evaluation of the marketing authorization application. Following the EMEA's advice increases the probability of a positive outcome.
The EMEA is responsible for the scientific evaluation of applications for European marketing authorization for medicinal products. Applicants submit a single marketing authorization application to the EMEA. Once granted by the European Commission, a centralized marketing authorization is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway).
"We are very pleased to receive this scientific advice from the EMEA on this very important trial protocol including advice on specific primary and secondary endpoints. This advice clarifies what the EMEA feels is critical to evaluating the efficacy and safety of NicVAX from a licensing perspective," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "The scientific advice reduces regulatory risk in the European Union associated with the NicVAX program and further strengthens our leadership position in bringing the first smoking cessation vaccine to market. We believe it also increases the attractiveness of our program to potential strategic partners. The advice we received confirms and supports our current phase III design which has recently been agreed to with the FDA through a Special Protocol Assessment (SPA). It is clear that 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 and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, 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: successfully partner with third parties to fund, develop, manufacture and/or commercialize our products in development; defend against indemnification claims by Biotest; initiate and conduct clinical trials and studies; raise sufficient new capital resources to fully develop and commercialize our products in development; attract, retain and motivate key employees; collect further milestone and royalty payments under the PhosLo Agreement; obtain regulatory approval for our products in the U.S. or other markets; successfully contract with third party manufacturers for the manufacture and supply of NicVAX and PentaStaph; and comply with reporting and payment obligations under government rebate and pricing programs. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 27, 2008 and our Quarterly Report on Form 10-Q for the period ended March 28, 2009 filed with the Securities and Exchange Commission.