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

− Master Supply Agreement encompasses clinical development and commercial supply for Clarity’s Cu-67-based candidates to treat neuroblastoma, breast and prostate cancers, among others −

BELOIT, Wis. and Sydney, Australia – May 25, 2021 – NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, 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 serious disease.

“Previously, the lack of an effective copper chelating technology has 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-chelating technology has enabled it to advance its product pipeline into a range of theranostic clinical trials that use copper-64 (Cu-64) for diagnostic imaging and Cu-67 as therapy. NorthStar is addressing the need for reliable Cu-67 radioisotope supply by advancing towards commercial-scale production. Our efforts use the proven expertise and innovative approach demonstrated in the successful development and commercialization of U.S.-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 serious disease.”

“Consistent with other NorthStar production processes, the Cu-67 production 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 produced domestically in the United States without a nuclear reactor, has no long-lived contaminants or bi-products from the manufacturing process, and its starting material, zinc, is readily available. As opposed to other therapeutic isotopes in the market and under development, Cu-67 is ideally suited for commercial production to meet the growing demand for radiopharmaceuticals in large disease indications and we look forward to meeting Clarity’s anticipated future demands as it develops and commercializes its suite of products.”

“Clarity leads the world in the development and commercialization of TCT,” said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. “Access to large, commercial supply of Cu-67 at a suitable price-point enables us to apply our TCT approach not only to rare diseases such as neuroblastoma in children, but also other cancers with very large patient populations such as prostate and breast cancers. In essence, the availability of large scale production of Cu-67 in the United States will increase the speed of Clarity’s clinical trials across our SARTATETM, SAR-bisPSMA, SAR-Bombesin and discovery programs and will help us to achieve our ultimate goal of better treating children and 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 due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian, and bladder cancers. A chelator, which 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 chelator for copper isotopes and is progressing a range of radiopharmaceuticals based on its proprietary SAR Technology Platform. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment purposes.

About Clarity Pharmaceuticals (Clarity)
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing 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-stage nuclear medicine company that develops, produces, and manufactures reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. Its 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 to assess extent and severity of heart disease and cancer. Tc-99m is generated by NorthStar’s novel RadioGenix® System (technetium Tc 99m generator) that uses U.S.-produced, non-uranium based molybdenum-99 (Mo-99) as its source material. The Company is executing a well-defined plan to consistently increase the scale of Mo-99 production and to continuously improve efficiencies to meet anticipated increased demand. Therapeutic radioisotopes are increasingly important cancer treatment options, and NorthStar is developing commercial-scale production technologies to meet high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is advancing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. For more information, visit: www.northstarnm.com.

CONTACTS:
For NorthStar Medical Radioisotopes, LLC
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
[email protected]

Investor Relations:
Paul Estrem
Executive Vice President and Chief Financial Officer
608-987-8318
[email protected]

Media:
Priscilla Harlan
781-799-7917
[email protected]

For Clarity Pharmaceuticals
Media:
Dr Alan Taylor, Executive Chairman
+61 (0)413 871 165
[email protected]