Fennec Pharmaceuticals Inc. (TSX: FRX) Announces PEDMARQSI Launch in Germany for Ototoxicity Prevention

Highlights

• Norgine Pharmaceuticals launches PEDMARQSI in Germany to prevent cisplatin-induced hearing loss.
• Fennec received a $43M upfront payment under licensing deal with Norgine.
• PEDMARQSI is the first approved therapy for cisplatin-induced ototoxicity in the EU and UK.

Fennec Pharmaceuticals Inc. (TSX:FRX), a specialty pharmaceutical company focused on developing therapies to improve the lives of cancer patients, has announced a significant milestone in its partnership with Norgine Pharmaceuticals Ltd. The companies jointly revealed that Norgine has successfully launched PEDMARQSI (sodium thiosulfate injection) in Germany, marking the first pharmacological intervention available to help prevent ototoxicity (hearing loss) induced by cisplatin chemotherapy in the region.

In March 2024, Fennec Pharmaceuticals entered an exclusive licensing agreement with Norgine Pharmaceuticals, which allowed Norgine to commercialize PEDMARQSI across Europe, Australia, and New Zealand. This agreement included an upfront payment of approximately $43 million to Fennec, along with the potential for up to $230 million in milestone payments. Additionally, Fennec is set to receive double-digit tiered royalties on the net sales of PEDMARQSI, starting in the mid-teens and potentially growing into the mid-twenties.

This partnership and product launch are of significant importance to the oncology community. Until now, there have been no pharmacological options available for patients undergoing cisplatin chemotherapy in Germany to prevent the permanent hearing loss that often accompanies treatment. The approval and subsequent launch of PEDMARQSI in Germany is a vital step forward, offering hope to both patients and healthcare providers who now have a treatment option to mitigate this life-altering side effect.

Jeff Hackman, CEO of Fennec Pharmaceuticals, shared his thoughts on this achievement: “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.” He further highlighted the critical role PEDMARQSI will play in helping pediatric cancer patients, stating that the product represents an important breakthrough in reducing cisplatin-induced ototoxicity.

PEDMARQSI’s approval is grounded in solid clinical data. The product was studied in two open-label, randomized Phase 3 trials—SIOPEL 6 and the Clinical Oncology Group (COG) Protocol ACCL0431. The trials demonstrated that the use of sodium thiosulfate in combination with cisplatin resulted in a roughly 50% reduction in the occurrence of ototoxicity, compared to patients who received cisplatin alone. These results cemented the therapy’s value in improving the quality of life for pediatric cancer patients.

In June 2023, PEDMARQSI received marketing authorization from the European Commission under the Paediatric Use Marketing Authorization (PUMA) regulation, granting it eight years of market exclusivity plus two years of data protection. This regulatory approval provides a unique opportunity for Fennec and its partners to address a significant unmet need for pediatric patients undergoing chemotherapy treatment.

The availability of PEDMARQSI in Germany is just the first step in what is expected to be a broad rollout of this breakthrough therapy across multiple European markets. As Fennec Pharmaceuticals and Norgine continue their collaboration, the companies look forward to making this much-needed therapy accessible to more patients and healthcare providers in Europe, Australia, and New Zealand, further reinforcing their commitment to advancing pediatric oncology treatments.