BioSante Pharmaceuticals Comments on Study Showing No Increased Risk of Breast Cancer in Women Using Testosterone for Low Libido
Research Published in The Journal of Sexual Medicine
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jun 29, 2009 - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), which is developing a testosterone gel (LibiGel®) to treat hypoactive sexual desire disorder (HSDD) in women, is pleased to comment on results in a paper published in the July issue of The Journal of Sexual Medicine showing testosterone has no effect on the incidence of invasive breast cancer among menopausal women who use testosterone to improve sexual function.
The study, led by Susan Davis, M.D. of the Women's Health Program, Department of Medicine at Alfred Hospital in Australia, evaluated 631 women treated with testosterone between January 1989 and December 2007 in a clinical endocrinology practice. In the report the use of testosterone therapy was not associated with a statistically significant increase in the risk of breast cancer compared to their control population, and that testosterone exposure did not increase breast cancer risk.
“These findings are another significant and reassuring set of data indicating the safety of testosterone in the treatment of hypoactive sexual desire disorder,” said Michael C. Snabes, M.D., Ph.D, BioSante's vice president, clinical development. “Recently BioSante reported positive safety data from our Phase III Cardiovascular and Breast Cancer Safety Study showing an exceptionally low number of cardiovascular adverse events. In addition to this safety study, we are conducting two LibiGel Phase III efficacy trials under an FDA agreed SPA. LibiGel is the only pharmaceutical product in the U.S. in active development for the treatment of HSDD in menopausal women. We believe LibiGel can be the first product the FDA approves for this indication. We expect to be able to submit a New Drug Application by the middle of 2011.”
The authors of the published paper reviewed medical records of all women in a single practice treated with testosterone for loss of sexual desire over the course of nearly nine years. The mean age of the women at the start of therapy was 49.1. Women used testosterone for a median of 1.3 years, and were followed for an average of 6.7 years, with a total of 4,015 woman-years of follow-up. The incidence rate of invasive breast cancer was 299 cases/100,000 person-years, which is very similar to the rate reported for hormone therapy non-users in the U.S. Nurses Health Study (295/100,000 women-years).
As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
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.
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,” “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,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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Posted: June 2009