Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenou... ( BOULDER Colo. and MONTREAL Feb. 1...)

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Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia

Date:2/11/2008

BOULDER, Colo., and MONTREAL, Feb. 11 /PRNewswire-FirstCall/ -- Pharmion (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced that the European Medicines Agency (EMEA) and the European Commission (EC) designated MGCD0103, a histone deacetylase (HDAC) inhibitor, as an Orphan Medicinal Product for the treatment of acute myelogenous leukemia in the European Union (EU). Criteria for designation require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons in the EU.

Orphan Medicinal Product Designation allows special incentives for sponsors planning to test a product for use in a rare disease or condition generally characterized by a small number of patients. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Once approved, the product may qualify for 10 years of marketing exclusivity in the EU.

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) for the treatment of Hodgkin lymphoma 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 (
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Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenou...( BOULDER Colo. and MONTREAL Feb. 1...),Health