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Clarity Pharmaceuticals, an Australia-based clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, has announced the signing of a large-scale Manufacturing Supply Agreement for copper-64 with US-based Theragenics.
Theragenics has capacity to 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.
Mark Pugh, CEO of Theragenics, commented, "This agreement continues our expansion into the contract manufacturing organisation (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision. Clarity is in a unique position with two diagnostic Phase III trials nearing completion, three Fast Track Designations (FTDs) from the US FDA and impressive data generated to date. With our core expertise and experience in producing radiometals for commercial medical purposes at Theragenics, together we can expand access to radiopharmaceuticals and bring a next-generation platform to patients in need of better diagnostics in the US."
