BioSante Pharmaceuticals, Inc. (BPAX)

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BioSante Pharmaceuticals Announces Positive LibiGel® Phase III Safety Data Review and Decision to Conclude the Safety Study
BY Business Wire
— 9:00 AM ET 09/04/2012

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- BioSante Pharmaceuticals, Inc. (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.