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Schering-Plough Announces Hepatitis C Data Presentations at,Digestive Disease Week (DDW) 2007 Annual Meeting

eoside HCV polymerase inhibitor HCV-796.

In Addition, Schering-Plough has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1), a large Phase II study with boceprevir ongoing at sites across the U.S., Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) in the HCV genotype 1 treatment-naive patient population. The first part of the study (screening cohort 1) has completed enrollment and involves more than 500 patients in five treatment arms. A second part to the study (screening cohort 2) recently opened for patient enrollment and adds two additional treatment arms. This second cohort will evaluate the safety and efficacy of boceprevir in combination with PEGINTRON and a lower dose of REBETOL (400-1000 mg daily). In total, approximately 550-600 patients will be enrolled in the HCV SPRINT-1 study.

Schering-Plough also is conducting a large Phase II study evaluating the safety and efficacy of boceprevir in combination with PEGINTRON and REBETOL in patients chronically infected with HCV genotype 1 who were null responders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not achieve undetectable HCV-RNA or a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). This represents a very difficult-to-treat patient population for which there is a great unmet medical need. The study involves approximately 350 patients and is ongoing at centers in the United States and Europe. All study participants have completed treatment with boceprevir in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) and are in the follow-up phase of the study. Data from this study will be available later in 2007, and will help guide future clinical development of boceprevir.

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