BioSante Gains on Approval of Testosterone Gel: Chicago Mover

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February 15, 2012, 5:09 PM EST

By Molly Peterson

(Updates with comment from analyst in fifth paragraph.)

Feb. 15 (Bloomberg) -- BioSante Pharmaceuticals Inc. rose 27 percent after the testosterone replacement therapy it developed for men won U.S. regulatory approval.

BioSante gained 21 cents to close at 97 cents in New York. 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.”

Teva may delay sales of the drug by at least a year under a confidential patent settlement the company reached with Abbott Laboratories in December, said Graig Suvannavejh, an analyst at Jefferies & Co. in New York.

Delayed Royalties

“Clearly, any delay in Bio-T-Gel’s commercial launch would necessarily push out the timing of sales-related royalties” to BioSante, Suvannavejh said today in a note to investors.

Abbott won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the product’s patent. Abbott, of Abbott Park, Illinois, and Teva settled the litigation in December without disclosing the terms.

“We do not disclose launch plans,” Denise Bradley, a Teva spokeswoman, said today in an e-mail. “However, it is public knowledge that we entered into a confidential settlement agreement with Abbott with an undisclosed future entry date.”

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 and Catherine Larkin in Indianapolis. 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

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BioSante Gains on Approval of Testosterone Gel: Chicago Mover