Zeneus Pharma Ltd., now Cephalon, Inc., for the commercialization of Myocet™ (a liposome-encapsulated doxorubicin-citrate complex) in the United States and Canada. Sopherion’s current business focus is the execution of a Phase III, global, randomized, registration trial for first line therapy of invasive, metastatic breast cancer and the development and commercialization of Sopherion’s lead agent, Myocet™. Myocet is being investigated in an FDA agreed upon registration trial in combination with two other drugs, Herceptin® (Trastuzumab) and Taxol (Paclitaxel) vs. Herceptin® and Taxol alone, the current standard of care for first line HER-2-overexpressing metastatic breast cancer. Myocet™, a liposome-encapsulated doxorubicin with reduced cardiotoxicity, is a nanotechnology product that localizes into tumor vasculature and in contrast to parental doxorubicin avoids homing to the heart. This 363 patient global trial in twelve countries has as of 03/06/09 been fully recruited. Unblinding is anticipated by the summer of 2010 with NDA submission for full approval following within 6 months. Myocet® is already a registered drug in Canada, where Sopherion has commercial rights and in Europe where Cephalon has commercial rights for use in first line metastatic breast cancer in combination with cyclophosphamide.; Their Phase III trial is based on a Phase II trial, supported by Roche, which gave a 96% response rate and two and a half year median progression free survival for patients with metastatic breast cancer.