ProStrakan announces positive results from Fortigel study

Source: Exec

Date :09/05/2008 13:50:25

ProStrakan Group Plc, the international pharmaceutical company, announced positive results from the pivotal US clinical program on Fortigel, its testosterone replacement treatment.

The Group expects to re-file Fortigel with the FDA in the third quarter of 2008, having demonstrated that the product was able to maintain adequate testosterone levels within the parameters agreed with the FDA.

US market

Fortigel is a patented two percent testosterone transdermal gel which uses a system that permits dose adjustment to individual patient requirements.

An estimated six percent to twelve percent of men over the age of 40 have clinically low testosterone which can be alleviated through replacement therapy.

The product forms an important part of ProStrakan’s commercial strategy in Europe and the US. In 2007, the total US testosterone market was $660 million, representing an increase of seventeen percent compared to one year earlier.

Dr Wilson Totten, Chief Executive of Prostrakan, said, “Fortigel would be the second US product for ProStrakan, following the planned launch of Sancuso later this year, subject to regulatory approval.”

He added, “We are now well on track with our strategy to grow a significant US specialty pharmaceutical business, in addition to our European infrastructure, through which we can market our range of new medicines designed for easier patient use.”

May 09, 2008