Societal CDMO was selected to support the clinical development of a new drug in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus (HIV) in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications.
Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study.
“This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe,” said David Enloe, chief executive officer of Societal CDMO. “We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.”
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