SuperGen Inc. and MGI Pharma Inc. announced that the European Medicines Agency (EMEA) has accepted for review the Marketing Authorization Application (MAA) for Dacogen (decitabine) for injection.
Dacogen is an investigational anti-cancer therapeutic for the treatment of patients with myelodysplastic syndromes or MDS. MGI Pharma has exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen.
"We are pleased by the EMEA's response to our application for review of Dacogen, and we look forward to working closely with the EMEA and MGI Pharma throughout the review process," Dr. James S. Manuso, president and CEO of SuperGen stated adding, "SuperGen remains committed to bringing Dacogen through the regulatory approval process as quickly as possible, and we look forward to completing the NDA submission to the US Food and Drug Administration."
SuperGen completed phase III clinical trials of Dacogen in patients with MDS in March 2004. SuperGen and MGI Pharma are collaborating on the regulatory development process for Dacogen in MDS, and expect to complete the NDA submission to the FDA during the fourth quarter of 2004.
MGI Pharma plans to initiate a phase III trial of Dacogen for the treatment of acute myelogenous leukaemia (AML) in early 2005 and plans to evaluate Dacogen for further development in other haematologic malignancies. Alternative dosing schedules for Dacogen, including subcutaneous administration and other intravenous infusion regimens, are currently being evaluated in clinical studies.
MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukaemia.
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumours, haematological malignancies and blood disorders. MGI Pharma is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients.