Schering-Plough Corporation announced that Schering-Plough K.K., the company's subsidiary in Japan, has received marketing approval from the Ministry of Health, Labor and Welfare (MHLW) for Rebetol (ribavirin) Capsules for use only in combination with interferon alfa-2b (recombinant) injection (Intron A) for the treatment of chronic hepatitis C. Rebetol and Intron A is the first combination therapy approved in Japan for treating chronic hepatitis C. Rebetol will be launched in Japan upon receiving pricing approval.

Hepatitis C is estimated to affect some 2 million people in Japan, according to MHLW. It is the leading cause in Japan of chronic liver disease, cirrhosis and hepatocellular carcinoma, with an estimated 40,000 to 50,000 deaths there annually attributed to hepatitis C-related complications. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to a study conducted by the World Health Organization (WHO).

Schering-Plough K.K. currently markets Intron A in Japan as monotherapy for hepatitis C, hepatitis B and several cancer indications. It is among the most frequently prescribed alpha interferon products in Japan. Intron A is a recombinant 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.

Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has exclusive worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with ICN Pharmaceuticals Inc of Costa Mesa, California.