RESEARCH TRIANGLE PARK, N.C. - Fennec Pharmaceuticals (NASDAQ:FENC) Inc., a commercial stage specialty pharmaceutical company, has entered into an exclusive licensing agreement with Norgine, a prominent European specialist pharmaceutical firm. The deal grants Norgine the rights to commercialize PEDMARQSI® in Europe, Australia, and New Zealand.
PEDMARQSI® is recognized as the first and only therapy approved within the EU and U.K. for the prevention of hearing loss caused by cisplatin chemotherapy in pediatric patients with localized, non-metastatic solid tumors. The licensing agreement stipulates an upfront payment of €40 million to Fennec, with potential additional payments reaching up to €210 million based on commercial and regulatory milestones. Additionally, Fennec is set to receive tiered royalties on net sales, which could reach the mid-twenties percentage range.
Norgine will assume responsibility for all commercial activities within the licensed territories and will manage the marketing authorizations. The European Commission granted marketing authorization to PEDMARQSI® in June 2023, followed by U.K. approval in October 2023. These decisions were supported by data from two open-label, randomized Phase 3 trials, which demonstrated a significant reduction in the incidence of cisplatin-induced hearing loss among pediatric patients treated with PEDMARQSI®.
The collaboration between Fennec and Norgine aims to address the unmet medical need for over 5,000 pediatric patients in Europe who are eligible for platinum-based chemotherapy annually. This partnership is a strategic step for both companies, with Fennec benefiting from Norgine's established presence and expertise in the European pharmaceutical market.
Chris Bath, CEO of Norgine, expressed enthusiasm for the partnership, which is expected to establish PEDMARQSI® as a standard of care for pediatric patients at risk of hearing loss due to cisplatin treatment.
This information is based on a press release statement from Fennec Pharmaceuticals Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.