First Transdermal Testosterone Gel to Significantly Increase
Sexual Activity In Surgically Menopausal Women
BioSante's LibiGel(TM) Shows 238% Increase in Frequency Of Satisfying Sexual
Events, According to Data at ISSWSH
LINCOLNSHIRE, Ill., Nov. 1 /PRNewswire-FirstCall/ -- BioSante Pharmaceuticals,
Inc. (AMEX:BPA) today announced the presentation of new Phase II clinical data
on LibiGel(TM) (transdermal testosterone gel) at the International Society for
the Study of Women's Sexual Health (ISSWSH) Annual Meeting in Atlanta (October
28-31). Results show the ability of LibiGel to significantly increase the
number of satisfying sexual events experienced by surgically menopausal women
with female sexual dysfunction (FSD).
BioSante's Phase II study assessed the safety and efficacy of LibiGel in the
treatment of surgically menopausal women with FSD. Results showed that LibiGel
150 mcg per day significantly increased the number of satisfying sexual events
by 238 percent versus baseline (from 2.1 events per month at baseline to 7.1
events during month three; p<0.0001); this increase also was significant versus
placebo (a LibiGel increase of 5.0 sexual events versus a placebo increase of
1.6 events; p<0.05). 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, with no serious adverse events observed.
Notably, there was minimal application site irritation reported; in contrast,
during previous trials with a transdermal testosterone patch delivery system,
approximately 30 percent of subjects reported such reactions.
Approximately 43 percent of American women suffer from FSD, according to a
study published in the Journal of the American Medical Association. Currently,
there is no FDA-approved pharmaceutical treatment for this condition.
"These impressive results support the potential of LibiGel in helping to safely
and effectively improve sexual activity in menopausal women," said James A. Simon, M.D., Clinical Professor of Obstetrics and Gynecology, George Washington
University, Washington, D.C.; Medical Director, Women's Health Research Center,
Laurel, Maryland and lead investigator of the study. "These study data show
the ability of LibiGel to increase women's sexual functioning and enjoyment,
and provide a valuable alternative for testosterone delivery in the treatment
of female sexual dysfunction." "We believe the efficacy of LibiGel, combined with its convenience of
application and safety profile, will provide an important new treatment option
for this under-served population of women," said Dr. Leah M. Lehman, vice
president of clinical and regulatory affairs of BioSante. "We plan to initiate
Phase III clinical development of LibiGel early in 2005." Note: BioSante will hold a conference call for investors today at 8:30 a.m. EST. To participate, dial toll-free (877) 407-9205. To access the live
broadcast in listen-only mode, please visit: http://www.vcall.com/CEPage.asp
?ID=89677, which will be available until February 1, 2005.
Study Details The multicenter, randomized, double-blind, placebo-controlled study included 46
subjects. Treatment groups included 75 mcg, 150 mcg or 300 mcg of LibiGel once
daily for three months, following an eight-week baseline period. Subjects in
the control group received a placebo gel. At baseline, all subjects
(surgically menopausal women age 39-60 distressed by low sexual desire and
activity) were assessed on testosterone levels, sexual function, as well as
other exploratory measures, including a global efficacy question to determine
overall improvement in sexual desire. Sexual activity was recorded in a diary
for the duration of the trial.
Increases from baseline in four-week sexual event rate were observed in all
LibiGel dose groups during treatment. LibiGel at 150 mcg was shown to be the
effective dose with an increase from baseline of five (5) satisfying sexual
events at month three (the primary endpoint), compared to an increase of 1.6
for placebo; a statistical difference of 3.4 (p< 0.05). LibiGel was well
tolerated during the three months of treatment, with an adverse event profile
similar to placebo. No serious adverse events and no discontinuations due to
adverse events occurred; notably, no hirsutism or acne was reported.
About FSD, Testosterone & LibiGel FSD is often defined as a lack of sexual desire, arousal or pleasure. The
majority of women with FSD are postmenopausal, experiencing symptoms due to
hormonal changes that occur with aging, and natural or surgical menopause.
Though generally characterized as a male hormone, testosterone is also present
in women and its deficiency has been found to decrease sexual desire and
activity.
LibiGel is a once daily transdermal testosterone gel in clinical development
for the treatment of female sexual dysfunction (FSD) in surgically menopausal
women who have had both ovaries removed. LibiGel's formulation of bioidentical
testosterone is quickly absorbed through the skin after application on the
arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly
over time in a non-invasive, painless manner.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men
and women. In addition to LibiGel, the Company's hormone therapy products are
gel formulations for transdermal administration, including Bio-E- Gel(TM)
(bioidentical estradiol gel) for treatment of women with menopausal symptoms
and Bio-T-Gel(TM) (bioidentical testosterone gel) for treatment of men with
testosterone deficiency. 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. BioSante licenses
the transdermal gel formulations used in the women's gel products from Antares
Pharma, Inc. (AMEX:AIS). Additional information is available online at
http://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 18 to 25 of BioSante's
Form 10-KSB, which discussion also is incorporated herein by reference. DATASOURCE: BioSante Pharmaceuticals, Inc.
CONTACT: Phillip B. Donenberg, CFO of BioSante Pharmaceuticals, +1-847-478-0500, ext. 101, or ; or Ritu S. Baral, The Trout Group LLC, +1-212-477-9007, ext. 25, or ; or Daniel Budwick, BMC Communications; +1-212-477-9007, ext. 14, or , both for BioSante Pharmaceuticals Web site: http://www.biosantepharma.com/
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