) announced that the U.S. Food and Drug Administration (FDA) has
granted orphan drug status to the company's pipeline candidate
EPZ-5676. Epizyme is developing the candidate for treating a rare
form of acute leukemia characterized by a re-arranged MML gene
(mixed lineage leukemia). The re-arrangement is caused by
chromosomal translocation. Epizyme is currently in phase I
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We note that the FDA grants orphan drug designation to those
drugs that are meant for treating rare diseases affecting not
more than 200,000 people in the U.S. The orphan drug designation
granted to EPZ-5676 will facilitate its development by providing
incentives such as tax credits and research and development grant
We note that Epizyme has the entire rights pertaining to EPZ-5676
in the U.S. The company granted
) an exclusive license to develop and commercialize the candidate
in ex-U.S. markets. Moreover, in Apr 2013, Epizyme joined forces
) for the development of a molecular companion diagnostic test
for use with EPZ-5676.
Under this deal, Abbott Labs will use its fluorescence in situ
hybridization technology to develop the test. It will help in
identifying patients eligible for treatment with EPZ-5676.
Financial details of the deal were not provided.
Epizyme was also in the news recently when it raised $88.7
million (gross) through an initial public offering. The funds
will help Epizyme in developing its pipeline further.
Epizyme, a biopharmaceutical company, carries a Zacks Rank #3
Gilead Sciences, Inc.
) looks well-positioned in the biopharma space with a Zacks Rank
#1 (Strong Buy).