Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (AMEX:BPA) today
announced that it has exercised an option for a license from Wake
Forest University Health Sciences and Cedars Sinai Medical Center to
three patents encompassing triple hormone contraception technology, a
novel combination of estrogens and progestins with androgens, such as
testosterone. This license, which covers all potential routes of
administration, follows BioSante's existing license to triple hormone
therapy for menopausal women.
Data indicate that a woman's testosterone levels decrease by
approximately 30 to 50 percent between her 20s and 40s. This natural
decrease, combined with a decrease in testosterone levels due to oral
contraceptive use, may result in lower sexual desire and activity in
some women. The testosterone component of the triple hormone
contraceptive formulation may help restore sexual desire and activity
to women taking traditional oral contraceptives who have experienced
this side effect.
"This license agreement with Wake Forest and Cedars Sinai is a
very valuable addition to BioSante's hormone therapy product
pipeline," said Stephen M. Simes, president and chief executive
officer of BioSante. "We hope to enhance the value of hormone
contraception for women and help alleviate the negative side effect of
decreased libido associated with these drugs. Our plan is to study
LibiGel(TM), our transdermal testosterone gel for female sexual
dysfunction, as the androgen component of this technology, and
ultimately combine these hormones in a single product that would aid
therapy, compliance and cost. Currently, approximately ten million
American women use oral contraceptives."
"BioSante is a perfect fit to develop this technology, given its
strong pipeline of hormone therapy products and successful product
development experience," said Dean Stell, associate director of
Technology Asset Management for Wake Forest.
The financial terms of the exclusive, worldwide license include an
upfront payment by BioSante and regulatory milestone payments,
maintenance payments and royalty payments if a product incorporating
the licensed technology is approved and subsequently marketed.
BioSante currently is preparing a New Drug Application for
submission to the U.S. Food and Drug Administration for Bio-E-Gel(TM)
(bioidentical estradiol gel) for reducing hot flashes. Also, BioSante
plans to initiate Phase III testing of LibiGel(TM) (bioidentical
testosterone gel) for the treatment of female sexual dysfunction in
menopausal women by year-end 2005.
Triple hormone technology was developed through research conducted
at the Comparative Medicine Clinical Research Center by two former
Wake Forest faculty members, Dr. Manuel Jayo and Dr. Claude L. Hughes,
Jr., who also was an associate professor of obstetrics and gynecology.
Cedars-Sinai Medical Center in Los Angeles also participated in the
developmental process.
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(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 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. (AMEX:AIS). 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, 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.