BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin(TM) and LibiGel(R)
10 Avril 2007 - 2:00PM
Business Wire
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.
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