DBV lays off employees, scales down programs after receiving no word from FDA
For years, it was a two-company race to develop the first treatment for peanut allergy. Then in January, Aimmune won approval for its peanut powder pill and now it looks like their competitor and the erstwhile frontrunner is struggling to stay alive.
DBV Technologies said today that it has not heard from the FDA since the agency said they were concerned about how effective DBV’s experimental peanut patch would be and, as a result, plan to lay off a “significant” number of employees. These cuts will be part of a “global and comprehensive restructuring plan” that will begin immediately and attempt to keep the company solvent past Q1 2021.
A spokesperson for DBV declined to comment on how many employees would be laid off and in what departments, but the company’s release indicates they will silo themselves tightly around their lead drug, scaling down both their other clinical programs and their preclinical research. Those programs includes a cow’s milk allergy patch, a hen’s egg patch, a diagnostics program with Nestlé and five other non-disclosed projects.
“We have carefully reviewed the situation and given the prevailing uncertainties, the goal of the plan that we are launching aims to preserve our core functions, extend our cash runway and maintain operating latitude to bring the first and only epicutaneous immunotherapy for the treatment of peanut allergy to patients in need, if approved,” CEO Daniel Tassé said in a statement.
The troubles for DBV began nearly a year and a half ago, when the French company pulled their first FDA submission, citing concerns that the BLA lacked “sufficient detail regarding data on manufacturing procedures and quality controls.” Known as Viaskin, the company’s patch is designed to build tolerance in kids with severe peanut allergy. Aimmune was trying to do the same with a pill, but DBV had gotten to regulators first, and were in a position to become the first approved therapy before they withdrew the application.
DBV refiled last August and the FDA accepted their review in October, setting up an advisory committee hearing in May and a decision by August 2020. Then in March, two months after Aimmune won approval, DBV disclosed that the FDA had questions about their second patch too, this time about efficacy.
The company had just missed the primary endpoint on their Phase III trial, falling short of a 15% confidence interval they had set for improved peanut tolerance after one year. Tassé said, though, that the issue had to do with reports that kids could scratch the patch off.
“This has nothing to do with the 15% confidence interval,” he told investors on a conference call. “The question for the agency has to do with the potential impact on efficacy of path adhesion and patch attachments.”
DBV submitted data it said showed the stickiness of the patch didn’t interfere with efficacy. Nevertheless, the FDA canceled the advisory committee hearing, raising concern among some analysts that a decision on the drug would likely be delayed and it could be rejected.
“At this point, we view DBVT as effectively dead in the water,” Baird analyst Brian Skorney, who has been consistently bullish on Aimmune’s prospects, said in a note.
Joseph Schwartz of SVB Leerink, though far less bearish, still called it “a sticky situation.”
“With many current unknowns,” he wrote, “we look forward to updates on DBVT’s discussions with the FDA and the next steps for Viaskin Peanut’s BLA review.”
Now DBV said that although it asked for guidance, discussions never materialized, aside from a message that the data were being reviewed and the target date for a decision was still August 5. The company’s cash balance now stands at €262.4 million. With the cuts, that will be enough to go “beyond” first quarter of 2021, they said.
Social: Daniel Tassé (DBV Technologies)