Epizyme Statement on COVID-19
Updated March 25, 2020
At Epizyme, our commitment is the patients we aim to help, and we have activated business continuity plans to allow us to continue to advance our TAZVERIK™ program and early pipeline, while minimizing disruptions and ensuring the safety and well-being of our team, their families and our partners. We recognize this is a quickly evolving situation and cannot rule out potential future impacts on our business. As with our industry peers, we continue to assess the situation and will make adjustments, as necessary.
Employee Safety and Remote Operations
Epizyme is committed to ensuring the safety of our employees, and we have implemented several precautions, including restrictions in travel and external meetings, training on proper sanitation habits, social distancing and self-isolation if any flu-like symptoms occur. In late February, we activated an internal team and began working on plans to shift to a fully remote operating model for our in-house and field-based employees, which we executed in early March. Certain changes have been made to enable critical lab and information technology operations to continue with appropriate social distancing for the safety of our employees.
Commercialization and Patient Access to TAZVERIK (tazemetostat)
Our priority is to ensure that all eligible patients have access to treatment – importantly, TAZVERIK is an oral medication allowing for treatment at home. Our commercial infrastructure utilizes a specialty pharmacy distribution network enabling delivery of TAZVERIK directly to a patient’s home.
We continue to provide an uninterrupted supply of TAZVERIK for commercial use and for use in our ongoing clinical trials. Based on inventory levels today, at this time we do not anticipate any shortage of TAZVERIK, should COVID-19 disruptions continue to persist resulting in an interruption in our supply chain. We’ve already built additional redundancy in our supply chain and have plans to continue to do so throughout 2020.
Finally, our supplemental NDA for TAZVERIK for the treatment of patients with relapsed or refractory follicular lymphoma who have received two prior systemic therapies remains under review with the U.S. FDA with a target PDUFA action date of June 18, 2020.
Supporting Our Ongoing Clinical Trials
Our active clinical trials remain ongoing, and we are leveraging virtual capabilities for site initiations and trial monitoring, as well as alternative methods for patient participation in our trials. We are working with clinical trial sites and CROs to continue to implement these plans immediately. We know that healthcare institutions are prioritizing how to deal with the COVID-19 pandemic, and we want to ensure that our corporate objectives support their ability to do that.
TAZVERIK™ (tazemetostat) is the first EZH2 inhibitor approved by the U.S. Food and Drug Administration (FDA). TAZVERIK™ is an enhancer of zeste homolog 2 (EZH2) methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For more information, visit TAZVERIK.com.
This update includes forward-looking statements based on our current expectations and beliefs that are subject to risks and uncertainties. The response to the COVID-19 pandemic continues to evolve and change on a rapid basis. We will update this statement on a periodic basis. Should you have any immediate concerns or questions about the utilization of TAZVERIK or any planned or ongoing clinical trials, please contact us at 1-866-4EPZMED. As we continue to react to this dynamic environment, we acknowledge that facts and circumstances of our business may differ materially from what is described in this update. Please consult the risk factors section of our recent SEC filings, including our Annual Report on form 10-K, which was filed in February of this year.