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Biotech / Medical : Sepracor-Looks very promising

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From: Icebrg4/16/2008 8:16:53 AM
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UCB to sue Synthon over alleged Xyzal patent infringement
April 16, 2008: 03:19 AM EST

BRUSSELS, Apr. 16, 2008 (Thomson Financial delivered by Newstex) -- Belgian healthcare group UCB S.A. said it will take legal action against Dutch group Synthon for allegedly infringing the patent on its antihistamine drug Xyzal.

UCB said it is filing a lawsuit in the U.S., together with American partner Sepracor (NASDAQ:SEPR) , claiming Synthon used the active Xyzal ingredient levocetirizine in the treatment of allergic rhinitis.

UCB said the move is a response to Synthon's statement at the end of March that it believes itself to be the 'single first filer' of an Abbreviated New Drug Application for the Xyzal drug product.

'As a result (of the filing) Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of the generic drug product,' Synthon said on its website.

The Hatch-Waxman Act allows generics to win U.S. Food and Drug Administration approval on the submission of bioequivalence studies and grants a period of additional marketing exclusivity to make up for the time a patented pipeline drug remains in development.

Xyzal is the successor to blockbuster drug Zyrtec, whose patent has expired.
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