Aimmune Therapeutics announced an expansion and extension of its exclusive supply agreement with Golden Peanut and Tree Nuts (Golden), a subsidiary of Archer Daniels Midland Company (ADM), to support the anticipated potential commercialization of AR101. Golden is a handler, processor and exporter of peanuts and tree nuts and exclusively supplies the starting material for AR101, Aimmune’s investigational biologic oral immunotherapy (OIT) for desensitization of patients with peanut allergy. AR101 is currently in Phase 3 clinical trials, with pivotal topline data expected in February.
The expanded agreement secures Aimmune’s exclusive global use of the starting material of AR101 for the oral treatment of peanut allergy for 10 years, with an option to extend the agreement up to an additional five years, through 2033. Further, it gives Aimmune exclusive access to additional Golden products that could be developed into peanut oral immunotherapies. As part of the agreement, Aimmune has granted ADM a 300,000-share equity stake in Aimmune.
“We’re honored and delighted to strengthen our alliance with Golden Peanut,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “As drug developers, we have a responsibility to thoroughly secure our supply chain, and this exclusive agreement, with the largest and most established supplier in the industry, fulfills that very well. Golden Peanut shares our mission to protect people with peanut allergies and has been a great partner for ensuring that we have a consistent, stable, reliable source for our clinical trials and our potential future commercial requirements.”
The batch-to-batch consistency of the AR101 starting material Aimmune receives from Golden is an essential component of the AR101 manufacturing process, as Aimmune controls for both the quantity of peanut protein and the relative concentrations of key peanut proteins in the final drug product. Additionally, the Golden peanut production process takes place in a peanut-only environment, from field to shipment. This is an important safeguard for Aimmune’s manufacture of an investigational peanut allergy treatment that is free from other common food allergens, such as tree nuts, as some people with peanut allergy are allergic to tree nuts as well.