Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic...( Submission of Five-Day Dosing Regim...),Health

Submission of Five-Day Dosing Regimen sNDA Targeted for Fiscal Year-end

2008

WOODCLIFF LAKE, N.J., July 1, 2008 /PRNewswire/ -- Eisai Corporation of North America today announced the preliminary efficacy data from a trial initiated in 2002 comparing Dacogen(R) (decitabine) to Best Supportive Care (BSC) in elderly patients with myelodysplastic syndromes (MDS). The data did not demonstrate a statistically significant advantage of Dacogen treatment on median overall survival. However, response rates were similar to those observed in other clinical trials of Dacogen in patients with MDS. In the trial, conducted by the European Organisation for the Research and Treatment of Cancer (EORTC), Dacogen was administered on a three-day dosing schedule. In this study, the number of treatment cycles was limited. MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells.

Subsequent to database lock and the completion of data analysis, comprehensive results of the study, including secondary efficacy endpoints and safety data, will be presented by EORTC at an upcoming scientific forum.

Current Development

Eisai plans to submit a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration by the end of the fiscal year for a five-day regimen for Dacogen. The sNDA will be based on a North American, multi-center, open-label, single arm Phase II trial (DACO-020) in which patients received Dacogen every day for five days. The regimen was repeated every four weeks with no limit on the number of treatment cycles that patients could receive as long as they received clinical benefit or until their disease progressed. Median survival at the time of data analysis was 19.4 months and the one-year survival rate for patients treated with Dacogen was 66 percent. An overall complete response rate of 32 percent (International Working Group 2006 C
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