Epizyme Earns $8 Million Milestone Payment from GlaxoSmithKline for Initiation of Clinical Development for First-in-Class PRM...
December 18 2018 - 6:30AM
Business Wire
Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company
developing novel epigenetic therapies, today announced it has
earned an $8 million milestone payment from GlaxoSmithKline (GSK).
The milestone payment follows GSK’s initiation of patient dosing in
a Phase 1 clinical trial of GSK3368715, a first-in-class protein
arginine methyltransferase1 (PRMT1) inhibitor discovered by Epizyme
and licensed to GSK. PRMT1 has been implicated in a number of human
cancers.
“We are very pleased to see the progress that GSK has made with
its PRMT1 inhibitor program, which marks the second program under
our collaboration agreement to enter the clinic,” said Robert
Bazemore, president and chief executive officer of Epizyme. “This
milestone reinforces the promising role that epigenetic medicines
may play in treating a variety of diseases, and our leadership in
the discovery of novel epigenetic targets. It also validates our
strategic business model of establishing collaborations that allow
us to focus our internal resources on our lead programs, while
facilitating the advancement of novel treatments for people with
cancer. We look forward to GSK’s continued progress with this
clinical program.”
This Phase 1 study by GSK will assess the safety,
pharmacokinetics, pharmacodynamics and preliminary clinical
activity of GSK33368715 in patients with relapsed and/or refractory
diffuse large B-cell lymphoma (DLBCL) and selected solid tumors
with frequent methyl-thioadenosine phosphorylase
(MTAP)-deficiency.
About the Epizyme-GSK CollaborationUnder the terms of its
collaboration and license agreement with GSK, Epizyme granted GSK
exclusive worldwide license rights to methyltransferase inhibitors
directed to three targets. Using its proprietary drug discovery
platform, Epizyme discovered and optimized compounds targeting
three methyltransferases. During the research term of the
collaboration, which has been completed, Epizyme was primarily
responsible for preclinical research on such compounds. GSK is
responsible for subsequent research, development and
commercialization of each program. Epizyme has earned an aggregate
of $89 million in up-front, research and milestone payments to
date, and may receive up to an additional $375 million from GSK if
all remaining milestones are met. Epizyme is eligible to receive up
to double-digit royalties on worldwide net sales of collaboration
products.
About Epizyme, Inc.Epizyme, Inc. is a clinical-stage
biopharmaceutical company committed to rewriting treatment for
cancer and other serious diseases through novel epigenetic
medicines. Epizyme is broadly developing its lead product
candidate, tazemetostat, a first-in-class EZH2 inhibitor, with
studies underway in both solid tumors and hematological
malignancies, as a monotherapy and combination therapy in relapsed
and front-line disease. The company also is developing a novel G9a
program with its next development candidate, EZM8266, which is
targeting sickle cell disease. By focusing on the genetic drivers
of disease, Epizyme's science seeks to match targeted medicines
with the patients who need them. For more information, visit
www.epizyme.com.
Cautionary Note on Forward-Looking StatementsAny
statements in this press release about future expectations, plans
and prospects for Epizyme, Inc. and other statements containing the
words "anticipate," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
uncertainties relating to the Company’s ability to resume
enrollment in its tazemetostat trials and the timing of such
resumption, and the impact of the safety finding in the company’s
pediatric trial on enrollment of patients in ongoing and future
trials of tazemetostat following the lifting of the partial
clinical hold and the resumption of enrollment; uncertainties
inherent in the initiation of future clinical studies and in the
availability and timing of data from ongoing clinical studies;
whether interim results from a clinical trial will be predictive of
the final results of the trial; whether results from preclinical
studies or earlier clinical studies will be predictive of the
results of future trials; whether results from clinical studies
will warrant meetings with regulatory authorities, submissions for
regulatory approval or review by governmental authorities under the
accelerated approval process; whether Fast Track Designation and
Orphan Drug Designations will provide the benefits for which
tazemetostat is eligible; expectations for regulatory approvals to
conduct trials or to market products; whether the company's cash
resources will be sufficient to fund the company's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements; other matters that could affect the availability or
commercial potential of the company's therapeutic candidates; and
other factors discussed in the "Risk Factors" section of the
company's most recent Form 10-Q filed with the SEC and in the
company's other filings from time to time with the SEC. In
addition, the forward-looking statements included in this press
release represent the company's views as of the date hereof and
should not be relied upon as representing the company's views as of
any date subsequent to the date hereof. The company anticipates
that subsequent events and developments will cause the company's
views to change. However, while the company may elect to update
these forward-looking statements at some point in the future, the
company specifically disclaims any obligation to do so.
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version on businesswire.com: https://www.businesswire.com/news/home/20181218005121/en/
Media:Erin Graves, (617) 500-0615Epizyme,
Inc.media@epizyme.comInvestors:Monique Allaire, (617)
896-9511THRUST Strategic Communicationsmonique@thrustsc.com
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