Australia-based clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) announced on Wednesday that it has signed a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics, a US manufacturer of minimally invasive medical devices and radiation-based treatments.

The agreement relates to Theragenics' 134,000 square foot production facility with a fleet of 14 cyclotrons close to Atlanta, Georgia, for centralised, large-scale copper-64 (Cu-64 or 64Cu) production ahead of anticipated 64Cu-SAR-bisPSMA commercial launch upon successful completion of Clarity's Phase III registrational trials with this product, AMPLIFY and CLARIFY, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Theragenics can produce around 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates into around 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life. Together with Clarity's existing copper-64 supply agreements with SpectronRx and Nusano, this agreement with Theragenics further enhances Clarity's broad network of high-volume copper-64 manufacturers in distinct US geographies. The network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless and abundant supply of this diagnostic isotope, made possible with the 12.7-hour half-life of copper-64, which is unique in the radiopharmaceutical commercial space, Clarity said.