There's nothing like same-day FDA approvals to trigger a market showdown--and that's the case for a pair of new idiopathic pulmonary fibrosis (IPF) treatments. After snagging nods from the agency Wednesday, Roche's ($RHHBY) Esbriet and Boehringer Ingelhem's Ofev will be going head to head.
The rivals will become the first treatments for IPF available in the U.S. Though they work differently--Esbriet is believed to work by interfering with proteins involved in inflammation and cell growth, while Ofev blocks growth factor receptors involved in the disease--both have shown their ability to significantly cut the decline in the amount of air that can be forcibly exhaled from the lungs, Pharmafile reports.
While both drugs nabbed the FDA's orphan product, fast-track and priority review designations along their journeys through the clinic, very different paths have led them to this point. When U.S. regulators in June agreed to an accelerated review of Boehringer's drug, Esbriet--a candidate from InterMune, which Roche later bought out--had already received one FDA rejection. Analysts had gone back and forth on which contender was most likely to hit the U.S. market first.
While Roche has the lead with Esbriet abroad--it won European approval in 2011 and has since gotten the thumbs up from Norway, Iceland and Canada--when it comes to the U.S. market, Boehringer's commercial heft should help provide for a compelling matchup. The German pharma got a head-start on marketing a few months back, backing a Discovery Channel disease awareness documentary on IPF featuring country music star Joe Nichols.
As far as price, both therapies are likely to come in on the high side, Pharmafile notes. But both Roche and BI have already set up financial assistance programs to help prevent those costs from hindering uptake.
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