UCB says Crohn's test fails to prove drug

BRUSSELS Dec 21 (Reuters) - Belgian pharmaceutical group UCB (UCB.BR) said on Monday a test of a drug to treat Crohn's disease did not achieve the required results, casting doubt on its chances of approval in the European Union. UCB, a central nervous system and immunology specialist, conducted Phase IIIb testing of its drug Cimzia to assess its efficacy and safety in patients with moderate to severe Crohn's disease, a bowel disorder.

The test was carried out following rejection of the drug to treat Crohn's by European Union medical experts. Cimzia has received U.S. and EU clearance to treat rheumatoid arthritis.

The study of more than 400 adults from March 2008 to August 2009 showed that 32 percent of patients achieved clinical remission as early as week six after taking Cimzia. However, the remission rate of those taking a placebo was 25 percent.

UCB said Cimzia's results were superior to those of the placebo at all time points but were not statistically significant in the overall population and so the initial objective of the test was not achieved.

A spokeswoman said UCB would examine the test results and that its options were still open. One issue could have been that the test population had more moderate than severe Crohn's cases, explaining why the placebo results had been so high, she said. (Reporting by Philip Blenkinsop; Editing by Greg Mahlich)