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Press Release
(June 23rd, 2009)
BioSante Pharmaceuticals
Announces Elestrin™ NDA Submission in Israel
LINCOLNSHIRE, Illinois (June 23,
2009) – BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) today announced that an Elestrin (estradiol gel) new
drug application (NDA) has been submitted in Israel by its
Israeli licensee, PharmaSwiss SA. The Elestrin filing is
based on BioSante’s U.S. FDA approved NDA for the treatment
of moderate-to-severe vasomotor symptoms (hot flashes)
associated with menopause. PharmaSwiss is responsible for
regulatory and marketing activities in Israel. Approval in
Israel is expected to take approximately one year.
“This is a positve development by 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. We look forward to working with
PharmaSwiss on the successful marketing of Elestrin in
Israel, and expanding the distribution of Elestrin beyond
the United States.”
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 approved by the FDA for
the treatment of hot flashes. The gel dries quickly in one
to two minutes.
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. Also in
development are
Bio-T-Gel™, a testosterone gel for male hypogonadism, and an
oral contraceptive in Phase II 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 aesthetic medicine (BioLook™), novel
vaccines and drug delivery. Additional information is
available online at: www.biosantepharma.com.
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 €130 million in 2008.
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 “will,” ”potential”,
“could,” “can,” “believe,” ”intends,” “continue,” “plans,” “expects,”
“estimates” 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 could
cause actual results to differ materially from those
expressed in such forward-looking statements include
BioSante’s need for and ability to obtain additional
financing, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and
achieving market acceptance; the marketing success of
BioSante’s licensees or sublicensees; the success of
clinical testing, 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 annual report on Form 10-K,which
discussions also are 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.
For more information, please contact:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316;
azachary@mckinneychicago.com
For PharmaSwiss:
Maja Simic, tel. +381 11 30 93 900
office@pharmaswiss.com
Please visit:
www.pharmaswiss.com
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