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MGI PHARMA, INC. (Nasdaq: MOGN), Minneapolis, has announced that Dacogen(tm) (decitabine) for Injection is now commercially available in the United States. Dacogen was approved by the U.S Food and Drug Administration (FDA) on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.

"In line with our strategy, MGI PHARMA continues to expand its presence in oncology and acute care. The introduction of Dacogen is a significant step in our penetration of these markets and in our path to generating $1 billion in total revenue by 2010. In addition to Dacogen, MGI PHARMA markets Aloxi and Gliadel, and has five ongoing pivotal programs to drive future growth," said Lonnie Moulder, president and CEO of MGI PHARMA. "With our field commercial organization now trained, we look forward to discussing the availability of Dacogen with the hematologists and oncologists who treat patients with MDS."

Results from a phase 3 clinical trial of Dacogen demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed MDS at baseline who received at least 2 cycles of treatment, compared to 0% in the supportive care arm. All patients who responded to Dacogen treatment became or remained transfusion independent during the time of the response. It is recommended that patients be treated with Dacogen for a minimum of four cycles, and treatment may continue as long as the patient continues to benefit.

Important Safety Information

Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for 2 months afterwards.

The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and diarrhea (34%). Visit for full prescribing information.

Ongoing Clinical Studies

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

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 is a hypomethylating agent that is believed to exert its antineoplastic effects by incorporation into DNA and inhibition of an enzyme called DNA methyltransferase. Methylation is a process in which methyl (CH3) groups are added to DNA, resulting in the inactivation of genes that are critical for control of cellular differentiation and proliferation. Abnormal methylation, which silences certain genes, is associated with the development of many types of tumors. Dacogen-induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. In rapidly dividing cells, the cytotoxicity of Dacogen may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA. Non-proliferating cells are relatively insensitive to Dacogen.


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 has a portfolio of proprietary pharmaceuticals, and intends to become a leading biopharmaceutical company. MGI PHARMA markets Aloxi(r) (palonosetron hydrochloride) Injection, Dacogen(tm) (decitabine) for 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.

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Publication:Biotech Business
Geographic Code:1USA
Date:Jul 1, 2006

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