Six months after cessation of treatment, patients were tested for the presence of virus. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. The American Liver Foundation has reported that liver failure due to hepatitis C infection is the leading cause of liver transplants in the United States. The Advisory Committee based its recommendation, in part, on clinical data reported by Schering-Plough from two pivotal multicenter Phase III studies involving patients with hepatitis C who relapsed following alpha interferon therapy. Six months after cessation of treatment, patients were tested for the presence of the virus.
Ribavirin is a synthetic nucleoside with antiviral activity.
Under the terms of the agreement, ICN will receive royalties on Schering-Plough's worldwide sales of ribavirin. The CDCP has estimated that 20 to 50 percent of chronically infected hepatitis C patients will develop liver cirrhosis, and 20 to 30 percent will go on to develop liver cancer or liver failure requiring liver transplant. The American Liver Foundation reported that liver failure due to hepatitis C infection is the leading cause of liver transplants in the U.S. ICN Pharmaceuticals, Inc. manufactures and markets a broad range of prescription and non-prescription pharmaceuticals and biotechnology research products in over 90 countries. More than half of the company's revenues come from Eastern European countries, where ICN is a leading healthcare provider. The company employs some 17,000 people worldwide, of whom 13,300 are in Eastern and Central Europe.