Biosante Pharma (AMEX:BPA)
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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(TM) (bioidentical estradiol gel) for the treatment
of women with menopausal symptoms, and LibiGel(TM) (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.
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, recruiting
subjects for clinical trials, 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.