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Epizyme Receives Orphan Drug Designation for EPZ-5676
Date:8/16/2013

CAMBRIDGE, Mass., Aug. 16, 2013 /PRNewswire-USNewswire/ -- Epizyme, Inc., (NASDAQ: EPZM) a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for EPZ-5676. Criteria for orphan drug designation requires that the product be intended for treatment of a rare disease or condition, classified as affecting fewer than 200,000 people in the United States.

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 during development or at the time of application for marketing approval. Once approved, the product may qualify for seven years of marketing exclusivity independent of any other intellectual property.

About EPZ-5676

Epizyme is developing EPZ-5676, a small molecule inhibitor of DOT1L created with Epizyme's proprietary product platform, for the treatment of acute leukemias in which the MLL gene is rearranged due to a chromosomal translocation (MLL-r). Due to the translocation, DOT1L is recruited to specific locations in the chromosome where it would not normally be present. As a result, DOT1L causes inappropriate methylation at these locations, which results in the increased expression of genes causing leukemia.

In September 2012, Epizyme initiated a Phase 1 clinical trial for EPZ-5676. The company believes EPZ-5676 is the first HMTi to enter human clinical development. As of August 2013, this program is in the dose escalation phase and is expected to initiate an expansion phase in the second half of 2013 that wil
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SOURCE Epizyme, Inc.
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