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InterMune Reports First Quarter 2009 Financial Results and Business Highlights
Date:4/30/2009

ween 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 pirfenidone.
  • InterMune is preparing an NDA for submission to the FDA in the summer of 2009, to be followed by an MAA submission to the European Medicines Agency (EMEA) around the end of 2009.
  • Results from the CAPACITY studies will be presented in an oral late-breaker session at 3:35 p.m. PDT on May 19 at the International Conference of the American Thoracic Society (ATS) in San Diego.

    • ITMN-191:

    • On January 12, InterMune announced top-line results from a 14-day, Phase 1b study of ITMN-191 in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin).
      • After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 log10 in five of the six dosage cohorts, and was -5.4 log10 and -5.7 log10 in the best performing q12h and q8h cohorts, respectively. ITMN-191 delivered viral kinetic performance that is comparable to the best results reported to date for other protease inhibitors in similar experiments.
      • There was no evidence of viral rebound during ITMN-191 treatment in any cohort.
      • On April 24, InterMune reported that data from the triple combination study had informed the dose selection for the Phase 2b program of ITMN-191. The Phase 2b trial, expected to begin in the summer of 2009, will study both q12h regimens (600mg and 900mg q12h) and a q8h regimen (300mg q8h) and both 12-week and 24-week treatment durations.

    • At the Annual Meeting of the European Association for the Study of the Liver (EASL
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    SOURCE InterMune, Inc.
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