InterMune Soars on IPF Study That May Support ApprovalMeg Tirrell
InterMune Inc. rose the most ever after its drug pirfenidone for a fatal lung disease met goals of a study expected to support U.S. approval.
InterMune more than doubled to $37.80 at the close in New York for the shares’ biggest single-day increase since the company had its initial public offering in March 2000. The stock has more than quadrupled in the last year.
The drug, also called Esbriet, is approved in Europe to treat idiopathic pulmonary fibrosis, a lung disease with no cure that often kills people three to five years after diagnosis. The medicine was rejected in 2010 by U.S. regulators, who asked for a new trial to prove it works. With today’s results from the late-stage study, the company said it plans to file for U.S. clearance early in the third quarter.
“InterMune’s positive Phase 3 data today for Esbriet in IPF could double the market opportunity (from only Europe today), as the study should support USA approval,” Michael Yee, an analyst with RBC Capital Markets, wrote in a research note today. He estimated the drug may generate $300 million to more than $500 million worldwide, depending on whether Boehringer Ingelheim GmbH’s experimental medicine for the same disease succeeds in testing.
The study today showed pirfenidone reduced disease progression as measured by forced vital capacity, a measure of lung function, compared with placebo, Brisbane, California-based InterMune said in a statement. After a year, 16.5 percent of patients on pirfenidone had died or experienced an FVC decline of 10 percent or more, compared with 31.8 percent for those on placebo. The drug was generally well-tolerated, InterMune said.