NorthStar Medical Technologies Signs Letter of Intent with Clarity Pharmaceuticals to Supply Therapeutic Radioisotope Copper-67 (Cu-67)

BELOIT, Wis. and Sydney, Australia – February 11, 2020 – NorthStar Medical Technologies, LLC (NorthStar), a global innovator in the production and distribution of radioisotopes used for medical imaging, and Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, today announced the signing of a Letter of Intent for the commercial supply of copper-67 (Cu-67) as an active pharmaceutical ingredient for Clarity’s pipeline of copper-based radiopharmaceuticals. Under terms of the agreement, NorthStar will provide Clarity Pharmaceuticals with Cu-67, a beta-emitting radioisotope with potential applications as a targeted radiopharmaceutical for treatment of a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity.

“NorthStar is committed to developing and commercializing innovative technologies for Cu-67 radioisotope production to advance medical research and meet patient needs,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Technologies. “Clinical development of Cu-67 based radiopharmaceuticals has been limited to date due to lack of stable chelators for Cu-isotopes and limitations in supply. With Clarity Pharmaceuticals’ leading copper chelating technology and product pipeline advancing into a range of theranostic clinical trials that use Cu-64/Cu-67 pairing, industrialization of Cu-67 production is required. NorthStar is addressing this need and advancing towards commercial-scale production. This commercialization process will apply our proven expertise and innovative approach as demonstrated in the successful launch of the RadioGenix® System (technetium Tc 99m generator), which provides our customers with reliable domestic Mo-99 supply and is increasingly helping to alleviate supply shortages. We look forward to working with Clarity and supporting its plans for further clinical development and commercialization to improve the lives of patients with serious disease.”

“NorthStar is working towards scale-up of Cu-67 production in collaboration with select institutions and laboratories using its electron accelerator technology to produce Cu-67,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. “We will advance Cu-67 production technology, with the aim to produce high specific activity and high purity Cu-67, eliminate supply shortages and establish commercial production capacity sufficient to meet anticipated future market demands.”

“We believe that NorthStar’s proven experience in the development and commercialization of innovative radioisotope technologies will be helpful for us to further advance our research and clinical development efforts,” said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. “Having access to a reliable and scalable supply of Cu-67 in the United States will enable us to apply our proprietary copper-chelating technology to a range of targeting agents for potential treatment of neuroblastoma, prostate, breast and ovarian cancers. The perfect pairing of Cu-64 and Cu-67 labelled radiopharmaceuticals for diagnosis and therapy has been discussed for many years, but has been hampered by poor chelator technology that leaks copper isotopes in-vivo, and has led to limited demands for Cu-67. We have now overcome this issue, and the use of electron accelerator technology enables Clarity to be free of reliance on the aging fleet of nuclear reactors which currently produce therapeutic radionuclides. This technology will also increase the speed of Clarity’s clinical trials across our SARTATE, SAR-bisPSMA and SAR-Bombesin programs.”

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which 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. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment.

About NorthStar Medical Technologies, LLC (NorthStar)
NorthStar Medical Radioisotopes is a global innovator in the production and distribution of radioisotopes used for medical imaging and therapeutic purposes. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Technologies is the parent organization of several wholly-owned subsidiaries, including NorthStar Medical Radioisotopes, LLC. NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix® System (technetium Tc 99m generator), an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. For more information, visit: https://www.northstarnm.com.

About Clarity
Clarity is a personalised medicine 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

CONTACTS

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

Investor Relations:
Paul Estrem, Senior 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]