03.05.2006 11:00:00

U.S. FDA Approves Dacogen(TM) (Decitabine) for Injection; Dacogen(TM) Approved for Patients with all FAB Classifications of MDS; Commercial Launch Planned For Late May

MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc.(Nasdaq:SUPG) today announced that the U.S. Food and DrugAdministration (FDA) has approved Dacogen(TM) (decitabine) forInjection. Dacogen is indicated for treatment of patients withmyelodysplastic syndromes (MDS) including previously treated anduntreated, de novo, and secondary MDS of all French-American-British(FAB) subtypes (refractory anemia, refractory anemia with ringedsideroblasts, refractory anemia with excess blasts, refractory anemiawith excess blasts in transformation, and chronic myelomonocyticleukemia), and Intermediate-1, Intermediate-2, and High-RiskInternational Prognostic Scoring System (IPSS) groups. MGI PHARMAplans to make Dacogen commercially available during the second quarterof 2006.

"The FDA approval of Dacogen marks an important advancement forpatients who suffer from MDS," said John M. Bennett, M.D., Chair ofThe Myelodysplastic Syndromes Foundation. "Patients with this seriouscondition are often anemic, experience fatigue and weakness and, incertain cases with an increase in leukemic blast cells, MDS can resultin bone marrow failure."

Results from a phase 3 clinical trial demonstrated an overallresponse rate of 21% in Dacogen-treated patients considered evaluablefor response, defined as those patients with pathologically confirmedMDS at baseline who received at least 2 cycles of treatment, comparedto 0% in the supportive care arm. All patients who responded toDacogen treatment became or remained transfusion independent duringthe time of the response. The most commonly occurring adversereactions with Dacogen include neutropenia, thrombocytopenia, anemia,pyrexia, fatigue, nausea, cough, petechiae, constipation, anddiarrhea. It is recommended that patients be treated with Dacogen fora minimum of four cycles, and treatment may continue as long as thepatient continues to benefit.

"The approval of Dacogen demonstrates MGI PHARMA's ability toidentify, acquire, develop, and register promising products," saidLonnie Moulder, president and chief executive officer of MGI PHARMA."We look forward to providing clinicians with an effective therapy tooffer their MDS patients. MGI PHARMA is committed to continuing thedevelopment of Dacogen for patients with acute myeloid leukemia,chronic myelogenous leukemia, and solid tumors, in addition todeveloping alternative dosing regimens for patients with MDS."

"This approval is a significant milestone for SuperGen. Over thecourse of more than seven years, SuperGen developed Dacogen by workingwith scientists, clinicians, patient advocacy groups, and regulatoryagencies to get this product approved for patients with MDS," saidJames S. Manuso, Ph.D., President and CEO of SuperGen. "The approvalof Dacogen is a significant benefit for patients because of the drug'sability to address the underlying disease and, potentially, to improvepatient outcomes."

Summary of Clinical Results

SuperGen conducted a randomized open-label, multicenter,controlled trial that evaluated 170 adult patients withmyelodysplastic syndromes meeting FAB classification criteria and IPSSHigh-Risk, Intermediate-2 and Intermediate-1 prognostic scores.Eighty-nine patients were randomized to Dacogen therapy plussupportive care, 83 of whom received Dacogen, and 81 were randomizedto supportive care alone. Dacogen was intravenously infused at a doseof 15 mg/m(2) over a 3-hour period, every eight hours, for threeconsecutive days. Dacogen therapy was repeated every 6 weeks,depending on the patient's clinical response and toxicity. Supportivecare consisted of blood and blood product transfusions, prophylacticantibiotics, and hematopoietic growth factors. Co-primary endpoints ofthe study were overall response rate (complete responses plus partialresponses) and time to acute myeloid leukemia (AML) or death.Secondary endpoints included hematologic improvement, duration ofresponse, cytogenetic response rate, transfusion requirements, qualityof life, survival, and safety.

The overall response rate in the Dacogen study arm was 17% with amedian response duration of 288 days, compared to 0% in the supportivecare arm (p less than 0.001). A complete response rate of 9% and apartial response rate of 8% were observed in the Dacogen arm. Theoverall response rate was 21% in Dacogen-treated patients consideredevaluable for response, defined as those patients with pathologicallyconfirmed MDS at baseline who received at least 2 cycles of treatment.In addition, 13% of patients in the Dacogen arm had hematologicimprovement, compared to 7% of patients in the supportive care arm.

Two additional open label, single arm, multicenter studies wereconducted to evaluate the safety and efficacy of Dacogen in patientswith MDS of any FAB subtype. The results of the phase 2 studies wereconsistent with the results of the phase 3 trial with overall responserates of 26% (N=66) and 24% (N=98).

"Dacogen represents a new treatment option that can reduce oreliminate the need for patients with MDS to receive frequent bloodtransfusions, which is an important clinical benefit," said HagopKantarjian, M.D., Professor and Chairman, Department of Leukemia, atthe University of Texas MD Anderson Cancer Center and clinicalinvestigator of the ongoing Dacogen clinical development program forMDS and AML. "This approval is a major advance in our fight againstmyelodysplastic syndromes."

Important Safety Information

Dacogen may cause fetal harm when administered to a pregnantwoman. Women of childbearing potential would be advised to avoidbecoming pregnant while using Dacogen. Men should be advised not tofather a child while receiving treatment with Dacogen and for 2 monthsafterwards.

The most commonly occurring adverse reactions with Dacogen includeneutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia(53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%),constipation (35%), and diarrhea (34%). Please visit www.mgipharma.comfor full prescribing information.

Ongoing Clinical Studies

MGI PHARMA is currently conducting a phase 3 pivotal trial toevaluate Dacogen in patients with AML. Additional phase 2 studies arealso underway to evaluate alternative dosing regimens for Dacogen inpatients with MDS and in patients with AML and chronic myelogenousleukemia, or CML. A phase 3 European Organization for Research andTreatment of Cancer- (EORTC-) sponsored study of Dacogen in patientswith MDS is ongoing in Europe.

About MDS

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

About Dacogen(TM) (Decitabine) For Injection

Dacogen is a hypomethylating agent that is believed to exert itsantineoplastic effects by incorporation into DNA and inhibition of anenzyme called DNA methyltransferase. Methylation is a process in whichmethyl (CH(3)) groups are added to DNA, resulting in the inactivationof genes that are critical for control of cellular differentiation andproliferation. Abnormal methylation, which silences certain genes, isassociated with the development of many types of tumors.Dacogen-induced hypomethylation in neoplastic cells may restore normalfunction to genes that are critical for the control of cellulardifferentiation and proliferation. In rapidly dividing cells, thecytotoxicity of Dacogen may also be attributed to the formation ofcovalent adducts between DNA methyltransferase and decitabineincorporated into DNA. Non-proliferating cells are relativelyinsensitive to Dacogen. Please visit www.mgipharma.com for fullprescribing information.

Conference Call & Webcast Information

MGI PHARMA will host a conference call at 9:00 a.m. ET onWednesday, May 3, 2006, to discuss the FDA approval of Dacogen. LonnieMoulder, President and CEO of MGI PHARMA, will host the call. The livewebcast can be accessed by visiting the Investor Relations section ofMGI PHARMA's website, www.mgipharma.com. An archived version of thecall will be available via the MGI PHARMA website for seven daysfollowing the call.

About SuperGen

Based in Dublin, California, SuperGen is a pharmaceutical companydedicated to the discovery, acquisition, rapid development andcommercialization of therapies for solid tumors, hematologicalmalignancies and blood disorders. SuperGen's portfolio includesOrathecin(TM) (rubitecan) capsules, an investigational drug intendedfor the treatment of pancreatic cancer, Nipent(R) (pentostatin forinjection), Mitomycin, SurfaceSafe(R) cleaner, and a numberpreclinical products being developed as inhibitors of aurora-Atyrosine kinase and DNA methyltransferase. For more information aboutSuperGen, please visit http://www.supergen.com.

About MGI PHARMA

MGI PHARMA, INC. is an oncology- and acute care-focusedbiopharmaceutical company that acquires, researches, develops andcommercializes proprietary products that address the unmet needs ofpatients. MGI PHARMA has a portfolio of proprietary pharmaceuticals,and intends to become a leading biopharmaceutical company. MGI PHARMAmarkets Aloxi(R) (palonosetron hydrochloride) Injection and Gliadel(R)Wafer (polifeprosan 20 with carmustine implant) in the United States,and intends to make Dacogen(TM) (decitabine) for Injectioncommercially available during the second quarter of 2006. The Companydirectly markets its products in the U.S. and collaborates withpartners to reach international markets.

This news release contains certain "forward-looking" statementswithin the meaning of the Private Securities Litigation Reform Act of1995. These statements are typically preceded by words such as"believes," "expects," "anticipates," "intends," "will," "may,""should," or similar expressions. These forward-looking statements arenot guarantees of MGI PHARMA's or SuperGen's future performance andinvolve a number of risks and uncertainties that may cause actualresults to differ materially from the results discussed in thesestatements. Factors that might cause the Companies' results to differmaterially from those expressed or implied by such forward-lookingstatements include, but are not limited to the ability of MGI PHARMAto successfully introduce Dacogen for Injection into the marketplace;acceptance by physicians and patients of the product; and Dacogen forInjection competing successfully with other therapies for MDS; andother risks and uncertainties detailed from time to time in theCompanies' filings with the Securities and Exchange Commissionincluding its most recently filed Form 10-Q or 10-K. MGI PHARMA andSuperGen undertake no duty to update any of these forward-lookingstatements to conform them to actual results.

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