Epizyme announces an extended loan facility with Pharmakon Advisors for an additional $ 150 million to fund its growth initiatives
CAMBRIDGE, Mass .– (BUSINESS WIRE) –Epizyma, (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 updated agreement with funds managed by Pharmakon Advisors, LP, a subsidiary of Royalty Pharma, to extend its loan facility and plans to withdraw $ 150 million. Epizyme and Pharmakon Advisors initially signed their agreement in November 2019, in conjunction with the Company’s financing agreement with Royalty Pharma.
As part of the original loan agreement, Epizyme leveraged $ 70 million to fund regulatory milestones owed to Eisai Co., Ltd. for new drug submissions and approvals of TAZVERIK by the Food and Drug Administration. the United States.® for epithelioid sarcoma and follicular lymphoma. The expansion of the loan facility was subject to the approval of TAZVERIK for follicular lymphoma and subject to mutual agreement. Based on its current plans and projections, and following the conclusion of the amended and restated agreement, Epizyme estimates that its existing cash, cash equivalents and marketable securities will finance the operations of the company until at least 2023.
“The decision to extend our loan with Pharmakon was strategic, designed to further strengthen our balance sheet and fund a number of critical growth initiatives for Epizyme, including the continued commercial execution of TAZVERIK, the ongoing development of tazemetostat. and anticipated in new indications and combination patterns, and advancing our research efforts and early pipeline, ”said Robert Bazemore, President and CEO of Epizyme. “Pharmakon is a supporting partner, and we believe this additional capital extends our operating track for several years, thereby reducing the need for additional funding for the foreseeable future.
“Pharmakon is deeply committed to supporting innovative biotechnology companies to advance medicines important to patients in need, ”said Martin Friedman, Managing Member of Pharmakon Advisors. “We strongly believe in the short and long term therapeutic potential of TAZVERIK and the desirability of the Epizyme pipeline to impact many patients. We are happy to continue to support the company with additional funds to fuel its future growth. ”
For a more detailed description of the 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 16 years of age and older with metastatic or locally advanced epithelioid sarcoma are not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation detected by an FDA-approved test and who have received at least two previous systemic treatments.
Adult patients with relapsed or refractory follicular lymphoma who do not have satisfactory alternative treatment options.
These indications are approved under expedited approval based on the overall response rate and duration of response. Continued approval of these indications may be contingent on verification and description of clinical benefit in one or more confirmatory trials.
The most common side effects (≥ 20%) in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common side effects (≥ 20%) in patients with follicular lymphoma are fatigue, upper respiratory tract infections, musculoskeletal pain, nausea and abdominal pain.
View full prescribing information in the US here: Epizyme.com
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission to rewrite the treatment of cancer and other serious diseases with new epigenetic drugs. In addition to an active research and discovery pipeline, Epizyme has a US FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced (ES) epithelioid sarcoma who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation detected by an FDA-approved test and who have received at least two previous systemic treatments; and adult patients with relapsed or refractory follicular lymphoma who do not have satisfactory alternative treatment options. These indications are approved under expedited approval based on the overall response rate and duration of response. Continued approval of these indications may be contingent on verification and description of clinical benefit in one or more confirmatory trials. The company is also exploring the treatment potential of tazemetostat in experimental clinical trials in other solid tumors and hematologic malignancies, as monotherapy and in combination in relapsed and first-line cases. By focusing on the genetic factors of the disease, Epizyme seeks to match drugs to 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 debt investor in the life sciences sector. Founded in 2009, Pharmakon has invested $ 5 billion in 40 different financing deals for life science companies.
Caution regarding forward-looking statements
Any statement contained in this press release about the future expectations, plans and prospects of Epizyme, Inc. and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “expect”, “ intend “,” may “,” plan “,” “Predict”, “plan”, “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 these forward-looking statements due to various important factors, including: whether the conditions of the additional levy under the company’s loan facility are satisfied and the drawdown is complete; whether the commercial launch of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be carried out successfully; whether tazemetostat will receive marketing authorization for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether the results of preclinical or previous clinical studies will be predictive of the results of future trials, such as ongoing confirmatory trials; whether the results of clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval, or review by government authorities as part of the expedited approval process; expectations regarding regulatory approvals, including expedited approval, to conduct trials or market products; the impact of the COVID-19 pandemic on the business, results of operations and financial condition of the company; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unpredictable operating expenses and capital expenditures; other matters that could affect the availability or commercial success of the 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 other documents filed from time to time by the Company with the SEC. Further, the forward-looking statements included in this press release represent the opinions of the company as of the date hereof and should not be taken as representative of the views of the company as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause a change in the outlook of the company. However, although the company may choose to update these forward-looking statements at some time in the future, the company expressly disclaims any obligation to do so.
TAZVERIK® is a registered trademark of Epizyme, Inc.