Clarity Pharmaceuticals, an Australia-based clinical-stage radiopharmaceutical company, has announced a manufacturing supply agreement aimed at scaling up copper-64 production, as the company advances its radiopharmaceutical development program toward potential commercialisation.
The agreement, signed with Theragenics, centres on manufacturing capacity at Theragenics’ production facility near Atlanta, which houses 14 cyclotrons.
In a media release, Clarity said the facility is expected to support centralised, large-scale manufacturing of copper-64 ahead of a possible launch of its investigational product, 64Cu-SAR-bisPSMA, subject to successful Phase III trial outcomes and regulatory approval.
Clarity said the agreement forms part of a broader manufacturing strategy designed to support future demand, adding to existing supply arrangements with other US-based producers.
The company noted that copper-64’s 12.7-hour half-life allows for wider distribution compared to shorter-lived isotopes, which may enable more flexible scheduling and logistics in clinical settings.
Theragenics Chief Executive Officer Mark Pugh said the agreement reflects the company’s expansion into isotope contract manufacturing and its interest in radiopharmaceutical development.
“We are excited to enter into this Manufacturing Supply Agreement for copper-64 with Clarity,” Pugh said, adding that Theragenics’ experience in radiometal production and its existing presence in prostate cancer care informed its decision to partner with Clarity.
He said the collaboration could help “expand access to radiopharmaceuticals” in the United States.
Clarity Executive Chairperson Dr Alan Taylor said the company is progressing toward commercial readiness for 64Cu-SAR-bisPSMA, citing ongoing late-stage clinical trials and recent data releases.
“Building out a secure, reliable and abundant supply and manufacturing strategy is now coming into play,” Taylor said, noting that the agreement is intended to support a potential launch, subject to approval by the US Food and Drug Administration.
Taylor also pointed to operational considerations linked to copper-64’s longer half-life, stating it may reduce inefficiencies associated with shorter-lived isotopes commonly used in prostate-specific membrane antigen imaging. He said this could allow for a “multi-tiered service approach” involving centralised manufacturing and broader geographic distribution.
Theragenics said its facility has the capacity to produce approximately 100 curies of copper-64 per day on a single cyclotron, which Clarity indicated could equate to around 2,000 patient doses daily per unit, depending on dosing requirements.
The agreement, effective 25 March 2026, includes standard industry provisions for cancellation and extension.
Clarity noted that 64Cu-SAR-bisPSMA remains an investigational product and has not yet been approved by regulators, including the FDA. The company stated there is no guarantee the product will become commercially available.
