PharmaEssentia Announces Licensing Agreement with FORUS Therapeutics to Commercialize BESREMi® (ropeginterferon alfa-2b-njft) in Canada

September 4, 2024, Burlington, MA – 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 it has entered into an exclusive licensing agreement with FORUS Therapeutics Inc (“FORUS”) for the registration and distribution of BESREMi® (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera (PV), in Canada.

FORUS focuses on the hematology and oncology market in Canada, with extensive experience in local drug registration and commercialization. Under the terms of the agreement, PharmaEssentia is licensing BESREMi for PV to FORUS in Canada, with potential expansion to other investigational myeloproliferative neoplasms (MPN) indications in the future. FORUS will oversee the drug registration and commercialization of BESREMi in Canada, with potential milestone payments of up to $107 million USD – including for securing approval of BESREMi in PV and meeting sales milestones. FORUS will make a portion of the milestone payments within 2024 and pay PharmaEssentia double-digit percentage royalties on sales.

“FORUS and PharmaEssentia are aligned in our missions to bring new treatments to patients with hematologic and oncologic conditions that may meaningfully enhance their lives,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “We continue to expand scientific data to demonstrate the clinical value of BESREMi for patients with MPNs such as PV, and we look forward to collaborating with FORUS to introduce BESREMi in Canada, to expand our footprint in North America and to benefit even more patients with PV.”

“Strategic partnerships pave the way to unlocking innovation and advancing healthcare solutions,” said Kevin Leshuk, President and CEO of FORUS. “We are extremely pleased and honored to be partnering with PharmaEssentia so that we can deliver potentially transformative outcomes for those living with PV and hopefully other hematologic conditions in the future.”

BESREMi has been approved for the treatment of PV in approximately 40 countries and regions, including the United States, Japan, China, and the European Union.

About PharmaEssentia

PharmaEssentia (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.

For more information about PharmaEssentia USA, visit the website, LinkedIn or Twitter.

About Forus Therapeutics

FORUS Therapeutics is a Canadian biopharmaceutical company dedicated to advancing differentiated, novel medicines for hematologic malignancies and other forms of cancer. Our mission is to bring solutions to cancer patients, caregivers, physicians and our partners by accelerating unique and important treatments that meaningfully enhance life. www.forustherapeutics.com

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)

BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications.

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

Read the full press release here.