DBV Technologies SA’s top priority is to win over U.S. regulators and get its experimental peanut allergy patch to pharmacy shelves by 2019, even after it failed in an important test.
The French biotech expects to hold a meeting with Food and Drug Administration representatives next year, the first contact since late October, when its Viaskin patch wasn’t as effective as had been hoped in the study, called Pepites, Chief Operating Officer David Schilansky said in a telephone interview on Monday. The company still aims to file an application for approval next year.
DBV can bring “very consistent” data to the FDA with results from the disappointing study, along with data from a smaller mid-stage trial that was successful and another large test that showed the patch is safe to use, Schilansky said. “We wouldn’t see what an additional phase III study would bring in terms of new information,” he said.
The company is seeking a way forward after the Pepites trial failure sheared away about half of DBV’s market value and left investors questioning the future of the experimental skin patch. Success in the safety trial, dubbed Realise, may give DBV a window of time to seek additional funding before competitor Aimmune Therapeutics Inc. reports study results for a rival product, Oddo & Cie. analysts wrote in a note to investors this month.
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