SuperGen withdraws European marketing application for Orathecin

By Angela McDaniels

Seattle, Jan. 20 - SuperGen Inc. said it has withdrawn its Marketing Authorization Application for Orathecin (rubitecan) capsules after extensive discussions with the European Medicines Agency.

The company is developing the investigational drug for the treatment of pancreatic cancer in patients who have failed at least one prior chemotherapy regimen.

SuperGen said it intends to decide on future development or the alternative disposition of Orathecin based on a review of the interim results of an ongoing phase 2 clinical trial, expected to occur during the first half of 2006.

The U.S. phase 2 clinical trial is investigating Orathecin in combination with gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy.

Orathecin has orphan drug status in the United States and European Union.

SuperGen is a pharmaceutical company based in Dublin, Calif., that acquires, develops and commercializes therapies for solid tumors, hematological malignancies and blood disorders.

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