French Drugmaker Crashes After Peanut Allergy Treatment Fails a Major TrialBy and
DBV falls 53% in Paris; Aimmune soars 46% in New York
Patch may still be approved, but sales may disappoint: analyst
After its experimental peanut allergy patch failed in a major trial, French drugmaker DBV Technologies SA pressed ahead, saying it’s continuing discussions with regulators and will seek approval as planned.
Investors remained skeptical about the patch’s prospects on Monday: DBV’s stock fell by a record 53 percent in Paris trading, wiping out about 1.3 billion euros ($1.5 billion) in market value. Aimmune Therapeutics Inc., which is developing its own peanut allergy treatment, soared as much as 46 percent in New York.
The Viaskin patch was safe and increased children’s ability to tolerate peanuts in a final-stage study, although not enough to meet the trial’s main statistical goal, Bagneux, France-based DBV said late Friday. The product may still gain approval, since it currently has no rivals, but sales may fall short of what investors had hoped, analysts said.
“The question is not so much on the approvability of the drug, it’s more on the commercial potential,” said Delphine Le Louet, an analyst with Societe Generale in Paris.
DBV was down 48 percent to 43 euros as of 4:24 p.m. in Paris. Aimmune rose 34 percent to $34.47, after reaching $37.50, the highest intraday level since the company’s 2015 initial public offering.
About 6 million people in the U.S. and Europe have peanut allergies, including more than 2 million children, according to Brisbane, California-based Aimmune. Desensitization works by exposing patients to gradually increasing amounts of the substance to which they’re allergic to retrain their immune system.
The potential for offering a skin patch that could protect children from sometimes fatal allergic reactions has made DBV an investor darling. Before today, its shares had soared in value, gaining by more than ninefold since March 2012 when they began trading.
The U.S. Food and Drug Administration agreed to fast-track Viaskin’s review. The agency has approved other allergy products despite studies that missed the required confidence interval -- a measure of statistical significance -- such as Stallergenes SA’s Oralair and Alk-Abello A/S’s Odactra, according to analysts at Bryan, Garnier & Co.
DBV has been in contact with the FDA and intends to propose “a path forward” toward approval for sale in the U.S., Hugh Sampson, the chief scientific officer, said in a conference call with analysts early on Saturday.
“The treatment works and there is currently no efficacious and safe alternative on the market,” Sebastien Malafosse, an analyst at Oddo BHF in Paris, wrote in a note to clients. He reiterated his buy rating on the stock and said he believes the product is still on track to win U.S. regulatory clearance.