LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced a corporate update.
Corporate development: In light of the recently announced top-line results from BioSante’s two pivotal Phase III LibiGel® (testosterone gel) efficacy trials, BioSante is evaluating its corporate strategy. 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™: 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.
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 according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). 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 Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. 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 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, BioSante’s future burn rate, and other statements identified by words such as “will,” “continue,” “could,” “believe,” “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 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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