ProStrakan confident of US approval for key drug

Published on Thursday 15 May 2008 21:39

THE chief executive of one of Scotland's specialist drug companies has predicted that its latest hormone-based product will win approval from US regulators.

Wilson Totten, head of ProStrakan, claimed that approval by the Food and Drug Administration (FDA) for its testosterone gel should now be "a relatively straightforward process".

The Galashiels-based pharmaceutical company reported positive results from clinical trials in the US for its Fortigel product earlier this month.

A previous study using the drug resulted in some patients showing unacceptably high levels of testosterone and was not approved by the FDA.

But in the latest study, the results of which were reported earlier this month, ProStrakan agreed different dose levels with the FDA. As a result, all of the patients showed acceptable levels of the hormone.

In comments accompanying a strong trading statement yesterday, Totten said he believed that, given the agreement with the FDA over the terms of the latest trial, the approval process "should be relatively straightforward".

He said: "It's not guaranteed, the FDA can change their mind like any human being, but we have agreed with them what would be the terms of the trials, we've run the study and hit all its end points, so it should be a relatively straightforward process (to have the product approved]."

Totten added that the company now expects to re-file the drug for approval in the third quarter of this year.

ProStrakan already held the European rights to Fortigel – where it is sold as Tostran – but bought the US rights from Cellegy, in a distress sale at the end of 2006.

Under the deal, ProStrakan acquired the USA sales rights to Fortigel and another product, as well as buying its way out of royalty payments for sales in Europe, for $9 million (4.6m).

The gel has a 35 per cent market share in Sweden, while in Spain, where it was launched at the start of the year, it already has a 16 per cent market share.

In the US, the market for gel-based testosterone products is worth $550m a year.

"You can imagine what 20 per cent of a $550 million market would be for us," Totten said yesterday.

Totten made the comments as ProStrakan reported that sales in the four months to 31 April rose 38 per cent on the same period in 2007, although the strength of the euro contributed 8 per cent of that growth.

Shares were unchanged at 56p yesterday.