Allied on Aimmune’s peanut allergy med, Nestlé is betting big on the biotech after the Phase III efficacy data pointed to an NDA filing with the FDA next month. Their timeline projects a potential market launch in H2 of next year.
In its Q3 review a few days ago the company said it had gained new data to back up the safety profile of their treatment, AR101, designed to build tolerance to peanuts among a patient group suffering from a severe allergy.
Once again, said Aimmune, about 1 in 5 of the patients taking the drug dropped out of the study, matching a dropout rate tracked during the PALISADE trial. A much smaller number of placebo patients also stopped treatment in the earlier pivotal trial, raising some questions about the adverse events tracked in the trial.
None of that, though, has blunted Nestlé’s appetite for Aimmune shares, though. Their $98 million — at $30.27 a share — adds to the $255 million bankroll the company enjoyed at the end of Q3, putting them in position to roll out their new therapy next year, if the FDA proves obliging on that score and no nasty surprises await investors.
Baird’s Brian Skorney, by the way, recently outlined his expectations for back-to-back AdComs for AR101 and DBV Therapeutics’s rival Viaskin Peanut therapy. Analysts have pitched prospective peak sales for AR101 at or a bit above the $1 billion blockbuster mark.
The two companies are also extending their collaboration pact by 2 years.
“The imminent U.S. regulatory filing for AR101 and the anticipated launch to follow in the coming year will be great news for people with peanut allergy, who need robust, reliable protection from accidental-exposure reactions,” says Nestlé Health Science CEO Greg Behar. “This collaboration exemplifies Nestlé Health Science’s commitment to food allergy and our excitement to continue an alliance with a leading innovator in the development of food allergy therapeutics.”
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