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Licensing Agreements Sopherion entered into an exclusive licensing agreement with Zeneus Pharma Ltd,. for commercialization of Myocet™ in North America. Zeneus was subsequently acquired by Cephalon Europe. Cephalon currently markets Myocet in 20 countries in Europe, and Sopherion currently markets in Canada. The drug therapy was originally discovered and developed by the Liposome Company. Myocet has been approved by the European and Canadian regulatory agencies for first-line therapy in combination with cyclophosphamide for patients with metastatic breast cancer. Under the terms of the agreement, in the United States Sopherion will manage the regulatory process, and pending FDA approval, be responsible for the commercialization of this therapy. To date, several large clinical trials of Myocet have been completed in the United States, Canada and Europe. The Company is conducting an additional Phase III global, pivitol, registrational clinical study prior to filing a New Drug Application. |
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