Cell>Point announced today that it has entered into a long-term collaboration agreement including product licenses for Brazil with MJM Productos Farmaceuticos e de Radioprotecao Ltda., or “Radiopharmacus.”
The agreement leads with Cell>Point’s cancer and cardiology molecular imaging agent—EC-G or, specifically, 99mTc-EC-G (99mTechnetium-EthylenediCysteine-n-acetyl-Glucosamine)—but covers the entire portfolio of products being developed by Cell>Point. EC-G has completed a U.S. Phase 2 clinical trial for non-small cell lung cancer diagnosis and staging, and a Phase 1 trial for coronary artery disease diagnosis.In addition to the exclusive right to manufacture and sell Cell>Point products in Brazil following regulatory approval, Radiopharmacus will also provide a range of services including commercial scale synthesis, cGMP (certified Good Manufacturing Practice) manufacturing, preclinical studies, clinical studies, and regulatory interface.
“We are very pleased to have a strategic partner in Brazil like Radiopharmacus,” said Greg Colip, Cell>Point chief executive officer.
“The broad scope of the relationship shouldhelp shorten the lead time to complete the chemistry, manufacturing and control process for each of our products, and allow us to explore the clinical feasibility of each product before ramping up clinical-development investment.”
Regarded as one of the most promising and attractive pharmaceutical markets in the Americas, the Brazilian market is the 11th largest globally at $17 billion dollars in annual sales, per Business Monitor International 2010 data. The Brazilian pharmaceutical market also has had consistently high growth over the last decade.
Radiopharmacus will manufacture EC-G product “kits” for Brazilian clinical studies and for sale in Brazil, following marketing approval by ANVISA, Brazil’s National Health Surveillance Agency.Radiopharmacus is affiliated with a leading Brazilian Contract Research Organization (CRO), which will oversee clinical trials conducted in Brazil.