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UPDATE 1-UCB hails earlier-than-expected CHMP Neupro clearance

Fri Apr 25, 2008 2:59am EDT

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BRUSSELS, April 25 (Reuters) - Belgian pharmaceutical group UCB SA (UCB.BR) said it had won sooner than expected approval for its Neupro restless legs syndrome (RLS) drug by the Committee for Medicinal Products for Human Use (CHMP).

"This is earlier than expected ... this drug has a huge potential," a UCB spokeswoman said on Friday after the company announced CHMP's approval for the drug late on Thursday.

Recommendations for marketing approval by the CHMP are usually endorsed by the European Commission within a couple of months.

RLS is a chronic neurological disorder causing tingling or burning or sensations in the legs that can disturb sleep. It affects between 3 and 10 percent of the population, UCB said.

Neupro is a once-daily patch designed to provide drug delivery for 24 hours and is already used to treat Parkinson's disease.

UCB recalled batches of the drug in the United States last month after the clinical performance of some samples on the market was not satisfactory, prompting UCB to put its 2008 forecast under review.

UCB Chief Executive Roch Doliveux said on Thursday it would be some time before the drug returned to the U.S. market. He said UCB would update its forecast for 2008 when it delivers first-half results. (Reporting by Julien Ponthus; Editing by David Brunnstrom and David Holmes)



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