BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study, and also has begun to explore new product development projects through in-licensing and mergers and acquisitions. In addition, a full review of the GVAX cancer vaccine portfolio is underway.
"We are committed to rebuilding BioSante in order to maximize value for our company and stockholders. Although we are disappointed about the recently reported LibiGel clinical efficacy results, we are optimistic about the future of BioSante," said Stephen M. Simes, BioSante president & chief executive officer. "We thank our employees and stockholders for their loyalty and understanding."
Cash resources: As of December 31, 2011, BioSante had approximately $57 million in cash and cash equivalents and $20.8 million in principal amount of convertible notes outstanding, due on May 1, 2013. The projected burn rate for 2012 is approximately $2.5 million per month, assuming the LibiGel safety study continues. In order to conserve cash, a reduction of 21 full-time equivalents of employees and contractors has been implemented, representing 25 percent of BioSante's headcount. In addition, if the safety study is halted, the monthly burn rate will decline to approximately $1 million per month, pending other corporate product development and activities.
LibiGel: BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
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 LibiGel Phase III safety study continues and will continue during further analysis of the LibiGel efficacy data and until a final strategic decision has been made. It is BioSante's objective to meet with the FDA to determine the best path forward, and to make a decision whether to continue the LibiGel safety study within the next 90 days. Appropriate cost savings have been instituted to minimize the continuing cost of the safety study.
Bio-T-Gel(TM): A Bio-T-Gel (male testosterone gel) new drug application (NDA) was submitted to the FDA by BioSante's licensee Teva Pharmaceuticals USA, Inc. in the first quarter of 2011. Bio-T-Gel is assigned a PDUFA date of February 14, 2012. Soon after the NDA was submitted, Teva was sued for patent infringement by subsidiaries of Abbott Laboratories asserting patent infringement against Abbott's patent for AndroGel (testosterone gel). That litigation was settled in December 2011; however, the terms of the agreement have not been publicly disclosed. BioSante will issue Bio-T-Gel updates as available and appropriate.
GVAX Cancer Vaccines: BioSante's cancer vaccines are in development for the treatment of several different types of cancer including melanoma, pancreatic, breast and prostate cancer. Currently, there are 17 Phase I and Phase II clinical studies ongoing, primarily being conducted at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The studies are being funded by various sources, including certain foundations and BioSante licensees. BioSante's objective is to help facilitate further studies and commercialization in order to bring important cancer therapies to patients in need and to maximize the value of the cancer vaccine portfolio to BioSante stockholders.