Clearwater, Florida, May 14, 2019 — CoreRx, Inc. today announced that it has executed a commercial supply agreement with Aimmune Therapeutics, Inc., for the commercial manufacture of AR101, an investigational treatment for peanut allergy currently under review for potential approval by the U.S. Food and Drug Administration. CoreRx has been the development manufacturer of AR101 through multiple successful phase 2 and phase 3 clinical trials of the drug.
Todd R. Daviau, President and CEO of CoreRx stated: “Aimmune has long been an important client-partner of CoreRx, and we’re pleased to build on that relationship with this agreement as the company prepares for the potential commercial launch of AR101. We’re proud to be part of the team working to make the potential first treatment for peanut allergy available to the millions of children at risk of having allergic reactions to peanut. This agreement positions CoreRx to meet the anticipated strong demand for AR101, both in the United States and globally, for the next several years. This agreement is also a significant milestone for CoreRx, providing the opportunity to showcase the capabilities of our world-class organization in a major emerging therapeutic space, and we expect to follow it with additional strategic manufacturing arrangements with other CoreRx clients.”
AR101 is being developed as a treatment to reduce the risk of anaphylaxis following accidental exposures to peanut. Aimmune began phase 2 clinical trials of AR101 in early 2014, followed by phase 3 clinical trials in early 2016. The 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. It can manufacture approximately 189 million dosage units of AR101 per year.
“CoreRx shares Aimmune’s commitment to improving the lives of people with food allergies and has been a great partner through the complex operation of supplying multiple different doses of AR101 for our clinical trials on a timely basis,” said William Turner, Aimmune’s Senior Vice President, Technical Operations and Regulatory Science. “We’re pleased to have their experience and expertise on board as we prepare for commercial launch of what could be the first treatment for peanut allergy, as we have seen them become a key contributor to the rapidly growing life science and biotechnology industry in the central Florida area.”
About CoreRx, Inc.
CoreRx is a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical – niche commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi-solid dosage forms.
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