Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex:BPA) announced that a new patent
has issued covering the formulations used in Elestrin™
(estradiol gel), BioSante’s newly approved
treatment for moderate to severe vasomotor symptoms associated with
menopause and LibiGel®
(testosterone gel), which recently moved into Phase III clinical
development for the treatment of female sexual dysfunction. The patent,
which issued on April 3, 2007 covering both Elestrin and LibiGel, will
expire on June 25, 2022.
"The named inventors of this new patent are from BioSante and Antares,
our licensor. BioSante received approval of Elestrin from the U.S. Food
and Drug Administration (FDA) in December 2006. In addition, the
Elestrin trademark is owned by BioSante," said Stephen M. Simes,
president and chief executive officer of BioSante. "We look forward to
the launch of Elestrin mid-year 2007 by Bradley Pharmaceuticals, Inc.,
BioSante’s marketing licensee. The product
will be promoted through Bradley’s Kenwood
Therapeutics division."
Two doses of Elestrin, 12.5 micrograms per day and 37.5 micrograms per
day, were approved by the FDA. The 12.5 micrograms dose of Elestrin is
the lowest dose of estradiol approved by the FDA for the treatment of
moderate-to-severe vasomotor symptoms and is 50 percent lower than the
next lowest dose available.
About Elestrin™
Elestrin is a fast-drying gel formulation of bio-identical estradiol,
the same estrogen produced naturally in women. Elestrin is absorbed
through the skin after topical application on the upper arm, and
delivers estradiol to the bloodstream evenly over time in a
non-irritating, painless manner. Elestrin is administered using a
metered dose applicator thereby allowing for precise, uniform dosing.
The gel dries quickly in one to two minutes.
About LibiGel®
LibiGel is a gel formulation of bioidentical testosterone designed to be
quickly absorbed through the skin after application on the upper arm,
delivering testosterone to the bloodstream evenly over time and in a
non-invasive and painless manner. Though generally characterized as a
male hormone, testosterone also is present in women and its deficiency
has been found to decrease libido or sex drive. In addition, studies
have shown that testosterone therapy can increase bone density, raise
energy levels and improve mood, in addition to boosting sexual desire
and activity.
About Estrogens
Estrogen products today are approved for the treatment of menopausal
symptoms, including hot flashes. Estrogen products are not approved for
and should not be used for the treatment or prevention of heart disease,
breast cancer or dementia. The Women's Health Initiative (WHI) study
reported increased risk of stroke and deep vein thrombosis in
postmenopausal women (50 to 79 years of age) during 6.8 years of
treatment with 0.625 mg of oral conjugated equine estrogens alone per
day, relative to placebo. The WHI study reported increased risk of
myocardial infarction, stroke, invasive breast cancer, pulmonary emboli
and deep vein thrombosis in postmenopausal women (50 to 79 years of age)
during five years of daily treatment with 0.625 mg of oral conjugated
equine estrogens combined with 2.5 mg of medroxyprogesterone acetate per
day. Although studies involving hormone use and breast cancer risk have
produced varied results, newly reported estrogen-only data provide
strong evidence that estrogen alone does not increase the risk of breast
cancer, and in fact may decrease the risk. The North American Menopause
Society (NAMS), the American College of Obstetricians and Gynecologists
and the FDA all recommend women use the lowest effective dose of
estradiol for the shortest period of time.
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 bio-identical estradiol and
testosterone. BioSante's lead products include Elestrin™
(estradiol gel), developed through FDA approval by BioSante, indicated
for the treatment of moderate-to-severe vasomotor symptoms associated
with menopause, and LibiGel®
(transdermal testosterone gel) in Phase III clinical development 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. The company also
is developing its calcium phosphate nanotechnology (CaP) for novel
vaccines, including hepatitis B, avian flu and biodefense vaccines for
toxins such as anthrax, as well as a system for delivering drugs via
alternative routes of administration. 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 news release that
are not historical in nature, particularly those that utilize
terminology such as "may," "will," "should," "likely," "expects,"
"anticipates," "estimates," "believes", "plans, "hopes", 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 in BioSante's most recent Forms 10-K and 10-Q,
which discussion also is incorporated herein by reference. Additional
risk factors include the risk that Elestrin may not be
successfully marketed. 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.