27th August 2018
Curium and RadioMedix Announce Exclusive Global Agreement for 64Cu-Dotatate Development
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(St. Louis, MO and Houston, TX – August 27, 2018) – Curium and RadioMedix Inc. announce an exclusive agreement to develop and commercialize 64Cu-Dotatate, an investigational positron emission tomography (PET) diagnostic agent for patients with suspected Neuroendocrine Tumors (NETs). RadioMedix is currently engaged in Phase III clinical trials of the agent and expects to file a New Drug Application with the Food and Drug Administration in 2019. This partnership builds on the initial development work conducted by RadioMedix and will benefit from Curium’s regulatory, manufacturing, distribution, and commercial expertise.
“64Cu is a PET isotope that can be produced at a central location in quantities to meet the commercial needs of hospitals and imaging centers without the supply limitations of nuclear generator-based PET isotopes,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “Once approved, 64Cu-Dotatate will be available to patients in medical centers with PET capability across the country. This will address the shortage or lack of availability of somatostatin analogue PET agents that we are currently experiencing in many parts of the U.S.”
“This agreement demonstrates our commitment to bringing new diagnostic agents to the U.S. market,” said Curium CEO, North America, Dan Brague. “We have a long history of helping patients suffering from neuroendocrine tumors and we are excited to partner with RadioMedix to introduce 64Cu-Dotatate in the U.S. following FDA approval. Upon market launch of this agent, we expect to be the largest commercial scale manufacturer of 64Cu and are excited by the promise of this new isotope.”
To learn more about previous studies on 64Cu-Dotatate visit:
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 ovaries, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Formed by the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC, 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.
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 for targeted radionuclide therapy in cancer. RadioMedix has also established two service facilities for academic and industrial partners: cGMP Manufacturing Suite for human clinical trials and probe development and small animal Molecular Imaging Facility for pre-clinical evaluation of radiopharmaceuticals in animal models. More information at www.radiomedix.com.
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Media Contact for Curium:
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Media Contact for RadioMedix: