04.10.24
NorthStar Medical Radioisotopes, LLC, a global provider of radiopharmaceuticals used to detect and treat cancer and other serious diseases, has signed 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 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.”
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.
“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.”
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.
