BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch
December 03 2004 - 8:39AM
PR Newswire (US)
BioSante Pharmaceuticals Comments on FDA Advisory Committee's
Decision Not to Recommend Approval of Testosterone Patch Investor
Conference Call to be Held Today at 11 a.m. EST LINCOLNSHIRE, Ill.,
Dec. 3 /PRNewswire-FirstCall/ -- BioSante Pharmaceuticals, Inc.
(AMEX:BPA) today offered comment on the decision not to recommend
Procter & Gamble's Intrinsa(TM) testosterone patch for female
sexual dysfunction (FSD) in surgically menopausal women made
Thursday, December 2 by the U.S. Food and Drug Administration (FDA)
Advisory Committee for Reproductive Health Drugs. "The advisory
committee's decision against recommending approval of Intrinsa with
a request for additional safety data was unexpected," said Stephen
M. Simes, president and chief executive officer of BioSante.
"However, we are gratified that the panel agreed that FSD is an
indication worthy of treatment with testosterone, and BioSante
looks forward to the FDA's advice on what additional safety data
will be required." He added: "As we move forward in 2005 with our
Phase III studies of LibiGel(TM), our unique testosterone gel
formulation for FSD, we look forward to factoring in the
recommendations made by the FDA. Moreover, we remain confident that
LibiGel will provide an effective, convenient treatment option for
women with FSD." Note: BioSante will hold a conference call for
investors today at 11 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=90038, which will
be available until March 3, 2005 . 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 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. 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. BioSante's hormone therapy products are
gel formulations for transdermal administration that deliver
bioidentical estradiol and testosterone. 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 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, Inc., +1-847-478-0500, ext 101, or ;
or Ritu S. Baral of The Trout Group LLC, +1-212-477-9007, ext 25,
or ; or Daniel Budwick of BMC Communications, +1-212-477-9007, ext
14, or , both for BioSante Pharmaceuticals, Inc. Web site:
http://www.biosantepharma.com/
Copyright
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Sep 2023 to Sep 2024