FDA shocks UCB investors with Cimzia trial demand

The FDA has notified UCB that it will need to conduct another trial of Cimzia for Crohn's disease. The news sent UCB's stock down 10 percent as investors considered the consequences of a lengthy delay in gaining approval for the drug, which UCB needs to replace the revenue it gets from Keppra, which loses patent protection in 2009, and Zyrtec, which will face generic competition later this year. UCB says that the new Cimzia trial should be completed by the second half of 2008, offering new data to regulators that it hopes will confirm patient's clinical response to the therapy. One analyst who was blindsided by the regulatory decision says that the FDA's trial requirement will delay Cimzia by at least two years. UCB acquired Cimzia in the 2004 acquisition of Celltech.

- here's UCB's release [1]
- read the report [2] from PharmaTimes

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UCB submits BLA for Cimzia. Report [4]