Clarity Pharmaceuticals Secures Large-Scale Copper-64 Manufacturing Agreement with Theragenics for Prostate Cancer Diagnostic
核心洞察
Clarity Pharmaceuticals (搜索) signed a manufacturing supply agreement with Theragenics (搜索) for large-scale copper-64 (搜索) production at their 134,000 square foot facility with 14 cyclotrons near Atlanta, Georgia.
The agreement supports commercial preparation for 64Cu-SAR-bisPSMA, which has a 12.7-hour half-life offering superior logistics compared to current PSMA (搜索) PET isotopes with less than 2-hour half-lives.
Theragenics (搜索) can produce around 100Ci of copper-64 (搜索) per day per cyclotron, translating to approximately 2,000 patient doses daily with a 48-hour shelf life.
Clarity Pharmaceuticals (搜索) has signed a large-scale manufacturing supply agreement with Theragenics (搜索) for copper-64 (搜索) production, positioning the clinical-stage radiopharmaceutical company for potential commercial launch of its prostate cancer (搜索) diagnostic 64Cu-SAR-bisPSMA pending successful completion of Phase III trials and FDA approval.
The agreement leverages Theragenics (搜索)' 134,000 square foot production facility housing a fleet of 14 cyclotrons located near Atlanta, Georgia. This strategic location at a major US transport hub enables centralized, large-scale copper-64 (搜索) production with broad geographic distribution capabilities.
Manufacturing Capacity and Capabilities
Theragenics (搜索) brings substantial expertise to the partnership, with 40 years of routine radiometal production experience and considerable background in medical radioisotope manufacturing. The company's high-current cyclotron fleet provides significant production capacity, with each cyclotron capable of producing around 100Ci (3.7 TBq) of copper-64 (搜索) per day.
This production capacity translates into approximately 2,000 patient doses per day per cyclotron at 200 MBq per dose, with a 48-hour shelf life. The extended shelf life is made possible by copper-64 (搜索)'s 12.7-hour half-life, which represents a significant advantage over current PSMA (搜索) PET imaging isotopes.
"We are excited to enter into this Manufacturing Supply Agreement for copper-64 (搜索) with Clarity," said Mark Pugh, CEO of Theragenics (搜索). "Having a current commercial sales force in prostate cancer (搜索), we have a deep insight into this field and have seen the excitement from key opinion leaders around 64Cu-SAR-bisPSMA."
Strategic Supply Network Expansion
This agreement with Theragenics (搜索) enhances Clarity's existing copper-64 (搜索) supply network, which includes manufacturing agreements with SpectronRx and Nusano (搜索). The multi-partner approach creates a broad network of high-volume copper-64 manufacturers across distinct US geographies, designed to support commercial-scale demand across multiple large oncology indications.
The network strategy addresses the unique logistical advantages of copper-64 (搜索)'s extended half-life compared to current radiodiagnostic isotopes. While gallium-68 (搜索) and fluorine-18 used in current PSMA (搜索) PET imaging have half-lives of less than 2 hours, copper-64's 12.7-hour half-life enables up to 48 hours of shelf life for 64Cu-SAR-bisPSMA.
Clinical Development Progress
Clarity is advancing 64Cu-SAR-bisPSMA through two Phase III registrational trials: AMPLIFY and CLARIFY. The company recently announced achieving its target number of participants in the Phase III AMPLIFY trial and released data from the head-to-head Co-PSMA (搜索) investigator-initiated trial.
The diagnostic candidate has received three Fast Track Designations from the US FDA (搜索), providing regulatory momentum for the development program. Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals (搜索), noted that the company is "closer than ever to commercialisation of 64Cu-SAR-bisPSMA."
Commercial Advantages and Market Positioning
The longer half-life of copper-64 (搜索) offers several commercial advantages over existing PSMA (搜索) PET imaging solutions. The extended shelf life provides greater flexibility for supply chain management and patient scheduling, while potentially reducing the costs, waste, and inefficiencies associated with short half-life isotopes.
"This represents a unique opportunity to implement a multi-tiered service approach comprising of large, local, centralised manufacturing with broad geographic distribution," Taylor explained. "Our goal is to take the industry in a new direction of scalability and profitability while delivering universal access to radiodiagnostics for physicians and the patients they serve."
The Manufacturing Supply Agreement became effective March 25, 2026, with cancellation and extension provisions aligned with industry standard rates. The partnership positions both companies for potential market entry pending successful completion of clinical trials and regulatory approval.
Pugh emphasized the strategic value of the partnership: "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 from the US FDA (搜索) and impressive data generated to date."