Presentations to illustrate long-term results from the PROUD/CONTINUATION studies as well as new insights on ropeginterferon alfa-2b in polycythemia vera (PV) patients in Japan

PharmaEssentia Corporation (TPEx: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 a series of data presentations will illustrate outcomes with ropeginterferon alfa-2b (marketed as BESREMi®) among adults with polycythemia vera (PV) during the European Hematology Association’s Hybrid Congress (EHA2022), June 9-17 in Vienna, Austria.

“Ongoing evaluations of ropeginterferon alfa-2b expand the depth and duration of data on this innovative therapeutic supporting its ability to control the effects of polycythemia vera (PV),” said Albert Qin, MD, PhD, Chief Medical Officer, PharmaEssentia. “We believe these important new data offer greater clarity and confidence to physicians that this therapeutic tool represents an approach to effectively and durably treat PV.”

Ropeginterferon alfa-2b presentations during EHA2022 will include:

• Ropeginterferon Alfa-2b Achieves Patient-Specific Treatment Goals in Polycythemia Vera: Final Results from the PROUD-PV/CONTINUATION-PV Studies (Oral presentation, #S196, presented by Heinz Gisslinger, M.D. of Medical University Vienna)

• Phase 2, Open-Label, Multicenter, Single-Arm Study Investigating the Efficacy and Safety of Ropeginterferon Alfa-2b in Japanese Patients with Polycythemia Vera (PV) (Poster presentation, #P1007, authored by Keita Kirito, MD, University of Yamanashi, Japan)

The data presentation regarding the final results of studies leading to marketing authorization of BESREMi^® in Europe are a result of clinical development work of AOP Health, Vienna. PharmaEssentia has licensed ropeginterferon alfa-2b in Europe to AOP.

About Polycythemia Vera

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 JAK2.¹

About BESREMi® (ropeginterferon alfa-2b)

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 treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, in the United States 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 Corporation (TPEx: 6446), based in Taipei, Taiwan, is a rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, the company aims to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, 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 the company 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. For more information, visit our website.

¹ Cerquozzi S, Tefferi A. Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors. Blood Cancer Journal (2015) 5, e366; doi:10.1038/bcj.2015.95.

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