Pharmion's Oral Azacitidine Granted Fast Track Status for Myelodysplastic...( BOULDER Colo. Aug. 29 /- Pharmion...)

BOULDER, Colo., Aug. 29 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oral Azacitidine in the treatment of Myelodysplastic Syndromes (MDS).

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track emphasizes the critical nature of close, early communication between the FDA and sponsors. The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, and the option of submitting a New Drug Application in sections rather than all components simultaneously. These meetings can help the FDA and sponsors reach early agreement on design of the clinical efficacy studies that will be needed to support approval.

The FDA stated that Fast Track designation was granted for oral Azacitidine for MDS because Azacitidine is approved to treat all subtypes of MDS, and because it will potentially provide a safer, more comfortable, more convenient and more efficient route of administration of Azacitidine.

"We are extremely enthusiastic about working closely with Pharmion to drive the development of oral Azacitidine," said Dr. Hagop Kantarjian, chair of the department of leukemia at the University of Texas M.D. Anderson Cancer Center. "Vidaza has now demonstrated a unique and profound survival benefit in higher-risk MDS, and we think oral Azacitidine may provide significant benefit in treating lower risk forms of MDS as well. We are delighted that the FDA shares our view that its developme
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