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Published on 12/22/2005 in the Prospect News Biotech Daily.

Schering-Plough receives Japanese approval for additional Peg-Intron indication

By Angela McDaniels

Seattle, Dec. 22 - Schering-Plough Corp. said subsidiary Schering-Plough KK has received marketing approval for Peg-Intron (peginterferon alfa-2b) Powder for Injection in combination with Rebetol (ribavirin) capsules for the treatment of chronic hepatitis C in adult patients with a high viral load and virus genotypes other than genotype 1.

This additional indication represents about 40% of the estimated 1 milion to 2 million people in Japan chronically infected with hepatitis C and reduces the recommended duration of therapy to 24 weeks from 48 weeks.

The company said Peg-Intron and Rebetol is the only pegylated interferon-based combination therapy for hepatitis C approved in Japan and that Peg-Intron is the only peginterferon product approved in Japan for which a blood test is not required before every injection.

Schering-Plough is a health care company based in Kenilworth, N.J., that develops prescription, consumer and animal health products. Schering-Plough KK is based in Osaka, Japan.


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