Clarity Pharmaceuticals (ASX:CU6) has entered into a large-scale manufacturing supply agreement with Theragenics for the production of copper-64.
The partnership centres on Theragenics' 134,000-square-foot facility near Atlanta, Georgia—a primary US transport hub. The site houses a fleet of 14 cyclotrons, providing the infrastructure necessary for the centralised, high-volume production of the radioisotope.
The agreement is designed to support the anticipated commercial launch of Clarity’s lead product, 64Cu-SAR-bisPSMA, following the completion of Phase 3 registrational trials and subsequent FDA approval.
Currently, the diagnostic landscape relies on isotopes with half-lives of less than two hours, such as gallium-68 and fluorine-18.
In contrast, copper-64 boasts a 12.7-hour half-life, enabling a shelf life of up to 48 hours.
The technical advantage offers unprecedented flexibility in patient scheduling and nationwide distribution, overcoming the logistical bottlenecks that often plague radiopharmaceuticals.
Theragenics brings 40 years of expertise to the table, with the capacity to produce approximately 100Ci of Cu-64 per day on a single cyclotron—translating to roughly 2,000 patient doses.
Dr Alan Taylor, Executive Chairperson of Clarity, noted that the deal ensures a secure, reliable supply chain is in place as the company nears the final stages of clinical development.