Fennec launches PEDMARK in US for cisplatin-induced hearing loss in pediatric patients

FENNEC PHARMACEUTICALS INC.

PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric patients aged 1 month+ with localized solid tumors.
Launch follows FDA approval in September 2022; based on Phase 3 trials COG ACCL0431 and SIOPEL 6.
Annual estimated 10,000+ US/European children receive platinum chemo; ~60% may develop permanent hearing loss without PEDMARK.
Fennec HEARS program launched to provide patient financial support, access coordinators, and prescription drug assistance.
EMA is currently evaluating Marketing Authorization Application for PEDMARQSI (sodium thiosulfate) in Europe.

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