NORGINE B.V. 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.[1]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.[2]

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."

About DFMO

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.[1]

About Norgine

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2020 and generated €448 million in net product sales, a growth of 7% over 2019.

Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are 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 our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.
In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. 

About US WorldMeds

US WorldMeds (USWM) is a specialty pharmaceutical company whose treatment options are making a difference in the lives of the patients and communities it serves. USWM takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, USWM has global presence and more than 15 years of experience in the development, licensure, and commercialization of unique products. 

References

[1] ClinicalTrials.gov Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission, Identifier: NCT02395666 https://clinicaltrials.gov/ct2/show/NCT02395666 
[2] Giselle L. et al. Maintenance DFMO Increases Survival in High Risk Neuroblastoma. Scientific Reports, 2018; 8 (1) DOI: 10.1038/s41598-018-32659-w