Battered BioSante soars on FDA approval for testosterone gel

An embattled BioSante Pharmaceuticals ($BPAX) gained some much needed wind at its back with reports that the FDA has approved its testosterone replacement therapy for men. Just two weeks ago the biotech company slashed its staff by 25% after reporting a pair of critical late-stage failures for its female libido gel. But news of the approval for its treatment for low testosterone swelled the value of its battered shares by 59% early today.

Teva ($TEVA) acquired the marketing license on Bio-T-Gel, a transdermal formulation that can be used now to treat hypogonadism, the medical term for low testosterone, in a pact that included an upfront payment of a mere $1.5 million. BioSante claims that the approval will open the doors on a U.S. market worth a blockbuster $1 billion-plus, where it will gain a royalty on sales and milestones. Some 5 million men in the U.S. suffer from the condition.

Bloomberg got the word of the approval out first, saying that the FDA confirmed the news in an e-mail. Then Reuters and others confirmed the report, though no official statement has been released yet.

BioSante had whetted investors' appetite for its stock with the prospects awaiting its late-stage "female Viagra" treatment LibiGel. But many of those same investors were burned badly after the treatment failed to outperform a placebo in Phase III, triggering a plunge in its share price.  

- here's the story from Bloomberg
- read the Reuters report