Firm’s lead product is LibiGel, a testosterone gel in Phase III for hypoactive sexual desire disorder.
BioSante Pharmaceuticals received commitments from several institutional investors to purchase $18 million of securities in a registered direct offering. BioSante expects to receive net proceeds of approximately $16.9 million after deducting placement agent fees and other offering expenses.
BioSante will sell an aggregate of approximately 10.6 million shares of its common stock and warrants to purchase up to approximately 5.3 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 $1.70, while its closing price on the last full trading day of Thursday, December 23, 2010, was $1.575. The warrants to purchase additional shares will be exercisable at an exercise price of $2.00 per share and will expire five years from the date that the warrants are issued.
“This additional funding from these high-quality biotechnology institutional investors provides us with a strong cash position as we close out the year, ensuring our ongoing focus on our LibiGel® Phase III clinical study program,” says Stephen M. Simes, BioSante’s president and CEO. “Our objective is to submit a new drug application to the U.S. Food and Drug Administration by the end of 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.”
LibiGel is a transdermal testosterone gel designed to be quickly absorbed through the skin after a once-daily application on the upper arm. Two Phase III double-blind, placebo-controlled trials are each enrolling approximately 500 surgically menopausal women for six months of treatment.
Proceeds from the transaction will also be used to seek opportunities for the company’s GVAX cancer vaccines and other technologies. The GVAX pipeline was obtained through the $38 million buy-out of Cell Genesys in June 2009. BioSante bought the company to gain financial resources that would help LibiGel development and said at the time simply that GVAX development would be evaluated.
Cell Genesys’ stock and performance was struggling for about a year before the merger. In August 2008, the firm reported more deaths in the GVAX treatment arm of a Phase III study in prostate cancer compared to those getting Taxotere plus prednisone. Subsequent analysis of another late-stage trial found that it wouldn’t meet its primary endpoint.
Other products in BioSante’s development pipeline are Bio-T-Gel™, a Phase III testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II development.