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UPDATE 1-Pharming on track for Rhucin EU marketing filing

Wed Jul 1, 2009 2:41am EDT

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* Says final study confirms positive Rhucin effects

* On track to file for EU approval in September

* No relapse, safety concerns in Rhucin-treated patients

(Adds details, background)

AMSTERDAM, July 1 (Reuters) - Dutch biotech firm Pharming (PHAR.AS) said it was on track to re-file a request for European Union marketing approval for its lead product, Rhucin, in September as it confirmed positive results from a final study.

The European Medicines Agency (EMEA) has twice rejected Pharming's application to market Rhucin, which treats hereditary angioedema, characterised by acute attacks of painful swelling of the skin, intestine, mouth and throat.

However, Pharming said on Wednesday it had completed the final analysis of randomised placebo-controlled clinical studies in Europe and in North America involving 70 patients.

None of the Rhucin treated patients experienced a relapse of symptoms in the same attack, Pharming said, adding no clinically relevant safety concerns were reported in either study.

"We believe that our current clinical database adequately supports the efficacy and safety of Rhucin, in single and repeated use, in acute attacks at all anatomical locations," Pharming Chief Operations Officer Bruno Giannetti said in a statement.

Pharming said it was on track to submit its European Union marketing authorisation application for Rhucin in September. A filing with the U.S. Food and Drug Administration (FDA) would follow after the European filing. (Reporting by Aaron Gray-Block; editing by Simon Jessop)



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