Clarity signs commercial supply deal with SpectronRx for Cu-64 SAR-bisPSMA
by Gus Iversen, Editor in Chief | June 18, 2025
Business Affairs
Molecular Imaging
Clarity Pharmaceuticals has finalized a commercial manufacturing agreement with SpectronRx to support large-scale U.S. production and distribution of its lead diagnostic agent, 64Cu-SAR-bisPSMA, as the product moves toward potential FDA approval.
Under the deal, SpectronRx’s Indiana-based facility will manufacture both the copper-64 isotope and the finished radiopharmaceutical, with the capacity to supply up to 400,000 patient-ready doses annually. This site will also serve as a national distribution hub, supplying all 50 states.
The commercial agreement builds on earlier manufacturing and isotope supply contracts between the two companies, including clinical production for Clarity’s ongoing Phase III trials, CLARIFY1 and AMPLIFY2. The new contract includes provisions for potential expansion to other regional sites in the U.S., aimed at creating a decentralized supply network.
SpectronRx CEO John Zehner said the collaboration “marks a significant step forward in expanding access to radiopharmaceuticals and improving healthcare outcomes in the United States.”
Clarity’s executive chairperson, Dr. Alan Taylor, emphasized the logistical advantage of using copper-64, which has a 12.7-hour half-life — significantly longer than gallium-68 and fluorine-18, the isotopes commonly used in current PSMA PET diagnostics. “We are ready to roll out large-scale manufacturing and distribution of 64Cu-SAR-bisPSMA on day one of commercialisation,” Taylor said.
He added that copper-64’s longer shelf life enables broader access to diagnostic imaging at more treatment sites, avoiding the supply limitations linked to shorter-lived isotopes.
64Cu-SAR-bisPSMA is designed for use in prostate cancer imaging. It is based on Clarity’s proprietary SAR chelator platform, which tightly binds the copper isotope to reduce off-target activity. The product is not yet approved by the U.S. Food and Drug Administration.
The commercial agreement takes effect June 17 and runs for five years, with standard cancellation and extension terms.
Under the deal, SpectronRx’s Indiana-based facility will manufacture both the copper-64 isotope and the finished radiopharmaceutical, with the capacity to supply up to 400,000 patient-ready doses annually. This site will also serve as a national distribution hub, supplying all 50 states.
The commercial agreement builds on earlier manufacturing and isotope supply contracts between the two companies, including clinical production for Clarity’s ongoing Phase III trials, CLARIFY1 and AMPLIFY2. The new contract includes provisions for potential expansion to other regional sites in the U.S., aimed at creating a decentralized supply network.
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Clarity’s executive chairperson, Dr. Alan Taylor, emphasized the logistical advantage of using copper-64, which has a 12.7-hour half-life — significantly longer than gallium-68 and fluorine-18, the isotopes commonly used in current PSMA PET diagnostics. “We are ready to roll out large-scale manufacturing and distribution of 64Cu-SAR-bisPSMA on day one of commercialisation,” Taylor said.
He added that copper-64’s longer shelf life enables broader access to diagnostic imaging at more treatment sites, avoiding the supply limitations linked to shorter-lived isotopes.
64Cu-SAR-bisPSMA is designed for use in prostate cancer imaging. It is based on Clarity’s proprietary SAR chelator platform, which tightly binds the copper isotope to reduce off-target activity. The product is not yet approved by the U.S. Food and Drug Administration.
The commercial agreement takes effect June 17 and runs for five years, with standard cancellation and extension terms.
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