12th March 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection Was Granted Priority Review by the U.S. FDA
Download as PDF: English
(Houston, TX and St. Louis, MO – March 12, 2020) – RadioMedix Inc. and its commercial partner Curium announced the U.S. Food and Drug Administration (FDA) has granted copper Cu 64 dotatate injection a priority review. Copper Cu 64 dotatate is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). Curium is preparing to launch copper Cu 64 dotatate in Q3 of this year.
“If approved, we expect that copper Cu 64 dotatate injection will have a significant impact on physicians, neuroendocrine tumor patients and their caregivers as this will help alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents,” said Ebrahim Delpassand, MD, CEO of RadioMedix.
“We are preparing for the full-scale commercialization of copper Cu 64 dotatate injection and are excited to introduce a new product and a new isotope into the market. We are pleased that our significant efforts will result in helping neuroendocrine tumor patients receive a specific, sensitive and timely diagnosis,” said Curium CEO, North America, Dan Brague.
RadioMedix, Inc. is a clinical-stage biotechnology company, based in Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and targeted alpha and beta-emitter therapy. RadioMedix has research and contract service facilities for academic and industrial partners: the cGMP Dose Manufacturing and Analytical suites for the investigational clinical trials, and the Drug Discovery and Pre-clinical Core Facility for pre-clinical evaluation of drugs, both located in Houston, TX. Also, a second new state of art commercial manufacturing facility located in Humble, TX, has been recently established. To learn more, visit www.radiomedix.com. For more information about this press release, please contact: email@example.com. Follow us on social media: LinkedIn https://www.linkedin.com/company/radiomedix-inc-/ Facebook: https://www.facebook.com/RadioMedix-Inc/
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium: firstname.lastname@example.org.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).