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
"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 www.biosantepharma.com.
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.
For more information please contact:
Harris D. McKinney, Inc.