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InterMune Reports Fourth Quarter and Full Year 2009 Financial Results and Business Highlights
Date:2/17/2010

cepted for review by the FDA, and was granted "Priority Review" status with an expected PDUFA action date of May 4, 2010.
  • On February 1, 2010, we reported that the pirfenidone NDA is scheduled to be discussed at the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting on March 9, 2010.
  • A Marketing Authorization Application (MAA) for pirfenidone for the treatment of IPF is expected to be submitted to the European Medicines Agency (EMA) in the current quarter.
  • Seven abstracts concerning pirfenidone and IPF have been accepted for presentations at the Annual Meeting of the American Thoracic Society (ATS) in New Orleans, May 14-19, 2010.  

  • RG7227:

    • On January 11, we reported preliminary, top-line results of a Phase 1b multiple-ascending-dose (MAD) study of low doses of once-daily and twice-daily RG7227 co-administered with low-dose ritonavir in combination with standard of care (SOC) for 15 days in treatment-naive HCV-infected patients.  Preliminary data from the first two cohorts of the study indicated that in the presence of SOC, the majority of patients achieved an undetectable level of HCV RNA after 15 days of treatment.  No drug-related serious adverse events have been reported to date.  InterMune and our collaboration partner Roche plan to amend the protocol of the on-going Phase 1b MAD study to evaluate 12 weeks of RG7227 ritonavir-boosted therapy plus SOC.
    • The companies anticipate presenting the results of the MAD ritonavir-boosting study at a medical conference in the first half of 2010, subject to abstract acceptance.
    • Un-blinded 4-week RVR (rapid virologic response) and 12-week EVR (early virologic response) data from the 12-week
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    SOURCE InterMune, Inc.
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    1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
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    3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
    4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
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