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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer -- Ignore unavailable to you. Want to Upgrade?

To: tom pope who wrote (1609)	10/26/2005 11:53:48 AM
From: tuck	Respond to of 1826

Fears of EMEA wanting more Dacogen data have sent MOGN down 4.5%. CVTX had to withdraw its MAA and resubmit. Would MOGN have to do the same? >>MINNEAPOLIS & DUBLIN, Calif.--(BUSINESS WIRE)--Oct. 26, 2005--MGI PHARMA, INC. (Nasdaq:MOGN - News) and SuperGen, Inc. (Nasdaq:SUPG - News) today provided a regulatory updates for Dacogen(TM) (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). The MDS New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA), and the Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMEA). MGI PHARMA and SuperGen have completed the required collection and analysis of transfusion data in response to the Approvable Letter received for Dacogen injection on September 1, 2005. Following discussions with the FDA, MGI PHARMA and SuperGen will finalize and submit their response to the Approvable Letter. The companies believe this planned submission confirms the clinical benefit of Dacogen injection compared to supportive care with regard to overall response rate, duration of response, and transfusion independence in patients with MDS. The review process for the MAA for Dacogen injection continues to be underway in Europe. Following a meeting with EMEA staff earlier this morning, the Companies believe that the potential outcomes of the MAA review may include a final CHMP opinion or the need to submit additional data to support the application. MGI PHARMA and SuperGen will provide an update on the status of the MAA by year-end. MGI PHARMA continues to conduct late-stage licensing negotiations with potential partners for rights to Dacogen injection outside of North America, and anticipates that a final decision regarding the European regulatory strategy may be finalized in collaboration with a partner. << snip Cheers, Tuck