On November 6, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported 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 (Press release, Epizyme, NOV 6, 2020, View Source [SID1234570194]). Epizyme and Pharmakon Advisors originally executed their agreement in November 2019, in conjunction with the company’s funding agreement with Royalty Pharma.
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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.
About TAZVERIK
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.