The European Medicines Agency (EMA) has agreed to an accelerated review of Boehringer Ingelheim's much-watched lung disease therapy, likely shortening its path to market.
The drug, nintedanib, is a treatment for idiopathic pulmonary fibrosis (IPF), a lung-scarring disease that complicates oxygen absorption and often leads to death. In its two late-stage studies on more than 1,000 patients, the treatment reduced the annual rate of lung-function decline by 48% and 55%, compared to just 5% in the placebo arm.
Now, with a speedy EMA review guaranteed, Boehringer will work toward playing catch-up with IPF rival InterMune ($ITMN), whose pirfenidone is already on the market in Europe. Despite a two-year head start, however, pirfenidone brought in just $70.2 million last year, and Boehringer, with its commercial heft, should be able to compete if and when it launches nintedanib on the continent.
The bigger test will come in the U.S., where InterMune has just refiled an FDA application for its once-rejected drug. Boehringer has yet to submit nintedanib to stateside regulators.
Analysts have gone back and forth on which IPF drug is most likely to win out, but a look at InterMune's share price suggests a great deal of faith in the Brisbane, CA, biotech. The company shot up in March after Boehringer revealed that nintedanib missed a secondary endpoint of improving overall health and delaying IPF exacerbations in one of its Phase III trials, and, after disclosing excellent late-stage results of its own, InterMune popped again in May, now trading at about 266% above its price at the start of the year.
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