Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it has signed an agreement with U.K.-based ProStrakan Group plc (LSE: PSK) for the exclusive right to commercialize FORTESTA(TM) (testosterone gel) 2 percent in the United States.
FORTESTA, a patented 2 percent testosterone transdermal gel for testosterone replacement therapy in male hypogonadism, utilizes a metered dose delivery system designed to permit accurate dose adjustment to individual patient requirements. This product is in registration in the U.S., where the Food and Drug Administration (FDA) is currently reviewing ProStrakan's New Drug Application submission.
Under the terms of the agreement, Endo Pharmaceuticals has agreed to make an upfront payment to ProStrakan of $10 million, with the potential for up to $40 million more in milestone payments by the end of 2010 for regulatory approval and the achievement of certain commercial milestones. Endo Pharmaceuticals has also agreed to pay ProStrakan an additional $160 million upon the achievement of certain sales targets. ProStrakan will exclusively supply FORTESTA to Endo Pharmaceuticals in the U.S. for an undisclosed supply price.
"We are committed to advancing men's health with effective new medicines. Being in a position to potentially offer this treatment, alongside our new long-acting injectable testosterone product, will help fill an important gap in testosterone replacement," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "This treatment option is synergistic with our recent therapeutic expansion and strengthens our portfolio in urology and endocrinology."