Three Rivers Pharmaceuticals Seeks Permission for Generic Treatment for Hepatitis C

Pittsburgh August 24

Three Rivers Pharmaceuticals, LLC, a Pittsburgh-based and privately-owned company, has filed an Abbreviated Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for permission to market the antiviral prescription drug ribavirin.

Ribavirin in combination with alpha interferon-2b is indicated for the treatment of Hepatitis C (HCV) and is marketed by Schering-Plough Corp.

Hepatitis C affects nearly four million Americans and an estimated 170 million people worldwide. HCV is responsible for an estimated 8,000 to 10,000 deaths per year and is the number one cause of liver transplants. HCV can also lead to cirrhosis, end-stage liver failure, and liver cancer. Over 30,000 new cases are diagnosed each year.

Our mission, said Donald J. Kerrish, president of Three Rivers Pharmaceuticals, LLC, is to develop and market generic prescription drugs, specifically antiviral medications used in the treatment of Hepatitis C and HIV/AIDS.

By forging partnerships with international manufacturers of active pharmaceutical ingredients and utilizing contract research manufacturers and contract research organizations located in the United States, Three Rivers Pharmaceuticals can develop, seek FDA approval, and market generic drugs faster and less expensively than its competitors, according to Kerrish.

We are concentrating our resources, added Kerrish, on developing lower cost generic drugs for infectious diseases that have a significant national and worldwide impact with the goal of pricing them as aggressively as possible. We also will provide public education and disease state management programs for Hepatitis C and HIV/AIDS.

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