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InterMune Reports Third Quarter 2009 Financial Results and Business Highlights
Date:11/5/2009

nd 900mg q12h) and three-times-daily regimens (300mg q8h) and both 12-week and 24-week treatment durations. Enrollment is proceeding well with approximately 165 patients enrolled to date.
  • A Phase 1b multiple-ascending-dose (MAD) study was initiated in September of 2009 to evaluate once-daily and twice-daily ITMN-191 co-administered with low-dose ritonavir in combination with standard-dose pegylated interferon and ribavirin in HCV-infected patients. Ritonavir is an antiviral compound commonly used at low doses to enhance or "boost" the pharmacokinetic (PK) profiles of protease inhibitors. Potential benefits of ritonavir boosting are less-frequent administration and a lower dose or pill burden for ITMN-191, which may enhance the possibility of co-formulation with other direct antiviral agents.
  • Leadership Additions - Preparation for Potential Pirfenidone Launch

    The company today announced in a separate press release the expansion of its senior leadership team that will prepare the company to bring pirfenidone to patients, should InterMune's NDA and/or MAA be granted approval by the regulatory authorities in the United States and Europe, respectively:

    • Sr. Vice President and General Manager, Europe - Mr. Giacomo di Nepi.
    • Vice President, Sales - Ms. Terri Shoemaker.
    • Vice President, Marketing - Mr. Erik Harris.
    • Vice President, Managed Care and Access - Mr. Darren Cline.

    Further expansion of InterMune's commercial infrastructure will be made upon the successful outcome of key regulatory events related to the NDA and MAA, expected in 2010.

    2009 Key Project Guidance

    The company provided the following guidance on its key development projects, pirfenidone and ITMN-191 (RG7227).

        Milestones And Key Events                                  Expected Date
        -------------------------                                  ------------
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    SOURCE InterMune, Inc.
    Copyright©2009 PR Newswire.
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    Related medicine technology :

    1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
    2. InterMune Announces Start of Phase 1b Trial of ITMN-191
    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
    5. InterMune Announces Progress on Pirfenidone in IPF
    6. InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
    7. InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
    8. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
    9. InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
    10. InterMune to Conduct Conference Call and Webcast to Discuss Results of Triple Combination Study of ITMN-191
    11. InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3
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