Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, will present at the Institute for Clinical and Economic Review's (ICER) Public Meeting reviewing the effectiveness and value of treatments for peanut allergy, to be held today in Oakland, California. Aimmune is developing AR101, an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts.

Cost per QALY, or quality-adjusted life year, measures the economic value of a health care intervention; the lower the cost per QALY, the higher the value of the treatment. Using only clinical data from the landmark Phase 3 PALISADE trial, ICER found AR101 to be cost-effective well-below ICER's traditional threshold of $100,000-$150,000 per QALY. Additionally, when factoring in the societal perspective, ICER found AR101 to be even more cost-effective compared to avoidance alone. This early analysis does not include recent efficacy and safety data from the Phase 3 ARTEMIS trial or long-term patient reported outcomes.

"We are committed to delivering AR101 to patients and families with peanut allergy, and we look forward to providing our perspective at today's meeting about the important value AR101 will provide to patients, payers, healthcare systems and society as a whole," said Jayson Dallas, M.D., President and Chief Executive Officer of Aimmune. "We have been working collaboratively with ICER over the last eight months to provide data about the strong value proposition of AR101 which, if approved, will be the first-ever treatment for peanut allergy."

Peanut allergy is one of the most common food allergies, affecting more than 1.6 million children and teens in the United States.¹ It can be a chronic and life-long condition, and symptoms from accidental exposures to peanut are often severe and potentially life-threatening.² The threat of a severe reaction dominates families' daily lives and interferes with their quality of life.

Stephen Tilles, M.D., Senior Director of Medical Affairs, will represent Aimmune at today's meeting. A board-certified allergist and immunologist and recent past president of the American College of Allergy, Asthma and Immunology (ACAAI), Dr. Tilles will discuss the critical need for rigorously developed, clinically tested, approved treatment for peanut allergy.

In his statement, Dr. Tilles will note that, "For more than 20 years, as the peanut allergy epidemic has continued to grow, I have shared in the sadness and frustration of young patients and their families about the lack of any approved options for treatment. Avoidance has ruled the day - but it is the opposite of a patient-centered treatment because it often prevents children from living a normal childhood. For example, data from a new study found that 40% of teens believe they have a high likelihood - and some believe a certainty - of dying from an accidental exposure to peanuts. Avoiding peanuts in the real world is a difficult and ineffective way of managing peanut allergy. Accidental exposures are inevitable, traumatic - and can be fatal. With this in mind, Aimmune has deployed an oral immunologic approach that uses defined, precise amounts of key allergens to address the broad spectrum of scenarios that could cause exposure."

New data released at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress reinforce the clinical profile of AR101 and demonstrate improved safety and immunomodulation with continued longer-term daily treatment.

Dr. Dallas added, "While Aimmune has provided ICER with additional evidence to support an accurate evaluation of AR101, data continue to emerge suggesting improved efficacy and decreased adverse effects over time. This pattern is identical to subcutaneous immunotherapy for pollen allergy and stinging insect allergy, both of which have been shown to result in disease modification after three to five years of therapy. Therefore, although ICER finds AR101 to be cost-effective well within standard thresholds, we believe the value estimates for AR101 in ICER's evidence report are overly conservative, especially as the potential for disease modification was not considered."

The FDA's Allergenic Products Advisory Committee (APAC) will review Aimmune's Biologics License Application (BLA) for AR101 at its meeting scheduled for September 13, 2019. The FDA accepted the BLA for AR101 in March 2019 and previously informed Aimmune that completion of its review would be targeted by late January 2020. The FDA granted AR101 Fast Track Designation in September 2014 and Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4 to 17.