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InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
Date:3/2/2010

izing new treatments for unmet medical needs, including advancing care for patients with this devastating disease."  

InterMune currently expects the validation process by the EMA to be completed by late March.  Validation of the MAA indicates that InterMune's application is complete and that the review process has begun.

Pirfenidone has been granted Orphan Drug designation in Europe.  If approved by the EMA, InterMune currently plans to commercialize pirfenidone independently in Europe and is prepared to expand its commercial infrastructure to support European marketing efforts. Given the significant unmet medical need, the approval of pirfenidone in Europe would represent a second and important value-creation opportunity to that represented by the U.S. market.

U.S. Regulatory Status

The MAA is the second major regulatory filing by InterMune to seek approval to market pirfenidone for the treatment of patients with IPF. The New Drug Application (NDA) for pirfenidone was filed by InterMune in

SOURCE InterMune, Inc.
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