vidaza

BOULDER, Colo., February 23, 2004 -- Pharmion Corporation, (Nasdaq: PHRM) todayannounced that the U.S vidaza. Food and Drug Administration (FDA) has accepted forfiling and granted Priority Review classification for the company's New DrugApplication (NDA) for Vidaza (azacitidine for injectable suspension) for thetreatment of Myelodysplastic Syndromes (MDS) vidaza. Priority Review status of theapplication reduces the standard agency response time to six months, and targetsan agency response on or before June 29, 2004.

"The FDA's acceptance of our Vidaza application for filing and designationof Priority Review status represents a significant milestone for Pharmion,"said Patrick J vidaza. Mahaffy, president and chief executive officer of Pharmion vidaza. "There are currently no approved therapies for MDS, and we look forwardto working closely with the FDA in the coming months as we seek regulatory approvalfor this potential new treatment for this very serious disease."

Vidaza has been granted Orphan Product Designation by the FDA, which, if theNDA is approved, entitles the drug to seven years of market exclusivity forMDS in the U.S vidaza. Pharmion submitted the NDA under the provisions of the SubpartH Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesseson December 29, 2003 vidaza. As a condition of its NDA submission, Pharmion is requiredto conduct a confirmatory study of Vidaza in the treatment of MDS.

In September 2003, Pharmion initiated a confirmatory clinical trial comparingthe effect of Vidaza to conventional care options on survival in patients withMDS vidaza. The study, which will examine survival outcomes as well as secondary endpoints,will recruit more than 350 patients at treatment centers across the U.S., Europeand Australia and will be one of the largest studies to date in this disease.

The NDA submission was based upon an NCI-sponsored Phase III study for thetreatment of MDS, conducted by Cancer and Leukemia Group B (CALGB), and twosupportive Phase II CALGB studies, which were also sponsored by the NCI vidaza. Theresults of this Phase III study were published in the May 2002 Journal of ClinicalOncology.

About Vidaza (azacitidine)
In addition to its cytotoxic effects, azacitidine is member of a class of drugsin development known as "hypomethylating" or "demethylating"agents vidaza. Methylation of DNA is a major mechanism regulating gene expression vidaza. Researchers have found that an increase in methylation of DNA can result inblockage of the activity of genes that regulate cell division and differentiation,known as "suppressor genes." With suppressor gene expression blocked,cell division becomes unregulated, allowing or promoting cancer vidaza. In in-vitrostudies, researchers have found that azacitidine can reverse the methylationof DNA, leading to reexpression of suppressor genes and a resulting differentiationand maturation of cells.

About MDS
MDS is a bone marrow disorder characterized by the production of abnormallyfunctioning, immature blood cells vidaza. The highest prevalence of MDS is in patientsover 60 years of age vidaza. According to the American Cancer Society, there are anestimated 10,000-20,000 new cases of MDS in the United States each year vidaza. Survivalrates range from six months to six years for the different subtypes of MDS vidaza. MDS can result in death from bleeding and infection in the majority of patients,and transformation to acute myelogenous leukemia (AML) occurs in up to 40 percentof patients vidaza. The prognosis for patients transforming to AML is exceptionallypoor.

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