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UPDATE 1-EU lifts restrictions on UCB's Neupro

Published 06/29/2009, 03:16 AM
Updated 06/29/2009, 03:24 AM
UCB
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BRUSSELS, June 29 (Reuters) - Pharmaceutical group UCB said the European Commission has lifted restrictions on its Parkinson's disease drug Neupro, and that its talks with U.S. regulators to once again market the drug there are ongoing.

The European Union has also approved Neupro for adults with restless leg syndrome, Belgium's UCB said in its statement on Monday.

In 2008, UCB sold 58 million euros ($81.19 million) of Neupro, before crystallisation problems were discovered and it was removed from the U.S. market in March 2008 and restricted in June 2008 to European patients already on it, a UCB spokeswoman told Reuters.

She added while Neupro was still not marketed in the U.S., UCB was in ongoing talks with the U.S. Federal Drug Administration.

In May, the European Union's drug watchdog recommended the commission -- the 27-nation bloc's executive, regulatory and legislative branch -- lift the limits, saying UCB had established a cold-chain supply system that met quality standards.

UCB shares traded up 1.5 percent at 2.94 euros as of 0709 GMT. ($1=.7143 Euro) (Reporting by Anne Jolis and Ben Hirschler; Editing by Jon Loades-Carter)

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