LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that the independent Data Monitoring Committee (DMC) has completed the ninth unblinded review of the LibiGel Phase III cardiovascular events and breast cancer safety study. 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.
The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular (CV) events, as well as the incidence of breast cancer. At the time of this DMC review, there have been 53 adjudicated CV events, with a lower than anticipated event rate of approximately 0.72 percent. In the same population of subjects, there have been 27 breast cancers reported, a rate of approximately 0.37 percent, which is in line with the expected rate based on the ages of the subjects enrolled in the study. At this time, BioSante remains blinded to all data.
Given this latest review during which no specific or general safety issues were raised, and after extensive consideration, BioSante also announced the conclusion of the LibiGel Phase III safety study effective immediately. Prior to the initiation of the LibiGel safety study in 2008, the FDA advised BioSante that subjects in the cardiovascular event and breast cancer safety study had to have a minimum average exposure in the safety study of 12 months prior to submitting a LibiGel new drug application (NDA), and prior to a potential FDA approval of LibiGel. At this time, subjects have been in this study for an average time of 24.5 months; more than 3,200 subjects have been in the study for more than one year and over 1,700 subjects have been enrolled for more than two years. With this ninth positive unblinded review of the study by the DMC, and over 7,300 women-years of exposure, BioSante believes that adequate safety data of LibiGel use in menopausal women has been obtained.
“We are very pleased with this ninth DMC review of our LibiGel Phase III safety study. Based on this latest DMC review, the long term exposure to LibiGel in the safety study, and other considerations, we believe that we have sufficient exposure to establish pre-approval LibiGel safety and conclude the study,” stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
"The LibiGel Phase III safety study conducted by BioSante is the largest testosterone trial of its kind in men or women, and we have accumulated a large amount of safety data over many years. In addition to our careful consideration of information to date, and previous FDA communications, we believe that the LibiGel safety study will provide the FDA with strong evidence that LibiGel is safe for use in menopausal women, and concluding the study at this time will result in significant on-going cost savings to BioSante,” said Stephen M. Simes, BioSante’s president and chief executive officer.
In addition, BioSante is continuing protocol development of the two new LibiGel Phase III efficacy trials, and intends to provide additional trial design information and timing of trial initiation as appropriate. As stated previously, BioSante intends to apply for an FDA Special Protocol Assessment (SPA) agreement prior to initiating the efficacy trials. It is expected that any new efficacy trial will include the same FDA-required efficacy endpoints as prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire. The Company targets an FDA SPA agreement by first quarter 2013.
About LibiGel
LibiGel is a testosterone gel in Phase III development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Two Phase III efficacy trials of LibiGel that enrolled 1,172 subjects and a cardiovascular (CV) events and breast cancer study that enrolled 3,656 subjects have been completed. The two completed efficacy trials were double-blind, placebo-controlled trials in surgically menopausal women each for six-months of therapy. In the two completed Phase III efficacy trials, LibiGel performed as predicted based on previous experience with testosterone products for FSD, including an increase in satisfying sexual activity and sexual desire and a decrease in distress. However, the placebo response in the two efficacy trials was greater than expected; and therefore, LibiGel´s results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA special protocol assessment (SPA) agreement. BioSante is developing a protocol for two new LibiGel Phase III efficacy trials. 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 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. The LibiGel safety study tracked 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 has been tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
About BioSante Pharmaceuticals, Inc.
BioSante’s corporate strategy is to develop high value medically-needed pharmaceutical products and to implement strategic alternatives with respect to its products and its company, including licenses, business collaborations and other business combinations or transactions with other pharmaceutical and biotechnology companies. 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 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 an FDA-approved testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product, Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, is 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 BioSante’s plans with respect to the LibiGel clinical development program, anticipated cost savings as result of the conclusion of the safety study and other statements identified by words such as “plans,” “intends,” "anticipates," “continues," "believes," "expects," "may," "could," “should,” “will,” “targets,” 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other 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 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 quarterly report 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.