According to Endo Pharmaceuticals (Endo), Fortesta is a patented 2% testosterone transdermal gel for testosterone replacement therapy in male hypogonadism. It utilizes a metered dose delivery system designed to permit accurate dose adjustment to individual patient requirements.
Endo claims that the new product is in registration in the US, where the Food and Drug Administration (FDA) is currently reviewing ProStrakan’s new drug application submission.
Under the terms of the agreement, Endo has agreed to make an upfront payment of $10m to ProStrakan (with the potential for up to $40m more in milestone payments by the end of 2010), for regulatory approval and the achievement of certain commercial milestones.
Endo has also agreed to pay ProStrakan an additional $160m upon the achievement of certain sales targets. ProStrakan will exclusively supply Fortesta to Endo Pharmaceuticals in the US for an undisclosed supply price.
David Holveck, president and CEO of Endo, said: 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. This treatment option is synergistic with our recent therapeutic expansion and strengthens our portfolio in urology and endocrinology.