RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection New Drug Application

RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection New Drug Application

Press releases may be edited for formatting or style | January 08, 2020 Molecular Imaging
Houston and St Louis, Jan. 07, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.

“If approved, we expect that copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “Copper Cu 64 dotatate injection will be the first neuroendocrine PET diagnostic agent available to all medical centers with PET capability across the country. This will alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents. We are currently pursuing a Priority Review with the FDA to expedite commercial availability.”

“If approved, the clinical utility of this new agent will allow Curium to enhance patient care in the U.S. by bringing the accuracy of PET SSTR to all hospitals and imaging centers,” said Curium CEO, North America, Dan Brague. “Our ability to manufacture copper Cu 64 dotatate injection at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued focus on patients with neuroendocrine tumors. We are excited to be bringing Cu 64, an exciting new isotope for PET imaging, to the market. We look forward to exploring additional applications that can help patients and physicians.”

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About RadioMedix
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, in addition to small animal Molecular Imaging Center for the pre-clinical evaluation of new targets in vitro and in vivo.


About Curium
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.


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).

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