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Press Release (December
8th, 2008)
BioSante Pharmaceuticals
Signs Elestrin™ Marketing Agreement with PharmaSwiss SA for
Israel
Lincolnshire, Illinois
(December 8, 2008) - BioSante Pharmaceuticals, Inc.
(NASDAQ: BPAX) today announced that it has signed an
exclusive agreement with PharmaSwiss SA for the marketing of
Elestrin(estradiol gel) in
Israel. Elestrin is
indicated in the
U.S.
for the treatment of moderate-to-severe vasomotor symptoms
(hot flashes) associated with menopause. PharmaSwiss is
responsible for regulatory and marketing activities in
Israel. Financial terms of
the agreement were not disclosed.
PharmaSwiss will submit BioSante's approved U.S. NDA (new drug
application) to the Israeli authorities based on BioSante
results and manufacturing information. Approval in
Israel
is expected to take approximately one year.
"We are happy to sign this agreement with PharmaSwiss," said
Stephen M. Simes, president & CEO of BioSante. "We believe
PharmaSwiss is in an excellent position to capture an
important share of the Israeli estrogen therapy market once
Elestrin is approved in
Israel. We look forward to
working with PharmaSwiss on the regulatory approval and on
the successful marketing of Elestrin in Israel."
About Elestrin™
Elestrin is a fast-drying gel formulation of 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 that delivers
12.5 micrograms of estradiol, one of the two lowest
estradiol doses and 67 percent lower than the lowest dose
estrogen patch approved by the FDA for the treatment of hot
flashes. The gel dries quickly in one to two minutes.
About PharmaSwiss
Established in 2000 and based in Zug, Switzerland,
PharmaSwiss offers full third party representation of
specified drugs or portfolios from research-based
pharmaceutical and biotech companies, including drug
registration, promotion, sales, compliance and
pharma-covigilance. It represents several blue chip clients
such as Amgen, Bristol-Myers Squibb, Wyeth Pharmaceuticals,
Ipsen, Astellas Pharma, Eli Lilly and Ferring.
PharmaSwiss currently operates not only in Israel, but also in
Serbia,
Croatia, Slovenia, the Baltic countries, the Czech Republic,
Bulgaria, Slovakia, Albania,
and
Greece. During the course
of 2008 PharmaSwiss has launched operations in Hungary, Romania
and
Turkey. Development plans
for the following years include also entering Poland, Russia and CIS.. The company has
nearly 550 employees and achieved turnover of 103 million
Euros in 2007.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on
developing products for female sexual health, menopause,
contraception and male hypogonadism. BioSante's lead
products include LibiGel® (transdermal testosterone gel) in
Phase III clinical development by BioSante under a U.S. Food
and Drug Administration (FDA) SPA (Special Protocol
Assessment) for the treatment of female sexual dysfunction
(FSD), and Elestrin™ (estradiol gel) developed through FDA
approval by BioSante, indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with
menopause, currently marketed in the U.S. Under BioSante's
license agreement with Antares Pharma, BioSante is required
to pay Antares 25 percent of license and milestone payments
received for products covered by that agreement in the U.S. Also in
development are Bio-T-Gel™, a testosterone gel for male
hypogonadism, and an oral contraceptive in Phase II/III
clinical development using BioSante patented technology. The
current market in the U.S. for estrogen and testosterone
products is approximately $2.5 billion and for oral
contraceptives approximately $3 billion. The company also is
developing its calcium phosphate technology (CaP) for novel
vaccines, drug delivery and aesthetic medicine (BioLook™).
Additional information is available online at:
http://www.biosantepharma.com
For more information, please contact:
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McKinny Chicago
Alan Zachary
phone: (312) 944-6784 Ext.316
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The Investor Relations Group
Media: Laura Colontrelle/Janet Vazquez 212-825-3210
Investors: Adam S. Holdsworth / Christine Berni 212-825-3210
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