Ioflupane-I-123

CHALFONT ST GILES, England--([BUSINESS WIRE](https://www.businesswire.com/))--GE HealthCare (Nasdaq: GEHC) has agreed to acquire full ownership of Nihon Medi-Physics Co., Ltd (NMP), by purchasing from Sumitomo Chemical (TYO: 4005) the 50% stake it does not already own. As part of GE HealthCare, NMP can build on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. Sumitomo and GE HealthCare expect the agreement to close in early 2025, subject to regulatory approvals. NMP’s product portfolio includes GE HealthCare radiopharmaceuticals used to enable clinical images across neurology, cardiology and oncology procedures, such as its amyloid visualization radiotracer, VIZAMYL® Injection (Flutemetamol (18F) Injection), used in the Alzheimer’s pathway; DaTSCAN® Injection (Ioflupane (¹²³I) injection) used to evaluate patients with suspected Parkinson’s Disease or Dementia with Lewy Bodies; and MYOVIEW® (Technetium (99mTc) Tetrofosmin), used in SPECT myocardial perfusion imaging for the evaluation of known or suspected coronary artery disease. NMP, headquartered in Tokyo, was formed in 1973 and generated revenues of 28.2B JPY (~$183M) in 2023. In addition to 13 manufacturing facilities, NMP also focuses on research and development, including nonclinical and clinical development of radiotracers and theranostics research. GE HealthCare has held its 50% stake in NMP since acquiring Amersham plc in 2004 and holds three positions on its Board of Directors. Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said: “As the third largest pharmaceutical market in the world1, and amongst the leading countries by number of cyclotrons2, Japan is on a path to becoming a leader in the $7 billion molecular imaging global market and a center of excellence for Asian markets. NMP will play a key role in that journey, including bringing its deep expertise and scale to global innovators looking to bring novel products to the Japan market and beyond. This will strengthen our precision care strategy in Asia and our existing footprint in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country.” Hiroshi Ueda, Executive Vise President, Sumitomo Chemical, said: “We are proud of our 50-year relationship with NMP and our partnership with GE HealthCare to ensure patients in Japan could benefit from access to molecular imaging. At a time of exciting developments in the industry, following its discussions with Sumitomo Chemical, we believe GE HealthCare is the best owner to enable NMP to continue its successful growth journey. I would like to recognize NMP’s leadership and talented team for their significant achievements to date and their commitment to patients.” As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiotracers used across major patient care areas. The recent U.S. FDA approval of GE HealthCare’s first-of-its-kind PET radiopharmaceutical, Flyrcado™ (flurpiridaz F 18 injection), its in-licensing of Phase II FAPI assets and broadening theranostics offerings are all examples of the company’s commitment to novel diagnostics that are shaping the future of molecular imaging to drive improved patient outcomes. GE HealthCare’s PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second. The Company expects this transaction to be neutral to Adjusted EPS3,4 in year one and accretive thereafter. GE HealthCare was advised by Solomon Partners Securities, LLC. **Forward-Looking Statements** This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the completion and expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the conditions to the completion of the transaction may not be satisfied; closing of the transaction may not occur or may be delayed; the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; the Company may assume unexpected risks and liabilities; and completing the transaction may distract the Company’s management from other important matters. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation. **About GE HealthCare Technologies Inc.** GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. 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ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024. This expansion in capacity should help address a growing need for SPECT brain imaging. Approximately 90,000 people in the US each year are diagnosed with Parkinson’s1 and nearly 1.24 million will be diagnosed by 20302. Additionally, one in four patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease3. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease4. Robert Burke, North American Senior Vice President of Commercial at Curium, commented: “Curium’s expanded capacity on Fridays will allow our customers and their patients greater scheduling flexibility. Our customers have asked for this expansion and Curium is thrilled to be able to satisfy this request. We look forward to launching Friday patient use on April 5.” About Ioflupane I 123 Injection INDICATION AND USE Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Important Risk Information CONTRAINDICATIONS Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to Ioflupane I 123. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration. Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection. Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. ADVERSE REACTIONS In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established. USE IN SPECIFIC POPULATIONS Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection. Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant. Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients. Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies. Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images. OVERDOSAGE The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. Please see full Prescribing Information by clicking here or visit References: 1 Willis AW, Roberts E, Beck JC, et al. “Incidence of Parkinson disease in North America.” NPJ Parkinsons Disease. 2022;8:170. 2 Marras C, Beck JC, Bower JH, et al. “Prevalence of Parkinson’s disease across North America.” NPJ Parkinsons Disease. 2018;4:21. doi:10.1038/s41531-018-0058-0 3 Barker, Warren W, Luis, Cheryl A, Kashuba A, et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer Disease and Associated Disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001 4 Warr L, Walker Z. “Identification of biomarkers in Lewy-body disorders.” Quarterly Journal of Nuclear Med Mol Imaging; 2012; 56: 39-54 About Curium Curium is a world leader in nuclear medicine. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Ross Bethell ross.bethell@curiumpharma.com or +44.7827.833.176.