MGI PHARMA Announces Publication of Phase 3 Data for Dacogen(TM) (Decitabine) for Injection in Cancer.

MINNEAPOLIS -- MGI PHARMA, INC. (Nasdaq:MOGN), an oncology- and acute care-focused biopharmaceutical company, today announced publication of data from a randomized, controlled phase 3 trial (study 0007) of Dacogen(TM) (decitabine) for Injection in the journal Cancer. Dacogen is an investigational drug currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with myelodysplastic syndromes (MDS). The Prescription User Fee Act (PDUFA) goal date for Dacogen is May 15, 2006.

A randomized phase 3 controlled trial of Dacogen versus supportive care was conducted in 170 patients with myelodysplastic syndromes (MDS) meeting French-American-British (FAB) subtypes and IPSS intermediate-1, intermediate-2, and high-risk prognostic scores. Co-primary endpoints of the study were overall response rate (complete responses plus partial responses), as determined by International Working Group (IWG) criteria, and time to acute myeloid leukemia (AML) transformation or death. Secondary endpoints included hematologic improvement, duration of response, cytogenetic response rate, transfusion requirements, quality of life, survival, and safety.

The overall response rate (ORR) was 17%, including a complete response rate of 9% and a partial response rate of 8%. The overall improvement rate (CR plus PR plus hematologic improvement, or HI) for patients who received Dacogen was 30% compared to 7% for those who received supportive care alone. The response was durable with a median time of 10.3 months (p less than 0.001).

All patients who responded to Dacogen treatment became or remained transfusion independent, and cytogenetic complete responses were observed in 35% of patients treated with Dacogen.

The most common adverse events related to Dacogen were neutropenia, thrombocytopenia, and anemia.

About MDS

Myelodysplastic syndromes, or MDS, are a group of diseases of the bone marrow characterized by the production of poorly functioning and immature blood cells. People with MDS may experience a variety of symptoms and complications, including anemia, bleeding, infection, fatigue and weakness. Those patients with high-risk MDS may experience bone marrow failure, which may lead to death from bleeding and infection. Over time, MDS can progress to acute leukemia, or AML. The Aplastic Anemia and MDS International Foundation currently estimates that up to 30,000 new cases of MDS are diagnosed annually in the United States.

About Dacogen(TM) (Decitabine) For Injection

Dacogen(TM) (decitabine) for Injection is a product candidate that belongs to a class of drugs called hypomethylating agents that is currently being evaluated in a broad clinical development program in patients with MDS, acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), and solid tumors. Dacogen is not approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. The Dacogen New Drug Application (NDA) is under review by the FDA for the MDS indication, with a PDUFA goal date of May 15, 2006.

A phase 3 EORTC-sponsored trial is currently ongoing in Europe to evaluate Dacogen in patients with MDS. MGI PHARMA is conducting a pivotal program to evaluate Dacogen in patients with AML. Additional clinical studies are also underway in patients with MDS to evaluate alternative dosing regimens.

About MGI PHARMA

MGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.

This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of Dacogen to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements.