DBV Technologies’ peanut allergy patch is back in the game. Investors have sent the company’s stock up as much as 12% this morning on news that the company plans to refile Viaskin Peanut with the FDA in the third quarter. But there are still plenty of reasons to be cautious.
A big one is money: at the last update DBV had €158m ($178m) in cash, which should fund it into the fourth quarter – enough to take it beyond the filing, but not to the point of approval.
The approval timeline for Viaskin Peanut is also somewhat uncertain. The project, a patch that is placed on the skin, is designed to deliver peanut protein, with the ultimate aim of desensitising patients to the allergen.
However, products containing allergen extracts are not included in the FDA’s user fee programme, which means that the agency is not bound to accept DBV’s submission within the 60-day period that is standard for projects covered by PDUFA.
“I cannot speak for the agency or the pace at which they’ll review our file,” admitted DBV’s chief executive, Daniel Tasse, on a conference call yesterday. But he pointed to Viaskin Peanut’s breakthrough status with the FDA, which the company will “certainly be taking advantage of”.
At least DBV should not need to do any more clinical trials, a prospect that might have been worrying investors since the company pulled the filing for Viaskin Peanut in December (DBV Technologies investors go into shock with filing withdrawal, 20 December 2018).
At the time, DBV said it had withdrawn its submission after the FDA raised questions about manufacturing and quality controls rather than clinical issues – a stance that it reiterated yesterday.
Another potential stumbling block for DBV is competition. Viaskin Peanut’s nearest rival, Aimmune Therapeutics’ oral peanut allergy project AR101, is ahead in the race towards approval.
Still, things have not gone smoothly for Aimmune, which saw the FDA review of AR101 delayed by the US government shutdown (As the US shutdown rolls on, blockbuster launches line up for 2019, January 17, 2019).
A spokesperson for Aimmune told Vantage that AR101 is now under review at the agency, and that the company hopes to find out in late March whether the filing has been accepted. At this time the group also hopes to provide details on the approval timeline for AR101, and whether the project will be reviewed by an advisory committee, the spokesperson added.
Still, Aimmune's stock was down as much as 4% this morning after the upturn in its rival's fortunes.
Both DBV and Aimmune could be suffering from a realisation among investors that the peanut allergy market might not be as big as once hoped. Stifel analysts recently cut their expectations for the sector, citing problems with adherence in children, the target population for Viaskin Peanut and AR101.
This might help explain why Sanofi recently canned a phase I peanut allergy candidate, SAR439794.
DBV does not have much choice but to continue with Viaskin Peanut, its lead project and biggest growth driver. Still, sales forecasts for the candidate have dipped since December, and now sit at $648m in 2024, according to EvaluatePharma sellside consensus.
The latest news appears to have assuaged worries that Viaskin Peanut was a dead end. But Leerink analysts do not expect the project to be approved until 2021, leaving DBV in need of cash. Investors who have already tasted disappointment might not be receptive to a new fund raising.
This story has been updated to incorporate comments from Aimmune.