BioSante Pharmaceuticals Presents LibiGel® Clinical Study Update at North American Menopause Society Meeting
LINCOLNSHIRE, Illinois (October 11, 2010) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) presented a LibiGel clinical study update at the 21st Annual Meeting of The North American Menopause Society (NAMS) on October 8, 2010, with more than 1,000 experts and practitioners in menopause and women’s health in attendance.
Michael Snabes, MD, PhD, BioSante’s senior vice president of medical affairs, presented an update entitled, “LibiGel® (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events.” LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
Dr. Snabes presented data, based on approximately 2,300 women in the safety study for an average of approximately 10.5 months each, showing there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent. “If testosterone increased CV disease, we would expect to see a higher CV event rate, especially since the study subjects are at the higher end of cardiovascular risk for the intended treatment population. 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, also referred to as FSD,” stated Dr. Snabes.
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, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: biosantepharma.cdmail.biz.
For more information please contact:
Harris D. McKinney, Inc.
The Trout Group LLC
For information about participating in the LibiGel clinical studies call or visit the following: