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BioSante Pharmaceuticals Announces New Findings for Potential Bird,Flu Vaccine

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jul 11, 2007 - BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced new positive results demonstrating that its calcium phosphate (CaP) nanoparticle-based vaccine adjuvant, BioVant(TM), may serve as an effective vaccine adjuvant for the development of a dose sparing vaccine against H5N1 avian flu, widely known as bird flu.

The new results are based on a study using a hemagglutination inhibition assay (HAI), which showed the clear adjuvanting effect of BioVant. After a prime and one booster of BioVant-H5N1-combination-vaccine, the immune response in a rodent model was four-fold that of the H5N1 antigen alone. The study was done with 3 micrograms of H5N1 antigen in each vaccine dose. Earlier this year, the U.S. Food and Drug Administration approved an H5N1 vaccine that uses 90 micrograms of H5N1 antigen by itself given in each of two doses.

"We are working to create a vaccine using our BioVant that would be given at lower doses per injection yet still confer a higher level of immunity than the currently approved vaccine," said Stephen M. Simes, president and chief executive officer of BioSante. "These HAI study results confirm the BioVant antibody results previously reported and add to the data base for a potential BioSante improved BioVant adjuvanted bird flu vaccine."

"According to a paper published in the New England Journal of Medicine, the currently approved bird-flu vaccine without an adjuvant by a European drug company is effective only at high doses (90 micrograms per dose) and only 54 percent of subjects produced the desired immune response. We believe a BioVant-adjuvanted H5N1 vaccine may use less antigen per dose and protect a higher percentage of the population." Mr. Simes continued.

BioSante's preclinical study objective was to determine whether BioVant could enhance the body's natural immune response to the H5N1 viral antigen, the cause
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