New Oral Polymerase Inhibitor Shows Promising Results in Chronic Hepatitis C Patients
- Results Strengthen Pipeline for Next Generation of Roche Therapies -

Vienna, Austria – April 29, 2006 – R1626, one of a potential new class of hepatitis C therapies called polymerase inhibitors, demonstrates an antiviral effect by achieving clinically significant viral load reductions in chronic hepatitis C patients with genotype 1, the most difficult to treat genotype, according to preliminary data presented at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL). Further trials are planned to study how well R1626 works in combination with PEGASYSŪ (peginterferon alfa-2a) and COPEGUSŪ (ribavirin).

“Data from this study evaluating R1626 are encouraging,” said Frederick G. Thompson, President and Chief Executive Officer of the American Liver Foundation. “Since genotype 1 patients are the most common in the United States and also the most difficult to treat, there is a real need for a product that could potentially improve treatment outcomes.”

About the study

In this phase I study, patients are randomized to receive either oral treatment with R1626 or placebo for 14 days with 14 days of follow-up. Preliminary data were presented on the 18 patients who received 500 mg or 1,500 mg twice daily doses of R1626. The study is still ongoing and higher doses of R1626 are being evaluated.

The study found:[1]

· At the 1,500 mg twice daily dose, R1626 was associated with clinically significant reductions from baseline in serum HCV RNA (a measure of how much virus is in the blood) of 1.2 log10 (group mean).

· At both 500 mg and 1,500 mg twice daily, R1626 was well tolerated in patients, with no serious adverse events and no premature withdrawals.

“Development of R1626 demonstrates our ongoing scientific commitment to improving treatment for patients living with hepatitis C,” said James A. Thommes, M.D., Senior Medical Director, Roche. “PEGASYS is the preferred pegylated interferon for the management of hepatitis C in the United States today. Furthermore, we are undertaking collaborations and partnerships with other companies to continue to seek improvements of treatment outcomes.”

Additional data reported at EASL related to partnerships include Vertex Pharmaceutical’s VX-950, a protease inhibitor, which, in combination with PEGASYS and COPEGUS, showed a significantly increased antiviral effect in patients with hepatitis C. Subsequent studies will evaluate whether VX-950, in combination with PEGASYS and COPEGUS, may clear the hepatitis C virus with shortened treatment duration.[2]

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus 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 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. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
 

[1] Roberts S, Cooksley G, et al. Interim results of a multiple ascending dose study of R1626, a novel nucleoside analog targeting HCV polymerase in chronic HCV patients. Presented at the 41st European Association for the Study of the Liver. April 29, 2006.

[2] Reesink HW, Forestier, N, et al. Initial Results Of A 14-Day Study Of The Hepatitis C Virus Inhibitor Protease Vx-950, In Combination With Peginterferon-Alfa-2a. Presented at the 41st European Association for the Study of the Liver. April 29, 2006.