RESEARCH TRIANGLE PARK, N.C. — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, has announced that Norgine Pharmaceuticals Ltd., a European specialist pharmaceutical company, has commercially launched PEDMARQSI® (sodium thiosulfate injection) in Germany.
Licensing Agreement and Market Expansion
In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia, and New Zealand. As part of this agreement, Fennec received approximately $43 million in an upfront payment and may receive up to $230 million in additional commercial and regulatory milestone payments, along with double-digit tiered royalties on net sales of PEDMARQSI, ranging from the mid-teens to the mid-twenties.
“Until now, there have been no pharmacological interventions available to cancer patients in Germany to prevent ototoxicity, or permanent hearing loss, caused by treatment with cisplatin. We congratulate Norgine on making PEDMARQSI® available to patients and healthcare providers in Germany and look forward to future launches in other major European markets.”
–Jeff Hackman, CEO of Fennec Pharmaceuticals
Clinical data from two open-label, randomized Phase 3 trials, SIOPEL 6 and the Children’s Oncology Group (COG) Protocol ACCL0431, demonstrated an approximate 50% reduction in the occurrence of cisplatin-induced ototoxicity in patients treated with cisplatin and sodium thiosulfate compared to those receiving cisplatin alone.
PEDMARQSI® is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity induced by cisplatin chemotherapy in pediatric patients aged 1 month to <18 years with localized, non-metastatic solid tumors. It was granted marketing authorization by the European Commission in June 2023 under the Pediatric-Use Marketing Authorization (PUMA), providing eight years of data exclusivity and an additional two years of market protection.
About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapy agents are widely used in the treatment of pediatric malignancies. However, these treatments can cause permanent, irreversible hearing loss, which has a significant impact on childhood development and quality of life. The severity of ototoxicity depends on the dose and duration of chemotherapy, and many affected children require lifelong hearing aids or cochlear implants, which can be costly and do not fully restore natural hearing.
Hearing loss at a young age can impede speech and language development, literacy, and social-emotional growth, affecting a child’s long-term educational and personal outcomes. In adolescents, it may interfere with social interactions and academic achievements.
About PEDMARK® (sodium thiosulfate injection)
PEDMARK® is the first and only U.S. Food and Drug Administration (FDA)-approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic solid tumors. The treatment is also recommended for the Adolescent and Young Adult (AYA) population by the National Comprehensive Cancer Network® as a preventative option for reducing hearing loss associated with platinum-based chemotherapy.
PEDMARK® is a single-dose, ready-to-use formulation of sodium thiosulfate for intravenous administration in pediatric patients. The therapy has demonstrated efficacy and safety in two Phase 3 clinical studies—COG ACCL0431 and SIOPEL 6—which evaluated its impact on survival and ototoxicity reduction.
Each year, more than 10,000 children in the U.S. and Europe receive platinum-based chemotherapy, with many developing permanent hearing loss. Currently, there are no other approved pharmacological interventions to prevent this type of hearing damage, with cochlear implants being one of the few available alternatives.
PEDMARK® has been studied in two completed Phase 3 trials:
- COG ACCL0431: Enrolled pediatric patients with various cancers, including hepatoblastoma, germ cell tumors, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors, typically treated with intensive cisplatin therapy.
- SIOPEL 6: Focused on hepatoblastoma patients with localized tumors.
Indications and Usage
PEDMARK® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors.
Limitations of Use:
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than six hours. The treatment may not prevent ototoxicity if irreversible hearing damage has already occurred.
Important Safety Information
PEDMARK® is contraindicated in patients with a history of severe hypersensitivity to sodium thiosulfate or its components.
Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitoring for reactions is advised, with immediate discontinuation and appropriate treatment if hypersensitivity occurs.
Hypernatremia and hypokalemia were observed in clinical trials. Serum sodium and potassium levels should be monitored before and during treatment. Patients with compromised kidney function should be monitored more closely.
Antiemetics should be administered prior to each PEDMARK dose to mitigate nausea and vomiting.
The most common adverse reactions (≥25%) in clinical trials included vomiting, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.
For full prescribing information, please visit www.PEDMARK.com.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® for reducing the risk of platinum-induced ototoxicity in pediatric patients. PEDMARK® received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI®. The drug has Orphan Drug Exclusivity in the U.S. and Pediatric-Use Marketing Authorization in Europe, granting it regulatory protections.
For more information, visit www.fennecpharma.com.
PEDMARK® PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc.
©2025 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1
Source: Fennec Pharmaceuticals
