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European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
Date:9/24/2007

PEGINTRON and REBETOL(R) will be the only available hepatitis C therapy approved in the EU for a retreatment indication, upon European Commission

approval

KENILWORTH, N.J., Sept. 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of combination therapy with PEGINTRON(TM) (peginterferon alfa-2b, 1.5 mcg/kg once weekly) and REBETOL(R) (ribavirin, 800 - 1,400 mg daily) for retreating adult patients with chronic hepatitis C whose previous treatment with interferon alpha (pegylated or non- pegylated) and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response. Upon European Commission approval, PEGINTRON and REBETOL will be the only available hepatitis C therapy in the European Union (EU) indicated for retreatment of prior treatment failures.

"A large and growing number of patients whose previous hepatitis C therapy did not result in a sustained response are in need of viable treatment options today," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Upon EU approval of this new indication, PEG-INTRON combination therapy will help address this serious unmet medical need."

The CHMP recommendation serves as the basis for a European Commission approval of this expanded indication for PEGINTRON and REBETOL combination therapy, which is currently approved in the European Union (EU) for treating chronic hepatitis C in naive (previously untreated) adult patients, including naive patie
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SOURCE Schering-Plough Corporation
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