Norgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma - Seite 2

HRNB background

Children diagnosed with HRNB undergo an intense SoC regimen that still leaves
them vulnerable to relapse and death, a risk that is particularly acute during
the first two years.5 Approximately 30% of patients who attain remission
following upfront therapy will relapse, resulting in a poor prognosis and low
likelihood of long-term survival (e.g. estimates as low as 15% of patients will
live for five years after relapsing).6 Avoiding relapse is key to long-term
survival, yet outside of the United States there are no approved therapies for
sustaining remission following SoC treatment. The data with eflornithine
demonstrate using it as maintenance therapy extends remission and reduces risk
of relapse in patients with HRNB.

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
enable 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 more than 25 million patients around the world in 2022 and generated
EUR530 million in net product sales, a growth of nearly 5% over 2021.

Norgine has a direct presence in 16 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.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

References

1. FDA approves eflornithine for adult and pediatric patients with high-risk
neuroblastoma. FDA. News release. 13 December 2023. Available from: FDA
approves eflornithine for adult and pediatric patients with high-risk
neuroblastoma | FDA (https://www.fda.gov/drugs/resources-information-approved
-drugs/fda-approves-eflornithine-adult-and-pediatric-patients-high-risk-neuro
blastoma?utm_medium=email&utm_source=govdelivery)
2. Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine