BioSante Pharmaceuticals Initiates Phase III Study of LibiGel®
testosterone gel) in the Treatment of Female Sexual Dysfunction
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today that it has initiated a Phase III safety and efficacy trial of LibiGel® (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD). The double-blind, placebo-controlled Phase III trial will enroll approximately 360 surgically menopausal women for a six-month clinical trial, conducted under a Phase III protocol and investigational new drug application (IND) reviewed by and on file with the U.S. Food and Drug Administration (FDA).
“Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD)”
As previously announced by BioSante, treatment with LibiGel® in a Phase II study, significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II study 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 study was a double-blind, placebo-controlled study, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
“Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD)," said Stephen M. Simes, president and chief executive officer of BioSante.
“We are encouraged by the clinically significant improvement in sexual events with LibiGel treatment in the Phase II study,” said Michael C. Snabes, MD, PhD, a reproductive endocrinologist and Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology and BioSante’s key clinical development consultant. “Since there are no medications approved by the FDA for the treatment of this common disorder, there is significant demand by patients and their physicians. We are hopeful that if and when LibiGel is approved by the FDA that LibiGel treatment will be able to improve the sex lives of women with low sexual desire and activity.”
“We are pleased to be moving into Phase III clinical development of LibiGel. Female sexual dysfunction is underserved by the pharmaceutical industry today. LibiGel may help address this unmet medical need. We believe two Phase III safety and efficacy trials plus one year of safety data are the essential requirements for submission and approval by the FDA of a new drug application (NDA),” said Stephen M. Simes. “With the initiation of this Phase III LibiGel trial and our recent FDA approval of Elestrin™ (estradiol gel), this is a very exciting time for BioSante,” he added.
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.
BioSante's hormone product portfolio
In addition to LibiGel, BioSante recently received FDA approval for Elestrin™, a fast-drying gel formulation of bio-identical estradiol, in the treatment of moderate to severe vasomotor symptoms (hot flashes) in menopausal women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes. Elestrin will be launched in mid-2007 by Bradley Pharmaceuticals, Inc., under a marketing agreement between BioSante and Bradley.
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 (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel® (transdermal testosterone gel) in development for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including avian flu and biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. 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," "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 cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, the success of clinical testing, obtaining regulatory and other approvals and achieving market acceptance, 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 Forms 10-K and 10-Q, which discussion also is 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.