BioSante Pharmaceuticals Announces Elestrin™ NDA Submission in Israel |
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| Tuesday, 23 June 2009 07:19 |
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“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.” 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. The gel formulations used in Elestrin and LibiGel are licensed from Antares Pharma, Inc. 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. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section Add this page to your favorite Social Bookmarking websites            |
LINCOLNSHIRE, Ill.--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.
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