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

Amsterdam (ots/PRNewswire) - Norgine B.V. today announced its first marketing
authorisation application submissions on 10 April 2024, seeking approval for
eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia,
Switzerland and the United Kingdom. This milestone supports Norgine's efforts to
deliver patient access to eflornithine and bring a further treatment option in
the field of paediatric oncology.

Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty
pharmaceutical company, have an exclusive licensing agreement by which Norgine
will register and commercialise eflornithine, also referred to as DFMO, in
Europe, Australia and New Zealand.

On 13 December 2023, the US Food and Drug Administration (FDA) approved
eflornithine as the first oral maintenance therapy for high-risk neuroblastoma
(HRNB), indicated to reduce the risk of relapse in adult and paediatric patients
who have received certain prior therapies.1 The approval decision was based on
findings from a trial comparing outcomes from Study 3b (NCT02395666;
investigational arm)2,4 and Study ANBL0032 (NCT00026312; clinical-trial-derived
external control arm)3,4, where use of eflornithine resulted in improved
event-free survival and overall survival when compared to outcomes for patients
with high-risk neuroblastoma treated with the standard of care (SoC) without the
drug.1

Dr David Gillen , Chief Medical Officer at Norgine, added, "These submissions
via Project Orbis represent an important first step in the regulatory process
for eflornithine and re-emphasise Norgine's passion and commitment in attempting
to secure additional treatment options for patients living with HRNB, a
condition with a high level of unmet medical need."

http://www.norgine.com/ Follow @norgine

Notes to Editors:

Project Orbis

Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of
Excellence (OCE) and provides a framework for concurrent submission and
collaborative review of innovative oncology products among international
regulatory authorities. It was created with the overarching goal to speed
worldwide patient access to innovative cancer therapies. Project Orbis is
coordinated by the FDA, and its partners include United Kingdom Medicines and
Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods
Administration (TGA), Canada (Health Canada), Singapore (Health Sciences
Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de
Vigilância Sanitária (ANVISA), Israel (Ministry of Health).