Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced receipt of a
$7.0 million milestone payment under the terms of its Elestrin™
(estradiol gel) licensing agreement with Bradley Pharmaceuticals, Inc.
(NYSE:BDY). The payment is the first of two triggered by the December
2006 FDA approval of Elestrin. BioSante is entitled to receive an
additional payment for this milestone in the amount of $3.5 million in
December 2007. The net amount of the current milestone received by
BioSante after payment to its licensor was $5.25 million. The net amount
to BioSante of the December 2007 payment will be $2.625 million.
BioSante received approval from the FDA for the marketing of Elestrin in
the United States on December 15, 2006. The FDA approved two doses of
Elestrin, 12.5 micrograms per day and 37.5 micrograms per day in a
non-conditional full approval. Elestrin 12.5 micrograms per day is the
lowest dose of estradiol approved by the FDA for the treatment of
moderate-to-severe vasomotor symptoms, and is 50% lower than the next
lowest dose currently approved and marketed for the treatment of hot
flashes.
In November 2006, BioSante signed an agreement with Bradley
Pharmaceuticals, Inc. for the marketing of Elestrin in the United
States, through Bradley’s Kenwood Therapeutics
division. Under the terms of the agreement, BioSante received an initial
net payment of $2.625 million in 2006 based on a total licensing payment
of $3.5 million. Bradley expects to launch Elestrin in mid-2007 into the
$1.3 billion estrogen therapy market with a sales force of at least 50
sales representatives. BioSante has the right under the agreement to
receive up to an additional $40 million ($30 million net after payments
to its licensor) upon the achievement of certain sales-based milestones
plus royalties upon sales of the product.
“We are pleased with the progress Bradley is
making toward the marketing of Elestrin. We look forward to a mid-year
2007 launch,” said Stephen M. Simes, BioSante’s
president and chief executive officer. “With
about $15.0 million in cash, we are actively working on our recently
begun LibiGel Phase III development program,”
Simes continued.
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 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.
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 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 and that transdermal estrogen
may be safer than oral estrogen. The North American Menopause Society,
the American College of Obstetricians and Gynecologists and the FDA all
recommend women use the lowest effective dose of estrogen for the
shortest period of time.
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, the success of clinical testing, 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. 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.