On the 1st, PharmaEssentia announced that it has granted the marketing rights of its new drug, Ropeginterferon alfa-2b (Ropeg), for the treatment of Polycythemia Vera (PV) to FORUS Therapeutics Inc. (FORUS) in the Canadian market. The total potential milestone payments could reach up to approximately $107 million USD (around NT$3.4 billion), with additional double-digit percentage royalties on future sales. Market research estimates that there are about 17,000 PV patients in Canada.
According to the agreement, PharmaEssentia has licensed Ropeg to FORUS specifically for the PV indication, with the possibility of expanding to other Myeloproliferative Neoplasms (MPNs) in the future. FORUS is responsible for the regulatory submission and commercialization of Ropeg in Canada, and will pay PharmaEssentia milestone payments that could total up to $107 million USD. These payments include regulatory milestones for obtaining marketing authorization as well as sales milestones. Additionally, FORUS is obligated to pay a portion of the milestone payments within this year. As per the contract, FORUS will also pay PharmaEssentia double-digit percentage royalties on sales.
Ropeg has already been approved for PV in approximately 40 countries, including major markets such as the United States, Japan, China, and the European Union. In principle, the existing data should be sufficient to apply for the same indication in Canada, without the need for additional clinical trials.
FORUS focuses on the hematology and oncology market in Canada, with a team experienced in local regulatory approval and commercialization. FORUS’s partners include the U.S.-listed company Karyopharm Therapeutics, which has authorized FORUS to market its new drug for multiple myeloma in Canada.
CEO Ko-Chung Lin stated that PharmaEssentia has been planning its entry into the Canadian market for years. After careful evaluation and discussions with potential partners, the company chose the innovative FORUS as its sales partner, targeting the local population effectively. PharmaEssentia will work closely with FORUS to introduce Ropeg to Canada as soon as possible, completing Ropeg's strategic coverage across the entire North American market and benefiting more PV patients in the region.
Ropeg is a new-generation, long-acting interferon developed and manufactured by PharmaEssentia. Globally, PharmaEssentia has licensed Ropeg to foreign pharmaceutical companies in regions such as Europe, Latin America, and Canada for local regulatory approvals and sales. In other key markets, the company has established subsidiaries to manage operations independently. As PharmaEssentia continues to expand its global commercial footprint, the company remains optimistic about its future growth prospects.
Resource (mandarin): 藥華藥治PV新藥加拿大市場授權FORUS 里程碑金最高近1.1億美元
