Healthcare Industry News:  OP Orphan Pharma 

Biopharmaceuticals Regulatory

 News Release - December 17, 2018

PharmaEssentia and AOP Orphan Receive Positive CHMP Opinion For Besremi(TM) (Ropeginterferon alfa-2b) For Treatment Of Polycythemia Vera (PV) In EU

WALTHAM, Mass., Dec. 17, 2018 -- (Healthcare Sales & Marketing Network) -- PharmaEssentia, a global biopharmaceutical company focused on developing and commercializing novel treatments for treatment of rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly. The applicant for Besremi is AOP Orphan Pharmaceuticals AG (AOP Orphan).

"This is a big step for PharmaEssentia and our effort to develop and bring ropeginterferon to patients with PV," said Kochung Lin, PhD, Chief Executive Officer of PharmaEssentia. "In addition to the positive CHMP opinion, we are in on-going discussions with the FDA on the best path forward to make ropeginterferon alfa-2b available to patients in the US. At the same time, we are also discussing with respective authorities in China and Japan how to proceed to make Ropeg available for patients with PV in these countries as well."

Besremi will be available as a solution for injection (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b which is manufactured in the Taichung Science Park, Taiwan under PIC/S cGMP. The site was GMP certified by EMA in January 2018.

The benefits of Besremi are its ability to achieve complete hematological responses in patients with polycythaemia vera. The most common side effects are leukopenia, thrombocytopenia, arthralgia, fatigue, flu-like illness and myalgia.

Detailed recommendations for the use of Besremi will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission (EC). If approved by EC, the marketing authorization for Besremi will be granted in all European Union (EU) member states, Norway, Iceland, and Lichtenstein.

The positive CHMP opinion is based on the comprehensive data package from the PROUD-PV/CONTINUATION-PV clinical development program, which was sponsored by AOP Orphan. PharmaEssentia out-licensed the exclusive rights to develop and commercialize ropeginterferon alfa-2b to AOP Orphan in PV, other MPNs, and 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 expected to be the first interferon approved for PV worldwide.

Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in a Taichung plant, which was cGMP certified by 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 subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.

About PharmaEssentia

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.

Source: PharmaEssentia

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