Early Response to Individualised Weight-Based PegIntron(R) and Rebetol(R) Hepatitis C Therapy Allows Accurate Prediction of Treatment Success

BRUSSELS (Belgium) 27th August - (ots/PROTEXT) - 80 Percentof Early Responders Achieve Sustained Response After Full 48-WeekTreatment

Early Response Can Motivate Patients to Complete Treatment

Early virologic response (EVR) in patients with chronichepatitis C following 12 weeks of individualised, weight-baseddosing of PegIntron(r) (peginterferon alfa-2b) and Rebetol(r)(ribavirin) combination therapy can accurately predict thelikely outcome of a full, 48-week course of treatment, accordingto a paper appearing in the current issue of Hepatology.(1) Thefindings show that EVR is important to physicians in makingtreatment decisions and to patients as a treatment milestone.This analysis is consistent with the current European Union (EU)labeling for PegIntron.

As noted in the paper, 76 percent of patients demonstrated anEVR following 12 weeks of individualised, weight-based dosing ofPegIntron and Rebetol combination therapy, and, of those, 80percent of patients went on to achieve a sustained virologicresponse (SVR) after full treatment. EVR is defined as at leasta 99 percent (2 log10) reduction in hepatitis C virus (HCV) loadat week 12 of therapy. SVR is defined as the sustainedundetectability of HCV six months following 48 weeks oftreatment and is the accepted criterion for efficacy.

The paper also noted that, of the patients who failed toattain an EVR at 12 weeks, none achieved an SVR (100 percentnegative predictive value). When cost was considered, it wasestimated that discontinuing treatment in early non- responderscould reduce total overall drug treatment costs nearly 20percent.

"A 12-week EVR provides patients and physicians with an earlygoal, and, for the majority of patients who attain EVR, canmotivate treatment adherence and completion to achieve asustained virologic response," said Michael P. Manns, M.D.,professor, Department of Gastroenterology and Hepatology, MedicalSchool of Hannover, Germany. "On the other hand, as noted in theEU labeling for PegIntron, for patients who do not demonstratean EVR or take longer to respond to therapy, physicians shouldconsider discontinuing treatment or continuing it based on otherprognostic factors," he added.

Dr. Manns said that the positive predictive value ofindividualised, weight- based dosing of PegIntron and Rebetolcombination therapy in this study is very encouraging in that,of those patients who achieved an EVR, 80 percent went on toachieve an SVR. He also stated that the 100 percent negativepredictive value of this combination therapy indicates thatphysicians can predict, with a high degree of confidence, whichpatients will not respond to further treatment, and ensure thattherapy is not prematurely discontinued for any potentialresponders.

PegIntron and Rebetol combination therapy is the mostprescribed treatment for hepatitis C worldwide and is indicatedfor the treatment of chronic hepatitis C in patients withcompensated liver disease who have not been previously treatedwith interferon alpha and are at least 18 years of age. Morethan 300,000 hepatitis C patients worldwide, including 150,000U.S. patients, have received this combination therapy since itsintroduction in 2001.

About PegIntron and Rebetol Combination Therapy

PegIntron and Rebetol combination therapy for hepatitis C wasapproved in the EU in March 2001. PegIntron had previouslyreceived centralized marketing authorization in the EU and ismarketed as a monotherapy in cases of intolerance orcontraindication to ribavirin for the treatment of adult patientswith chronic hepatitis C.

PegIntron is a longer-acting form of Intron(r) A (interferonalfa-2b, recombinant) Injection that uses proprietary PEGtechnology developed by Enzon, Inc. (NASDAQ: ENZN) ofBridgewater, N.J. PegIntron, recombinant interferon alfa- 2blinked to a 12,000 dalton polyethylene glycol (PEG) molecule, isa once- weekly therapy dosed according to patient body weightthat is designed to achieve an effective balance betweenantiviral activity and elimination half- life. Schering-Ploughholds an exclusive worldwide license to PegIntron.

Rebetol is an oral formulation of ribavirin, a syntheticnucleoside analog with broad-spectrum antiviral activity. It isapproved worldwide for use in combination with PegIntron orIntron A for the treatment of adult patients with chronichepatitis C. Schering- Plough has rights to market oral ribavirinfor hepatitis C in all major world markets through a licensingagreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of CostaMesa, Calif.

Schering-Plough Europe, based in Brussels, Belgium, is partof Schering- Plough Corporation (NYSE: SGP) of Kenilworth, N.J.,USA, a research-based company engaged in the discovery,development, manufacturing and marketing of pharmaceuticalproducts worldwide.

Note to Editors: PegIntron and Rebetol are licensed to Aescain Austria, Essex Pharma in Germany and Essex Chemie inSwitzerland.

References

(1) Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J,Albrecht J. Early virologic response to treatment withpeginterferon alfa-2b plus ribavirin in patients with chronichepatitis C. Hepatology, Vol. 38, No. 3, 2003, pp. 645- 652.

ots Original Text Service: Schering-Plough CorporationInternet: http://www.presseportal.de

Contact: Robert J. Consalvo Company: Schering-PloughCorporation Phone: 908-298-7409

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