Stephen M. Simes, president and CEO of BioSante, said, "The need for an FDA-approved treatment to cope with this condition is accepted by an astonishing over 90 percent of the doctors surveyed by Campbell. It has been more than a decade since the FDA approved Viagra for the treatment of male sexual dysfunction; it is time to provide women and their healthcare providers with a safe and effective option."
BioSante is developing LibiGel®, a testosterone gel, for treatment of HSDD in menopausal women. LibiGel is currently in three Phase III clinical studies to prove its safety and efficacy.
The doctors surveyed indicated that if their patients are not experiencing relationship problems or some other condition that could suppress their desire for sex, therapeutic options should be considered. However, there are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 percent) reported that they prescribe off-label testosterone for women to treat FSD, however, these physicians are dissatisfied with the non-FDA approved, off-label alternatives. Nationally, it is estimated that 4.1 million of such off-label prescriptions are filled annually.
The doctors were asked their reactions to an unnamed therapeutic that fit LibiGel's profile. An overwhelming percentage (94%) responded favorably, as long as it is proven to be safe. BioSante is conducting a Phase III multicenter cardiovascular and breast cancer safety study. Based on approximately 2,800 women in the safety study for an average of approximately 11.5 months each, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.52 percent, compared to an expected rate of approximately two percent and only eight diagnoses of breast cancer, a rate of approximately 0.30 percent, compared to an expected rate of approximately 0.35 percent, after approximately 2,700 women-years of exposure in the study.
According to Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, "If testosterone increased the incidence of cardiovascular events, we would see a higher rate of such events, especially since the study subjects are at the higher end of cardiovascular risk for the intended treatment population. The expected rate of cardiovascular events in the women in the study is approximately two percent. Based on the safety seen to date, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women." BioSante anticipates the submission of a new drug application for LibiGel in 2011 and a product launch in 2012.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The two on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily, pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD 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 and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market size, acceptance and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, 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 BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release 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.
Contact:
BioSante Pharmaceuticals
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BioSante Pharmaceuticals, Inc. (