News Releases


BioSante Pharmaceuticals Presents New Anthrax Vaccine Data at World Vaccine Congress

LINCOLNSHIRE, Illinois (April 19, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced the presentation of new data from a study of BioVantœ, the company’s patented calcium phosphate (CaP) nanoparticle technology at the annual World Vaccine Congress in Montreal. Dr. Steve Bell, vice president of research and pre-clinical development for BioSante, will present a case study entitled, “Using Calcium Phosphate Particles for Safe Non-injection Delivery and Immune Enhancement of Biodefense and Other Vaccines” today at 2:45 p.m. ET.

The main focus of Dr. Bell’s presentation is the intranasal mucosal surface delivery of an anthrax vaccine, and highlights the simultaneous immune enhancement (i.e. immune adjuvant) effects and non-injected vaccine delivery potential of CaP. The anthrax vaccine is being developed under a subcontract with DynPort Vaccine Company for the U.S. Department of Defense.

Dr. Bell will present data from ongoing preclinical anthrax vaccine development work. The new results confirm that data from earlier immunogenicity studies in mice still hold true in their second animal model, namely the rabbit. Following intranasal administration of the non-injection anthrax vaccine candidate, formulated with BioSante’s proprietary BioVant, high and lasting titers of anthrax-specific systemic antibodies were generated. BioSante plans on moving forward with live anthrax challenge studies in rabbits to further test the anthrax vaccine candidate’s protective effects.

“These results further indicate BioVant’s potential as a safer, next-generation alternative to injectable alum salt derivatives, currently the only FDA-approved adjuvants,” said Stephen M. Simes, president and chief executive officer of BioSante. “We are pleased with these findings and remain dedicated to the continued development of BioVant under our subcontract with DynPort Vaccine Company for the U.S. Department of Defense, as well as other CAP development activities for improved vaccines and protein and peptide delivery.”

Dr. Bell will also participate in a panel session entitled, “General Considerations in Non-clinical Safety Testing of Adjuvant Technologies,” to be held at 5:45 p.m. ET.

For additional information on the World Vaccine Conference.

About BioVant

Formulated using BioSante’s proprietary CaP nanotechnology, BioVant is being tested as an adjuvant for orally and intranasally administered anthrax vaccines. While injectable aluminum salt (alum) derivatives are the only adjuvants approved by the FDA, they have been associated with adverse reactions including irritation and inflammation of the injection site. Composed of specially formulated calcium phosphate, BioVant has not been shown to cause inflammation or allergic reaction after administration. BioSante is developing BioVant under a subcontract with DynPort in support of the U.S. Department of Defense Joint Vaccine Acquisition Program (JVAP).

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante’s lead products include Bio-E-Gel® (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion.

The company also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,” or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.

Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed on pages 18 to 25 of BioSante’s Form 10-KSB, which discussion also is incorporated herein by reference.


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