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

l exclusively enroll MLL-r patients.

Epizyme retains all U.S. rights to EPZ-5676 and has granted Celgene an exclusive license to EPZ-5676 outside of the United States. Epizyme has partnered with Abbott to develop a companion diagnostic to identify MLL-r patients. Additional information about these partnerships may be found here: http://www.epizyme.com/about-us/partnerships.asp

About MLL-r

MLL-r is an aggressive subtype of two of the most common forms of acute leukemia, acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL). The disease predominantly occurs in two different age ranges, an adult population and a pediatric population. Although both age ranges share a common genetic driver, the adult disease is frequently a secondary leukemia resulting from prior chemotherapy for a different, unrelated cancer, while the pediatric disease is sporadic in nature. According to research published in the journal Blood in December 2002, the five-year overall survival rate for adult patients with the MLL-r subtype of AML ranges from approximately 5 to 24 percent. The five-year event-free survival rate in pediatric patients with the most common MLL-r subtype of ALL is approximately 27 percent, as identified in research published in the New England Journal of Medicine in 2004. The total annual incidence of MLL-r in all patients (adult and pediatric, AML and ALL) in major pharmaceutical markets is approximately 4,900 patients, according to a report by Clarion Healthcare commissioned by Epizyme. Patients with MLL-r are routinely diagnosed today with existing tests that are commonly used in clinical settings, and there is high awareness of MLL-r among oncologists.

About Epizyme, Inc.

Epizyme, Inc. is a clinical stage biopharmaceutical company creating personalized therapeutics for patients with genetically defined cancers.
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SOURCE Epizyme, Inc.
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