Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced positive
results of the use of BioSante’s calcium
phosphate nanotechnology (CaP) as a potential wrinkle filler in cosmetic
medicine. These results are based on work performed by Medical
Aesthetics Technology Corporation (“MATC”)
with whom BioSante has entered into an exclusive option and license
agreement in the field of aesthetic medicine. Pre-clinical work to date
indicates that BioSante’s CaP nanotechnology
performs well as a filler and may be as long lasting and safe as other
injectable fillers. Preliminary results indicate long lasting effects
and no adverse events. Further pre-clinical tests are being conducted to
confirm the positive results and determine whether BioSante’s
CaP can extend the beneficial wrinkle-filling effects longer than those
produced by the leading hyaluronic acid fillers, such as Restylane made
by Medicis Pharmaceutical Corp. (NYSE:MRX), which typically last about
six months after injection into the skin. Human clinical testing of CaP
for this use is being planned.
Stephen M. Simes, BioSante’s president and
chief executive officer, stated, “The area of
aesthetic medicine is growing both in prescription and non-prescription
products. Results to date are indicative that CaP may have a role
to play in aesthetic medicine in a large and growing market. Our option
and license agreement with MATC and the work in aesthetic medicine are
part of our strategic effort to maximize the value of CaP to our
stockholders."
BioSante and MATC have agreed to extend by four months the previous
exclusive option period that would have expired in July 2007. MATC has
the exclusive right to exercise an option to secure a license to this
technology in the field of aesthetic medicine upon payment to BioSante
of a license fee. BioSante has the right to receive additional milestone
payments upon approval by the U.S. Food and Drug Administration (FDA) or
first commercial sale of each product containing CaP, a royalty on net
sales of any such products, and a share of any milestones and license
fees from third party sublicenses.
About Medical Aesthetic Technologies Corporation
Medical Aesthetic Technologies is engaged in research and development to
produce novel products in the field of aesthetic medicine. MATC has
assembled a team of accomplished professionals out of Harvard and MIT
with expertise in aesthetic medicine as well as technology development.
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 bio-identical estradiol and
testosterone. BioSante's lead products include Elestrin™
(estradiol gel) developed through FDA approval by BioSante indicated for
the treatment of moderate-to-severe vasomotor symptoms associated with
menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc.,
BioSante's licensee, and LibiGel®
(transdermal testosterone gel) in Phase III development by BioSante for
the treatment of female sexual dysfunction (FSD). Also in development is
Bio-T-Gel™, a testosterone gel for male
hypogonadism, and an oral contraceptive using BioSante patented
technology. The current market in the U.S. for estrogen and testosterone
products is approximately $2.5 billion and for oral contraceptives
approximately $3.0 billion. The company also is developing its calcium
phosphate nanotechnology (CaP) for novel vaccines, including hepatitis
B, avian flu and biodefense vaccines for toxins such as anthrax, as well
as a system for delivering drugs via alternative routes of
administration and for aesthetic medicine. 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 news release that are
not historical in nature, particularly those that utilize terminology
such as “may,” “will,”
“should,” “would,”
“likely,” “expects,”
“anticipates,” “estimates,”
“believes,” “plans,”
“hopes,” 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 could cause
actual results to differ materially from those expressed in such
forward-looking statements include the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals and
achieving market acceptance, the success of clinical testing, and other
factors identified and discussed from time to time in BioSante's filings
with the Securities and Exchange Commission, including those factors
discussed in BioSante's most recent annual report on Form 10-K and
subsequent quarterly reports on Form 10-Q, which discussions also are
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.