Product will be launched in the U.S. during early 2011.
ProStrakan is eligible for a milestone payment of $12.5 million from Endo Pharmaceuticals as a result of FDA approving the testosterone replacement gel Fortesta (marketed as Tostran outside the U.S.). Endo is ProStrakan’s U.S. partner for Fortesta and plans to launch the transdermal gel in the U.S. during early 2011. FDA approval of Fortesta was based on data from a pivotal study in men with hypogonadism, which showed that 78% of participants using Fortesta achieved normal serum total testosterone levels by day 90.
Fortesta/Tostran is a transdermal 2% testosterone gel that utilizes a metered dose delivery system. The product was first launched in Europe in 2005, and is now marketed across the region. ProStrakan reported Tostran sales of £1.3 million (about $2 million) during the first half of 2010, up 27% on the equivalent period in 2009.
ProStrakan’s future in terms of structure and ownership remains uncertain. The firm has admitted it has been approached with respect to a potential takeover, and within the last couple of weeks inked a completely unrelated deal with Paladin Labs under which the latter assumed ProStrakan’s existing £50 million (about $79 million) debt facility, with conversion rights. The deal also gives Paladin an exclusive license to ProStrakan’s products for certain emerging territories.