NorthStar Medical Radioisotopes and GE Healthcare Sign Exclusive U.S. Manufacturing and Distribution Agreement
NorthStar Medical Radioisotopes and GE Healthcare have signed an exclusive agreement for the manufacture and distribution of iodine-123 (I-123) capsules in the U.S. GE Healthcare will produce I-123 under NorthStar's label using advanced technology at its Arlington Heights facility. NorthStar will hold exclusive U.S. marketing rights for I-123 in 100µCi and 200µCi formulations. I-123 is vital for diagnosing thyroid abnormalities, including cancer, with approximately 44,280 U.S. cases expected in 2021. This partnership strengthens NorthStar's commitment to enhancing nuclear medicine.
- Exclusive agreement with GE Healthcare for I-123 capsules enhances market position.
- I-123 capsules will expand NorthStar's diagnostic imaging portfolio.
- The partnership leverages advanced production technology, ensuring high-quality supply.
- None.
NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, and GE Healthcare today announced the signing of an exclusive agreement for the manufacturing and distribution of iodine-123 (I-123) capsules in the United States. Under the contract terms, GE Healthcare’s Pharmaceutical Diagnostics unit will manufacture and supply NorthStar with I-123 capsules under the NorthStar label using a new, state-of-the-art production system at its facility in Arlington Heights, Ill. Upon receipt of the required regulatory approvals, NorthStar will retain exclusive U.S. marketing and distribution rights for these I-123 capsules, which will be available in 100µCi and 200µCi formulations.
Iodide I-123 (as sodium iodide I-123) is a radioisotope of iodine, a staple product in radiopharmacies that is used routinely in nuclear medicine as the proven standard for the diagnosis of physiological abnormalities in the thyroid, including thyroid cancer. The American Cancer Society estimates that approximately 44,280 Americans will be diagnosed with thyroid cancer in 2021.
“This exclusive sales and manufacturing agreement marks NorthStar’s strong and growing relationship with GE Healthcare, and we look forward to working with the company in meeting the needs of radiopharmacy customers and the patients we all serve,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “NorthStar is strongly committed to the future of nuclear medicine. The ability to provide I-123 further expands our diagnostic imaging portfolio, which includes domestically produced, non-uranium Mo-99/technetium-99m and FibroScint, a novel fibrin-specific diagnostic imaging agent with potential clinical utility in cardiovascular care.”
“We are pleased to sign this agreement and look forward to working with NorthStar in providing patients across the United States with I-123 capsules,” said Chris Vessell, U.S. Nuclear Medicine Supply Chain Leader, GE Healthcare Pharmaceutical Diagnostics. “NorthStar has proven itself a leader in successfully driving technology development to produce innovative, real-world solutions for radioisotope production to meet healthcare needs, and we anticipate a productive relationship with the company.”
GE Healthcare Pharmaceutical Diagnostics imaging agents support three patient procedures every second worldwide across MRI, X-ray/CT, ultrasound and nuclear medicine imaging.
About GE Healthcare
GE Healthcare is the
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that develops, produces and manufactures reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. Its first FDA-approved diagnostic imaging product is technetium-99m (Tc-99m), which is used in 40,000 patient imaging studies per day in the United States as standard of care to assess extent and severity of heart disease and cancer. Tc-99m is generated by NorthStar’s novel RadioGenix® System (technetium Tc-99m generator) which uses U.S.-produced, non-uranium based molybdenum-99 (Mo-99) as its source material. The Company is executing a well-defined plan to consistently increase the scale of Mo-99 production and to continuously improve efficiencies to meet anticipated increased demand. Therapeutic radioisotopes are increasingly important cancer treatment options, and NorthStar is developing commercial-scale production technologies to meet high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is advancing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. For more information, visit: www.northstarnm.com.
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