Dacogen(TM) Approved For Patients With All FAB Classifications Of MDS

MGI PHARMA, INC.(Nasdaq: MOGN) and SuperGen, Inc. (Nasdaq: SUPG) today
announced that the U.S. Food and Drug Administration (FDA) has approved
Dacogen(TM) (decitabine) for Injection. Dacogen is indicated for 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. 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, 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 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, anemia, pyrexia, fatigue, nausea, cough, petechiae,
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, 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 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 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/m2 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 growth factors. Co-primary endpoints of the study were
overall response rate (complete responses plus partial responses) and time
to acute myeloid leukemia (AML) 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 in the Dacogen study arm was 17% with a
median response duration of 288 days, compared to 0% in the supportive care
arm (p