News Releases
Peanut allergy is one of the most common food allergies, affecting more than 1.6 million children and teens in
“We have been preparing diligently, and will continue to refine our preparations, for the
The
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.
About AR101
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
Forward-Looking Statements
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
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.
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1 Aimmune market research.
2
View source version on businesswire.com: https://www.businesswire.com/news/home/20190516005497/en/
Source:
Investors:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Jerica Pitts
(312) 858-3469
jpitts@w2ogroup.com