Fennec Pharmaceuticals to Commercialize Protective Treatment for Chemotherapy-Induced Hearing Loss

Shares in commercial stage pharmaceutical company, Fennec Pharmaceuticals Inc. (Nasdaq: FENC), rose 11% in morning trading on Monday after the company announced it will partner with Norgine, a leading European specialist pharmaceutical company, to commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and UK for the prevention of cisplatin chemotherapy-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors.

Commenting on the exclusive licensing agreement,  Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals, said “This partnership is an important step in achieving our mission of expanding PEDMARQSI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity. From a deal perspective, the terms provided us many important benefits, including an upfront payment further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-US success of PEDMARQSI and an experienced partner to successfully launch PEDMARQSI in the licensed territory.”

Highlights

Fennec will receive €40 million in upfront and up to €210 million in additional commercial and regulatory milestones, and tiered royalties up to the mid-twenties.

Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories.

An estimated 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe. The agreement enhances Norgine’s commitment to bringing transformative therapies to patients in Europe, the UK, Australia, and New Zealand who currently do not have access to a therapy to treat this life altering condition.

PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and PEDMARQSI® to reduce the risk of platinum-induced ototoxicity in pediatric patients. PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for PEDMARQSI. Further, PEDMARQSI received U.K. approval in October 2023. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. For more information, please visit www.fennecpharma.com.

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Fennec Pharmaceuticals to Commercialize Protective Treatment for Chemotherapy-Induced Hearing Loss

Catie Corcoran

Biotech Editor