NorthStar Medical Radioisotopes, GE Healthcare Sign Manufacturing and Distribution Pact

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 have signed 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 CEO 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.
 
GE Healthcare is the $18 billion healthcare business of GE. As a global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
 
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 U.S. Food and Drug Administration-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.