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PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy
Date:11/15/2007

First and Only Peginterferon Therapy Approved for Retreating Both Hepatitis

C Relapsers and Nonresponders

KENILWORTH, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission on October 30 approved 48-week standard-dose PEGINTRON(TM) (peginterferon alfa- 2b, 1.5 mcg/kg once weekly) and REBETOL(R) (ribavirin, 800 - 1,400 mg daily) combination therapy for retreating adult patients with chronic hepatitis C whose prior treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response. PEGINTRON and REBETOL is the first and only pegylated interferon combination therapy approved in the European Union (EU) for retreating both hepatitis C relapsers and nonresponders.

The European Commission approval of this expanded indication for PEGINTRON and REBETOL results in Marketing Authorization with unified labeling that is valid in the current EU 27 member states as well as in Iceland and Norway.

"This approval is an option for the large number of hepatitis C patients who failed prior therapy because it gives them a second chance at success," said Nadine Piorkowsky, president of the European Liver Patient Association (ELPA). "These patients want to eradicate the virus and now can determine after 12 weeks of retreatment with PEGINTRON combination therapy whether they are likely to go on to achieve a sustained response with a 48-week course of therapy."

The approval is based on results from an ongoing non-comparative clinical study (EPIC3)(1) in which 1,336 patients with moderate to severe fibrosis or cirrhosis who failed pre
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SOURCE Schering-Plough Corporation
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