InterMune Reports Japanese Regulatory Approval of Pirfenid... (

InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF

Date:10/16/2008

- Provides Progress Report on InterMune Phase 3 CAPACITY Program -

- Reports 97% patient retention rate in CAPACITY -

BRISBANE, Calif., Oct. 16 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today reported that on October 16, 2008, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the New Drug Application (J-NDA) submitted by Shionogi & Co. Ltd. to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in Japan. Pirfenidone was developed in Japan for the treatment of IPF by Shionogi, which has rights to pirfenidone in Japan, Taiwan and South Korea.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very encouraged by the Japanese regulatory approval of pirfenidone for IPF, making pirfenidone the first medicine approved for IPF patients in any major market in the world."

InterMune also provided a progress report on its Phase 3 CAPACITY program of pirfenidone in IPF. CAPACITY consists of two multinational, randomized, double-blind, placebo-controlled Phase 3 studies with a total enrollment of 779 IPF patients at 110 centers in the United States, Europe and Australia. The primary endpoint in CAPACITY is change in Forced Vital Capacity (FVC) from baseline to week 72.

InterMune reported that 97% of transplant-free, surviving patients had completed their Week 72 Visit, the study visit at which the primary endpoint is assessed.

The CAPACITY protocol calls for a final patient visit to be completed 30 days after the Week 72 Visit. This means that all patient visits for CAPACITY are expected to be completed around the end of October 2008. Based on this timeline for study completion, InterMune expects t
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InterMune Reports Japanese Regulatory Approval of Pirfenid...( - Provides Progress Report on In...)