Fennec Pharmaceuticals (FENC) Granted EMA Validation for Marketing Authorization Application for Sodium Thiosulfate

Fennec Pharmaceuticals Inc. (NASDAQ: FENC), a specialty pharmaceutical company, today announced that the company’s Marketing Authorization Application (MAA) for its investigational drug, sodium thiosulfate (unique formulation) for infusion (tradename to be determined in EU), has passed validation and is now under evaluation by the European Medicines Agency (EMA). The MAA for Pediatric Use Marketing Authorization (PUMA) was filed in early February 2020 for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

"The EMA validation of our marketing application represents another step forward in our efforts to address, if authorized, the critical unmet medical need to prevent or significantly reduce cisplatin induced hearing loss in children with localized solid tumors,” stated Rosty Raykov, chief executive officer of Fennec. “We look forward to working closely with the EMA during the review process with the goal of bringing this important product to patients.”

On August 7, 2018, Fennec announced that the Pediatric Committee (PDCO) of the EMA has accepted the Company’s pediatric investigation plan (PIP) for the condition of the prevention of platinum-induced ototoxic hearing loss. The company was also advised in August 2018 that sodium thiosulfate (unique formulation) is eligible for submission of a PUMA with incentives of automatic access to the centralized procedure and up to 10 years of data and market protection. No deferred clinical studies were required in the positive opinion given by PDCO.

About PEDMARK™ (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

In February 2020, Fennec completed its rolling submission of a New Drug Application (NDA) to the FDA for PEDMARK™ and submitted a MAA to the EMA for sodium thiosulfate (tradename to be determined). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

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