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InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
Date:4/1/2008

ubstantial anti-viral effect at twice daily doses and an excellent safety and tolerability profile to date, ITMN-191 has the potential to be the best-in-class protease inhibitor for the treatment of patients with chronic hepatitis C virus infection," said Dan Welch, President and Chief Executive Officer of InterMune. "Strong viral kinetic performance of ITMN-191 was observed at total daily doses of less than or equal to only 600 mg, confirming its exceptional potency."

Mr. Welch continued, "With our partner Roche, we plan to initiate in this quarter a 14-day triple combination therapy trial with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin). We also are exploring the combination of ITMN-191 with other small molecule compounds."

ITMN-191 Program Update - Clinical, Preclinical and Formulation Progress

InterMune also provided additional new information regarding the progress of the ITMN-191 program.

InterMune today reported that Clinical Trial Authorization (CTA) applications related to its 14-day triple combination study of ITMN-191 with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin) were submitted to the relevant European regulatory authorities in March. InterMune expects the 14-day triple combination study to begin in the second quarter of 2008, assuming timely approvals by the relevant authorities.

Regarding future clinical development approaches, InterMune and its collaboration partner Roche also reported that the companies are actively working together to launch a development program that will investigate the combination of various small molecule compounds for the treatment of patients suffering from chronic HCV infection.

InterMune also announced today that a 13-week chronic toxicology study in monkeys has been successfully completed and that this study supports the intended longer duration of dosing of ITMN-191 planned in the Phase 2 clinical development program, to be conduc
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SOURCE InterMune, Inc.
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