CENTENNIAL, Colo., June 16, 2016 – Cell>Point today announced that it has entered into an exclusive license agreement for China, Hong Kong and Macau with United Eastern Pharmaceutical (UEP), a company representing a consortium from the U.S. and China.
The license agreement covers Cell>Point’s diagnostic radiopharmaceutical Oncardia® (ethylenedicysteine-glucosamine) which was developed for labeling with technetium-99m for SPECT cameras or 68-gallium for PET cameras for imaging in cancer and cardiovascular disease. Oncardia® is based on an ethylenedicysteine drug conjugate platform licensed by Cell>Point from The University of Texas M.D. Anderson Cancer Center. The license with UEP provides for Cell>Point to receive an upfront payment, regulatory milestone payments as well as royalties on sales. Cell>Point will be seeking regulatory approval from the China FDA to expand its Phase 3 lung cancer imaging trial to include clinical sites in China. The parties have agreed that when the current cardiovascular study reaches Phase 3, Cell>Point will include China clinical sites as part of the study.
According to Haoran Xi, CEO of UEP, “China needs affordable and accessible diagnostic molecular imaging to reach a substantially larger universe of people than is presently the case with the current standard of care. Plans are to pursue approvals in diagnosing and staging lung, head and neck, colorectal, breast, liver, stomach, lymphoma and other cancers in addition to diagnosing the presence and extent of cardiac ischemia. Oncardia® can be used to assess the patient’s response to therapy while undergoing therapy. This will give oncologists a valuable tool to determine if the patient is benefiting from the selected therapy or should the oncologist reconsider the choice of therapy. The Chinese Central Government is implementing programs to improve the quality of medical care throughout the country. Cancer and vascular disease are the leading causes of death in China.”
Oncardia® was developed to address the limitations of FDG-PET in cancer imaging while increasing access to cancer imaging to a significantly greater number of hospitals worldwide. Cell>Point is completing a Phase 3 trial for Oncardia® in lung cancer under a Letter of Agreement with the FDA pursuant to a Special Protocol Assessment, and a Phase 2b cardiovascular trial in patients with coronary artery disease. The focus in cardiology is to assess the patient’s ischemia in a rest only imaging procedure which will
dramatically shorten the time required to complete the patient’s study and achieve noticeably greater diagnostic accuracy compared to the standard of care. “We are pleased to be working with UEP as our long term partner in China and are confident that UEP will be instrumental in helping to build a consensus of support for Oncardia® among the country’s nuclear medicine community and network of hospitals”, according to Greg Colip, CEO of Cell>Point.
Cell>Point is a biopharmaceutical company focused on the development of universal molecular imaging compounds and molecular therapeutics for the diagnosis, staging, treatment and treatment monitoring of cancer, cardiovascular disease, and a range of ischemic diseases. Cell>Point has exclusive licenses to five drug-development platforms, all from The University of Texas MD Anderson Cancer Center in Houston, a world leader in cancer research and care. Information on Cell>Point’s product candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The Company has offices in Centennial, Colo. and Houston, Texas.
About United Eastern Pharmaceutical
United Eastern Pharmaceutical (UEP), formerly TDD, Inc., is a Houston, Texas based cross-industry group whose focus is investment in energy and pharmaceutical development. UEP, together with a consortium of partners based in Tianjin, will be responsible for the clinical development, regulatory approval, marketing and distribution in China (including Hong Kong and Macau) of Cell>Point’s novel nuclear medicine imaging product Oncardia® for cancer and cardiovascular disease.