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 positive 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.”
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. Under BioSante’s license agreement with Antares Pharma, BioSante is required to pay Antares a portion of the royalties, license and milestone payments received for products covered by that agreement. 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: biosantepharma.cdmail.biz.
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,” “intends,” “continue,” “plans,” “expects” 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 the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, 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 and subsequent quarterly report on Form 10-Q, 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.
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