NorthStar Medical Radioisotopes Enters U.S. Supply Agreement for Commercial Supply of Therapeutic Radioisotope Copper-67 (Cu-67) Exclusively to Clarity Pharmaceuticals for Its Targeted Copper Theranostics Programs

BELIEVE, Delete. & SYDNEY – (BUSINESS WIRE) – NorthStar Medical Radioisotopes, LLC, a global innovator in the development, manufacture and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company in the treatment of serious diseases, today announced the signing of a Master Supply Agreement for the therapeutic radioisotope copper-67 (Cu-67). Under the agreement, NorthStar will supply Cu-67 exclusively to Clarity Pharmaceuticals as an active pharmaceutical ingredient used to support Clarity’s Targeted Copper Theranostics (TCT) programs.

Cu-67 is a beta-emitting radioisotope with clinical applications as a radiopharmaceutical to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with severe disease.

“Previously, the lack of effective copper chelate technology limited the clinical development of Cu-67 products and subsequent commercial production of Cu-67,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “Clarity Pharmaceuticals’ unique copper chelate technology has enabled it to expand its product pipeline into a range of theranostic clinical trials using copper-64 (Cu-64) for diagnostic imaging and Cu-67 as a therapy. NorthStar is responding to the need for reliable Cu-67 radioisotope supply by moving towards commercial scale production. Our efforts leverage the proven expertise and innovative approach demonstrated in the successful development and commercialization of US-produced, non-uranium molybdenum-99 (Mo-99) to generate technetium-99m. NorthStar is pleased to sign this agreement with Clarity Pharmaceuticals and we look forward to supporting its plans for further clinical development and commercialization of Cu-67-based therapeutic radiopharmaceuticals to improve the lives of patients with severe disease. ”

“In line with other NorthStar manufacturing processes, the Cu-67 manufacturing process is also environmentally friendly and non-uranium based,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar Medical Radioisotopes. “Cu-67 has an optimal half-life for a therapeutic radiopharmaceutical, is manufactured in the United States without a nuclear reactor, contains no long-lived contaminants or by-products from the manufacturing process, and the starting material, zinc, is available. Unlike other therapeutic isotopes on the market and under development, Cu-67 is ideally suited for commercial production to meet the growing demand for radiopharmaceuticals in major disease indications and we look forward to meeting the expected future requirements of Clarity as it develops and commercializes its suite. of products. ”

“Clarity is a world leader in the development and commercialization of TCT,” said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. “Access to a large, commercial range of Cu-67 at an appropriate price allows us to apply our TCT approach not only to rare diseases such as neuroblastoma in children, but also to other cancers with very large patient populations, such as prostate. – and breast cancer. . In essence, the availability of large-scale production of Cu-67 in the United States will accelerate the speed of Clarity’s clinical trials in our SARTATETM, SAR-bisPSMA, SAR-Bombesin and Discovery programs and help us reach our ultimate goal of better children. and treating adults with cancer. ”

About copper-67 (Cu-67)

Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope that is attractive for medical purposes because of its ability to carry enough radiant energy to cause cell death in targeted cells, while having a short enough half-life to to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes in a wide variety of cancers in adults and children. Possible radiotherapy targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian and bladder cancer. A chelator that strongly binds Cu-67 to the targeting agent is required to develop safe and effective targeted therapies. Clarity has successfully developed a highly specific and highly stable copper isotope chelator and is working on a range of radiopharmaceuticals based on its proprietary SAR technology platform. NorthStar is developing a proprietary process for the production of Cu-67 on a commercial scale to meet the demand for clinical research and treatment purposes.

About Clarity Pharmaceuticals (Clarity)

Clarity is a clinical-stage radiopharmaceutical company focused on the treatment of serious illnesses. The company is a leader in innovative radiopharmaceuticals and develops targeted therapies for the treatment of cancer and other serious diseases in adults and children. For more information, visit: www.claritypharmaceuticals.com

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial phase nuclear medicine company that develops, manufactures and manufactures reliable and environmentally friendly diagnostic and therapeutic radiopharmaceuticals. The first FDA-approved diagnostic imaging product is technetium-99m (Tc-99m), which is used in 40,000 patient imaging studies per day in the United States as standard of care for assessing the extent and severity of heart disease and cancer. Tc-99m is generated by NorthStar’s new RadioGenix® system (technetium Tc 99m generator) that uses US-produced non-uranium-based molybdenum-99 (Mo-99) as the source material. The company is implementing a well-defined plan to consistently increase the scale of Mo-99 production and continuously improve efficiency to meet expected increased demand. Therapeutic radioisotopes are increasingly important in cancer treatment, and NorthStar is developing commercial-scale manufacturing technologies to meet the high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is developing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. For more information, visit: www.northstarnm.com.

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