PharmaEssentia Highlights Availability of BESREMi® (ropeginterferon alfa-2b-njft) for Patients Affected by Pegasys® (peginterferon alfa-2a) Drug Shortage

BESREMi^® recognized by National Comprehensive Cancer Network^® (NCCN^®) as an appropriate substitute for Pegasys^® in the face of ongoing supply limitations

BURLINGTON, Mass.--(BUSINESS WIRE)--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 latest National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025, January 21, 2025) now highlight the substitution of ropeginterferon alfa-2b-njft (BESREMi^®) for treating polycythemia vera (PV) in the event that peginterferon alfa-2a (Pegasys^®) is unavailable.

The updated NCCN Guidelines come at a crucial time, as an ongoing Pegasys^® shortage poses challenges in treatment continuity. By identifying BESREMi^® as both a preferred treatment option and a viable substitute for patients who have been treated with Pegasys^®, the updated NCCN Guidelines recognize and address the Pegasys^® shortage by offering patients and providers alternative options. Healthcare professionals are encouraged to review the revised guidelines to fully understand the clinical implications and integrate this new option into their treatment protocols.

“The added clarity around BESREMi^® substitution is welcome and will enhance care continuity during the ongoing peginterferon alfa-2a supply shortage,” said Andrew Bernstein, M.D., Head of Medical of PharmaEssentia USA. “BESREMi^® is recognized as a preferred treatment option for patients with PV in the existing guidelines. PharmaEssentia is committed to enhancing patient care and ensuring patient access during the shortage.”

“The Pegasys^® shortage has created serious challenges for individuals living with PV, leaving many without access to their essential treatments,” said Ann Brazeau, CEO and Founder of MPN Advocacy and Education International. “Patients in the PV community can now feel empowered knowing that BESREMi^® is available as an alternative treatment option to support their care.”

To best meet the needs of healthcare providers and their patients, PharmaEssentia Corporation has extensive in-house drug manufacturing capabilities, which have been certified by the U.S. Food and Drug Administration, European Medicines Agency (EMA), and other regulatory bodies. The Company is working to further expand its global drug supply capacity, and a new plant is expected to begin operations in 2026, increasing total production capacity to over 100,000 patients worldwide.

About Polycythemia Vera (PV)

Polycythemia vera (PV) is a cancer 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) in polycythemia vera (PV)

BESREMi^® is an innovative monopegylated, long-acting interferon with FDA approval in PV. 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 marketing authorization in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It 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.

Please see full Prescribing Information, including Boxed Warning.

About peginterferon alfa-2a (Pegasys^®)

Pharma& GmbH owns worldwide rights to Pegasys^® (peginterferon alfa-2a) exclusive of China and Japan. Pegasys^® is a registered trademark of Hoffmann-LaRoche Inc.

About PharmaEssentia

PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation 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.

For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).