BioSante Pharmaceuticals Announces Elestrin[TM] NDA Submission in Israel.LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BPAX) today announced that an Elestrin (estradiol gel) new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) has been submitted in Israel by its Israeli licensee, PharmaSwiss SA. The Elestrin filing is based on BioSante's U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved NDA for the treatment of moderate-to-severe vasomotor vasomotor /vaso·mo·tor/ (-mo´tor) 1. affecting the caliber of blood vessels. 2. a vasomotor agent or nerve. va·so·mo·tor adj. symptoms (hot flashes hot flashes Hot flush Gynecology A symptom afflicting 80-85% of middle-aged ♀, first occurring during the perimenopause, continuing with ↓ intensity for yrs, manifesting itself as transient waves of erythema and uncomfortable warmth beginning in the ) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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[TM] 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 ap·pli·ca·tor n. An instrument for applying something, such as a medication. applicator, n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end. 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([R]) (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 sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. (FSD FSD Female Sexual Dysfunction FSD File System Driver FSD Family Support Division FSD Fire Services Department (Hong Kong) FSD Full Scale Development FSD Full Scale Deflection FSD Federal Systems Division ), and Elestrin[TM] (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[TM], a testosterone gel for male hypogonadism, and an oral contraceptive oral contraceptive n. A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill. 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 Oral Contraceptives Definition Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills. approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook[TM]), 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 Cis (sĭs), same as Kish (1.) (1) (CompuServe Information Service) See CompuServe. (2) (Card Information S . The company has nearly 550 employees and achieved turnover of [euro]130 million in 2008. This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5992579&lang=en |
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