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InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
Date:9/4/2007

- Phase 1b trial expected to begin in September -

BRISBANE, Calif., Sept. 4 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the amended Clinical Trial Authorization (CTA) related to the Phase 1b clinical trial of ITMN-191 (Roche-R7227) has been approved by the appropriate European regulatory authorities. InterMune also has received approval from the Ethics Committee of the institutions that will conduct the Phase 1b study. ITMN-191 is an orally available hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche.

InterMune expects that the Phase 1b multiple ascending dose (MAD) study will begin this month and expects to announce initial top-line viral kinetic and safety results from the first three dose cohorts of the MAD study in the first quarter of 2008.

Dan Welch, President and Chief Executive Officer of InterMune, said, "InterMune and Roche are pleased to announce that we have successfully secured the required regulatory approvals that enable us to initiate our very important Phase 1b multiple ascending dose study. By amending the Phase 1b protocol, we believe we have enhanced our ability to deliver the most robust Phase 1b results possible which we expect will place us in a stronger position to begin our Phase 2 trials."

In early May, InterMune announced that it would amend the CTA to take into consideration new information on competitive protease inhibitors, in-vitro and preclinical data on ITMN-191 and pharmacokinetic observations from a Phase 1a study that was completed in May of 2007. In that study, a higher than anticipated exposure of ITMN-191 in plasma was observed in subjects dosed with food, suggesting tha
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SOURCE InterMune, Inc.
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