#Australia #Sydney #Clarity Pharmaceuticals #Nusano #copper-64

Clarity Pharmaceuticals and Nusano Join Forces for Copper-64 Supply

In a pivotal move aimed at revolutionizing cancer diagnostics, Clarity Pharmaceuticals has recently cemented a commercial-scale supply agreement with Nusano, Inc. This partnership signals a breakthrough in the availability of the copper-64 (Cu-64 or 64Cu) isotope, essential for diagnostic imaging in oncology.

A State-of-the-Art Facility

Nusano operates a cutting-edge 190,000 square foot facility located in West Valley City, Utah. This facility is poised to produce over 1,000 Curie (Ci) of copper-64 daily, equivalent to approximately 18,000 patient doses with a manageable shelf life of 48 hours. This level of production far surpasses current market demands across various significant clinical applications. With Clarity in the late stages of several clinical trials and on the cusp of commercialization, this agreement is perfectly timed.

The copper-64 isotopes will not only provide abundant supplies for current needs but will also integrate seamlessly with Clarity's existing network of US-based suppliers. This ensures a reliable stream of isotopes as Clarity moves forward with its innovative product line centered on Targeted Copper Theranostics (TCTs).

Future Production Plans

Moreover, Nusano is not resting on its laurels; the company is set to initiate production of additional medical isotopes, including copper-67 and actinium-225, in the 2025-2026 timeframe. These isotopes are crucial components of Clarity's ongoing projects and highlight Nusano's commitment to expanding its isotopic offerings in the medical sector.

The Road Ahead for Clarity

Dr. Alan Taylor, Executive Chairperson of Clarity, expressed enthusiasm about the deal, indicating it fits into an overarching strategy to ensure a robust supply chain for their innovative diagnostic products. As Clarity makes headway with groundbreaking research and FDA Fast Track Designations for its flagship SAR-bisPSMA product, the integration of a stable, large-scale supply of copper-64 positions the company for leadership in the growing field of prostate cancer diagnosis.

Taylor underscored the importance of this supply agreement, noting its role in preparing for the commercial roll-out of their TCTs in the largest healthcare market globally—the United States. He emphasized how vital it is for Clarity to navigate a landscape affected by geopolitical and economic instability by stabilizing their supply chain from isotope production to in-market delivery.

“By ensuring a reliable isotopic supply chain, we aim to mitigate concerns prevalent in current market leaders whose products are hampered by short half-lives and limited availability. This integrated approach aims to facilitate timely diagnostics that can lead to better patient outcomes,” he stated.

A Game Changer in Diagnostics

Dr. Taylor's comments reflect the strategic advantage that Clarity seeks to achieve with this partnership. The longer half-life of copper-64, in comparison to others like 18F, presents an opportunity for maintaining high availability at imaging sites. The operational efficiencies expected from this supply agreement point to a more significant sensitivity in detecting cancer lesions, which could lead to improved treatment pathways for oncology patients.

Nusano's Chief Executive Officer, Chris Lowe, highlighted the company's groundbreaking platform designed to produce over 25 radioisotopes. He expressed excitement about collaborating with Clarity to provide a dependable source of copper-64 that supports their clinical endeavors and solidifies their standing in the market.

Conclusion

The Supply Agreement between Clarity Pharmaceuticals and Nusano comes into effect as of April 16, 2025, for an initial three-year term, with provisions for renewal. This collaboration not only underscores the importance of reliable isotope production in oncology but also emphasizes Clarity's commitment to enhancing patient care through innovative diagnostic solutions. As both companies gear up for production in the coming years, stakeholders can anticipate a transformative shift in the realm of cancer diagnostics, positioning Clarity at the forefront of this critical industry.