Clarity Pharmaceuticals in diagnostic manufacture deal for prostate cancer
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The news: Biotech company Clarity Pharmaceuticals has entered into a clinical manufacturing agreement to produce its diagnostic 64Cu-SAR-bisPSMA product for prostate cancer for its phase III clinical trials.
The numbers: Clarity has entered into an agreement with US-based SpectronRx for the streamlined manufacturing process of both the 64 Cu isotope and the 64Cu-SAR-bisPSMA product at the same facility. The agreement is effective as of 8 October and is for an initial period of 24 months.
It comes after the US Food and Drug Administration in August granted fast track designation for Clarity's imaging agent as a novel diagnostic option for patients with prostate cancer.
Clarity shares were down 3.4% to $7.62 in early trading on the ASX.
The context: Clarity said SpectronRx’s facility will enable on-demand manufacturing and distribution of the Cu-SAR-bisPSMA product to all 50 US states, which provides reliable, universal access in the country for Clarity’s phase III trials, as well as the upcoming pivotal trial for prostate cancer patients with biochemical recurrence (BCR).
The agreement with SpectronRx builds on the earlier Master Services Agreement and Supply Agreement for the production of the 64Cu isotope and complements Clarity’s existing supply network, it said.
The source: ASX announcement
