BioSante Pharmaceuticals Reports Positive Results of Long Acting Injectable Insulin.

Business Editors/Health/Medical Writers

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SAN FRANCISCO--(BUSINESS WIRE)--Nov. 6, 2003

BioSante Pharmaceuticals, Inc. (Amex:BPA) announced today that positive results of preclinical testing of its calcium phosphate (CAP) delivery system for the injection of insulin were presented here at the third annual meeting of the Diabetes Technology Society.

"The results of this study indicate that our unique technology may extend the duration of action many times over that of injecting insulin alone," said Dr. Tulin Morcol, associate director of drug delivery and related technologies for BioSante. "This represents a potential advance that would allow diabetics to substantially reduce the number of injections needed to control blood glucose levels."

The preclinical study evaluated the use of BioSante's proprietary CAP particles to extend the bioavailability of insulin over time. Scientists at BioSante's research center in Smyrna, Georgia, developed a formulation combining CAP, polyethylene glycol (PEG, a polymer) and insulin. The therapeutic efficacy of the formulation, known as CAPI, was tested in normal and diabetic mice, and pharmacokinetic analysis was also performed.

A single 12.5 U/kg dose of CAPI was administered to fasted non-obese diabetic mice via subcutaneous injection and blood glucose and serum insulin levels were monitored for eight hours. Diabetic mice treated with a 12.5-U/kg dose of standard insulin solution were used as controls.

A single dose of CAPI at two dosage levels (2.5 U/kg and 5.0 U/kg) was also administered to fasted normal mice via subcutaneous injection, and normal mice treated with a 2.5-U/kg dose of standard insulin solution were used as controls. Blood glucose and serum insulin levels were monitored for seven hours.

In all cases, subcutaneously injected CAPI prolonged the absorption of insulin and substantially lowered blood glucose levels compared to insulin solution, the researchers reported, and the glucose lowering effect of CAPI was more dramatic in the diabetic mice model. CAPI extended the hypoglycemic effect of insulin to at least eight hours, compared to two to four hours for insulin alone.

"Pharmacokinetic analysis indicated that CAPI significantly increased the half-life and mean residence time of the insulin," Dr. Morcol said. "Furthermore, relative bioavailability of insulin in CAPI was 150 percent greater than insulin solution."

Dr. Morcol also pointed out that while there are long-acting diabetes therapies now on the market, they are made with analogs of insulin, whereas CAPI is formulated with human insulin, long the treatment of choice.

"The results of this study strengthen our belief that CAP is an important delivery technology for insulin treatment," said Stephen M. Simes, president and chief executive officer of BioSante. "This potential advance may substantially reduce the number of injections required by diabetics, thereby enhancing their quality of life."

Simes said the company plans to continue research on the new treatment as well as other delivery systems currently in development, including CAPOral(TM) for oral insulin delivery (for which the company recently received an SBIR grant) and CAPAir(TM) for inhalable insulin delivery.

CAP, BioSante's proprietary calcium phosphate particulate technology, consists of microscopic particles of a natural compound similar to that found in teeth and bones. The patented formulation is nontoxic and biodegradable, offering a multitude of potential medical applications.

About BioSante Pharmaceuticals, Inc.

BioSante is an emerging pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women. BioSante is also developing its nanoparticulate-based platform technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com.

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, adverse reports from others about products similar to ours, 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 17 to 23 of BioSante's Form 10-KSB, which discussion also is incorporated herein by reference.