BioSante Pharmaceuticals Licenses Contraceptive Technology From Wake Forest University; Triple Hormone Technology May Benefit Wo
10 August 2005 - 10:00PM
Business Wire
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.
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