LINCOLNSHIRE, Ill., Jun 29, 2009 (BUSINESS WIRE) -- BioSante Pharmaceuticals,
Inc. (NASDAQ: BPAX), which is developing a testosterone gel (LibiGel(R)) to
treat hypoactive sexual desire disorder (HSDD) in women, is pleased to comment
on results in a paper published in the July issue of The Journal of Sexual
Medicine showing testosterone has no effect on the incidence of invasive breast
cancer among menopausal women who use testosterone to improve sexual function.
The study, led by Susan Davis, M.D. of the Women's Health Program, Department of
Medicine at Alfred Hospital in Australia, evaluated 631 women treated with
testosterone between January 1989 and December 2007 in a clinical endocrinology
practice. In the report the use of testosterone therapy was not associated with
a statistically significant increase in the risk of breast cancer compared to
their control population, and that testosterone exposure did not increase breast
cancer risk.
"These findings are another significant and reassuring set of data indicating
the safety of testosterone in the treatment of hypoactive sexual desire
disorder," said Michael C. Snabes, M.D., Ph.D, BioSante's vice president,
clinical development. "Recently BioSante reported positive safety data from our
Phase III Cardiovascular and Breast Cancer Safety Study showing an exceptionally
low number of cardiovascular adverse events. In addition to this safety study,
we are conducting two LibiGel Phase III efficacy trials under an FDA agreed SPA.
LibiGel is the only pharmaceutical product in the U.S. in active development for
the treatment of HSDD in menopausal women. We believe LibiGel can be the first
product the FDA approves for this indication. We expect to be able to submit a
New Drug Application by the middle of 2011."
The authors of the published paper reviewed medical records of all women in a
single practice treated with testosterone for loss of sexual desire over the
course of nearly nine years. The mean age of the women at the start of therapy
was 49.1. Women used testosterone for a median of 1.3 years, and were followed
for an average of 6.7 years, with a total of 4,015 woman-years of follow-up. The
incidence rate of invasive breast cancer was 299 cases/100,000 person-years,
which is very similar to the rate reported for hormone therapy non-users in the
U.S. Nurses Health Study (295/100,000 women-years).
As previously announced by BioSante, treatment with LibiGel in a Phase II
clinical trial significantly increased satisfying sexual events in surgically
menopausal women suffering from FSD. The Phase II trial results showed LibiGel
significantly increased the number of satisfying sexual events by 238 percent
versus baseline (p<0.0001); this increase also was significant versus placebo
(p<0.05). In this study, the effective dose of LibiGel produced testosterone
blood levels within the normal range for pre-menopausal women and had a safety
profile similar to that observed in the placebo group. In addition, no serious
adverse events and no discontinuations due to adverse events occurred in any
subject receiving LibiGel. The Phase II clinical trial was a double-blind,
placebo-controlled trial, conducted in the United States, in surgically
menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products
for female sexual health, menopause, contraception and male hypogonadism.
BioSante's lead products include LibiGel(R) (transdermal testosterone gel) in
Phase III clinical development by BioSante under a U.S. Food and Drug
Administration (FDA) SPA (Special Protocol Assessment) for the treatment of
female sexual dysfunction (FSD), and Elestrin(TM) (estradiol gel) developed
through FDA approval by BioSante, indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause, currently
marketed in the U.S. The gel formulations used in Elestrin and LibiGel are
licensed from Antares Pharma, Inc. Also in development are Bio-T-Gel(TM), a
testosterone gel for male hypogonadism, and an oral contraceptive in Phase II
clinical development 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 billion. The company also is
developing its calcium phosphate technology (CaP) for aesthetic medicine
(BioLook(TM)), novel vaccines and drug delivery. 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 "will," "potential",
"could," "can," "believe," "intends," "continue," "plans," "expects,"
"estimates" 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
BioSante's need for and ability to obtain additional financing, the difficulty
of developing pharmaceutical products, obtaining regulatory and other approvals
and achieving market acceptance; the marketing success of BioSante's licensees
or sublicensees; 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,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.
SOURCE: BioSante Pharmaceuticals, Inc.
CONTACT:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316; azachary@mckinneychicago.com