Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that the Allergenic Products Advisory Committee (APAC) will review the Biologics License Application (BLA) for AR101 at its meeting scheduled for September 13, 2019. Aimmune is developing AR101, an investigational biologic drug for use in oral immunotherapy, as a treatment to reduce the frequency and severity of adverse events, including anaphylaxis, following exposure to peanuts. Additionally, Aimmune has entered into a commercial supply agreement with CoreRx, Inc., the Company’s long-standing manufacturer of AR101.
Peanut allergy is one of the most common food allergies, affecting more than 1.6 million children and teens in the United States.1 It can be a chronic and life-long condition, and reactions to peanut are severe and potentially life-threatening.2 The threat of a severe reaction dominates families’ daily lives and interferes with their quality of life.
“We have been preparing diligently, and will continue to refine our preparations, for the September 13 APAC Meeting so that we are in the best position to introduce AR101 to patients and their families as the first-ever approved treatment for peanut allergy, indeed for any food allergy,” said Jayson Dallas, M.D., President and Chief Executive Officer of Aimmune. “As we have previously communicated, we will be ready to launch AR101 by the fourth quarter of this year. Our agreement with CoreRx will allow the manufacturing of commercial AR101 supply to begin this week and will ensure that there is sufficient supply at launch.”
The FDA accepted the BLA for AR101 in March 2019, and previously informed Aimmune that completion of its review would be targeted by late January 2020. The FDA granted AR101 Fast Track Designation in September 2014 and Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4 to 17.
Aimmune’s AR101 commercial manufacturing facility, located on the CoreRx campus, includes state-of-the-art air-handling systems and equipment to prevent cross contamination of allergens, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations. The CoreRx team has been responsible for the manufacture of AR101 supply through the entire clinical development program.
AR101 is a new, investigational biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral 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 exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product, AR101, is being developed as a treatment to reduce the frequency and severity and adverse events, including anaphylaxis, following exposure to peanuts. The BLA for AR101 is under review by the FDA, which in 2015 granted AR101 Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4 to 17 years of age. Aimmune expects to file for marketing approval of AR101 in Europe in mid-2019. Aimmune has filed an IND application for its second product, AR201 for the treatment of egg allergy, and intends to start a randomized phase 2 clinical trial in mid-2019. For more information, please see www.aimmune.com.
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 AR101; Aimmune’s expectations regarding the potential commercial launch of AR101, including the review period of the BLA for AR101; Aimmune’s ability to be launch ready in the fourth quarter of 2019; CoreRx’s ability to supply sufficient quantities of AR101 at launch; Aimmune’s expectations regarding the planned timing and filing for marketing approval of AR101 in Europe; Aimmune’s expectations on the timing of initiating a phase 2 clinical trial for AR201; 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 or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s 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 March 31, 2019. 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 AR101, a product candidate that is under clinical investigation, and AR201, a product candidate that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the FDA or the European Medicines Agency (EMA). AR101 and AR201 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.
1 Aimmune market research.
2 American College of Allergy, Asthma & Immunology. Available here: https://acaai.org/allergies/types/food-allergies/types-food-allergy/peanut-allergy. Accessed May 15, 2019.
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