BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.
"BioSante's LibiGel Phase III safety study continues," said Stephen M. Simes, BioSante president & chief executive officer. "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. 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, for example, 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. The study represents the largest data base of the safety of testosterone in women.
About LibiGel
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. These trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. Unfortunately, the placebo response in the two efficacy trials was overwhelming; and therefore, LibiGel's results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA-agreed 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.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante's other products include Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, which is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
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 the results of the two pivotal Phase III LibiGel efficacy trials, BioSante's plans, objectives, expectations and intentions with respect to its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante's decision whether to continue the safety study, and other statements identified by words such as "will," "continue," "could,""believes," "intends," "expects," "anticipates," "plans," "may," "potential," "projected," other words of similar meaning, derivations of such words and 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, additional analyses of data from the LibiGel efficacy trials and any other LibiGel clinical trials, including the safety study, may be inconsistent with previously announced results or previously conducted clinical trials or may produce negative or inconclusive results; there may be varying interpretations of data produced by clinical trials; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of clinical testing, the marketing success of BioSante's licensees or sublicensees and BioSante's future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante's product development programs and its need for and ability to obtain additional financing if needed. 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 and are based on BioSante's current beliefs and expectations.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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