Roche Files for Application with FDA to Market Leading Hepatitis C Medication Pegasys® for Chronic Hepatitis B Treatment

NUTLEY, N.J. -- Roche announced today the submission of a supplemental new biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) to market Pegasys® (peginterferon alfa-2a) for the treatment of chronic hepatitis B (CHB). Simultaneously, Roche has also filed with the European Medicines Agency to market Pegasys for this indication in the European Union. Pegasys received FDA approval for the treatment of chronic hepatitis C in October 2002 and today is the most prescribed chronic hepatitis C medication in the United States.

Hepatitis B is a serious public health threat worldwide and can be deadly if left untreated, said Salvatore Badalamente, M.D., medical director of Roche. We are committed to offering Pegasys as a new option to the millions of people throughout the world who are chronically infected with hepatitis B.

Roche submitted this filing based on Pegasys data from its comprehensive clinical development program in hepatitis B. This program involved more than 1,500 chronic hepatitis B patients from three separate studies. A phase II study compared Pegasys to standard interferon in patients with HBeAg-positive disease. Two phase III studies compared Pegasys to Epivir-HBV® (lamivudine) in patients with HBeAg-positive disease and in patients with HBeAg-negative disease (a more difficult to treat mutation of the hepatitis B virus), respectively. The two studies are the largest trials conducted to date in the patient populations infected with either variation of hepatitis B.

Each year an estimated 5,000 to 6,000 people die in the United States because of chronic hepatitis B liver disease. We recognize the need for new hepatitis B treatment options and commend Roche for its extensive research to advance hepatitis B therapy, said Alan Brownstein, president and CEO of the American Liver Foundation.

This filing demonstrates Roches continued focus on research to advance the field of hepatology. For example, this year, publications and data were presented from Pegasys and Copegus studies in difficult-to-treat hepatitis C populations including African Americans and patients co-infected with hepatitis C and HIV, said Badalamente.

About Chronic Hepatitis B

The National Center for Infectious Diseases of the Centers for Disease Control and Prevention (CDC) estimates that 1.25 million people in the United States are chronically infected with hepatitis B. Chronic hepatitis B can lead to cirrhosis, hepatocellular carcinoma, and death. In the United States, the most common modes of transmission of the hepatitis B virus are through sexual and blood-to-blood contact, although the disease can also be transmitted from pregnant women to their infants. The number of new infections in the United States has decreased in recent years, in part due to the introduction of the hepatitis B vaccine in 1982.

Source: Roche