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Acute Myelogenous Leukemia
Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
March 2nd, 2008
Pharmion Corporation (NASDAQ:PHRM) and MethylGene Inc. (TSX: MYG) 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....
Source: Pharma Investments, Ventures & Law Weekly (2008-03-02)
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