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BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced today that it has initiated its Phase III safety study of LibiGel. This study design is a result of an agreement with the U.S. Food and Drug Administration (FDA) on key FDA requirements for the development and approval of LibiGel in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD).
The LibiGel Phase III safety study protocol was finalized after meetings and discussions with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III (statistics). The primary focus of BioSante's LibiGel Phase III safety study is to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA. The final study protocol seeks to show the relative safety of using a low dose testosterone versus placebo in the treatment of FSD in menopausal women.
"We are quite excited by the initiation of the LibiGel Phase III safety study," said Stephen M. Simes, BioSante's president & CEO. "We are confident that the study covers the depth and scope of study requested by the FDA. The study initiation and the protocol agreement with FDA reaffirms our long-held belief that development of LibiGel will be both reasonable and affordable from both the financial and timeline aspects, especially considering the potential size of the FSD market and the potential sales of LibiGel, if and when approved. We have received written FDA meeting minutes that provide us with a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. In the U.S., no pharmaceutical product is approved for the treatment of FSD making this a truly unserved market. BioSante is committed to the development of LibiGel which if approved by the FDA could be the first product approved for this treatment in the U.S."
The Phase III safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. A new drug application (NDA) can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.
The LibiGel safety study will track a list of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least one cardiovascular risk factor including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.
In addition to the Phase III cardiovascular safety study, BioSante will conduct two Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD, one of which has been initiated, 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 trial already initiated is being conducted under a Phase III protocol reviewed by and on file with the FDA and in which written FDA comments have been received and incorporated. BioSante hopes to initiate the second Phase III efficacy trial in early 2008.
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.
LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
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 LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD) and 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. 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. 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. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications. 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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