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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.


MINNEAPOLIS & DUBLIN, Calif. -- MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG SUPG Streamline Upwind Petrov Galerkin ) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has approved Dacogen(TM) (decitabine) for Injection. Dacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS MDS,
n See temporomandibular pain-dysfunction syndrome.

MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there
) 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 Hematology A myelodysplastic syndrome of older persons characterized by anemia or pancytopenia and BM hypercellularity Clinical Nonspecific–anemia of gradual onset, fatigue, weakness, exacerbation of underlying heart , refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System prognostic scoring system Any scoring to help predict outcome(s) and identify Pts and clinical situations in which the potential value of intensive care is low, while the burden of therapy is high, providing a numerical prediction of mortality.  (IPSS IPSS International Prostate Symptom Score
IPSS Instituição Particular de Solidariedade Social (Portugese: Private Social Solidarity Institution)
IPSS International Prognostic Scoring System
IPSS Inferior Petrosal Sinus Sampling
) groups. MGI PHARMA plans to make Dacogen commercially available during the second quarter of 2006.

"The FDA approval of Dacogen marks an important advancement for patients who suffer from MDS," said John M. Bennett John M. Bennett (b. 1942, Chicago) is an American experimental text, sound, and visual poet, who has won the attention of critic Richard Kostelanetz, and other commentators on the avant-garde. , M.D., Chair of The Myelodysplastic Syndromes Foundation. "Patients with this serious condition are often anemic, experience fatigue and weakness and, in certain cases with an increase in leukemic blast cells, MDS can result in bone marrow failure."

Results from a phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  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. The most commonly occurring adverse reactions with Dacogen include neutropenia, thrombocytopenia Thrombocytopenia Definition

Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets.
, anemia, pyrexia pyrexia /py·rex·ia/ (pi-rek´se-ah) pl. pyrex´iae   fever.pyrex´ial

py·rex·i·a
n.
See fever.



py·rex
, fatigue, nausea, cough, petechiae Petechiae
Tiny purple or red spots on the skin associated with endocarditis, resulting from hemorrhages under the skin's surface.

Mentioned in: Endocarditis, Hantavirus Infections, Hemorrhagic Fevers, Idiopathic Thrombocytopenic Purpura

, constipation, and diarrhea. 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.

"The approval of Dacogen demonstrates MGI PHARMA's ability to identify, acquire, develop, and register promising products," said Lonnie Moulder, president and chief executive officer of MGI PHARMA. "We look forward to providing clinicians with an effective therapy to offer their MDS patients. MGI PHARMA is committed to continuing the development of Dacogen for patients with acute myeloid leukemia, chronic myelogenous leukemia Chronic myelogenous leukemia (CML)
Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream.

Mentioned in: Bone Marrow Transplantation
, and solid tumors, in addition to developing alternative dosing regimens for patients with MDS."

"This approval is a significant milestone for SuperGen. Over the course of more than seven years, SuperGen developed Dacogen by working with scientists, clinicians, patient advocacy groups, and regulatory agencies to get this product approved for patients with MDS," said James S. Manuso, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of SuperGen. "The approval of Dacogen is a significant benefit for patients because of the drug's ability to address the underlying disease and, potentially, to improve patient outcomes."

Summary of Clinical Results

SuperGen conducted a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 open-label, multicenter, controlled trial that evaluated 170 adult patients with myelodysplastic syndromes meeting FAB classification criteria and IPSS High-Risk, Intermediate-2 and Intermediate-1 prognostic scores. Eighty-nine patients were randomized to Dacogen therapy plus supportive care, 83 of whom received Dacogen, and 81 were randomized to supportive care alone. Dacogen was intravenously infused at a dose of 15 mg/m(2) over a 3-hour period, every eight hours, for three consecutive days. Dacogen therapy was repeated every 6 weeks, depending on the patient's clinical response and toxicity. Supportive care consisted of blood and blood product transfusions, prophylactic antibiotics, and hematopoietic hematopoietic /he·ma·to·poi·et·ic/ (-poi-et´ik)
1. pertaining to hematopoiesis.

2. an agent that promotes hematopoiesis.


hematopoietic

1. pertaining to or affecting the formation of blood cells.
 growth factors. Co-primary endpoints of the study were overall response rate (complete responses plus partial responses) and time to acute myeloid leukemia (AML AML - A Manufacturing Language ) or death. Secondary endpoints included hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 improvement, duration of response, cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik)
1. pertaining to chromosomes.

2. pertaining to cytogenetics.


cytogenetic

pertaining to or originating from the origin and development of the cell.
 response rate, transfusion requirements, quality of life, survival, and safety.

The overall response rate in the Dacogen study arm was 17% with a median response duration of 288 days, compared to 0% in the supportive care arm (p less than 0.001). A complete response rate of 9% and a partial response rate of 8% were observed in the Dacogen arm. The overall response rate was 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. In addition, 13% of patients in the Dacogen arm had hematologic improvement, compared to 7% of patients in the supportive care arm.

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

"Dacogen represents a new treatment option that can reduce or eliminate the need for patients with MDS to receive frequent blood transfusions, which is an important clinical benefit," said Hagop Kantarjian, M.D., Professor and Chairman, Department of Leukemia, at the University of Texas MD Anderson Cancer Center and clinical investigator of the ongoing Dacogen clinical development program for MDS and AML. "This approval is a major advance in our fight against myelodysplastic syndromes."

Important Safety Information

Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential would 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%). Please visit www.mgipharma.com 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 and in patients with AML and chronic myelogenous leukemia, or CML 1. CML - A query language.

["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986].
2. CML - Concurrent ML.
. 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 antineoplastic /an·ti·neo·plas·tic/ (-ne?o-plas´tik)
1. inhibiting or preventing development of neoplasms; checking maturation and proliferation of malignant cells.

2. an agent that so acts.
 effects by incorporation into DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 and inhibition of an enzyme called DNA methyltransferase. Methylation methylation,
n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances.

methylation
(meth´
 is a process in which methyl (CH(3)) groups are added to DNA, resulting in the inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent.  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 co·va·lent
adj.
Of or relating to a chemical bond characterized by one or more pairs of shared electrons.
 adducts between DNA methyltransferase and decitabine incorporated into DNA. Non-proliferating cells are relatively insensitive to Dacogen. Please visit www.mgipharma.com for full prescribing information.

Conference Call & Webcast Information

MGI PHARMA will host a conference call at 9:00 a.m. ET on Wednesday, May 3, 2006, to discuss the FDA approval of Dacogen. Lonnie Moulder, President and CEO of MGI PHARMA, will host the call. The live webcast can be accessed by visiting the Investor Relations section of MGI PHARMA's website, www.mgipharma.com. An archived version of the call will be available via the MGI PHARMA website for seven days following the call.

About SuperGen

Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the discovery, acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. SuperGen's portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer, Nipent(R) (pentostatin for injection), Mitomycin mitomycin /mi·to·my·cin/ (mi?to-mi´sin)
1. any of a group of antitumor antibiotics (e.g., mitomycin A, B, C) produced by Streptomyces caespitosus.

2. mitomycin C; used as a palliative antineoplastic.
, SurfaceSafe(R) cleaner, and a number preclinical products being developed as inhibitors of aurora-A tyrosine kinase and DNA methyltransferase. For more information about SuperGen, please visit http://www.supergen.com.

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 has a portfolio of proprietary pharmaceuticals, and intends to become a leading biopharmaceutical company. MGI PHARMA markets 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 Injection commercially available during the second quarter of 2006. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets.

This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 or SuperGen'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 the Companies' results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to the ability of MGI PHARMA to successfully introduce Dacogen for Injection into the marketplace; acceptance by physicians and patients of the product; and Dacogen for Injection competing successfully with other therapies for MDS; and other risks and uncertainties detailed from time to time in the Companies' filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty to update any of these forward-looking statements to conform them to actual results.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:May 3, 2006
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