InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU).  Currently, there are no EMA-approved treatments for IPF in the EU.

"IPF is a debilitating and universally fatal disease that affects as many Europeans as Americans," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Today's MAA submission marks an important first step toward making the first IPF treatment available to patients in Europe. It also represents an important milestone for InterMune, demonstrating our commitment to developing and commercializing 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 the United States in early November 2009. The U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss the company's NDA for pirfenidone on March 9, 2010.  Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.

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.  

SOURCE InterMune, Inc.