Foiled in U.S., InterMune wins EU approval for pirfenidone

InterMune ($ITMN) took a big step forward today with its announcement that it won European approval for pirfenidone, a new therapy for idiopathic pulmonary fibrosis that is being sold as Esbriet. The approval gives the developer a chance to start earning revenue on the orphan drug as it mounts a new late-stage study to satisfy the doubtful regulators at the FDA, who rejected their marketing application.

This could well be a blockbuster event for InterMune, noted Avik Roy, an equity research analyst at Monness, Crespi, Hardt & Co. "We continue to believe Esbriet has billion-dollar potential in Europe alone," he wrote. "Intermune now joins the exclusive club of commercial-stage biotechnology companies." InterMune shares were up about eight percent this morning.

"The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, but also an exciting new chapter for our company as we now transition to become an international commercial organization," said CEO Dan Welch. "Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible, beginning with Germany in September of this year."  

InterMune plans to launch Esbriet in the top five EU countries: Germany in September of 2011; France, Spain and Italy in the first half of 2012 and in the United Kingdom in mid-2012. InterMune also plans to launch Esbriet in all or substantially all of the 10 most important pharmaceutical markets in the EU by approximately mid-2012.

InterMune announced in January that it will begin enrollment of another late-stage trial of pirfenidone in the first half of 2011. Ten months ago, the FDA rejected the company's application for approval, noting that another trial would be necessary if the company ever hopes to sell the drug in the U.S. The oral drug inhibits the synthesis of TGF-beta, which plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.  

- here's the Intermune release