Adial Pharmaceuticals and Tedor Pharma announced they entered into a collaboration agreement to provide cGMP contract manufacturing services for AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD).
Adial is on track to commence its first Phase 3 trial of AD04 next quarter and plans to conduct that trial using its current inventory of drug product. The engagement with Tedor is expected to provide Adial with a qualified manufacturing partner for any further developmental requirements and for commercialization of AD04 upon approval.
“We are pleased to announce our collaboration with Tedor to manufacture AD04 tablets. This should allow us to continue performing against our strategic plan, and Tedor has the capabilities to support commercial sales of AD04 once it is approved,” William Stilley, President and Chief Executive Officer of Adial Pharmaceuticals, said. “In the U.S. alone, we estimate there are over 10 million Americans with the target genotypes for AD04 and over 15 million Europeans. For this reason, we need a contract manufacturer with the resources and ability to rapidly scale manufacturing in order to meet the anticipated global demand, and Tedor is well-suited for this role.”
“We are delighted to partner with Adial to provide CDMO services for AD04,” said Doug Drysdale, President and CEO of Tedor Pharma. “AD04 can be easily and efficiently manufactured at large scale to the U.S. Food and Drug Administration and the European Medicines Agency standards, with high consistency and a long-expected shelf life, which make it well suited for both the clinical trials and mass commercialization.”