Clarity Pharmaceuticals announced the signing of a Commercial Manufacturing Agreement for 64Cu-SAR-bisPSMA with Nucleus RadioPharma.
The Agreement relates to Nucleus RadioPharma's state-of-the-art facility in Rochester, Minnesota, which is capable of manufacturing around 50,000 patient doses per year, and future production in Spring House, Pennsylvania. The Spring House facility is a 47,000 square foot site that is planned to open in 2028, enabling broad coverage across the northeast of the US with up to 600,000 doses of 64Cu-SAR-bisPSMA per year. Together, these two facilities in Minnesota and Pennsylvania will provide access to key commercial markets with manufacturing and distribution to all 50 states in the US and select international sites, including Europe.
The Commercial Manufacturing Agreement further builds on Clarity's existing partnership with Nucleus RadioPharma with a Master Services Agreement and 67Cu-SAR-bisPSMA Clinical Supply Agreement in place from November 2024, covering the existing site in Rochester with additional facilities in Pennsylvania and future strategic sites to expand patient access.
This Agreement represents an important step in Clarity's continued build out of its manufacturing capabilities ahead of 64Cu-SAR-bisPSMA's anticipated commercial launch upon successful completion of Phase III registrational trials with this product, AMPLIFY3 and CLARIFY4, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.