BioSante Announces CaP Manufacturing Agreement and Progress in Protein Delivery
03 May 2005 - 10:01PM
Business Wire
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.
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