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Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C
Date:11/24/2008

the boceprevir P/R lead-in regimen and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR was 94 percent in the 48 week regimen and 82 percent in the 28-week regimen. RVR has been shown to be a reliable predictor for achieving SVR. These final results are from the HCV SPRINT-1 study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

"We are very encouraged by the strong boceprevir results to date. We look forward to our ongoing Phase III studies, which are designed to demonstrate that boceprevir has the potential to benefit a broad range of patients by significantly increasing sustained response rates with a potentially shorter course of treatment," Koestler said.

He noted that the company has now completed patient enrollment in the HCV RESPOND-2 study, a pivotal Phase III study in patients who failed prior treatment, and has screened more than 1,200 patients in the HCV SPRINT-2 study, a pivotal Phase III study in treatment-naive patients.

Next-Generation HCV Protease Inhibitor SCH 900518

As part of its long-term commitment to hepatitis C therapy, Schering-Plough also is developing SCH 900518 ("518"), a next-generation HCV protease inhibitor. A Phase IIa study with 518, known as the NEXT-1 study, is currently ongoing. The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. 518 also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic (PK) profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors. Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination
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