InterMune Inc. (ITMN) rose in early trading on investor optimism that results from a new study of its lung disease drug pirfenidone will lead to U.S. regulatory approval.
InterMune gained 5.9 percent to $36.32 at 9:07 a.m. New York time. Pirfenidone will be submitted for approval in the next few weeks and may be on the market in the first quarter of 2015, the Brisbane, California-based company said in a regulatory filing.
The drug, also known as Esbriet, is approved in Europe to treat idiopathic pulmonary fibrosis, a lung-scarring disease without a cure whose cause is unknown. The medicine was rejected in 2010 by U.S. regulators, who asked for a new trial on effectiveness. Pirfenidone and another drug, Boehringer Ingelheim GmbH’s nintedanib, both showed progress in slowing the disease’s progression, according to a report in the New England Journal of Medicine.
“The data actually favors InterMune,” Ritu Baral, an analyst with Canaccord Genuity Corp., said in a telephone interview from San Diego. “It’s incredibly important. This is their lead product.”
The disease causes tissue deep in the lungs to become increasingly thick and stiff, or scarred, over time, according to the National Heart, Lung and Blood Institute. When that happens, it inhibits the ability of the lungs to move oxygen into the bloodstream, limiting the amount that gets to the brain and other organs. It’s a malady mostly found in middle-aged and older adults.
Nintedanib and pirfenidone were studied separately and were not compared with each other. Data from the Boehringer trial has a “very convincing basis,” Susanne Stowasser, the Ingelheim, Germany-based company’s team leader of global medical affairs-respiratory, said in an interview. Judith von Gordon, another spokeswoman, said the closely held company will file for approval this year.
Geoff Curtis, a spokesman for InterMune, wasn’t immediately available for an interview.
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