BioSante Pharmaceuticals Announces License Agreement for its CaP Technology for Use in Aesthetic Medicine
Lincolnshire, Illinois (November 19, 2007) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced it has signed a license agreement covering the use of BioSante’s patented calcium phosphate nanotechnology (CaP) as a facial filler (BioLook™) in aesthetic medicine. The license was signed with Medical Aesthetics Technology Corporation (“MATC”) with whom BioSante has been working in the field of aesthetic medicine. This license agreement is a result of MATC’s exercise of a previously signed option agreement. Under the agreement, MATC will be responsible for continued development of the product, including required clinical trials, regulatory filings and all manufacturing and marketing associated with the product.
In exchange for this license, BioSante has taken an ownership position in MATC of about five and one-half percent. In addition to the ownership position, BioSante may receive certain milestone payments and royalties as well as share in certain payments if MATC sublicenses the technology.
Pre-clinical work to date indicates that BioSante’s BioLook nanotechnology performs well as a filler and may be at least as long lasting and safe as other injectable fillers. Preliminary results indicate long lasting effects with no adverse events. BioLook should be extremely user friendly with minimal risk of side effects and may be applicable to improving both facial wrinkles and larger facial volume needs. Further pre-clinical tests are currently underway to confirm the positive results and determine whether BioSante’s BioLook can extend the beneficial wrinkle-filling effects longer than those produced by the leading hyaluronic acid fillers, such as Restylane currently marketed by Medicis Pharmaceutical Corp. (NYSE:MRX), which typically last about six months after injection into the skin. Human clinical testing of BioLook for this use is being planned and is expected to be initiated within the next six months.
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 BioLook may have a role to play in this large and growing market. Our license agreement with MATC and the work in aesthetic medicine as well as the ownership position in MATC all are part of our strategic effort to maximize the value of CaP to our stockholders.”
MATC has the exclusive right to the use of CaP/BioLook in the field of aesthetic medicine. 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 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.
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 bioidentical estradiol and testosterone. BioSante’s lead products include Elestrin™ (estradiol gel) developed through U.S. Food and Drug Administration (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 clinical development by BioSante for the treatment of female sexual dysfunction (FSD).
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 $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, drug delivery, and aesthetic medicine (BioLook™). Additional information is available online at www.biosantepharma.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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. Also, 25 percent of the upfront and milestone payments received from Bradley are paid to our licensor of the formulation in Elestrin. 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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Harris D. McKinney, Inc.