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Schering-Plough Reports Top-Line Results of the IDEAL Study
Date:1/14/2008

randomized to one of the three treatment regimens and received up to 48 weeks of combination therapy with 24 weeks of follow-up. SVR, the primary endpoint of the study, was similar for the three treatment regimens (40 vs. 38 vs. 41 percent, respectively).

Importantly, while end of treatment response was higher in the Pegasys combination therapy arm, IDEAL showed that fewer patients receiving PEGINTRON combination therapy relapsed after the end of treatment (24 vs. 20 vs. 32 percent, respectively).

Overall adverse events reported for the three treatment regimens were similar and, as seen in other studies with these treatments, a range of "flu- like symptoms" were the most commonly reported adverse events for all three treatment regimens. Discontinuation rates due to adverse events also were similar (13 vs. 10 vs. 13 percent, respectively).

"While the sustained response rates were similar in the IDEAL study, we were pleased to see that fewer patients relapsed following PEGINTRON combination therapy," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "With these results, we now have, for the first time, a large body of well-controlled clinical data demonstrating how the similarities and differences of the two leading combination therapies for hepatitis C affect outcomes for patients. These findings provide important clinical-based evidence that will help physicians in making treatment decisions and in guiding their patients through what is a long and challenging course of therapy. We look forward to further analyses of this large data set to gain additional clinical insights into the management of this serious disease."

In IDEAL, the combination regimen of Pegasys and Copegus used the recommended doses in accordance with their approved U.S. labeling, which includes a flat dose of Pegasys (180 mcg/week) for all patients regardless of body weight, and 1,000 or 1,200 mg/day of Cop
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SOURCE Schering-Plough Corporation
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