CHMP Upholds Negative Opinion For The EU Application For Cimzia(R) In The Treatment Of Crohn's Disease

Main Category: Crohn's
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Mar 2008 - 12:00 PDT

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UCB announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has rejected the appeal following CHMP refusal of the Marketing Authorization Application (MAA) for Cimzia® (certolizumab pegol) in the treatment of patients with Crohn's disease, a chronic and debilitating inflammatory disease. This decision comes following an appeal the company filed after a previous negative opinion was adopted by the CHMP in November 2007 and only applies to UCB's filing for Cimzia® in Crohn's disease in the EU.

"The CHMP's negative opinion is disappointing for UCB," said Olav Hellebo, Senior Vice President UCB & President Inflammation Operations. "Nevertheless, we are pleased that specific safety and quality concerns raised by the committee in November, were resolved through the appeal process. UCB remains committed to the development of medicines to satisfy the needs of patients with autoimmune disorders."

About UCB

UCB (Brussels, Belgium) is a global leader in the biopharmaceutical industry 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 around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A. is listed on Euronext Brussels.

UCB Forward-Looking Statement

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the development and commercialization of certolizumab pegol. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of research, development and clinical trials; the timing and success of submission, acceptance, and approval of regulatory filings; the time and resources UCB devotes to the development and commercialization of certolizumab pegol and the scope of UCB's patents and the patents of others.

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