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1
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2004
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- Clarity Pharmaceuticals signed a manufacturing supply agreement with Theragenics for large-scale copper-64 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 PET isotopes with less than 2-hour half-lives. - Theragenics can produce around 100Ci of copper-64 per day per cyclotron, translating to approximately 2,000 patient doses daily with a 48-hour shelf life. - This partnership expands Clarity's copper-64 supply network alongside existing agreements with SpectronRx and Nusano, positioning for commercial launch pending FDA approval of ongoing Phase III trials AMPLIFY and CLARIFY.
- Clarity Pharmaceuticals has entered a five-year commercial manufacturing agreement with SpectronRx to produce up to 400,000 patient-ready doses of Cu-SAR-bisPSMA annually for prostate cancer diagnosis and treatment. - The partnership leverages copper-64's optimal 12.7-hour half-life to overcome supply chain limitations of current-generation PSMA diagnostics that rely on shorter-lived isotopes like gallium-68 and fluorine-18. - The agreement positions Clarity for immediate commercial rollout upon FDA approval of its Phase III registrational trials CLARIFY and AMPLIFY, with distribution capabilities to all 50 US states. - SpectronRx's Indiana facility will provide integrated manufacturing of both copper-64 isotope and the finished Cu-SAR-bisPSMA product under one roof, with options to expand to additional regional manufacturing sites.
- Clarity Pharmaceuticals partners with SpectronRx for manufacturing Cu-64 SAR-bisPSMA, ensuring reliable supply for Phase III trials. - The agreement supports trials including CLARIFY (pre-prostatectomy) and a pivotal trial for prostate cancer patients with biochemical recurrence. - Cu-64's 12.7-hour half-life overcomes supply limitations of shorter-lived isotopes like Ga-68 and F-18. - SpectronRx's facility enables on-demand manufacturing and distribution across the U.S., enhancing access to advanced imaging.
