Aimmune Therapeutics (NASDAQ:AIMT), a biopharmaceutical company that specializes in treatments for life-threatening food allergies, reported fourth-quarter results Thursday after the market close. Despite being down 14% at one point in Friday's trading, shares closed down only 2.5% on a day the market took a beating.
Investors weren't interested as much in the financials as they were to hear about the launch of Aimmune's peanut allergy drug, Palforzia, which was approved by the U.S. Food and Drug Administration (FDA) on Jan. 31. The company didn't take in any revenue in the quarter ended Dec. 31, as expected. The Palforzia launch is progressing, but complexities relating to the management of risk to patients means that revenue will ramp up slowly during the year.
Palforzia is a complex biologic drug derived from peanuts that works by desensitizing the patient to the allergen and has been approved for children aged 4 through 17. Since there is a risk that patients could have a dangerous allergic reaction to the medicine itself, the FDA specified a Risk Evaluation and Mitigation Strategy (REMS) that must be followed in order to make the medicine available. Patients and prescribing physicians must be enrolled in the program, the initial doses need to be administered in healthcare settings where the patient can be monitored, and those clinics and the dispensing pharmacies need to be certified.
Aimmune set up a website for certification and enrollment, and 300 physicians had enrolled after four days, which was a good start. Yet the complicated process will take time with competition on the horizon, and the company still has work to do to get the drug covered by payer formularies.
Looking ahead, the company expects a decision on the drug by the European Medicines Agency in Q4 and the completion of a phase 3 trial of Palforzia in children under 4 years old in the second half of the year.