Gadodiamide

PDF (141KB)PDF For Immediate Release Daiichi Sankyo GE Healthcare Tokyo, Japan and Chicago, US (June 25, 2019) – Daiichi Sankyo Company, Limited (Head Office: Chuo-ku Tokyo; hereafter, Daiichi Sankyo) and GE Healthcare (Head Office: Chicago, US) have agreed[1] that, Daiichi Sankyo will return the exclusive development and marketing rights in Japan for four approved diagnostic imaging agents[2] to GE Healthcare and transfer marketing authorization rights in Japan to GE Healthcare Pharma Limited[3] (GE Healthcare Pharma). The four diagnostic imaging agents to be transferred to GE Healthcare by Daiichi Sankyo are: Product name Product description Omnipaque® Nonionic X-ray contrast agent Omniscan® Linear, nonionic magnetic resonance imaging contrast agent Visipaque® Nonionic, iso-osmolar X-ray contrast agent Sonazoid® Ultrasound contrast agent Daiichi Sankyo and GE Healthcare have collaborated since 1987 when they started sales of Omnipaque® in Japan. Throughout this transfer, both companies are committed to continue providing reliable supply to medical facilities. Based on this agreement*, Daiichi Sankyo and GE Healthcare will closely collaborate on the transfer of marketing authorization rights which is expected to be complete in March 2020. GE Healthcare Pharma will then be responsible for all aspects of commercialization, regulatory, medical and safety of these products in Japan. Daiichi Sankyo will continue to distribute the products to drug whole sellers until March 2022, after which they will transfer these operations to GE Healthcare Pharma. Through this transaction, GE Healthcare will strengthen its position as a leading medtech and diagnostics innovator at the center of an ecosystem striving for precision health. The company is working to improve quality of healthcare and bring more precise diagnoses for patients in Japan, the third largest contrast media market globally[4]. Daiichi Sankyo will be increasing investments in its oncology pipeline in order to realize its 2025 vision of becoming a “Global Pharma Innovator with competitive advantage in oncology,” providing new treatment options to more patients faster. [1] Subject to customary regulatory approvals and closing conditions. [2] Diagnostic contrast imaging agents are administered to patients prior to Computed Tomography, Magnetic Resonance Imaging or Ultrasound scans to improve quality of images that radiologists use to diagnose and monitor disease. [3] GE Healthcare Pharma Limited is newly established an entity of GE Healthcare to run the business of its Pharmaceutical Diagnostics business in Japan. [4] CMIG/IMS (industry data). About GE HealthcareGE Healthcare is the $19.8 billion healthcare business of GE (NYSE: GE). As a leading provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics and monitoring through intelligent devices, data analytics, applications and services. With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, the company helps improve outcomes more efficiently for patients, healthcare providers, researchers and life sciences companies around the world. Follow us on Facebook, LinkedIn, Twitter and The Pulse for latest news, or visit our website https://corporate.gehealthcare.com/en/Open new window. for more information. About Daiichi SankyoDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com Contact DAIICHI SANKYO COMPANY, LIMITED Corporate Communications Department Phone：+81-3-6225-1126 GE Healthcare Japan Corporate Communications Email: Gehcj.commc@ge.com

Enhanced screening recommended to detect kidney dysfunction SILVER SPRING, Md., Sept. 9 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease. (Logo: ) (Logo: ) Three of the GBCAs Magnevist, Omniscan, and Optimark will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration. GBCAs are intravenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessels, and other tissues. NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs. The FDA's review of the safety of the most widely used GBCAs determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other GBCAs for NSF in certain patients with kidney disease. Data suggest that NSF may follow the administration of any GBCA and the FDA continues to assess the safety of each GBCA to better estimate its NSF risks. "The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain agents among patients at highest risk for nephrogenic systemic fibrosis," said Rafel (Dwaine) Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research. To further enhance the safe use of the imaging agents, the FDA recommends that health care professionals: Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast Monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease Administer a GBCA only once during an imaging session Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien. For more information: Gadolinium Safety Announcement Questions and Answers on Gadolinium-Based Contrast Agents Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA SOURCE U.S. Food and Drug Administration