Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the submission of its investigational new drug (IND) application for AR201 for the treatment of egg allergy. The company also announced an exclusive supply agreement for egg protein with Michael Foods, Inc., the largest U.S. processor of value-added eggs. Aimmune 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,” said Jayson Dallas, M.D., President and CEO of Aimmune. “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.”
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 egg is 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.
“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.”
The 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.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens 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. Aimmune expects to submit its regulatory filing for marketing approval of AR101 in the United States in 2018, with its filing in Europe to follow in 2019. For more information, please see www.aimmune.com.
About Michael Foods
Michael Foods, Inc., a business unit of Post Holdings, Inc., is based in Minnetonka, Minnesota, and is a producer, marketer and distributor of food products to the retail, foodservice and food ingredient markets. Its principal products are specialty egg products, refrigerated potato products, cheese and other dairy products. Michael Foods also serves customers across North America, Europe and Asia with Crystal Farms®, Papetti’s®, Simply Potatoes®, and Abbotsford Farms® branded products.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of AR201 for egg allergy; Aimmune’s expectations on the timing of initiating a Phase 2 clinical trial for AR201; Aimmune’s expectations on the potential size of the market opportunity in egg allergy; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in the United States and Europe, including the timing of these submissions; Aimmune’s expectations regarding the potential commercial launch of AR101; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of its product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
This press release concerns AR201, a product that Aimmune expects will be under clinical investigation in 2019, and AR101, a product that is under clinical investigation. Neither AR201 nor AR101 has been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). AR201 and AR101 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.