PharmaEssentia Corporation (TWSE: 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 its wholly owned subsidiary, FORUS Therapeutics Inc, has received a Notice of Compliance (NOC) authorizing BESREMi® (ropeginterferon alfa-2b) for the treatment of adults with polycythemia vera (PV). BESREMi® is expected to become commercially available in Canada in the coming weeks.
PV is a rare, chronic blood cancer characterized by overproduction of red blood cells, which increases blood viscosity and can lead to serious complications, including thrombosis, stroke, myocardial infarction, and progression to myelofibrosis or acute myeloid leukemia.
“We are very pleased that Health Canada has approved BESREMi® for the treatment of adults with PV,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “BESREMi® is a next-generation interferon demonstrated to provide durable hematologic and molecular responses, reduced symptom burden, and a favorable safety and tolerability profile. We look forward to working closely with Canadian hematologists and other key stakeholders to make BESREMi® available to patients living with PV across Canada.”
“PV is a chronic myeloproliferative neoplasm that requires long-term management to reduce the risk of complications and control symptoms. The approval of BESREMi® in Canada is an important and welcome development for patients living with PV and for the physicians who care for them,” said Shireen Sirhan, M.D., President, Canadian Myeloproliferative Neoplasms Group; Vice-President (Research), Quebec Research Group for Chronic Myeloid Leukemia and Myeloproliferative Neoplasms (GQR-LMC-NMP); Hematologist, Jewish General Hospital, McGill University Montreal. “The availability of an interferon therapy specifically approved for PV has been long anticipated within the Canadian MPN community and represents a meaningful expansion of the treatment options available to patients. This approval reflects continued progress in the field and supports a more individualized approach to the management of PV.”
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 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. For more information about PharmaEssentia Corp visit the website, LinkedIn or X (formerly Twitter).
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.
About BESREMi® (ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company is seeking a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted an sBLA with the U.S. FDA.
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), the Pharmaceuticals and Medical Devices Agency in Japan (2023), and Health Canada (2026).
The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.
INDICATION
BESREMi® is indicated for the treatment of adults with polycythemia vera.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
Existence of or history of severe depression, suicidal ideation, or suicide attempt
Hypersensitivity to interferons or any inactive ingredients
Moderate or severe hepatic impairment
History or presence of active serious or untreated autoimmune disease
History of transplantation and receiving immunosuppressant agents
WARNINGS AND PRECAUTIONS
Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:
- Depression and Suicide: Monitor closely for symptoms and need for treatment.
- Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed.
- Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently.
- Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment.
- Hypersensitivity Reactions: Stop treatment and immediately manage reaction.
- Pancreatitis: Consider discontinuation if confirmed pancreatitis
- Colitis: Discontinue if signs or symptoms of colitis
- Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment
- Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders.
- Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated.
- Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity.
- Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops.
- Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations.
- Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity.
- Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination.
Please see full Prescribing Information, including Boxed Warning.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260706087060/en/
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