PEGINTRON(TM) and REBETOL(R) approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy

Schering-Plough Corporation has received approval from European Commission on October 30 approved 48-week standard-dose PEGINTRON(TM) and REBETOL® 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.

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 previous treatment with combination alpha interferon/ribavirin therapy were retreated with PEGINTRON combination therapy.

PEGINTRON and REBETOL combination therapy was previously approved in the EU for treating chronic hepatitis C in naïve (previously untreated) adult patients, including naïve patients with clinically stable HIV coinfection.