Michael Foods enters supply agreement with drug company

Michael Foods has reached an exclusive egg protein supply agreement with Aimmune Therapeutics, a biopharmaceutical company that is developing an investigational new drug (IND) for the treatment of egg allergies.

Roy Graber Headshot
Photo by Andrea Gantz
Photo by Andrea Gantz

Michael Foods has reached an exclusive egg protein supply agreement with Aimmune Therapeutics, a biopharmaceutical company that is developing an investigational new drug (IND) for the treatment of egg allergies.

Aimmune Therapeutics, in a press release dated December 20, announced the submission of its investigational new drug (IND) application for AR201, for the potential treatment of egg allergies. Aimmune Therapeutics expects to initiate a Phase 2 clinical trial of AR201 for the treatment of egg allergy in 2019.

“The prevalence, severe reactions and difficulty of avoidance associated with egg allergy create an urgent need for treatment, which we are eager to address with our AR201 program. We are extremely pleased to be working with Michael Foods on this effort,” 

Jayson Dallas, M.D., president and CEO of Aimmune, stated in the press release. “Michael Foods provides excellent technical and operational capabilities, including an extensive and reliable supply chain for our AR201 starting material. Additionally, they’re committed to our mission to improve the lives of people with food allergies. We look forward to starting the AR201 Phase 2 clinical trial in the coming months.”

According to Aimmune Therapeutics, nearly 6 million people worldwide are allergic to eggs, including 800,000 in the United States and as many as 4 million across Asia, where allergy to egg is the most common food allergy.

Since eggs are an ingredient in so many foods, it can be especially difficult for people with egg allergy to avoid accidental consumption. Academic studies of the oral immunotherapy approach for egg allergy treatment have shown efficacy, and Aimmune’s AR201 program will study this more broadly, with a biologic drug product, in order to enable widespread availability of a potential treatment, Aimmune Therapeutics stated.

“Food allergies have become a major factor in the food industry and they affect the lives of so many people in our community. We’re thrilled to offer our market leadership and innovation in value-added eggs to help bring a solution to people with egg allergy,” said 

Mark Westphal, president of Michael Foods. “We are pleased to provide the product quality and consistency required for egg proteins to be used to develop Aimmune’s treatments. Our involvement with Aimmune is deeply fulfilling for everyone involved at Michael Foods. We are aligned with Aimmune’s mission and the integrity with which they’ve pursued it and we’re honored to be their supply partner of choice.”

Aimmune Therapeutics’ agreement with Michael Foods includes all of the company’s egg products, worldwide, and gives Aimmune exclusive access to the clinical and commercial use of Michael Foods egg products for any egg allergy treatment, prevention or cure for a period of up to 15 years beyond the potential approval of AR201.

Aimmune expects AR201, which has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to be under clinical investigation in 2019, and AR101, a product that is under clinical investigation. AR201 is currently limited to investigational use, and no representation is being made as to its safety or effectiveness for the purposes for which they are being investigated.

Michael Foods, a subsidiary of Post Holdings, is the largest supplier of processed eggs in the world. At the conclusion of 2017, according to the WATTAgNet Top Poultry Companies Database, Michael Foods had a flock of 12.18 million hens.

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