BioSante Pharmaceuticals reports that several institutional investors will purchase $15 million of securities in a registered direct offering to advance LibiGel, its Phase III candidate for hypoactive sexual desire disorder (HSDD). The commitment comes a few days after an FDA advisory panel unanimously voted against recommending approval of Boehringer Ingelheim’s HSDD therapy, flibanserin.
On June 18, the Reproductive Health Drugs Advisory Committee found that the risks linked to the drug outweighed the benefits. Side effects included dizziness, nausea, and fatigue, particularly with long-term daily use. And while flibanserin did significantly increase sexually satisfying events, it did not improve women’s desire.
At the time of the FDA Advisory Committee’s decision, BioSante commented that the recommendation would have no impact on its own ongoing development program or approval pathway for LibiGel. “There are important scientific differences between the way LibiGel and flibanserin work on the body and differences in their clinical development programs,” president and CEO, Stephen M. Simes, stated.
“The LibiGel safety and efficacy trials are being conducted under an SPA agreement with FDA, a level of agreement that the flibanserin program did not have. BioSante also is conducting a large safety study comparing LibiGel to placebo to show cardiovascular and breast cancer safety.”
BioSante expects to receive net proceeds of approximately $14.2 million from today’s registered direct offering after deducting placement agent fees and other offering expenses. The funding will be used primarily to progress LibiGel, a transdermal testosterone gel, with the aim of submitting an NDA in 2011.
“LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the FDA for this common and unmet medical need,” Simes says.
Under the securities purchase agreements, BioSante will sell an aggregate of approximately 7.1 million shares of its common stock and warrants to purchase up to approximately 3.55 million additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.50 of a share of common stock, will be sold for a purchase price of $2.1025. The warrants to purchase additional shares will be exercisable at $2.45 per share beginning immediately and will expire five years from the date that the warrants are issued.
Proceeds will also be used for general corporate purposes including seeking opportunities for its GVAX cancer immunotherapies, 2A/Furin, and other technologies. GVAX cancer vaccines use cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immunostimulant. The cells then are irradiated to prevent further cell division but remain metabolically active.
The company reports that it has multiple candidates in Phase I and Phase II trials. Studies are conducted primarily at Johns Hopkins Cancer Center and are sponsored/funded by The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, various philanthropies, foundations, and the NCI.
BioSante is working to get the clinical hold on its prostate cancer program lifted and Phase II trials restarted by the fourth quarter. Other cancer types being studied are chronic myeloid leukemia, acute myeloid leukemia, pancreatic, breast, and colorectal cancers, multiple myeloma, and melanoma.
BioSante’s other technologies include a vaccine adjuvant, a drug delivery platform, and transgenic milk-derived recombinant protein processing.