) were up 75.6% a day after the company announced the achievement
of the proof of concept (POC) milestone in the development
program of its pipeline candidate EPZ-5676 in an ongoing phase I
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. We note that Epizyme is developing EPZ-5676 in
) which holds the license for EPZ-5676 outside the U.S.
The achievement led to Epizyme earning a milestone payment of
$25 million, triggered by objective responses in patients with
translocations of the MLL gene (MLL-r). These patients are
currently enrolled in the fourth dose cohort in the dose
escalation stage of the ongoing phase I trial.
Epizyme expects to present data from this phase I study on
EPZ-5676, in 2014 including the dose escalation stage that is
fully enrolled and the adult MLL-r expansion stage which is
currently enrolling patients.
We remind investors that EPZ-5676 enjoys orphan drug status in
the U.S. since May 2013. Meanwhile, the European Medicines
Agency's Committee for Orphan Medicinal Products recommended
orphan drug designation for EPZ-5676 to the European Commission
in Dec 2013.
In addition, Epizyme earned a $4 million milestone payment for
one of the three histone methyltransferase (HMT) targets, which
are included in the company's collaboration agreement with
The total milestone payments from Celgene and
GlaxoSmithKline is expected to boost the estimated 2013 end cash
and account receivables balance to approximately $145 million, up
from the previous guidance of $115 million.
Going forward, Epizyme expects to have as many as five
clinical POC programs in 2014. These include the ongoing adult
MLL-r expansion stage, MLL-r in pediatric patients, and adult
MLL-PTD patients on EPZ-5676. Additionally, the POC program
includes indications like adult non-Hodgkin lymphoma patients and
pediatric and young adult patients with synovial sarcomas on
Epizyme, a clinical stage biopharmaceutical company, carries a
Zacks Rank #3 (Hold). At current levels,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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