• Clarity signs Commercial Manufacturing Agreement with Nucleus RadioPharma
• Agreement covers manufacturing at facilities in Minnesota and Pennsylvania
• Enables broad commercial coverage across the US and select international markets

Clarity Pharmaceuticals (ASX: CU6) has announced the signing of a Commercial Manufacturing Agreement for its 64Cu-SAR-bisPSMA product with Nucleus RadioPharma, an innovative contract development and manufacturing organisation (CDMO) in the radiopharmaceutical industry. The agreement covers Nucleus RadioPharma's state-of-the-art facility in Rochester, Minnesota, which can manufacture around 50,000 patient doses per year, as well as a future production site in Spring House, Pennsylvania, which is planned to open in 2028 and will enable up to 600,000 doses of 64Cu-SAR-bisPSMA per year. Together, these two facilities 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 builds on Clarity's existing partnership with Nucleus RadioPharma, which includes a Master Services Agreement and 67Cu-SAR-bisPSMA Clinical Supply Agreement from November 2024. This new agreement represents an important step in Clarity's continued build-out of its manufacturing capabilities ahead of the anticipated commercial launch of 64Cu-SAR-bisPSMA upon successful completion of Phase III registrational trials and subsequent FDA approval.

The Commercial Manufacturing Agreement with Nucleus RadioPharma will enable Clarity to provide 64Cu-SAR-bisPSMA on demand through centralised manufacturing and distribution, broadly with sites servicing the entirety of the US and beyond, including sites close to areas of high demand. The half-life of copper-64 gives Clarity the flexibility to deliver a number of models to meet future demand for its products.