RESEARCH TRIANGLE PARK, NORTH CAROLINA — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX) has joined forces with Norgine, a prominent European pharmaceutical company, to bring PEDMARQSI® to the markets of Europe, Australia, and New Zealand.
PEDMARQSI, the first and only approved therapy in the European Union (EU) and the United Kingdom (U.K.) designed to reduce the risk of cisplatin-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors, represents a significant advancement in pediatric oncology.
Preventing Cisplatin-Induced Hearing Loss
Under the exclusive licensing agreement, Fennec is set to receive €40 million upfront (~$44M USD), with additional payments potentially reaching up to €210 million (~$228M USD) based on commercial and regulatory milestones. Moreover, Fennec stands to benefit from double-digit tiered royalties on PEDMARQSI’s net sales in the licensed territories up to the mid-twenties.
Norgine will spearhead all commercialization endeavors in these regions, holding sole marketing authorizations.
The introduction of PEDMARQSI marks a significant breakthrough in pediatric oncology, particularly for the prevention of ototoxicity induced by cisplatin chemotherapy in pediatric patients aged 1 month to < 18 years with localized, non-metastatic solid tumors.
“We are delighted to partner with Norgine, who shares our belief in the potential of PEDMARQSI to mitigate the risk of permanent and irreversible hearing loss that can occur in pediatric patients treated with cisplatin. Further, 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.”
–Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals
With more than 5,000 pediatric patients eligible for platinum-based chemotherapy annually in Europe alone, the licensing of PEDMARQSI heralds a new era in pediatric oncology treatment accessibility across these regions. Based on robust safety and efficacy data from two Phase 3 trials, SIOPEL 6 and Clinical Oncology Group [COG] Protocol ACCL0431, PEDMARQSI received EU marketing authorization in June 2023 and U.K. approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in October 2023.
According to the results of the pivotal SIOPEL 6 trial involving 114 children with hepatoblastoma and the subsequent study involving 125 children with various cancers, including hepatoblastoma, neuroblastoma, and central nervous system tumors, PEDMARQSI demonstrated remarkable efficacy in reducing cisplatin-induced hearing loss.
These findings underscore the critical importance of this therapy in safeguarding the auditory health of pediatric patients undergoing cisplatin chemotherapy.
“We are thrilled to announce our partnership with Fennec, to bring this vital medicine to pediatric patients who are being treated with cisplatin, across Europe and ANZ. We look forward to working with the Fennec team and launching PEDMARQSI in our territories in the coming months, establishing it as the standard of care in this critical patient population with high unmet need. This important milestone for our company builds on our 30-year track record of creating partnerships of enduring value and further underscores Norgine’s position as the specialty pharma partner of choice across Europe and ANZ.”
–Chris Bath, Chief Executive Officer of Norgine
Through this partnership, Fennec and Norgine are poised to make PEDMARQSI accessible to a broader patient population, thereby significantly improving the standard of care for pediatric oncology patients across Europe, Australia, and New Zealand.
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.
About Norgine
Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Commitment to transforming people’s lives drives everything Norgine does with fully integrated infrastructure and exceptional partnership approach enabling creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients annually around the world and generated over €500 million in net product sales in 2023.
Norgine has a direct presence in 18 European countries, as well as Australia and New Zealand and has a strong global network of partnerships in non-Norgine markets. Norgine possesses a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to sales and marketing infrastructure.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Source: Fennec Pharmaceuticals
