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The European Medicines Agency Completes Validation Stage for InterMune's Marketing Authorization Application for pirfenidone
Date:3/23/2010

BRISBANE, Calif., March 23 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe combined. If approved by the EMA, pirfenidone would be the first medication to be made available to IPF patients in the European Union. Pirfenidone was approved for marketing in Japan in October of 2008 and is marketed as Pirespa® by Shionogi & Co. Ltd.

Pirfenidone has been granted Orphan Drug designation in Europe. If approved by the EMA, InterMune intends to commercialize pirfenidone independently in Europe an
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SOURCE InterMune, Inc.
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