SuperGen Inc and MGI Pharma Inc announced that a Marketing Authorization Application (MAA) seeking approval of Dacogen (decitabine) for injection has been submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) by SuperGen's European subsidiary, EuroGen Pharmaceuticals Ltd.
According to a release, Dacogen is the Company's 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 very pleased to have completed this regulatory milestone for Dacogen," Dr. James Manuso, president and CEO of SuperGen said. "SuperGen remains committed to bringing Dacogen to patients as quickly as possible, with the support of our new partner, MGI Pharma," he added.
"The MAA submission for Dacogen marks a key regulatory milestone," Lonnie Moulder, president and chief executive officer of MGI Pharma said adding, "We believe that Dacogen will become an important treatment option for hematologic cancer patients, and we look forward to the upcoming US NDA filing as the next regulatory milestone."
SuperGen completed phase III clinical trials of Dacogen in patients with MDS in March 2004. SuperGen and MGI are collaborating on the regulatory development process for Dacogen in MDS, and expect to complete the NDA filing 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 hematologic malignancies. Alternative dosing schedules for Dacogen, including subcutaneous administration and more rapid intravenous infusions, 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. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease.