ProStrakan plans US drugs trials

Published on Tuesday 21 August 2007 01:19

PROSTRAKAN, the Borders-based pharmaceutical specialist, has begun recruiting for final stage trials in the US for a drug tipped to make it millions, and potentially alleviate excruciating pain, writes Hamish Rutherford.

The Galashiels-based company said it had begun the process of gathering 246 patients suffering chronic anal fissures to trial its drug Cellegesic - branded Rectogesic in Europe - for a major US trial.

The painful condition is believed to affect thousands of people across the world and ProStrakan holds the European and US rights to sales of a pain-relieving treatment.

It also announced it had begun searching for patients to take part in a trial for Fortigel, branded Tostran in most of Europe - a treatment for male hypogonadism. Both drugs have been identified by analysts as having the potential to generate annual sales of more than $100 million (50.4m).

A spokesman for ProStrakan said the trials were "pivotal" for the company. It is expected results will be available in the first half of next year, after which the company will apply for registration from the US Food and Drug Administration (FDA), and potentially be launched for sale in the first half of 2009.

Chief executive Wilson Totten said: "With the US FDA approval process for Sancuso [a chemotherapy drug] already under way and these two new US products in late stage development, I am confident that, by 2009, we will have a substantial US business that will contribute significantly to the success of ProStrakan."