Aimmune Therapeutics completes Florida facility
- Aimmune Therapeutics, which makes treatments for food allergies, has completed a new commercial manufacturing facility in Clearwater, Florida.
- The facility will produce AR101, Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy that is currently in Phase 3 clinical studies.
- The new manufacturing facility is upwards of 20,000 square feet and will handle full-scale current Good Manufacturing Practices (cGMP)commercial production of AR101.
"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," said the company in a statement.
The Florida plant will handle manufacturing of future clinical trial supply for AR101, as well as other future product candidates.
Aimmune is working to complete qualification and validation activities with the expectation that the facility will be fully functioning in 2018 and the hope of manufacturing 450 million capsules of AR101 annually.
On the clinical side, the company has completed the updosing phase of the PALISADE study, and the RAMSES trial is underway, to be followed soon by the ARTEMIS trial in Europe.
Food allergies reportedly affect 15 million people in the U.S. and have grown by more than 50% from 1997 to 2011, according to the Centers for Disease Control and Prevention. During that time, the prevalence of peanut and tree nut allergies has more than tripled in the U.S.
Mylan has largely cornered the market on treating allergic reactions with its EpiPen, but due to controversies surrounding pricing, competitors are starting to gain ground in that space.
- Aimmune Therapeutics Statement
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