BioSante Pharmaceuticals Comments on Benefits of Testosterone Use in HIV-Infected Women
Research Published in Journal of the International AIDS Society
LINCOLNSHIRE, Illinois (June 2, 2009) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), which is developing a testosterone gel (LibiGel®) for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women, today commented on a paper published in the May 15, 2009 issue of AIDS, the Journal of the International AIDS Society, on the effect of testosterone in women infected with HIV. The peer-reviewed journal reported results of a randomized, placebo-controlled trial of testosterone in HIV-infected women indicating that long-term testosterone administration was well tolerated in HIV-infected women and resulted in significant improvement in body composition, bone mineral density (BMD), and quality of life indices.
The 18-month study was conducted in 25 HIV-infected women (average age of 43-45 years old) with free testosterone below the normal female range. The women were randomized to testosterone (300 micrograms per day delivered by patch) or identical placebo. The study was conducted at Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). The study was funded by the NIH (National Institutes of Health) and the Harvard Clinical Center For Research Resources.
“These newly published testosterone data are very exciting for many reasons,” said Stephen M. Simes, BioSante president and CEO. “BioSante is in late-stage development of LibiGel testosterone, at the same dosage employed in the published study, for the treatment of HSDD in menopausal women. We are conducting three LibiGel Phase III clinical trials including the first large long-term cardiovascular and breast cancer safety study of testosterone in women. The newly published data are positive when considering our current LibiGel development program as well as for the new potential use of LibiGel in HIV-infected women. We will consider this new use carefully and add it to our development program at the appropriate time. Women, whether HIV-infected or not, deserve the same options for therapy as men have had for many years.”
According to the authors of the published paper, the study is the first to investigate the effects of testosterone use over 18 months among HIV-infected women, and shows that testosterone is well tolerated over a long treatment period. They go on to say that prior data demonstrate that low androgen levels are common among HIV-infected women. In this study, testosterone had no significant effect on lipid levels, including high-density lipoprotein, and study-related adverse events were similar between the testosterone and placebo groups without significant differences in hirsutism (hair growth), hair pattern, acne or changes in menstrual pattern. No testosterone subjects withdrew from the study due to adverse events. No serious study-related adverse events occurred during the randomized portion of the study.
The authors comment that women with HIV are known to have reduced BMD, lean body mass, and reduced quality of life. Low androgen levels are common in this population and may contribute to such changes; yet no treatment strategies exist for women, and research investigating sex-specific treatment strategies in HIV-infected women has been limited. In contrast, among HIV-infected men, treatment of hypogonadism is routine and improves body composition, BMD, and depression. Data from this new study in women demonstrate that testosterone treatment, at the same low daily dose being used in BioSante’s LibiGel studies, is well tolerated over 18 months and results in significant improvements in body composition, BMD and quality of life.
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.
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. Under BioSante’s license agreement with Antares Pharma, BioSante is required to pay Antares a portion of the royalties, license and milestone payments received for products covered by that agreement. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at: biosantepharma.cdmail.biz.
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,” “intends,” “continue,” “plans,” “expects” 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 report 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.
For more information please contact:
Harris D. McKinney, Inc.