InterMune and Boehringer win tandem FDA nods for 'breakthrough' lung drugs

InterMune ($ITMN) and Boehringer Ingelheim have spent the last year or so jockeying for the spotlight with in-development treatments for a rare lung disease, hoping to take pole position upon reaching the market. Now, as the FDA has decided to approve both drugs at once, the two companies will set off from equal starting points in the race for dominance.

The two treatments, each an FDA-designated "breakthrough," are designed to combat the often-fatal idiopathic pulmonary fibrosis (IPF), a lung-scarring disease that inhibits oxygen absorption and hampers pulmonary function. InterMune's drug, pirfenidone, will sell as Esbriet, as it does in Europe, while Boehringer's nintedanib will be called Ofev.

Until now, there were no FDA-approved treatments for IPF, which kills about 40,000 people a year, according to the Coalition for Pulmonary Fibrosis. Analysts figure the market for such drugs could top out at north of $2 billion a year, but just which company will take the lion's share of that demand remains an open question.

In pivotal trials, both drugs significantly improved lung function compared to placebo, and, on the safety side, both are contraindicated for patients with liver problems.

Now it'll be up to each company's commercial operation to fight for market share. But InterMune, which employs fewer than 400 people, won't be standing up to Boehringer on its own. In August, Roche ($RHHBY) signed a deal to buy the biotech for $8.3 billion, a 38% premium fueled largely by the promise of Esbriet. And the Swiss giant, with its army of salespeople, will be looking to make that deal look wise.

Both approvals came well in advance of the FDA's promised deadlines, which for InterMune was Nov. 23 and for Boehringer was Jan. 2. Each drug was the beneficiary of the agency's fast-track, priority-review, orphan-product and breakthrough designations.

Roche Chief Medical Officer Sandra Horning

The FDA's move to close the gap so drastically in Boehringer's favor could cut into InterMune and Roche's expected lead time on the market. And the approval may have something of a bittersweet taste for InterMune, as the FDA rejected the exact same drug in 2010 before it was won over by new Phase III data.

"This is a historic day for the people and their families in the United States who live with this deadly, incurable disease," Roche Chief Medical Officer Sandra Horning said in a statement. "With today's approval of Esbriet in the United States, people with IPF finally have an FDA-approved medicine that may slow the worsening of the disease."

- read Esbriet release
- here's the Ofev announcement
- here's Roche's statement

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