EMA validates InterMune's pirfenidone MAA for IPF

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 and would expand its commercial infrastructure to support European marketing efforts. Given the significant unmet medical need for medications to treat patients with IPF, 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 New Drug Application (NDA) for pirfenidone was submitted by InterMune to the United States Food and Drug Administration (FDA) in early November 2009. On January 4, 2010, InterMune announced that the FDA granted Priority Review designation for its New Drug Application (NDA) for pirfenidone for the treatment of IPF. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on the Prescription Drug User Fee Act, the FDA has set an action date for the NDA of May 4, 2010. On March 9, the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend the approval of pirfenidone for the treatment of U.S. patients with IPF to reduce decline in lung function.

SOURCE InterMune, Inc.