SO PAULO--(BUSINESS WIRE)-- Pint Pharma and PharmaEssentia announced today that ANVISA (Brazilian Health Regulatory Agency) has approved BESREMi® (ropeginterferon alfa-2b) for the treatment of adult patients with Polycythemia Vera (PV).

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Polycythemia Vera (PV) is a rare, chronic, debilitating, and potentially fatal myeloproliferative neoplasm, originating from a disease-initiating stem cell in the bone marrow. This results in a persistent increase in red blood cells, white blood cells, and platelets. PV can lead to cardiovascular complications such as thrombosis and embolism, and in a significant number of patients it can progress to secondary myelofibrosis or leukemia.

The global incidence of PV is estimated at approximately 2.8 cases per 100,000 people per year. In Brazil, between 2016 and 2020, DataSUS recorded 1,843 cases of Polycythemia Vera, representing an incidence of 0.16 per 100,000 inhabitants. Despite being a rare disease, these numbers suggest the possibility of underdiagnosis and underreporting, highlighting a challenge in identifying affected patients.

According to Fernanda Bertasi, General Manager of Pint Pharma in Brazil, "ANVISA’s approval of BESREMi® represents a transformative milestone for patients with Polycythemia Vera in Brazil. This new therapeutic option brings real hope, offering innovation and progress in disease treatment. This is an essential step in providing better health and well-being for these patients."

Valnei Canutti, Hematologist and Chief Scientific Officer at Pint Pharma, emphasized that "BESREMi® is an innovative, monopegylated interferon with extended action due to its unique pharmacokinetic properties. Its approval was based on robust evidence from the PEGINVERA clinical study, which demonstrated superior and more sustained hematologic and clinical responses compared to standard therapy."

For David Ricardo Muñoz Guzmán, CEO of Pint Pharma, "This therapeutic advancement reaffirms Pint Pharma’s commitment to being a community-centered company. Our mission goes beyond innovation and high technology, focusing on solutions that truly impact patients' lives by expanding access to treatments and improving healthcare quality."

Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia, added, "The approval of BESREMi® by ANVISA is a testament to the power of strong cross-border partnerships in advancing healthcare and reinforces our mission to transform care for PV patients worldwide. We deeply appreciate the collaboration with the Pint Pharma team, whose expertise and dedication have been instrumental in bringing BESREMi® to patients in Brazil."

BESREMi® is exclusively registered, marketed, and distributed by Pint Pharma in Brazil.

About BESREMi® (ropeginterferon alfa-2b) in Polycythemia Vera (PV)

BESREMi® is an innovative, monopegylated, long-acting interferon that has marketing authorization in over 40 countries, with approval from the European Medicines Agency (EMA) in 2019, the U.S. Food and Drug Administration (FDA) in 2021, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023.. With its exclusive pegylation technology, BESREMi® offers extended activity in the body and is designed for administration once every two weeks (or once every four weeks if hematologic stability is maintained for at least 1.5 years), allowing for flexible dosing tailored to individual patient needs.

About PharmaEssentia

PharmaEssentia Corporation (TWSE: 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, oncology, and immunology 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.

About Pint Pharma

Pint Pharma is a biopharmaceutical company that specialises in the commercialisation of innovative therapies with the potential to transform outcomes in rare disease and other patient communities across the Latin American region. By collaborating with world-class biotech and pharma companies, Pint Pharma is committed to improving the lives of Latin American patients in areas of significant unmet medical need. The company is headquartered in Europe and counts with over 250 employees across its territories in Latin America including Brazil, Mexico, Argentina, Colombia, Chile, Peru and Ecuador. Pint Pharma licensed from PharmaEssentia the rights to commercialize BESREMi® in Brazil.

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