SuperGen and MGI PHARMA Announce Submission of Dacogen NDA to U.S. FDA
Monday November 1, 8:02 am ET
DUBLIN, Calif. & MINNEAPOLIS--(BUSINESS WIRE)--Nov. 1, 2004--SuperGen, Inc. (Nasdaq:SUPG - News) and MGI PHARMA, INC. (Nasdaq:MOGN - News), today announced that the full New Drug Application (NDA) seeking approval of Dacogen(TM) (decitabine) for injection has been submitted to the U.S. Food and Drug Administration (FDA) for its review. 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.
"SuperGen is delighted to achieve this key U.S. regulatory milestone for Dacogen," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "Thanks to the valuable assistance from our partner MGI PHARMA and the diligent efforts of the entire SuperGen team, we completed our submission of the Dacogen NDA early in the fourth quarter. We look forward to FDA's response, and we remain committed to bringing Dacogen to patients as quickly as possible."
"Given today's announcement and the recently announced acceptance for review of the Marketing Authorization Application (MAA) for Dacogen by the European Medicines Agency (EMEA), we look forward to working closely with SuperGen and the regulatory authorities in both the U.S. and Europe throughout the review processes," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA.
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. MGI PHARMA plans to initiate a Phase III trial of Dacogen for the treatment of acute myelogenous leukemia (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 other intravenous infusion regimens, are currently being evaluated in clinical studies. <snip> |
