Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company, today announced that Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has received positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors.

PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity, or hearing loss, induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic solid tumors. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI in Europe, Australia, and New Zealand.

"Securing access to PEDMARQSI is a critical milestone for the cancer community in England and Wales to help reduce the risk of ototoxicity, or permanent hearing loss, associated with cisplatin treatment," said Jeff Hackman, chief executive officer and director of Fennec Pharmaceuticals. "We congratulate Norgine on their collaboration with NICE to reach this important agreement that recognizes the value of ototoxicity intervention as part of the cancer treatment journey."

Under the terms of the previously announced exclusive licensing agreement with Norgine, Fennec received approximately $43 million in an upfront payment and will receive up to approximately $230 million in additional commercial and regulatory milestone payments along with double-digit tiered royalties on net sales of PEDMARQSI starting in the mid-teens and growing to the mid-twenties.