Clarity Pharmaceuticals prepares to ramp up manufacturing under new deal
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The news: Clarity Pharmaceuticals has entered a commercial manufacturing agreement with SpectronRx in Louisiana that could boost annual production of its radiopharmaceutical Cu-SAR-bisPSMA to around 400,000.
The context: SpectronRx will provide on-demand commercial-scale manufacturing for the radioisotope copper-64, a key input to Clarity’s products, and Cu-SAR-bisPSMA - used in the diagnosis and treatment of prostate cancer.
The deal is effective from 17 June 2025 and will run for an initial five-year period. It also includes the option to expand production to other manufacturing sites and includes industry standard cancellation and extension terms.
The agreement has been signed in preparation for a commercial rollout, should it receive US Food and Drug Administration (FDA) approval.
SpectronRx is already producing small quantities of Cu-SAR-bisPSMA for use in Clarity’s phase three registrational trials required to apply for FDA New Drug Application approval.
What they 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 Cu-SAR-bisPSMA on day one of commercialisation,” Clarity’s executive chair Alan Taylor said.
The source: ASX
