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GEN News Highlights : Feb 16, 2012

BioSante, Teva Win FDA Nod for Male Hypogonadism Therapy

Sales may be delayed due to a confidential patent settlement with Abbott.

FDA has approved BioSante Pharmaceuticals’ Bio-T-Gel for the treatment of male hypogonadism, or low testosterone levels. It is a once-daily transdermal testosterone gel.

Bio-T-Gel was licensed to Teva Pharmaceuticals for late-stage development and marketing. Shortly after filing of the Bio-T-Gel NDA by Teva, Abbott Pharmaceuticals sued Teva for patent infringement of its approved testosterone product AndroGel. The patent litigation was settled in December, 2011, but terms of the settlement have not been disclosed.

Teva may delay sales of the drug by at least a year under this patent settlement, according to Graig Suvannavejh, an analyst at Jefferies & Co. “Clearly, any delay in Bio-T-Gel’s commercial launch would necessarily push out the timing of sales-related royalties” to BioSante, Suvannavejh said in a note to investors.

BioSante also has a Phase III testosterone product for female sexual dysfunction, LibiGel, which is a topical treatment applied to the arm. In December, however, the company reported that the drug did not work better than placebo in two trials. The company lost 77% of its value on this news. On January 31, it said it would decide on the fate of LibiGel within 90 days.