Amsterdam, Netherlands and Louisville, Ky. (ots/PRNewswire) 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,ararecancerthatformsfromimmaturenervecells,mostoftenoccursinyoungchildren.Itaccountsfor15%ofallpaediatriccancerdeathsduetothefactthatnearlyhalfofallpatientswhoreachremissionwillrelapse.[2]

Underthetermsofthelicenseagreement,NorginewillberesponsiblefortheregulatoryapprovalofDFMOandanysubsequentclinicaltrialsrequiredforapprovalintherelevantterritories.Norginewillholdmarketingauthorisationsinthelicensedterritories.ChristopherBath,ChiefOperatingOfficerofNorginesaid,”Weareproudtobeabletosupportthedevelopmentofthisimportanttreatmentforchildrensubjecttosuccessfulcompletionofitsresearchprogrammeandsubsequentregulatoryapproval.High-riskneuroblastomahasalowersurvivalratethanotherneuroblastomasandthereisanurgentneedtodevelopadditionaltreatmentoptionstoprolongsurvivalinthisgroupofpatients.”PeterStein,ChiefExecutiveOfficerofNorginealsocommented,”Thisagreementisanothersuccessfulmilestoneinourcompany’sgrowingpipelineofpotentiallytransformativetreatmentsthat,subjecttoitssuccessfuldevelopment,willenableustohelpmorepatientsinthefuture.”LeeWarren,ChiefOperatingOfficerofUSWMstated,”Wearepassionateaboutbringingmeaningfultherapiestothepatientsthatneedthem,andthisagreementisanimportantstepinfulfillingthatmission.OurpartnershipwithNorginewillextendthereachofthispromisingtherapeutictochildrenwithhigh-riskneuroblastoma,adevastatingdiseasethataffectschildreneverywhere,includinginareasoutsideoftheUnitedStates.”www.norgine.comFollowus@norgineNotestoEditors:AboutDFMODFMOisarepurposedmoleculeinvestigatedforuseasanextendedmaintenancetreatmentforhigh-riskneuroblastoma(HRNB)inpaediatricpatientswithnoactivedisease(NAD)/noevidenceofdisease(NED)afterfirstlinemultiagent,multimodalitytherapy.[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 EUR448 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/.
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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

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Rückfragen & Kontakt:

Contact:
Clara Bentham
+44 (0)1895 826654 or +44 (0)7734 367883

Eleni Fistikaki
+44 (0)1895826227 or +44 (0)7825 389477contact@norgine.com












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