Societal CDMO, a contract development and manufacturing organisation (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has been selected to provide services to support the ongoing clinical development of a novel drug candidate 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.
[There is] increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the US from other regions around the globe
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 labelling of both the active compound and matching placebo for the study.
Earlier in 2022, Societal unveiled its new '20/80 Second Source Technical Transfer' service model. This new service model was created as a response to the growing risks and vulnerabilities associated with the global supply chain that have significantly elevated the importance of second-source suppliers within the pharmaceutical industry.
“This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalise on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the US 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, CEO 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.”