CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that the company has entered into an amended and restated agreement with funds managed by Pharmakon Advisors, LP, an affiliate of Royalty Pharma, to expand its loan facility and plans to draw down $150 million. Epizyme and Pharmakon Advisors originally executed their agreement in November 2019, in conjunction with the company’s funding agreement with Royalty Pharma.
As part of the original loan agreement, Epizyme drew down $70 million to fund the regulatory milestones owed to Eisai Co., Ltd. for the New Drug Application submissions and U.S. Food and Drug Administration approvals of TAZVERIK® for epithelioid sarcoma and follicular lymphoma. The expansion of the loan facility was contingent upon approval of TAZVERIK for follicular lymphoma and subject to mutual agreement. Based on its current plans and projections, and following closing of the amended and restated agreement, Epizyme believes that its existing cash, cash equivalents and marketable securities will fund the company’s operations into at least 2023.
“The decision to expand our loan with Pharmakon was a strategic one, designed to further strengthen our balance sheet and fund a number of critical growth initiatives for Epizyme, including continued TAZVERIK commercial execution, ongoing and planned tazemetostat development in new indications and combination regimens, and advancing our research efforts and early pipeline,” said Robert Bazemore, president and chief executive officer of Epizyme. “Pharmakon is a supportive partner, and we believe this additional capital extends our operating runway out several years, reducing the need for an additional financing in the foreseeable future.”
“Pharmakon is deeply committed to supporting innovative biotechnology companies in order to advance important medicines for patients in need,” said Martin Friedman, managing member of Pharmakon Advisors. “We believe strongly in both the near- and long-term therapeutic potential of TAZVERIK and the opportunity of Epizyme’s pipeline to impact many patients. We are pleased to further support the company with the additional funding to fuel their future growth.”
For a further description of terms of the transaction agreements, please refer to Epizyme’s Form 10-Q filed today.
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
- Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
- Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
View the U.S. Full Prescribing Information here: Epizyme.com
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
TAZVERIK® is a registered trademark of Epizyme, Inc. For full prescribing information, please visit TAZVERIK.com.
About Pharmakon Advisors
Pharmakon Advisors, LP is the investment manager of the BioPharma Credit funds and of BioPharma Credit PLC (LON:BPCR), the only listed specialist investor in debt from the life sciences industry. Established in 2009, Pharmakon has invested $5 billion across 40 different financing transactions for companies in the life sciences.
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: whether the conditions to the additional draw-down under the company’s loan facility are satisfied and the draw-down is consummated; whether the commercial launch of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be successfully executed; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory 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; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; the impact of the COVID-19 pandemic on the company’s business, results of operations and financial condition; 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 success of tazemetostat or 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.
TAZVERIK® is a registered trademark of Epizyme, Inc.