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Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
Date:8/19/2007

in the most advanced MDS patients, validate the benefit Vidaza can provide patients with this extremely difficult to treat disease," said Dr. Lewis R. Silverman, Associate Professor of Medicine, Division of Hematology and Medical Oncology, Mount Sinai School of Medicine. "Building on the established data from our earlier clinical studies, which showed that Vidaza offers transfusion independence to many patients with MDS, we now see that Vidaza not only improves a patient's life, but extends it as well."

"With these very exciting results for Vidaza, survival should now be the standard by which we evaluate treatment options for higher-risk MDS," said Dr. Alan F. List, Chief, Malignant Hematology Division and Deputy Physician in Chief, H. Lee Moffitt Cancer Center and Research Institute. "Importantly, as the first and only epigenetic therapy to have demonstrated a survival benefit in any cancer, these findings should accelerate exploration of Vidaza in other malignancies where hypermethylation is believed to play a key role in tumor development and progression."

"We are extremely gratified with the results from the Vidaza Survival Study, which for the first time bring the hope of prolonged survival for patients with higher-risk MDS," said Patrick J. Mahaffy, Pharmion's chief executive officer and president. "As the only therapy to have ever demonstrated a survival advantage in MDS, and especially to have demonstrated an improvement of this magnitude, Vidaza is unique in the treatment for this disease."

Pharmion expects to present full study results at an upcoming medical meeting. Based on these results, Pharmion intends to file a Marketing Authorization Application (MAA) in the European Union (EU) for Vidaza for the treatment of higher-risk MDS before the end of this year and will shortly thereafter submit additional international regulatory submissions. The Company will also file a supplemental New Drug Application (NDA) with the U.S. Food and Drug
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SOURCE Pharmion Corporation

Copyright©2007 PR Newswire.

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