Pharming sees Rhucin launch in Europe early next year

Pharming sees Rhucin launch in Europe early next year

	Published : Mon, 20 Aug 2007 15:35 By : Agencies Print this Story

AMSTERDAM (Thomson Financial) - Pharming Group NV said it expects to release its main product Rhucin onto the European market in early 2008, chief commercial officer Rein Strijker told Thomson Financial News.

Strijker was commenting after the Dutch bio-tech group said today it has gained positive results from an interim analysis of Rhucin -- which treats hereditary angioedema, a rare illness that causes uncontrolled swelling.

The commercial officer said Pharming still expects the European Medicines Evaluation Agency EMEA to approve the product in the fourth quarter, adding that the company was not 'banking' on fasttrack approval.

But EMEA approval before the end of the year will allow Pharming to launch its product in Europe 'definitely in early 2008', Strijker said.

Pharming also expects to complete clinical studies in the US in 6-10 weeks (end of September to early October), allowing it to apply for approval with the FDA shortly after.

Strijker declined to give a guidance on when the FDA filing will be lodged.

'After concluding clinical studies, you need to report and meet with the FDA and based on that meeting you would have to plan a submission. If they say they have everything they need, you can file immediately,' he said.

Strijker added that approval from the FDA usually occurs quicker than the EMEA -- which will have needed about a year and half to approve Rhucin before the final decision is made -- and that an answer from the FDA could be given 'well within a year' of the application being lodged.

Currently, there are no officially registered drugs used to treat angioedema, Strijker said, adding that 200,000 attacks of the illness are reported in Europe and the US combined each year.

He added that analysts have estimated that total market sales for treating the illness could amount to 500-600 mln eur per year in Europe and the US combined.

At 4.09 pm, Pharming shares were 24.77 pct higher at 2.77 eur.

Aaron Gray-Block; aaron.gray-block@thomson.com

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