A BORDERS-BASED company's hopes of expanding its sales in America next year have been boosted by positive test results for one of its pharmaceutical products.
ProStrakan said yesterday that pivotal clinical trials – approved by the US drugs watchdog – for Fortegel, a testosterone gel applied to the skin, had been successful.
Prior to ProStrakan buying Fortegel, the US Food and Drugs Administration deeme
d it "non- approvable" after some patients in an earlier trial showed testosterone levels above acceptable limits.
But all patients in the latest study, completed in March, were within the acceptable parameters, the company said yesterday, adding that it expects to re-file Fortigel with the FDA in the third quarter of 2008.
While analysts said the test results did not provide certainty of regulatory approval, the trial, which required special dispensation from the FDA, was clearly positive.
Analysts at PiperJaffray said that, owing to the regulatory uncertainty over the gel, forecasts for the company had not included US sales of Fortegel.
Success for the gel with FDA – which will now have the final say – could mean "significant upside to our forecasts".
PiperJaffray, which has a target price of 100p on the shares, said ProStrakan management had indicated the treatment could one day generate sales of $100 million a year.
The gel is aimed at tackling male hypogonadism, characterised by reduced libido, loss of muscle mass, bone density and diminished energy levels. Studies suggest up to 12 per cent of men over the age of 40 may suffer from the condition.
The testosterone replacement market in the US is estimated to be worth around $660m a year, compared with around 50m in Europe.
Fortegel, which contains 2 per cent testosterone, is already sold in Europe as Tostran and, subject to regulatory approval, ProStrakan wants to have it on sale in the USA in the second half of 2009.
The company is planning to launch sales in the USA, the world's biggest market, later this years with Sancuso, an anti-nausea patch for chemotherapy patients.
Chief executive Wilson Totten said yesterday: "Fortigel has the potential to become a major product for ProStrakan in the US, with subject to approval, launch in the US mid 2009."
The full article contains 373 words and appears in The Scotsman newspaper.
