PharmaEssentia

NCCN Clinical Practice Guidelines in Oncology Update Recommends BESREMi® (ropeginterferon alfa-2b-njft) for the Treatment of Polycythemia Vera

Retrieved on: 
Wednesday, March 2, 2022
Other Health, Research, Managed Care, General Health, Pharmaceutical, Oncology, Clinical Trials, Science, Biotechnology, FDA, Other Science, Health, Polycythemia Vera, BESREMi, PharmaEssentia, POLYCYTHEMIA VERA, BESREMI, PHARMAESSENTIA

Its treatment practice guidelines are widely respected and followed by the U.S. physician community, and serve to inform and facilitate coverage decisions with payers for oncology therapies.

Key Points: 
  • Its treatment practice guidelines are widely respected and followed by the U.S. physician community, and serve to inform and facilitate coverage decisions with payers for oncology therapies.
  • The NCCN Guidelines update just three months following our approval illustrates the communitys recognition of the strong potential of BESREMi in PV care.
  • BESREMi has orphan drug designation for treatment of polycythemia vera (PV) in the United States.
  • Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi.

PharmaEssentia’s BESREMi® (ropeginterferon alfa-2b-njft) Now Available for the Treatment of People With Polycythemia Vera in the United States

Retrieved on: 
Monday, December 6, 2021
FDA, Pharmaceutical, Health, Oncology, Polycythemia Vera, BESREMi, PharmaEssentia, POLYCYTHEMIA VERA, BESREMI, PHARMAESSENTIA

BESREMi was approved by the FDA in November as the only interferon for adults with polycythemia vera.

Key Points: 
  • BESREMi was approved by the FDA in November as the only interferon for adults with polycythemia vera.
  • Our goal is to ensure that any appropriate person with PV who is prescribed BESREMi is able to receive the therapy.
  • BESREMi has orphan drug designation for treatment of PV in the United States.
  • Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi.

U.S. FDA Approves BESREMi® (ropeginterferon alfa-2b-njft) as the Only Interferon for Adults With Polycythemia Vera

Retrieved on: 
Friday, November 12, 2021
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Polycythemia Vera, BESREMi, PharmaEssentia, POLYCYTHEMIA VERA, BESREMI, PHARMAESSENTIA

View the full release here: https://www.businesswire.com/news/home/20211112005909/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20211112005909/en/
    BESREMi is an innovative monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow.
  • With the availability of an FDA-approved, next-generation interferon for this indication, its time that we focus on preserving the long-term health of patients with polycythemia vera.
  • Depression and Suicide: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa-2b products, including BESREMi.
  • Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors.

PharmaEssentia Announces Pipeline Presentation During Upcoming American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, October 21, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Safety, Hydroxycarbamide, Woman, Medical Affairs Bureau, Biotechnology, Polycythemia, Blood, LinkedIn, Disease, Hematology, European Medicines Agency, ET, Essential thrombocythemia, Twitter, File, EMA, Patient, Private Securities Litigation Reform Act, BLA, Pancreatic serous cystadenoma, FDA, MPN, Ropeginterferon alfa-2b, Food, Review, Risk, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PV, JAK2, MPL, Man, Myeloproliferative neoplasm, Pharmacokinetics, Solution, Ruxolitinib, Legislation, Society, ELN, Pharmaceutical industry, Medical imaging, Ropeginterferon alfa-2b, Essential Thrombocythemia, PharmaEssentia, ROPEGINTERFERON ALFA-2B, ESSENTIAL THROMBOCYTHEMIA, PHARMAESSENTIA

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 plans to present new updates on its pipeline during the 63rd American Society of Hematology Annual Meeting , December 11-14, 2021.

Key Points: 
  • 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 plans to present new updates on its pipeline during the 63rd American Society of Hematology Annual Meeting , December 11-14, 2021.
  • PharmaEssentia continues to enroll participants in the trial at sites throughout the United States and Asia, and has now expanded with new sites in Canada.
  • We are pleased to partner with these renowned MPN specialists to participate in this important study.
  • PharmaEssentia continues to build momentum with its pipeline to deliver new solutions in MPNs.

Dr. Norio Komatsu Appointed as a Chairperson of PharmaEssentia Japan

Retrieved on: 
Wednesday, April 21, 2021
Oncology, Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Yamanashi Prefecture, Chūbu region, Komatsu, University of Yamanashi, Prefectures of Japan, PharmaEssentia, PharmaEssentia Japan KK, PHARMAESSENTIA, PHARMAESSENTIA JAPAN KK

I look forward to leading the PharmaEssentia Japan team to contribute to patient care in Japan,\xe2\x80\x9d said Dr. Komatsu.

Key Points: 
  • I look forward to leading the PharmaEssentia Japan team to contribute to patient care in Japan,\xe2\x80\x9d said Dr. Komatsu.
  • Komatsu is a former professor and Chairman of the Department of Hematology at the Juntendo University School of Medicine.
  • He also previously taught at the Yamanashi University School of Medicine as a professor and the Jichi Medical University as an associate professor.
  • PharmaEssentia Japan aims to achieve \xe2\x80\x9ctrue therapeutic goals\xe2\x80\x9d that have been overlooked.

PharmaEssentia Initiates Pivotal Trial of Ropeginterferon alfa-2b to Treat Essential Thrombocythemia

Retrieved on: 
Thursday, January 7, 2021
Cardiology, Biotechnology, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical trials, Antiviral drugs, Drugs, Medical specialties, Health care, PEGylation, Interferon, Peginterferon-alfa, Peginterferon alfa-2b, Ropeginterferon alfa-2b, Essential Thrombocythemia, PharmaEssentia

Our goal with this important study is to determine if ropeginterferon alfa-2b may represent a potential solution that can help physicians significantly improve the therapy outcomes for patients in need.

Key Points: 
  • Our goal with this important study is to determine if ropeginterferon alfa-2b may represent a potential solution that can help physicians significantly improve the therapy outcomes for patients in need.
  • The company filed a Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA) for Ropeginterferon alfa-2b.
  • Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon aimed to be administered once every two weeks or longer.
  • Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018.

Five-Year Data on Ropeginterferon Alfa-2b Illustrate Durable Response at Five Years in People With Polycythemia Vera

Retrieved on: 
Monday, December 7, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Blood disorders, Blood, Hematopathology, Polycythemia vera, Thrombocythemia, Polycythemia, Ropeginterferon alfa-2b, Essential thrombocythemia, PV, the Ropeginterferon Alfa-2b Clinical Trials, Ropeginterferon alfa-2b, Polycythemia Vera, PharmaEssentia

This five-year data from the PROUD-PV/CONTINUATION-PV studies demonstrates the short- and long-term effects of ropeginterferon alfa-2b among PV patients.

Key Points: 
  • This five-year data from the PROUD-PV/CONTINUATION-PV studies demonstrates the short- and long-term effects of ropeginterferon alfa-2b among PV patients.
  • More than two-thirds of patients (69.1%) who received ropeginterferon alfa-2b experienced a molecular response, which was accompanied by a low risk of disease progression.
  • Long-Term Use of Ropeginterferon Alpha-2b in Polycythemia Vera: 5-Year Results from a Randomized Controlled Study and Its Extension.
  • Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors.

PharmaEssentia to Present Long-Term Data on Ropeginterferon Alfa-2b in Polycythemia Vera at Virtual ASH Annual Meeting

Retrieved on: 
Wednesday, November 4, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Blood disorders, Blood, Hematopathology, Polycythemia vera, Thrombocythemia, Essential thrombocythemia, Ropeginterferon alfa-2b, Polycythemia, Primary myelofibrosis, Myeloid leukemia, Acute myeloid leukemia, Myeloproliferative neoplasm, Ropeginterferon alfa-2b, Polycythemia Vera, PharmaEssentia

Without proper management, the disease can progress into myelofibrosis and malignancies including acute myeloid leukemia.3

Key Points: 
  • Without proper management, the disease can progress into myelofibrosis and malignancies including acute myeloid leukemia.3
    Follow PharmaEssentia on LinkedIn to get news and updates on our activity at the virtual ASH Annual Meeting.
  • Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States.
  • Patient-Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline): A
    Prospective Observational Study of Patients With Polycythemia Vera in the United States.
  • Blast transformation and fibrotic progression in polycythemia vera and essential thrombocythemia: a literature review of incidence and risk factors.

U.S. FDA Accepts PharmaEssentia’s Application for Ropeginterferon Alfa-2b to Treat Polythycemia Vera

Retrieved on: 
Thursday, June 4, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Antivirals, Cytokines, Interferon, Peginterferon-alfa, Cyclopropanes, Hepatitis C and HIV coinfection, Ropeginterferon alfa-2b, Polycythemia Vera, PharmaEssentia

At 36 months of treatment, patients who received Ropeginterferon alfa-2b maintained a complete hematological response longer than those who received HU/BAT (70.5% vs. 51.4%).

Key Points: 
  • At 36 months of treatment, patients who received Ropeginterferon alfa-2b maintained a complete hematological response longer than those who received HU/BAT (70.5% vs. 51.4%).
  • Response rates steadily increased in the Ropeginterferon alfa-2b arm throughout 24 months of treatment and remained constant after 36 months.
  • Further, after 36 months, two thirds (66.0%) of patients who received Ropeginterferon alfa-2b achieved a molecular response, compared with 27% in the HU/BAT arm.
  • Evidence for Superior Efficacy and Disease Modification after Three Years of Prospective Randomized Controlled Treatment of Polycythemia Vera Patients with Ropeginterferon Alfa-2b Vs. HU/BAT.