- Nucleus RadioPharma and Clarity Pharmaceuticals sign a three-year manufacturing agreement for the prostate cancer drug 67Cu-SAR-bisPSMA.
- New facilities in Minnesota, Arizona, and Pennsylvania will ensure robust U.S. supply for Phase III trials and potential commercialisation.
Nucleus RadioPharma to manufacture the cancer drug 67Cu-SAR-bisPSMA for Clarity Pharmaceuticals, a clinical-stage company focusing on radiopharmaceuticals. Under the agreement, Nucleus RadioPharma, a contract development and manufacturing organisation (CDMO), will produce the drug at its state-of-the-art facility in Rochester, Minnesota, with plans to expand into Arizona and Pennsylvania.
This partnership aims to support the manufacturing needs for Clarity’s SECuRE trial, a Phase III study set to begin in early 2025. The trial will involve administering the drug to prostate cancer patients and evaluating outcomes across an initial 24-week cohort. The agreement will enable Clarity to meet both clinical and anticipated commercial demand for 67Cu-SAR-bisPSMA, utilising Nucleus’s extended production capacity across three U.S. sites.
Dr Alan Taylor, Executive Chairperson of Clarity, highlighted the strategic importance of this partnership, saying, “We continue to strengthen our manufacturing network, ensuring prostate cancer patients in need of novel radiopharmaceutical treatments can get access to what we believe is a best-in-class product, on time and on demand.”
The expanded agreement also complements Clarity’s collaboration with NorthStar Medical Radioisotopes, ensuring a streamlined supply of the therapeutic copper-67 isotope for clinical use. Dr Geoffrey Johnson, Chief Scientific Officer of Nucleus RadioPharma and Principal Investigator for the SECuRE trial, remarked on the benefits of this domestic production, stating, “Nucleus RadioPharma’s location in Rochester, MN allows seamless access to prestigious medical centres in the vicinity.”
Read about the Radiopharmaceutical CDMO Market here.
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