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Endo to commercialize Fortesta in the U.S.

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CHADDS FORD, Pa. A U.S. drug maker has signed an agreement with a company in the United Kingdom to commercialize a testosterone gel in the United States.

Endo Pharmaceuticals announced Wednesday the agreement, with U.K.-based ProStrakan Group, regarding Fortesta (testosterone gel 2%).

Fortesta is a transdermal gel for testosterone replacement therapy in men with male hypogonadism, using a metered-dose delivery system designed to allow dose adjustment. The Food and Drug Administration is currently reviewing ProStrakan’s approval application for the drug.

Under the terms of the agreement, Endo will make an upfront payment of $10 million to ProStrakan and up to $40 million more in milestone payments by the end of 2010, additionally paying $160 million after reaching various sales targets. ProStrakan will supply Fortesta exclusively to Endo for sale in the U.S. market.

“We are committed to advancing men’s health with effective new medicines,” Endo CEO David Holveck said in a statement. “Being in a position to potentially offer ths treatment, alongside our new long-acting injectable testosterone product, will help fill an important gap in testosterone replacement.”

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