UCB S.A.
UCB S.A.: UCB announces positive results from two new phase III studies in rheumatoid arthritis and provides update on the status of US approval for CIMZIA(TM) in the treatment of Crohn’s disease
UCB S.A. / Miscellaneous Corporate news transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- UCB S.A. 60 Allée de la Recherche, B-1070 Brussels (Belgium) Press Release UCB announces positive results from two new phase III studies in rheumatoid arthritis and provides update on the status of US approval for CIMZIA(TM) in the treatment of Crohn’s disease Brussels (Belgium) - December 22, 2006 – 6.30 pm CET: UCB today announced positive top-line results for signs and symptoms from two new phase III studies for CIMZIA(TM) (certolizumab pegol), the first Fab’ fragment anti-TNF (Tumor Necrosis Factor), in the treatment of rheumatoid arthritis. In both the RAPID 1 (027) and RAPID 2 (050) studies CIMZIA(TM), in combination with methotrexate, demonstrated superiority to placebo, and a statistically significant improvement in the signs and symptoms of rheumatoid arthritis as measured by all American College of Rheumatology (ACR) scores: ACR20, 50, and 70. Further details on the results from the RAPID studies, including data on the prevention of structural damage, will be released during the first quarter of 2007. UCB also provided an update on the status of the US approval of CIMZIA(TM) 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 CIMZIA(TM) in Crohn’s disease. 'We have absolute confidence in both the efficacy and tolerability profile of CIMZIA(TM), 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 CIMZIA(TM) 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 € 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange. Enquiries, please contact: Jean-Christophe Donck, UCB Mareike Mohr, UCB Garry Daniels, UCB Phone: +32 2 559 9835 Phone +32 2 559 9264 Phone : +44 1753 777 116 DGAP 22.12.2006 ----------------------------------------------------------------------
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