UCB to Begin Confirmatory Study of Cimzia in Chron's Disease

UCB announced it has decided to initiate an additional short-term clinical study of Cimzia (certolizumab pegol) to confirm the induction of clinical response in moderate to severe active Crohn's disease. UCB will work closely with the FDA to finalize the design of the clinical study in order to provide additional clinical efficacy data.

Furthermore, by the end of April UCB will reply fully to the complete response letter received in December 2006. In its letter, the FDA raised no major issues or concerns about the safety of Cimzia or relating to chemistry, manufacturing and controls, but did question the adequacy of one study design.

UCB expects the results from its additional clinical study with Cimzia in Crohn's disease in the second half of 2008.

The initial Cimzia development program for Crohn's disease met all primary endpoints with statistical significance. Therefore, whether this additional study, which was not part of the trial program initially agreed on with the FDA, will be a preapproval requirement or a postapproval commitment is still the subject of ongoing communications with the FDA.

UCB plans to file a biologics license application with the FDA for Cimzia in the treatment of rheumatoid arthritis by the end of the year.

"We have complete confidence in Cimzia 's robust efficacy and competitive safety," Roch Doliveux, CEO of UCB, said. "Cimzia will be, at launch, the first anti-TNF which is a PEGylated and Fc-free antibody fragment. We are looking forward to making this new treatment option available to patients who suffer from rheumatoid arthritis and Crohn's disease, and will continue our dialogue with the FDA in order to obtain approval for Cimzia in the U.S. as soon as possible."