BioSante Gains on Approval of Testosterone Gel: Chicago Mover
February 23, 2012, 4:45 PM ESTBy Molly Peterson
(Updates with comments from BioSante in fourth paragraph.)
Feb. 15 (Bloomberg) -- BioSante Pharmaceuticals Inc. surged the most in 10 years after the testosterone replacement therapy it developed for men won U.S. regulatory approval.
BioSante gained 38 percent to $1.05 at 12:32 p.m. after climbing as much as 62 percent in the biggest intraday increase since November 2001. The U.S. Food and Drug Administration announced yesterday that it approved the transdermal gel, Bio-T- Gel. The product will be marketed by Teva Pharmaceutical Industries Ltd. of Petach Tikva, Israel, for men with low testosterone levels, 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.
“We are pleased that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels,” Stephen Simes, BioSante’s president and chief executive officer, said today in a statement. “We are confident that Teva has the commercialization and marketing expertise to implement a successful launch, and we look forward to Bio-T-Gel reaching the market.”
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: Andrew Pollack, Angela Zimm
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
