PharmaEssentia and AOP Orphan Receive EU Approval of Besremi(TM) (Ropeginterferon Alfa-2b) for Treatment of Polycythemia Vera (PV) in EU
BURLINGTON, Mass., Feb. 21, 2019 /PRNewswire/ -- PharmaEssentia today announced that the European Commission (EC) has approved Besremi® (ropeginterferon alfa-2b, P1101) as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. The European market authorization makes Besremi the first and only approved treatment for polycythemia vera (PV) independent of previous hydroxyurea exposure based on Phase III clinical data. The Marketing Authorization Holder for Besremi in Europe is AOP Orphan Pharmaceuticals AG (AOP Orphan).
"We are excited that there is now a new approved treatment for PV," said Kochung Lin, PhD, Chief Executive Officer of PharmaEssentia. "Patients living with PV have a great need for an effective treatment option early in their disease because suboptimal disease control can lead to serious cardiovascular complications."
Besremi will be available as a solution for injection in a pre-filled pen (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b which was discovered by and is manufactured by PharmaEssentia in the Taichung Science Park, Taiwan under PIC/S cGMP. The site was GMP certified by EMA in January 2018.
The European Commission approval is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.
PharmaEssentia out-licensed the exclusive rights to develop and commercialize ropeginterferon alfa-2b to AOP Orphan in PV, other myeloproliferative neoplasms (MPNs), and chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
About Ropeginterferon alfa-2b
Ropeginterferon alfa-2b is a novel, long-acting, predominately (>98%) single isomer mono-pegylated proline interferon (ATC L03AB15) with improved pharmacokinetic properties and demonstrated tolerability and convenience. It is administered once every 2 weeks, or once every 4 weeks during long-term maintenance, and is the first interferon approved for PV.
Ropeginterferon alfa-2b was discovered by and is manufactured by PharmaEssentia in Taichung Taiwan plant that was cGMP certified by the EMA in January 2018.
Ropeginterferon alfa-2b has Orphan Drug designation for treatment of PV in the European Union, Switzerland, and the United States of America.
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. This condition may result in cardiovascular complications such as thrombosis and embolism, as well as transformation to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still a subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of Janus kinase 2 (JAK2), JAK2V617F.
PharmaEssentia Corporation (Taipei Exchange:6446) is a global biopharmaceutical company delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases while aiming to bring long lasting value to stakeholders. PharmaEssentia was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies in order to develop treatments for myeloproliferative neoplasms, hepatitis and other diseases. The company is committed to the improvement of health and quality of life for patients suffering from these diseases. The Company's world-class cGMP biologics facility in Taichung was certified by the EMA in January 2018 and by the Taiwan Food and Drug Administration (TFDA) in December 2017. The Taichung plant is also designed and operated to be compliant with all US FDA requirements.
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