NORGINE B.V. (Norgine) a leading European specialist pharmaceutical company and US WorldMeds (USWM), a Kentucky-based specialty pharmaceutical company, today announced an exclusive licensing agreement by which Norgine will register and commercialise difluoromethylornithine, DFMO (eflornithine) in Europe, Commonwealth of Independent States, Australia and New Zealand.
DFMO is a repurposed molecule investigated for use as an extended maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.HRNB, a rare cancer that forms from immature nerve cells, most often occurs in young children. It accounts for 15% of all paediatric cancer deaths due to the fact that nearly half of all patients who reach remission will relapse.
Under the terms of the license agreement, Norgine will be responsible for the regulatory approval of DFMO and any subsequent clinical trials required for approval in the relevant territories. Norgine will hold marketing authorisations in the licensed territories.
Christopher Bath, Chief Operating Officer of Norgine said, “We are proud to be able to support the development of this important treatment for children subject to successful completion of its research programme and subsequent regulatory approval. High-risk neuroblastoma has a lower survival rate than other neuroblastomas and there is an urgent need to develop additional treatment options to prolong survival in this group of patients.”
Peter Stein, Chief Executive Officer of Norgine also commented, “This agreement is another successful milestone in our company’s growing pipeline of potentially transformative treatments that, subject to its successful development, will enable us to help more patients in the future.”
Lee Warren, Chief Operating Officer of USWM stated, “We are passionate about bringing meaningful therapies to the patients that need them, and this agreement is an important step in fulfilling that mission. Our partnership with Norgine will extend the reach of this promising therapeutic to children with high-risk neuroblastoma, a devastating disease that affects children everywhere, including in areas outside of the United States.”