Adjudicated Cardiovascular Events Continue to Be Lower Than Expected
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- 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.
In addition, BioSante sponsored a symposium entitled, “Sexual Quality of Life with Aging.” The moderator of the symposium was Steven R. Goldstein, MD, FACOD, CCD, NCMP, Professor of Obstetrics and Gynecology, New York University School of Medicine and the next president of NAMS. Jan L. Shifren, MD, NCMP, Associate Professor of Obstetrics, Gynecology, & Reproductive Biology at Harvard Medical School, and Director of the Menopause Program at Massachusetts General Hospital spoke on the “Prevalence of Sexual Function & Distress Across the Lifespan for Women.” Sheryl A. Kingsberg, PhD, Division Chief, Obstetrics & Gynecology, Behavior Medicine at the University Hospitals Case Medical Center, and Professor, Case Western Reserve University in Cleveland, Ohio covered the topic entitled, “Treatment Options for Postmenopausal Women With Sexual Dysfunction.”
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: www.biosantepharma.com.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release 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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INDUSTRY KEYWORDS: Seniors Women Health Biotechnology Cardiology Clinical Trials Oncology Pharmaceutical FDA Consumer