New treatment for Hep C

The FDA has granted Three Rivers Pharmaceuticals marketing approval for its Ribasphere (Ribavirin capsules) 200mg in combination with interferon alfa-2b for the treatment of Hepatitis C (HCV).

The president and ceo of Three Rivers Pharmaceuticals, Donald Kerrish, RPh., stated: 'The approval of Ribasphere marks a milestone in the treatment of HCV. Ribasphere is positioned to break down the economic barriers that have existed for the past decade in treating this chronic and potentially deadly disease.' Traditionally the cost of treatment for HCV can range from $20,000 - $25,000 annually. 'Our aim is to bring affordable medicine to all individuals infected with this dreadful disease,' Kerrish continued.

The ANDA for Ribasphere was filed with the FDA in July of 2001. During the past 33 months, Three Rivers has successfully battled multiple patent infringement lawsuits and overcome significant regulatory issues that both delayed and complicated the entry of Ribasphere into the marketplace.

Three Rivers Pharmaceuticals plans to launch Ribasphere immediately, assisted by its marketing partner PAR Pharmaceuticals of Spring Valley, New York.

Hepatitis C

Hepatitis C affects nearly 4m Americans and 170m people worldwide, and HCV is responsible for 8,000 to 10,000 deaths per year in the United States and is the number one cause of liver transplants. HCV can also lead to cirrhosis, end-stage liver disease, and liver cancer. Over 30,000 new cases are diagnosed each year.