Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL), both with and without EZH2 activating mutations. The company recently conducted a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss the FL registration strategy based on the current patient population in its ongoing Phase 2 clinical trial. Following the discussion, Epizyme has defined a registration strategy for tazemetostat in both EZH2 mutant and wild type FL patient populations, where patients’ disease has progressed following two or more lines of therapy. Based on this, the company anticipates submitting a New Drug Application (NDA) for this indication in the fourth quarter of 2019. In addition, the company provided an update on its clinical and preclinical pipeline and anticipated milestones for 2019.
“Follicular lymphoma is an incurable cancer today, and in the third line and later settings, there are limited effective treatment options. Defining a clear path to a regulatory submission for tazemetostat for this patient population marks a huge step forward for patients and an opportunity to change the course of FL treatment,” said Shefali Agarwal, M.D., chief medical officer of Epizyme. “This FL NDA submission would mark the second for tazemetostat in one year, following our first submission for epithelioid sarcoma, which is on track for the second quarter of 2019. If successful, tazemetostat is poised to be the first commercially available EZH2 inhibitor. We look forward to advancing our submission preparations and further engaging with FDA, as we work expeditiously to bring tazemetostat to the patients who need it.”
Tazemetostat Registration Update for Follicular Lymphoma
Tazemetostat Registration Update for Epithelioid Sarcoma
Tazemetostat Program Expansion Updates
Preclinical and Discovery Pipeline Update
Updated Financial Guidance
“We are at a point in our company’s evolution where we are beginning to realize the true value of all of the hard work to which we have dedicated ourselves over the past several years. 2019 is set to be a year of pivotal milestones for Epizyme, providing validation of our expertise in drug development and bringing us closer to achieving our mission of helping patients,” said Robert Bazemore, president and chief executive officer of Epizyme. “With defined registration paths for tazemetostat in two indications and plans to expand into other combinations and indications, tazemetostat has the potential to generate significant value for the patients and physicians who need new treatment options, and for Epizyme. Outside of tazemetostat, our research capabilities provide additional advantages to our company, and we are excited to be moving EZM8266 into the clinic and working with our partners to advance earlier programs. I am proud of what we have accomplished, and look forward to what is ahead as we transition to a commercial-stage company that can truly have an impact on patients.”
Conference Call Information
Epizyme will host a conference
call today, Jan. 4, at 8:30 a.m. ET to review this corporate update. To
participate in the conference call, please dial (877) 844-6886
(domestic) or (970) 315-0315 (international) and refer to conference ID
7289720. A live webcast and slides will be available in the investor
section of the company's website at www.epizyme.com.
The webcast and slides will be archived for 60 days following the call
and presentation.
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 Statements
Any 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190104005033/en/
Media:
Erin Graves, (617) 500-0615
Epizyme, Inc.
[email protected]
Investors:
Monique Allaire, (617) 896-9511
THRUST Strategic
Communications
[email protected]