Healthcare Industry News: Cimzia
News Release - December 22, 2006
UCB Announces Positive Results From Two New Phase III Studies in Rheumatoid Arthritis and Provides Update on the Status of US Approval for CIMZIATM in the Treatment of Crohn's DiseaseBRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Dec 22, 2006 -- 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 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."
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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