UCB announces submission of Kremers Urban's methylphenidate HCl ER bioequivalence study results to FDA 

• Kremers Urban has submitted to FDA final results of new bioequivalence studies 
• At this time, Kremers Urban plans to continue making its product available to patients
• UCB’s intention to divest Kremers Urban is unchanged

Brussels (Belgium), June 8, 2015 – 19:00 (CET) – UCB announced today that its US specialty generics subsidiary, Kremers Urban Pharmaceuticals Inc. ("KU"), has submitted to the U.S. Food and Drug Administration (FDA) the final results of new bioequivalence studies designed to assess whether KU’s methylphenidate hydrochloride extended-release tablets meet the criteria for establishing bioequivalence to the reference drug (Concerta®, registered trademark of ALZA Corporation) that are recommended in a revised draft guidance issued by FDA in November 2014. 

KU has requested a meeting with FDA to discuss the results and will continue to work with FDA in the best interests of patients. At this time, KU plans to continue making its BX-rated product available to patients. 

KU announced in November 2014 that FDA had requested additional bioequivalence testing based on the agency’s revised draft guidance.

UCB’s intention to divest its US specialty generic business remains unchanged. 

For further information, UCB:
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com

Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots 
Media Relations, UCB  T+32.2.559.92.64 
Laurent.schots@ucb.com 

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

About Kremers Urban Pharmaceuticals Inc. (KU)
KU is the generic subsidiary of UCB in the US. It is a specialty generic pharmaceutical company focused on generic products. To learn more visit www.kremersurban.com.

CONCERTA® is a registered trademark of ALZA Corporation.

Forward looking statements 
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