Boehringer's lung drug wins FDA 'breakthrough' tag

Boehringer Ingelheim's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy regulatory review and could help the company beat its nearest rival to market.

The drug, dubbed nintedanib, is a therapy for idiopathic pulmonary fibrosis (IPF), an often fatal disease that scars the lungs and stands in the way of oxygen absorption. In two Phase III studies on more than 1,000 patients, Boehringer's treatment reduced patients' annual rate of lung-function decline by 48% and 55%, compared to just 5% in the placebo arm.

Nintedanib had already received the agency's promise of a priority review and a fast-track designation. Adding the breakthrough tag should only accelerate the drug's path to market and possibly help Boehringer beat out InterMune ($ITMN), which is seeking agency approval for a similar therapy.

Pirfenidone, InterMune's competing IPF drug, endured an FDA rejection in 2010, but, thanks to some promising new Phase III data, the biotech has worked its way back into the agency's good graces. InterMune resubmitted the treatment in May and expects to win approval within 6 months, launching pirfenidone in the first quarter of 2015 if all goes according to plan.

Sabine Luik

Boehringer isn't disclosing its planned timeline for launching nintedanib, but Senior Vice President Sabine Luik said in a statement that the FDA's latest move should expedite the process.

There are no FDA-approved treatments for IPF, which kills about 40,000 people a year, according to the Coalition for Pulmonary Fibrosis. InterMune's drug is already on the market in Europe, but, despite two years of momentum, it brought in just $70.2 million last year. The European Medicines Agency has agreed to an accelerated review of nintedanib, and Boehringer, with its commercial heft, should be able to compete if and when it launches nintedanib on the continent.

Analysts have said the U.S. market for IPF treatments could peak at north of $2 billion, but just which company will claim the largest share of it remains a contentious subject. InterMune's shares shot up in March after Boehringer revealed that nintedanib missed a secondary endpoint in one of its Phase III trials, but a May editorial in The New England Journal of Medicine heralded the drug's efficacy and potential as a new hope for IPF patients.

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