Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has entered into a commercial manufacturing agreement with SpectronRx for the company's lead diagnostic product, 64Cu-SAR-bisPSMA.
SpectronRx’s facility in Indiana will provide on-demand, commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof, enabling distribution to all 50 US states. It is capable of producing up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually from one facility.
Clarity said this agreement substantially bolsters reliable, universal access to 64Cu-SAR-bisPSMA in the US for a commercial rollout upon successful completion of its Phase 3 registrational trials, CLARIFY1 and AMPLIFY2, and subsequent consideration by the US FDA.
The agreement with SpectronRx includes options to expand integrated 64Cu-SAR-bisPSMA manufacturing to additional locations in the US.
John Zehner, CEO of SpectronRx, said, "Partnering with Clarity marks a significant step forward in expanding access to radiopharmaceuticals and improving healthcare outcomes in the United States. SpectronRx's ability to reliably produce and distribute 64CuSAR-bisPSMA further solidifies our position as a trusted manufacturing partner for radiopharmaceutical companies, ensuring timely access to essential diagnostic and therapeutic resources for patients and providers alike."
Clarity’s executive chairperson, Dr Alan Taylor, said, “This Agreement, combined with other supply and manufacturing agreements for isotope and finished product we have secured to date, ensures that we are ready to roll out large-scale manufacturing and distribution of 64Cu-SAR-bisPSMA on day one of commercialisation. This will enable a seamless launch as soon as we have US FDA approval, allowing patients to get access to this next-generation diagnostic at any treatment facility in the US with a positron emission tomography (PET) scanner, 24 hours a day, 7 days a week."