BioSante Pharmaceuticals, Inc. to Host LibiGel(R) R&D Event in New York City
The LibiGel R&D Event will include presentations by independent experts in the fields of FSD and testosterone therapy, and BioSante's management will speak about the LibiGel Phase III clinical development progress. The independent experts' presentations include:
"Hypoactive Sexual Desire in Postmenopausal Women," by Sheryl Kingsberg, PhD - Chief, Division of Behavioral Medicine, University Hospitals Case Medical Center, MacDonald Women's Hospital; Professor of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio.
"Update on Testosterone Safety in Women," by Glenn D. Braunstein, MD - Chairman, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
Interested parties may access the presentation slides and an audio recording after the event on BioSante's website at www.biosantepharma.com.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). Enrollment has been completed in the two on-going Phase III efficacy trials which are double-blind, placebo-controlled trials of approximately 500 surgically menopausal women each. 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.
BioSante also is conducting a Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled over 3,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors 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 CV events. The incidence of breast cancer also is being tracked over the course of the study 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's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. 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 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. Additional information is available online at:
http://www.biosantepharma.com
For more information, please contact:
For Media:
McKinney Chicago
Alan Zachary
phone: (312) 506-5220
For Investors:
The Trout Group LLC
Tricia Swanson
E-Mail: tswanson@troutgroup.com
Phone: (646) 378-2953