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.
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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.
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