St. Louis and Houston, Aug. 26, 2018 (GLOBE NEWSWIRE) -- 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:
http://jnm.snmjournals.org/content/58/3/451.full