BioSante Pharmaceuticals, Inc. to Present LibiGel Safety Update at ENDO Annual Meeting
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Jun 18, 2010 - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), will present a LibiGel safety update at the 2010 Annual Meeting of the Endocrine Society (ENDO), being held from June 19-22, 2010 in San Diego, California.
Michael C. Snabes, MD, PhD, BioSante's vice president of clinical development, will give a presentation entitled, “Low Cardiovascular Event Rate in Post-menopausal Women with Increased Cardiac Risk: Findings from the Ongoing Blinded LibiGel (testosterone gel) Cardiovascular and Breast Cancer Safety Study,” on Sunday June 20, 2010. The update will include the results of the third unblinded review of safety data, which included 1,500 women-years of exposure, by the independent Data Monitoring Committee of the LibiGel Cardiovascular and Breast Cancer Safety Study.
BioSante is in Phase III clinical development of LibiGel for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women under an FDA-approved SPA (Special Protocol Assessment). BioSante is enrolling women in three Phase III clinical studies with a new drug application (NDA) planned for 2011. “There still is no FDA approved pharmaceutical product for the treatment of HSDD and it is clear from the extensive off-label use of testosterone products for HSDD, that women need an approved therapy. We believe LibiGel can be the first product to market for this unmet medical need,” said Dr. Snabes.
The ENDO Annual Meeting features over 200 scientific sessions covering the full breadth of endocrinology—from basic and translational research to clinical practice. The ENDO 2010 scientific program includes 16 Plenary lectures, 140 Case Management Forum & Meet-the-Professor sessions and 78 Symposia—a total of more than 350 presentations from some of the world's leaders in endocrine research & care. With over 7,500 attendees and 2,500 abstracts presented, ENDO offers an excellent venue for scientific exchange.
LibiGel® is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials 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 trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement.
LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. 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.
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™), as 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: 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 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.
Posted: June 2010