It looks like UBC has struck out in the EU. The EMEA told the company that the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Cimzia, a treatment for Crohn's disease. The CHMP raised several issues that UBC plans to address in order to gain approval by mid-2008. The company said it will submit an appeal on the decision. UBC's shares plunged on the rejection. Back in March [1] the FDA told UBC that it would need to conduct another trial of Cimzia, shocking investors and delaying the drug's U.S. approval by at least two years.
"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease," said Melanie Lee, Executive Vice President Research & Development of UCB.
- check out this release [2] on the rejection
Related Articles:
FDA shocks UCB investors with Cimzia trial demand. Report [1]
Late-stage Cimzia trial for RA hits endpoints. Report [3]
UCB submits BLA for Cimzia. Report [4]
Links:
[1] http://www.fiercebiotech.com/story/fda-shocks-ucb-investors-with-cimzia-trial-demand/2007-03-23
[2] http://www.fiercebiotech.com/press-releases/press-release-ucb-group-drug-cimzia-faces-eu-delay-shares-plunge
[3] http://www.fiercebiotech.com/story/late-stage-cimzia-trial-for-ra-hits-endpoints/2007-02-23
[4] http://www.fiercebiotech.com/story/ucb-submits-bla-for-cimzia/2006-03-02