BioSante Pharmaceuticals Comments on Updated FDA Guidance for Testosterone Therapy
November 02 2005 - 7:00AM
Business Wire
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(TM), 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(TM) 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(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. 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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