BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study
LINCOLNSHIRE, Illinois (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 aerosolizedpulmonary 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™ 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.
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 transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma Inc. 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 biosantepharma.cdmail.biz.
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 19 to 31 of BioSante’s Form 10-KSB, which discussion also is incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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