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Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
Date:2/14/2008

BOULDER, Colo. and MONTREAL, Feb. 14 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of acute myelogenous leukemia (AML) in the United States. Criteria for designation require that the product be intended for treatment of a condition affecting fewer than 200,000 people in the United States, and the application must include a rationale for the use of the drug in the rare disease or condition.

Orphan Drug Designation allows special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include, tax credits, research and development grant funding, and reduced filing fees at the time of application for marketing approval. Once approved, the product may qualify for seven years of marketing exclusivity in the United States.

About MGCD0103

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. The compound is currently in one Phase I combination clinical trial with Taxotere(R) for solid tumors, two Phase I/II combination trials with Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic cancer, and five Phase II clinical trials in hematological malignancies.

MGCD0103 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an Orphan Medicinal Product by the EMEA for the treatment of Hodgkin lymphoma and acute myelogenous leukemia.

About Acute Myelogenous Leukemia (AML)

Acute myelogenous leukemia (AML) is a cancer of the blood and bone marrow that
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SOURCE Pharmion Corporation
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