News | Radiopharmaceuticals and Tracers | January 05, 2024

NorthStar Medical Radioisotopes and Curadh MTR Enter Strategic Collaboration Agreement for Development and Production of Actinium-225 (Ac-225)-based Therapeutic Radiopharmaceuticals for Treatment of Primary and Metastatic Solid Tumors

Under the new agreement, NorthStar will manufacture and distribute patient doses for ongoing Curadh Ac-225 clinical studies and provide Ac-225 for commercial use upon NorthStar’s submission of a Type II Drug Master File (DMF) to the FDA

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January 5, 2024 — NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, and Curadh MTR Inc. (Curadh), a global MTR-focused clinical, research and advisory organization, today announced a long-term strategic collaboration to develop and produce novel radiopharmaceuticals for the diagnosis and treatment of solid tumor cancers.

Under the agreement, NorthStar will support the development of select Curadh radiopharmaceutical targets by preparing and distributing Curadh patient doses of n.c.a. Ac-225 for its ongoing clinical studies and, upon approval, may manufacture and supply radiopharmaceuticals for commercial use. The new agreement also provides Curadh access to NorthStar’s integrated radiopharmaceutical development and manufacturing organization to support development and commercialization of future radiopharmaceutical diagnostic and therapeutic agents.

“This collaboration leverages NorthStar’s advanced technology and development and manufacturing expertise to advance Curadh’s innovative radiopharmaceutical candidates to benefit patients with cancer,” said Frank Scholz, Ph.D., Chief Executive Officer of NorthStar Medical Radioisotopes.

NorthStar will become one of the first commercial-scale producers of n.c.a. Ac-225, using the advanced, environmentally preferable electron accelerator technology that today supports routine production of the therapeutic radioisotope copper-67 (Cu-67). “NorthStar’s radiopharmaceutical expertise,” continued Scholz, “coupled with our manufacturing expertise and experience, allows us to offer a uniquely powerful ‘end-to-end’ support package to our development collaborators. Build-out of our 52,000 square foot CDMO facility is on schedule, and we expect it to be in full operation by January 2025, pending appropriate licensure and regulatory approvals.”

“Our focus is on advancing new MTR treatments for patients with primary and metastatic solid tumors, “ said Dr. Alison Armor, MD, FRCR, FRCP, Chief Executive Officer and founder of Curadh. “Working with NorthStar, a proven leader in nuclear medicine innovation and production, we believe that together we can ensure timely and efficient progression of our programs towards the clinic, and give patients broader access to potentially life-saving therapies."

For more information: www.northstarnm.com