BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today hosted a ribbon-cutting ceremony to celebrate the completion of its commercial manufacturing facility in Clearwater, Florida. The facility will produce AR101, Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, which is currently in Phase 3 clinical studies.
The new manufacturing facility contains more than 20,000 square feet of space and will handle full-scale cGMP (current Good Manufacturing Practices) commercial production of AR101 in anticipation of potential regulatory approvals. It will also supply future clinical trials of AR101 as well as trials of future product candidates. The facility includes state-of-the-art air-handling systems and equipment, which will prevent cross contamination of allergens from one suite to another, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations.
“Our work in 2017 has been intensely focused on the two critical paths of drug development — manufacturing and clinical development,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “The completion of this world-class commercial manufacturing facility is a significant milestone. Next, we will complete qualification and validation activities and scale up to full functionality, so by early 2018 we will have the capacity to manufacture approximately 450 million capsules of AR101 per year. Meanwhile, on the clinical path, we are fast approaching completion of the up-dosing phase of PALISADE, and the RAMSES trial is underway, to be followed soon by the ARTEMIS trial in Europe. These are all timely and essential steps toward potentially being able to offer an approved treatment for patients with peanut allergy.”
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection 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 and is currently being evaluated in Phase 3 clinical trials. 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 for its commercial manufacturing facility for AR101, including expectations that the facility will be cGMP compliant, capable of producing commercial supplies of AR101 and clinical supplies for additional product candidates, prevent cross-contamination of allergens and produce approximately 450 million capsules of AR101 per year; Aimmune’s expectations that qualification and validation activities at the new manufacturing facility will be completed in early 2018; Aimmune’s expectation that completion of the up-dosing phase of its PALISADE trial of AR101 will occur soon; Aimmune’s expectation that its ARTEMIS trial of AR101 will begin soon; Aimmune’s expectation that AR101 may receive regulatory approvals in the United States and Europe; Aimmune’s expectations regarding the potential benefits 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; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible regulatory developments in the United States and foreign countries; and the company’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, 2017. 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 a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.