MGI/SuperGen's Dacogen filed in EU

10 October 2004

SuperGen has submitted a Marketing Authorization Application to the European Medicines Agency for use of Dacogen (decitabine) as a treatment for myelodysplastic syndromes.

Recently, SuperGen closed a deal with fellow US firm MGI Pharma, under which the latter was granted exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen (Marketletter September 27).

The companies expect to complete a New Drug Application for the drug by the end of the year in the USA, and MGI plans to begin a Phase III trial of Dacogen for the treatment of acute myelogenous leukemia in early 2005.

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