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Japan Approves Rebetol (Virazole) For Combo Use With Intron A (Interferon) For Chronic Hepatitis C COSTA MESA, CA -- November 26, 2001 -- ICN Pharmaceuticals, Inc. announced that Schering-Plough K.K., has received marketing approval from the Ministry of Health, Labor and Welfare (MHLW) for Rebetol® (ribavirin, USP) ICN Capsules for use only in combination with interferon alfa-2b (recombinant) injection (Intron® A) for the treatment of chronic hepatitis C. The Rebetol (ICN's ribavirin) and Intron A treatment regimen is the first and only combination therapy approved in Japan for treating chronic hepatitis C. Rebetol (ICN's Virazole) will be launched in Japan upon receiving pricing approval. According to Schering-Plough, approximately two million people suffer from hepatitis C in Japan. Rebetol is an oral formulation of ICN's ribavirin, a synthetic nucleoside analog, and an ICN developed drug. Schering-Plough has exclusive worldwide rights to market oral ribavirin for Hepatitis C through a licensing agreement under which ICN is entitled to royalties. ICN's ribavirin (Virazole) is also marketed in the United States and the European Union for aerosol use in the treatment of hospitalized infants and young children with severe lower respiratory tract infection caused by the respiratory syncytial virus (RSV), and is marketed in a total of 44 countries in a variety of forms around the world for 10 different viral indications sold by ICN. Rebetol was granted FDA approval on July 25, 2001, as a separately marketed product for use only in combination with Intron A (interferonalfa-2b, recombinant) Injection. Rebetol had been previously approved in the United States only as a component of Rebetron™ Combination Therapy, which contains Rebetol capsules and Intron A in a single package. Schering-Plough continues to market Rebetron Combination Therapy in the United States. Schering-Plough K.K. currently markets Intron A in Japan as monotherapy for hepatitis C, hepatitis B and several cancer indications. Intron A is are combinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets Intron A, the world's largest-selling alpha interferon, for 16 major antiviral and anticancer indications worldwide. SOURCE: ICN Pharmaceuticals, Inc E-mail this page to a friend or colleague! To print, use this version