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Exubera

Generic name: insulin inhalation
Treatment for: Diabetes, Type 1, Diabetes, Type 2

BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study

LINCOLNSHIRE, Ill., September 21, 2005 - BioSante Pharmaceuticals, Inc. (Amex:BPA) today expressed encouragement by the U.S. Food & Drug Administration (FDA) Advisory Panel's recommended approval of Pfizer, Inc.'s Exubera inhaled insulin therapy, and noted superior results in preclinical studies with its own inhalable insulin delivery system.

"The FDA Advisory Panel's recommended approval of Exubera is highly encouraging as we continue to develop our own inhaled insulin therapy," said Stephen M. Simes, president and chief executive officer of BioSante. "The most recent study found our aerosolized pulmonary insulin formulation offered equivalent insulin bioavailability compared to subcutaneous injection, which translates to about 60 percent absolute bioavailability. For comparison, the bioefficacy of the Exubera inhaled insulin is approximately 10 percent, according to data presented at the American Diabetic Association annual meeting."

Mr. Simes said development continues on BioSante's inhalable insulin product using the company's proprietary BioAir(TM) calcium phosphate nanoparticulate (CaP) delivery system. A previously announced preclinical study, conducted by scientists at the University of North Carolina and BioSante and published in the journal AAPS PharmSci, demonstrated that CaP-polyethylene glycol (PEG) particles significantly reduced the elimination of insulin, increasing its systemic residence time and duration of action. Consequently, the amount of insulin that became available through the bloodstream (bioavailability) using the BioAir insulin-CaP-PEG formulation was equivalent to or higher than that of insulin injected subcutaneously.

"This may mean that fewer or lower dosings will be required, resulting in greater convenience and safety potential," Simes said. He noted that the company will soon begin testing its innovative inhaled insulin in rabbits.

"The availability of inhalable insulin therapy will be a great advance in diabetes treatment, providing an easy, pain-free alternative to insulin injections and allowing diabetics to live more comfortable lives," he said.

BioSante's proprietary calcium phosphate nanoparticles are vehicles for delivering drugs and vaccines more efficiently and enhancing their therapeutic effects. The CaP 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.

Posted: September 2005

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