On June 2, 2023 PharmaEssentia Corporation (TPEx:6446), a leading fully integrated biopharmaceutical company in Taiwan, reported that it has entered into an exclusive license agreement with Pint-Pharma GmbH for the registration and promotion of BESREMi (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera (PV), a rare blood cancer, in Brazil, Argentina, Colombia, Chile, Peru, Ecuador, and Mexico (Press release, PharmaEssentia, JUN 2, 2023, View Source [SID1234632410]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Expanding our geographic reach is critical to our mission to address clear gaps in therapeutic options for people with myeloproliferative neoplasms (MPNs). With its track record of successfully commercializing therapeutics for rare diseases and oncology, and its strong regional network, we’re confident that Pint-Pharma is the right partner to bring BESREMi to PV patients in Latin America," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer, PharmaEssentia. "This regional expansion is a logical extension of our growing leadership in the Americas, led by Meredith Manning. With strong momentum in the U.S., we know Meredith and her team will effectively champion the PharmaEssentia mission into Latin and South America."
Under the terms of the agreement, PharmaEssentia may be eligible for certain milestone payments and royalties based on sales. Pint-Pharma will be responsible for obtaining and maintaining all marketing authorizations and for commercializing BESREMi in the region. PharmaEssentia will continue to be responsible for the supply of BESREMi. Pint-Pharma is an Austria-based pharmaceutical company with extensive experience in registering and commercializing rare disease, oncology and specialty treatments throughout Latin America. With this new partnership, Pint-Pharma further cements its position amongst the leaders in the field of haemato-oncology in Latin America.
"Our partnership with PharmaEssentia gives us the opportunity to provide another new treatment option to people living with MPNs in the region who are in need of effective therapies," said David Munoz, Chief Executive Officer, Pint-Pharma. "We look forward to the potential to add BESREMi to our established haemato-oncology portfolio."
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. 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 JAK2.1
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 treatment of polycythemia vera (PV) in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, in the United States in 2021, and has also received approval in Taiwan, South Korea and most recently, Japan. The product 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. The company retains full global intellectual property rights for the product in all indications.
BESREMi was approved in the US with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.