New presentations to inform applications for ropeginterferon alfa-2b in the treatment of PV
BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of 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 that new data on ropeginterferon-alfa-2b will be presented during the 64th American Society of Hematology (ASH) Annual Meeting, December 10-13, 2022.
Data to be presented at the meeting further explore the clinical profile of ropeginterferon alfa-2b in PV patients, including interim results from a regional study as well as safety and efficacy data in different risk populations. The company will also present details of the planned ECLIPSE-PV Phase 3b clinical trial, which aims to support an amended dosing regimen for ropeginterferon alfa-2b.
“The latest research to be presented at ASH will explore new insights on the profile of ropeginterferon alfa-2b as a therapeutic option for the treatment of PV,” said Raymond Urbanski, M.D., Ph.D., U.S. Head of Clinical Development and Medical Affairs. “We look forward to convening with the scientific community to discuss this latest research and our continued plans to address unmet needs in the PV community.”
ASH abstract details
- A Phase 3b, Single-Arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-Njft (P1101) in Adult Patients with Polycythemia Vera
- Abstract 3004 – Sunday, December 11, 2022, 6:00 PM-8:00PM
- Phase II, Open-Label, Multicenter, Single-Arm Study Investigating the Efficacy and Safety of Ropeginterferon Alfa-2b in Chinese Patients with Polycythemia Vera Resistant or Intolerant to Hydroxyurea (HU)
- Abstract 3050 – Sunday, December 11, 2022, 6:00 PM-8:00 PM
- Efficacy and Safety of Long-Term Ropeginterferon Alfa-2b Treatment in Patients with Low-Risk and High-Risk Polycythemia Vera (PV)
- Abstract 4345 – Monday, December 12, 2022, 6:00 PM-8:00 PM
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 JAK2.1
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 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 also 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.
Please see full Prescribing Information, including Boxed Warning.
PharmaEssentia (TPEx: 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 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 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.
Forward Looking Statement
This press release contains forward looking statements, including statements regarding our pipeline and research and development efforts. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks and uncertainties related to the initiation, timing, progress and results of our research and development programs, preclinical studies, clinical trials, and regulatory submissions. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
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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Rachel Lipsitz, [email protected]