Gel formulation of testosterone is being developed for hypoactive sexual desire and female sexual dysfunction.
BioSante Pharmaceuticals received commitments from several institutional investors to purchase $25.1 million of securities in a registered direct offering. BioSante expects to receive net proceeds of approximately $23.8 million.
Proceeds from the transaction will be used for general corporate purposes including continuing to fund BioSante’s LibiGel Phase III clinical study program. LibiGel is a gel formulation of testosterone that is being investigated in Phase III as a treatment for hypoactive sexual desire disorder (HSDD) and in Phase II for female sexual dysfunction (FSD).
While a few groups have been lobbying against HSDD and FSD, FDA has stated that both so-called disorders are true conditions that women experience with measurable endpoints that can be evaluated and which deserve therapeutic options. BioSante and other companies explain that lower levels of testosterone is linked to decreased libido.
LibiGel is designed to be quickly absorbed through the skin after a once-daily application on the upper arm. It reportedly delivers testosterone to the bloodstream evenly over time. The goal of testosterone treatment of women complaining of HSDD is to increase the serum testosterone toward the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder.
Palatin, another firm with an FSD treatment in trial, received $21.1 million through a public offering just two days ago. Its drug, called bremelanotide, belongs to a class of therapies called melanocortin agonists. It has shown initial positive results in a Phase IIa study evaluating bremelanotide in premenopausal women.
Commenting on BioSante’s registered direct offering, Stephen M. Simes, BioSante’s president and CEO, says, “This additional funding provides us with added financial power to continue to fund our ongoing LibiGel Phase III clinical study program. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women.
“We recently announced completion of enrollment in the first of the two LibiGel Phase III efficacy trials and expect to announce completion of enrollment in the second in the near future.” These two studies are designed as double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six months of treatment. In addition, BioSante will conduct another late-stage trail with naturally menopausal women. The company anticipates filing an NDA this year.
Under the securities purchase agreements, BioSante will sell an aggregate of about 12.2 million shares of its common stock and warrants to purchase up to roughly 4.0 million additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.33 of a share of common stock, will be sold for $2.0613.
The warrants to purchase additional shares will be exercisable at $2.25 per share beginning immediately and will expire three years from their date of issuance.