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BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced positive results of the use of BioSante's calcium phosphate nanotechnology (CaP) as a potential wrinkle filler in cosmetic medicine. These results are based on work performed by Medical Aesthetics Technology Corporation ("MATC") with whom BioSante has entered into an exclusive option and license agreement in the field of aesthetic medicine. Pre-clinical work to date indicates that BioSante's CaP nanotechnology performs well as a filler and may be as long lasting and safe as other injectable fillers. Preliminary results indicate long lasting effects and no adverse events. Further pre-clinical tests are being conducted to confirm the positive results and determine whether BioSante's CaP can extend the beneficial wrinkle-filling effects longer than those produced by the leading hyaluronic acid fillers, such as Restylane made by Medicis Pharmaceutical Corp. (NYSE:MRX), which typically last about six months after injection into the skin. Human clinical testing of CaP for this use is being planned.
Stephen M. Simes, BioSante's president and chief executive officer, stated, "The area of aesthetic medicine is growing both in prescription and non-prescription products. Results to date are indicative that CaP may have a role to play in aesthetic medicine in a large and growing market. Our option and license agreement with MATC and the work in aesthetic medicine are part of our strategic effort to maximize the value of CaP to our stockholders."
BioSante and MATC have agreed to extend by four months the previous exclusive option period that would have expired in July 2007. MATC has the exclusive right to exercise an option to secure a license to this technology in the field of aesthetic medicine upon payment to BioSante of a license fee. BioSante has the right to receive additional milestone payments upon approval by the U.S. Food and Drug Administration (FDA) or first commercial sale of each product containing CaP, a royalty on net sales of any such products, and a share of any milestones and license fees from third party sublicenses.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bio-identical estradiol and testosterone. BioSante's lead products include Elestrin™ (estradiol gel) developed through FDA approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee, and LibiGel® (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive 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 $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration and for aesthetic medicine. Additional information is available online at http://www.biosantepharma.com .
About Medical Aesthetic Technologies Corporation
Medical Aesthetic Technologies is engaged in research and development to produce novel products in the field of aesthetic medicine. MATC has assembled a team of accomplished professionals out of Harvard and MIT with expertise in aesthetic medicine as well as technology development.
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 “may,” “will,” “should,” “would,” “likely,” “expects,” “anticipates,” “estimates,” “believes,” “plans,” “hopes,” 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 reports 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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BioSante Pharmaceuticals, Inc.
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