MOGN Mgi Pharma (MM)

Dacogen(TM) NDA Accepted for Filing by FDA DUBLIN, Calif., and MINNEAPOLIS, Jan. 3 /PRNewswire-FirstCall/ -- SuperGen, Inc. (NASDAQ:SUPG) and MGI PHARMA, INC. (NASDAQ:MOGN) today announced that the New Drug Application (NDA) for Dacogen(TM) (decitabine) for injection was accepted for filing by the United States Food and Drug Administration (FDA). The NDA for Dacogen injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Dacogen injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by September 1, 2005. During October 2004 the Marketing Authorization Application (MAA) for Dacogen injection was submitted and is currently under review by the European Medicines Agency (EMEA). As previously reported, the NDA included clinical data from one phase 3 clinical trial of Dacogen injection in MDS patients in addition to two phase 2 studies. The co-primary endpoints of the phase 3 study were response rate and time to AML transformation or death. The phase 3 trial achieved the co-primary endpoint of overall response rate. Patients in the Dacogen arm had a response rate of 17% as determined by intent to treat (ITT) analysis, compared to a 0% response rate for patients who received supportive care (p