UCB also provided an update on the status of the US approval of CIMZIATM in the treatment of Crohn's disease. UCB has received a Complete Response Letter from the United States Food and Drug Administration (FDA) requesting additional information and clarification on data submitted in its Biologics License Application (BLA) for the approval of CIMZIATM in Crohn's disease.
"We have absolute confidence in both the efficacy and tolerability profile of CIMZIATM, and in gaining US approval" said Melanie Lee, Executive Vice President R&D for UCB. "We are extremely pleased by the rheumatoid arthritis results and will work closely with the FDA to clarify any questions that they have, or may have, regarding CIMZIATM for the treatment of Crohn's disease and rheumatoid arthritis."
About UCB
UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy / respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, UCB achieved revenues of EUR 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange.
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Enquiries, please contact:
Jean-Christophe Donck UCB Phone: +32 2 559 9835
Mareike Mohr UCB Phone +32 2 559 9264
Garry Daniels UCB Phone : +44 1753 777 116
SOURCE: UCB