BURLINGTON, Mass. — PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have recently been updated to include ropeginterferon alfa-2b-njft, marketed as BESREMi®, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk polycythemia vera (PV). Ropeginterferon alfa-2b-njft is the only preferred therapeutic option for both high-risk and low-risk (symptomatic) PV regardless of treatment history.
“The recent update to the NCCN Guidelines® reflects the ongoing shift in PV care towards earlier intervention, focusing on long-term patient health,” said Rami Komrokji, M.D., Vice Chair of the Malignant Hematology Department and Head of the Leukemia and MDS Section at Moffitt Cancer Center.
National Comprehensive Cancer Network® (NCCN®) is a well-recognized, not-for-profit alliance of leading cancer centers in the United States. Its treatment practice guidelines, which are reviewed and updated on a continual basis to reflect the most current evidence, are widely respected and followed by the U.S. physician community and serve to inform and facilitate coverage decisions with payers for oncology therapies. Based on its growing body of supporting clinical evidence and broad label, ropeginterferon alfa-2b-njft is now categorized by the latest NCCN Guidelines® update as a preferred first-line cytoreductive therapy based on NCCN®’s determination of superior efficacy, safety and evidence, as well as a category 2A therapy, which means that there is uniform NCCN® consensus that the intervention is appropriate. The updated NCCN Guidelines® were released on December 21, 2023.
“This is another important milestone for BESREMi as a preferred, FDA-approved option for both symptomatic low- and high-risk PV patients,” said Albert Qin, M.D., Ph.D., Chief Medical Officer at PharmaEssentia Corporation. “We are encouraged by the increasing dialogue across academic and community healthcare practitioners rethinking treatment approaches given the potential of BESREMi for this myeloproliferative neoplasm.”
About Polycythemia Vera (PV)
Polycythemia vera (PV) is a myeloproliferative neoplasm originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.
About BESREMi® (ropeginterferon alfa-2b-njft)
BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients.
BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021 and has recently received approval in Taiwan and South Korea. The drug candidate was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications.
BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.
About PharmaEssentia
PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.
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Muriel Huang