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CRANBERRY TOWNSHIP, Pa. -- Three Rivers Pharmaceuticals, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its Ribasphere (Ribavirin capsules) 200mg in combination with interferon alfa-2b for the treatment of hepatitis C (HCV).
Donald J. Kerrish, RPh., president and CEO of Three Rivers Pharmaceuticals, 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 to $25,000 annually. "Our aim is to bring affordable medicine to all individuals infected with this dreadful disease," Kerrish
"This victory for the approval of Ribasphere did not come without a great deal of pain and persistence on the legal and regulatory fronts," said Paul F. Fagan, executive vice president and general counsel of Three Rivers. The ANDA 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.
Hepatitis C affects nearly 4 million Americans and 170 million people worldwide. HCV is responsible for 8,000 to 10,000 deaths per year in the United States and is the No. 1 cause of liver transplants. HCV can also lead to cirrhosis, end-stage liver disease, and liver cancer. More than 30,000 new cases are diagnosed each year.
Three Rivers Pharmaceuticals plans to launch Ribasphere immediately, assisted by its marketing partner PAR Pharmaceuticals of Spring Valley, N.Y. Three Rivers Pharmaceuticals is a closely held, privately owned company, and its mission is to develop and market generic prescription drugs. Its plan is to focus in the areas of HCV/HIV, urology and oncology.
Source: Three Rivers Pharmaceuticals