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BioSante Pharmaceuticals Comments on
Updated FDA Guidance for Testosterone Therapy
LINCOLNSHIRE, Illinois (November 2, 2005) – BioSante
Pharmaceuticals (AMEX: BPA) today offered comment on updated U.S. Food
and Drug Administration (FDA) safety and efficacy guidance for the development
of testosterone products for the treatment of female hypoactive sexual
desire disorder (HSDD). The new guidance was announced on Saturday, October
29 at the International Society for the Study of Women's Sexual Health
(ISSWSH) Annual Meeting in Las Vegas, during a presentation by Dr. Daniel
Shames, Director of the FDA’s Division of Reproductive and Urologic
Products.
Dr. Shames stated that the FDA acknowledges testosterone’s efficacy
in treating HSDD and the need for testosterone products to be approved
for women affected by this condition. As extended long-term, pre-marketing
safety studies are often not economically feasible for companies, the
FDA will now permit a complete safety profile to be submitted post-marketing,
with efficacy and some safety data submitted pre-approval. The agency
will assist companies in determining the best development plan for their
testosterone products, consistent with the need for sufficient efficacy
and safety requirements. The FDA is most interested in safety data addressing
cardiovascular and breast cancer risk associated with testosterone therapy.
“We are pleased that the FDA has validated testosterone’s potential
as an effective therapy for HSDD,” said Stephen M. Simes, president
and chief executive officer of BioSante. “Based on the updated FDA
guidance, we plan on filing our Phase III efficacy and safety protocols
for studies of LibiGel®, our testosterone gel. The new guidance may
allow for a more timely review process than previously projected by many.
We look forward to working cooperatively with the FDA to finalize our
LibiGel Phase III efficacy and safety protocols.”
Additionally, to build the safety profile of testosterone, the FDA will
accept and review epidemiological and surrogate endpoint data. The co-primary
endpoints for approval of testosterone in HSDD are successful and satisfying
sexual events, and increased sexual desire.
About LibiGel® and Female Sexual Dysfunction (FSD)
LibiGel is a once-daily transdermal testosterone gel in late-stage clinical
development for the treatment of FSD, specifically HSDD. LibiGel's formulation
of bioidentical testosterone is quickly absorbed through the skin after
application on the arm or shoulder, delivering testosterone to the bloodstream
evenly over time in a non-invasive, painless manner. In a Phase II clinical
trial, LibiGel increased the number of successful and satisfying sexual
events by 238 percent, which was statistically significant compared to
baseline and placebo.
Approximately 43 percent of American women suffer from FSD, according
to a study published in the Journal of the American Medical Association.
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, or with natural or surgical
menopause.
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® (bioidentical
estradiol gel) for the treatment of women with menopausal symptoms, and
LibiGel® (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. 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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For more information please contact:
For Media:
Harris D. McKinney, Inc.
Alan Zachary
(312) 506-5220
azachary@harrisdmckinney.com
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