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news.Cell>Point has signed a long-term collaboration agreement including product licenses for Brazil with MJM Productos Farmaceuticos e de Radioprotecao ("Radiopharmacus").
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Under the collaboration agreement, Radiopharmacus will gain exclusive rights to manufacture and sell Cell>Point products in Brazil, and also provide a range of services such as commercial scale synthesis, cGMP (certified Good Manufacturing Practice) manufacturing, preclinical studies, clinical studies, and regulatory interface.
The deal includes Cell>Point’s cancer and cardiology molecular imaging agent, EC-G or (99m)Tc-EC-G ((99m)Technetium-EthylenediCysteine-n-acetyl-Glucosamine).
The company said EC-G has completed a Phase 2 clinical trial for non-small cell lung cancer diagnosis and staging, and a Phase 1 trial for coronary artery disease diagnosis.
Following marketing approval by ANVISA, Brazil’s National Health Surveillance Agency, Radiopharmacus will develop EC-G product "kits" for Brazilian clinical studies and for sale in Brazil.
The partnership agreement is expected to shorten the clinical development time and reduce development cost for Cell>Point’s earlier-stage products.