Product license is part of larger collaboration agreement covering chemistry, manufacturing and control; preclinical and clinical studies; regulatory interface; and Brazilian sales for product candidates from five Cell>Point drug platforms
CENTENNIAL, Colo.--(BUSINESS WIRE)-- 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 should help 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 Cell>Point clinical trials conducted in Brazil.
The long-term collaboration agreement should significantly shorten the clinical development time—and reduce development cost—for Cell>Point’s earlier-stage products, like its Platinum-EC-G cancer therapeutic, which is undergoing preclinical studies for treating diffuse aggressive B-cell lymphoma and is slated to enter clinical trials this year.
Specific terms of the Brazil product license and long-term collaboration agreement were not disclosed.
99mTc-EC-G is Cell>Point’s cancer and cardiovascular molecular imaging agent. It is the first product stemming from Cell>Point’s EC Technology drug platform. More information on 99mTc-EC-G and EC Technology can be found at the Cell>Point website (www.cellpointweb.com) under Technology/Pipeline. For cancer, Phase 2 clinical trial results showed 100 percent concordance between 99mTc-EC-G and FDG (FluoroDeoxyGlucose) in non-small cell lung cancer lesion location, size, and confidence that lesions represented cancer.
MJM Productos Farmaceuticos e de Radioprotecao Ltda., or “Radiopharmacus,” is Brazil’s leading radiopharmaceutical company. Its sales comprise approximately one-half of the country’s radiopharmaceutical and contrast agent market. With its market presence and equally impressive synthesis and manufacturing capabilities, it is the partner of choice in its specialty area in South America, as evidenced by relationships with top global radiopharma companies. Radiopharmacus is headquartered in Porto Alegre, Brazil.
Cell>Point is a clinical-stage biopharmaceutical company developing universal molecular imaging agents and molecular therapeutics for the diagnosis, treatment and treatment monitoring of cancer, heart, and other diseases. Cell>Point has exclusive license to five drug-development platforms, all from The University of Texas M. D. Anderson Cancer Center in Houston, a world leader in cancer research and care. Information on Cell>Point’s drug candidates, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The company has headquarters in Centennial, Colo., and has additional offices in San Francisco and Houston.
KEYWORDS: United States Brazil North America South America Colorado
INDUSTRY KEYWORDS: Health Cardiology Oncology Pharmaceutical Manufacturing Other Manufacturing Research Science