NorthStar Medical Radioisotopes, LLC Enters Clinical Supply Agreement To Support Clarity Cu-67 SAR-bisPSMA Pivotal Trials

Highlights

• New Clinical Supply Agreement with Clarity for production of 67Cu-SAR-bisPSMA drug product ensures seamless product supply as Clarity pursues upcoming pivotal therapy trials
• NorthStar is uniquely able to provide large-scale U.S. manufacturing of both the therapeutic isotope (Cu-67) and cGMP radiopharmaceutical product ready for shipment to clinical sites
• NorthStar’s vertically integrated manufacturing offers significant manufacturing, supply chain and environmental advantages, including simplified logistics with minimal shipping requirements, efficient utilization of the radioisotope and reduced carbon footprint
• Agreement builds upon the existing Copper-67 supply agreement with Clarity, signed in 2021

NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the signing of a Clinical Supply Agreement with Clarity Pharmaceuticals for the production of 67Cu-SAR-bisPSMA drug product for Clarity’s Phase I/II and Phase III trials. The overarching Master Service agreement and associated Clinical Supply Agreement are effective immediately and the initial production of supply to support Clarity trials is expected to occur before the end of calendar 2024.

“Given Clarity’s outstanding clinical trial data to date, NorthStar is very excited to play a pivotal role in securing the supply of Cu-67 and final drug product for the trials with 67Cu-SAR-bisPSMA in prostate cancer,” said Frank Scholz, President and Chief Executive Officer of NorthStar. “We share Clarity’s vision of making more innovative, highly effective radiopharmaceutical treatments available for children and adults with cancer, and our passion is to reduce barriers and increase the speed with which companies like Clarity can develop and deliver these new medicines and diagnostic agents to patients who need them.”

Recent years have seen an explosion of radiopharmaceutical research and clinical trials and yet today far too many patients still suffer from diseases without effective treatments. This is partly because the processes to develop, manufacture and deliver effective radiotherapeutics at a scale that meets patient needs are highly specialized and complex, and require a level of process precision above that required by most sophisticated small molecule or biologic manufacturing. Additionally, because the therapeutic nature of these therapies decays at a precise, known rate, there is a level of sophistication required to effectively manage supply chain volatility and uncertainty for radiopharmaceuticals that doesn’t exist for other medicines.

“These unique characteristics and requirements, and the specialized facilities, equipment, processes, talent, technology and know-how that it takes to manufacture and supply radiopharmaceuticals at scale, are what NorthStar does best,” continued Scholz. “We are building out our contract development and manufacturing (CDMO) capabilities so that the biopharma innovators like Clarity can focus on discovering the next breakthrough. As we build our business, our goal is for NorthStar to be recognized as a leader in reliable production and delivery of high-quality radiotherapeutics and acknowledged as an essential success factor by our partners.”