Biosante Pharma (AMEX:BPA)
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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.