Teva, BioSante Win U.S. Approval for Testosterone Therapy

February 15, 2012, 8:39 AM EST

By Molly Peterson

Feb. 15 (Bloomberg) -- BioSante Pharmaceuticals Inc. surged in early trading after the testosterone replacement therapy it developed for men won U.S. regulatory approval.

BioSante climbed 46 percent to $1.11 at 8:04 a.m. after the U.S. Food and Drug Administration announced the clearance yesterday. The transdermal gel, Bio-T-Gel, will be marketed by Teva Pharmaceutical Industries Ltd. of Petach Tikva, Israel, for men with low testosterone, a condition known as hypogonadism.

BioSante estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.

Hypogonadism can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.

BioSante also has an experimental testosterone product, LibiGel, a topical treatment applied to the arm for female sexual dysfunction. The company fell 77 percent, the most in 12 years, on Dec. 15 after the drug failed to work better than a placebo in two trials. BioSante said Jan. 31 that it would decide within 90 days whether to continue studying LibiGel.

--With assistance from Michelle Fay Cortez in Minneapolis. Editors: Bruce Rule, Chris Staiti

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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Teva, BioSante Win U.S. Approval for Testosterone Therapy

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