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UCB's Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended release methylphenidate hydrochloride
Date:7/10/2013

BRUSSELS and PRINCETON, N.J., July 10, 2013 /PRNewswire/ -- - regulated information - UCB announced today that Kremers Urban Pharmaceuticals Inc. (KU), its U.S. subsidiary focused on specialty generics, received approval from the U.S. Food and Drug Administration (FDA) for 18mg and 27mg extended release methylphenidate hydrochloride product, for which Concerta® is the reference listed drug product. KU has begun launch operations and supplying the US-market with the product. KU also received tentative approval for the 36mg and 54mg. KU will be eligible for final approval after exclusivity expiration in September 2013.

KU's extended release methylphenidate hydrochloride product is bioequivalent to Concerta QD® marketed by ALZA Corporation (a unit of Johnson & Johnson). Each tablet is designed to be effective for 12-hours.

In September 2011, KU announced that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product. The settlement allows Kremers Urban to commercially launch its methylphenidate ANDA product under the existing ALZA Corporation patents.

The launch of KU's new generic product was already considered in UCB's 2013 financial guidance.

For further information

Antje Witte, Investor Relations, UCB
T +32 2 559 9414,
antje.witte@ucb.com

Alexandra Deschner, Investor Relations, UCB
T +32 2 559 9683,
alexandra.deschner@ucb.com

France Nivelle, Global Communications, UCB
T +32 2 559 9178,
france.nivelle@ucb.com
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SOURCE UCB
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