News Releases


BioSante Announces CaP Manufacturing Agreement and Progress in Protein Delivery

LINCOLNSHIRE, Illinois (May 3, 2005) – BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced a new manufacturing agreement with a U.S.-based cGMP (current good manufacturing practices) manufacturer for large-scale quantities of its calcium phosphate-based nanotechnology (CaP). The CaP will be used to expand testing by a global pharmaceutical company in the development of an oral formulation of a currently marketed injectable protein product. The objective is to incorporate CaP with the injectable protein and to administer the new product orally. After signing the agreement, BioSante‰s CaP synthesis protocols were transferred and the manufacturing process was successfully scaled up to make large quantities of CaP nanoparticles.

Recent pre-clinical results consistently indicate that the CaP-therapeutic protein formulation can be delivered through the oral route, thus offering the potential to eliminate injections. The CaP-therapeutic protein formulation will now be tested in a large animal model.

“We continue to make significant progress with our proprietary CaP nanotechnology,” said Stephen M. Simes, BioSante’s president and chief executive officer. “We are very pleased with the success our collaborator, a global pharmaceutical company, has experienced with the CaP-protein formulation in a therapeutic area in which an oral product would make a major difference in the lives of patients who currently must undergo daily injections.”

About CaP Nanotechnology

CaP nanotechnology is being developed for two primary uses: for safer and more effective vaccines and for innovative therapeutic drug delivery, primarily proteins. BioSante is product-focused in these efforts, and continues to make progress in these exciting areas. The company receives primary funding for its CaP development program through potential corporate partners and the U.S. government in various collaborative agreements.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. These products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante‰s lead products include its non-partnered products 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 United States 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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