FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the Treatment of Hepatitis C

NUTLEY, N.J. -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved pre-filled syringes of Pegasys (Peginterferon alfa-2a) for the treatment of chronic hepatitis C.

Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.

Pegasys is the most prescribed interferon therapy in the United States for the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled syringes to be available in pharmacies by the end of the month. Pre-filled syringes will be packaged four per box. Pegasys is currently available in vials as a pre-mixed solution.

"Taking a medication by self-injection can be challenging for some people," said Dr. David Bernstein, director of hepatology at North Shore University Hospital. "Reducing the number of steps involved can make the process less intimidating for patients and reduce the risk of errors."

The introduction of pre-filled syringes is yet another way in which Roche is working to add value to the management of hepatitis C, including:

* developing approaches to reduce the duration of treatment with Pegasys

and Copegus and the dose of Copegus therapy for certain patients

* introducing Copegus with a list price or wholesale acquisition cost

that is 43 percent less per milligram than the other available brand of

ribavirin

* backing Pegasys with the most extensive development program ever

undertaken in hepatitis C

* formulating Pegasys as a pre-mixed solution requiring no reconstitution

prior to self-injection

Hepatitis C is a bloodborne infectious disease of the liver and the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S. An estimated 2.7 million Americans are chronically infected with hepatitis C.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose.

Hoffmann-La Roche Inc. (Roche), is the U.S. prescription drug unit of the Roche Group, a leading research-based healthcare enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

* IMS weekly data for the week ending Dec. 26, 2003.

Source: Roche