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.
