Aimmune rose 40% last year as investors anticipated Palforzia, the first treatment approved by the Food and Drug Administration for peanut allergy in children. The regulatory agency approved the treatment on Jan. 31, and now investors are waiting to see how the first weeks of sales progress. The process is taking time because of the risk management procedure involved in the launch.
Palforzia, an orally administered powder made of peanut protein, works by desensitizing patients to the allergen. In order to lower risk in case a new patient suffers a reaction to the therapy, the FDA has set up the Risk Evaluation and Mitigation Strategy (REMS) program. Physicians and patients must enroll in REMS and follow guidelines before treatment can begin. This process, along with the FDA's standard procedure of examining and releasing the first batches of biologic product, lengthened the timeline from approval to sales. Aimmune said during its recent earnings call that it expects to record the first Palforzia sales this month.
Getting physicians and patients on board in the next few months will be crucial for Aimmune. DBV Technologies (DBVT -6.01%) is close behind, with an FDA decision on its peanut allergy drug expected in August. Aimmune now has the advantage of being first to market, before rivals enter with competing products. Aimmune is also expecting a decision on Palforzia from the European regulatory agency in the fourth quarter, and said a decision in Switzerland could come in mid-2021.
All of these elements represent catalysts for the shares over the next year or so. If Aimmune can assure its position as market leader, the shares of this biotech company will benefit in the long term.