BioSante Pharmaceuticals To Present Validation Data Required for Development of LibiGel (transdermal testosterone gel) in the Treatment of Female Sexual Dysfunction
As per U.S. Food and Drug Administration (FDA) published guidance for Patient Reported Outcome (PRO) studies, the pivotal efficacy studies of LibiGel require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. BioSante has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire. BioSante worked with FDA's Division of Reproductive and Urologic Products and followed the FDA's guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of Sexual Events and Desire (ISED) was able to differentiate between women with HSDD and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p less than 0.001).
"We are pleased with these results," said Stephen M. Simes, BioSante's president & CEO. "Patient reported outcome tools are difficult to validate and these results allow us to confidently move forward with the pivotal efficacy studies for the development and potential approval of LibiGel in the treatment of female sexual dysfunction, an underserved market in the U.S. since no pharmaceutical product is approved for its treatment. BioSante is committed to the development of LibiGel for FSD which may ultimately be the first product approved by the FDA for this treatment in the U.S."
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 by early 2008.
In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be 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, BioSante will continue to follow the women enrolled in the study for an additional four 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 less than 0.0001); this increase also was significant versus placebo (p less than 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 Elestrin(TM) (estradiol gel) developed through 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(R) (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel(TM), 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, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration and for aesthetic medicine. 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 "may," "will," "should," "would," "likely," "expects," "anticipates," "estimates," "believes," "plans," "hopes," 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 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.
BioSante Pharmaceuticals, Inc.
Phillip Donenberg, (847) 478-0500
Posted: October 2007