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Schering-Plough Completes Enrollment of Boceprevir Registration Studies in Treatment-Naive and Treatment-Experienced HCV Patients
Date:1/27/2009

KENILWORTH, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that it has completed patient enrollment in the boceprevir HCV SPRINT-2 study, a pivotal Phase III study in treatment-naive patients. Together with the HCV RESPOND-2 study, a pivotal Phase III study in patients who failed prior treatment that completed enrollment in November 2008, the Company has fully enrolled its registration studies for boceprevir, its lead investigational oral hepatitis C protease inhibitor. A total of more than 1,500 patients were enrolled in these studies at U.S. and international sites.

"We believe boceprevir has the potential to be a first-in-class and best-in-class protease inhibitor for treating chronic hepatitis C," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "We are very encouraged by the boceprevir study results reported to date and look forward to the completion of these registration studies." The Company expects to complete the studies in mid-2010.

Schering-Plough previously reported Phase II study results from Part I of the HCV SPRINT-1 study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. In that study, a 48-week boceprevir regimen achieved a 75 percent SVR rate in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir (P/R lead-in, n=103). This represents a near doubling of the 38 percent SVR rate for patients in the control group receiving 48 weeks of PEGINTRON and REBETOL alone (n=104) (ITT).(1,2) In a 28-week boceprevir P/R lead-in regimen, the SVR rate was 56 percent (n=103). Importantly, for patients who received the boceprevir P/R lead-in regimen and had rapid virologic response (RVR), defined as undetectable
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SOURCE Schering-Plough Corporation
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