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InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights

    Recent Highlights

    -- On October 16, 2008 Shionogi & Co., Ltd of Japan, which has rights to
       pirfenidone in Japan, reported approval of its j-NDA to market
       pirfenidone as Pirespa(R) in IPF.
    -- On February 3, 2009, InterMune reported results from its Phase 3
       CAPACITY program for pirfenidone in IPF, which consisted of two,
       multinational, randomized, double-blind, placebo-controlled clinical
       trials named CAPACITY 1 and CAPACITY 2.
        - The primary endpoint of change in percent predicted Forced Vital
          Capacity (FVC) at Week 72 was met with statistical significance in
          CAPACITY 2 (p=0.001), as were the secondary endpoints of categorical
          change in FVC (p=0.001) and Progression-Free Survival  (p=0.023).
        - The primary endpoint was not met in CAPACITY 1 (p=0.501), but
          supportive evidence of a pirfenidone treatment effect was observed
          on a number of measures and at various time points.  In CAPACITY 1,
          there was evidence of a pirfenidone treatment effect on the
          pre-specified secondary endpoint of Six-Minute Walk Test distance
          (p = 0.001) when compared to placebo.
        - Pirfenidone was safe and generally well tolerated in both CAPACITY
          studies.  There was no difference between pirfenidone and placebo in
          the percentage of patients that experienced a serious adverse event
          (SAE) and the pattern of adverse events (AEs) was, in general,
          comparable to that observed in previous clinical studies of
        - InterMune is preparing an NDA for submission to the FDA, to be
          followed by an MAA submission to the European Medicines Agency
    -- InterMune reported that 603 patients from CAPACITY have been enrolled
       in RECAP, the on-going open-label roll-over study from CAPACITY to
SOURCE InterMune, Inc.
Copyright©2009 PR Newswire.
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Related biology technology :

1. InterMune to Release Fourth Quarter, Full Year 2008 Financial Results on February 26
2. InterMune Announces Issuance of U.S. Patent for ITMN-191
3. InterMune Announces Pricing of Public Offering of 3,500,000 Shares of Common Stock
4. InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
5. InterMune to Present at J.P. Morgan Healthcare Conference
6. InterMune to Present at Deutsche Bank Biotech Boston Confab
7. InterMune Reports Third Quarter 2008 Financial Results and Business Highlights
8. InterMune to Release Third Quarter 2008 Financial Results on November 6
9. InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF
10. InterMune to Present Four Abstracts on HCV Protease Inhibitor ITMN-191 at the AASLD Meeting
11. InterMune Earns Development Milestone in HCV Protease Inhibitor Collaboration With Roche
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