Aimmune Therapeutics Cuts Ribbon on Commercial Manufacturing Facility in Clearwater, Florida

BRISBANE, Calif.-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today hosted a ribbon-cutting ceremony to celebrate the completion of its commercial manufacturing facility in Clearwater, Florida. The facility will produce AR101, Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, which is currently in Phase 3 clinical studies.

The new manufacturing facility contains more than 20,000 square feet of space and will handle full-scale cGMP (current Good Manufacturing Practices) commercial production of AR101 in anticipation of potential regulatory approvals. It will also supply future clinical trials of AR101 as well as trials of future product candidates. The facility includes state-of-the-art air-handling systems and equipment, which will prevent cross contamination of allergens from one suite to another, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations.

“Our work in 2017 has been intensely focused on the two critical paths of drug development — manufacturing and clinical development,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “The completion of this world-class commercial manufacturing facility is a significant milestone. Next, we will complete qualification and validation activities and scale up to full functionality, so by early 2018 we will have the capacity to manufacture approximately 450 million capsules of AR101 per year. Meanwhile, on the clinical path, we are fast approaching completion of the up-dosing phase of PALISADE, and the RAMSES trial is underway, to be followed soon by the ARTEMIS trial in Europe. These are all timely and essential steps toward potentially being able to offer an approved treatment for patients with peanut allergy.”

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.