FDAnews
www.fdanews.com/articles/81856-schering-to-initiate-additional-trial-of-sargramostim

SCHERING TO INITIATE ADDITIONAL TRIAL OF SARGRAMOSTIM

October 21, 2005

Schering AG has announced plans to initiate an additional Phase III trial to evaluate sargramostim as a potential new treatment option for Crohn's disease. The trial is being initiated as a result of a patient recruitment delay faced by NOVEL 3, one of two ongoing Phase III studies of sargramostim in Crohn's disease, and aims to achieve finalization of the program as soon as possible.

Patient enrollment for NOVEL 4, the other pivotal Phase III clinical trial of sargramostim in Crohn's disease, recently completed enrollment of more than 240 patients ahead of schedule. Data from NOVEL 4 are expected to be available in 2006.

These trials are part of N.O.V.E.L. (New Opportunities to Verify Evolving Logic in Crohn's disease), a comprehensive, worldwide clinical trials program supported by Schering AG for the ongoing development of sargramostim.