Clarity Pharmaceuticals has signed a large-scale manufacturing supply agreement with Theragenics for copper-64 (Cu-64) to support the potential commercial launch of its Cu-64 SAR-bisPSMA PSMA-PET imaging agent.
Under the agreement, Theragenics will produce Cu-64 at its 14-cyclotron facility near Atlanta, with capacity for around 100 Ci of the isotope per day on a single cyclotron -- equivalent to roughly 2,000 patient doses daily, according to Clarity.
The deal adds to existing copper-64 supply agreements Clarity has with SpectronRx and Nusano.
Commercial launch of Cu-64 SAR-bisPSMA is contingent on successful completion of Clarity's phase III AMPLIFY and CLARIFY trials and subsequent U.S. Food and Drug Administration approval of a new drug application.
