PR90812

Norgine B.V. and US WorldMeds enter into exclusive licensing agreement to commercialise DFMO (eflornithine) in Europe, Commonwealth of Independent States, Australia and New Zealand

AMSTERDAM, Netherlands and LOUISVILLE, Ky., July 23, 2021 /PRNewswire=KYODO JBN/--

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.[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."

www.norgine.com

Follow us @norgine

Notes to Editors:

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. For more information, please visit

www.norgineventures.com

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

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.  

For more information about USWM, visit http://www.usworldmeds.com/.

Follow us on Twitter [https://twitter.com/USWorldMeds?lang=en], LinkedIn

[https://www.linkedin.com/company/usworldmeds/], and on Facebook

[https://www.facebook.com/USWorldMeds/].

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

[http://dx.doi.org/10.1038/s41598-018-32659-w]

Logo - http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg

Source: Norgine and US WorldMeds