Norgine B.V. Enters Into Exclusive Licence and Distribution Agreements for the Commercialisation of PLENVU® in a Number of Countries in Latin America, Southern Africa, Central and Eastern Europe

Amsterdam (ots/PRNewswire) - Norgine B.V. (Norgine), a leading European specialist pharmaceutical company, today announced a number of deals for the commercialisation of Norgine's product PLENVU® around the world. Norgine entered into exclusive licence and distribution agreements with:

- Norgine to receive upfront payments, undisclosed milestone payments along with double-digit percentage royalties

- Norgine retains full commercial rights to PLENVU® in all unlicensed countries

  • Faes Farma S.A. in Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama and Peru.
  • Pharmacare Limited T/A Aspen Pharmacare in the Republic of South Africa, Lesotho, Eswatini, Botswana and Namibia.
  • Swixx Biopharma in Central and Eastern Europe including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Kosovo, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, and Slovenia.

Peter Stein, Chairman and Chief Executive Officer of Norginesaid, "Colonoscopy plays a critical role in the prevention of gastrointestinal diseases including colorectal cancer. Through these partnerships with Faes Farma, Aspen Pharmacare and Swixx Biopharma PLENVU® will be able to help more patients around the globe."

Gonzalo Lopez, General Manager of Faes Farma commented, "We are pleased to include PLENVU® in our portfolio and are convinced that it will contribute to the development and improvement of colonoscopy in Latin America, a region where our company invests significantly to bring added value treatments to patients. We hope this collaboration with Norgine will be a first step and new cooperation opportunities may materialize in the future."

Lorraine Hill, Aspen Pharmacare Group Chief Operating Officer said, "The agreement completed between Pharmacare Limited, a wholly owned subsidiary of Aspen Holdings and the Group's primary South African trading company, and Norgine is a positive extension of our relationship locally. The inclusion of the PLENVU® brand will supplement our existing portfolio in this therapeutic area."

Swixx CEO, Jean-Michel Lespinasse noted, "Adding PLENVU® to our gastrointestinal (GI) portfolio, represents a great opportunity for Swixx, building on our existing excellent collaboration with Norgine. PLENVU® has the potential to help improve colonoscopy outcomes, patient experience and adherence."

Following the announcement of Norgine's exclusive licence agreement with Korea Pharma in January 2019, PLENVU® has now launched in South Korea.

PLENVU® is a lower-volume (1L) polyethylene glycol (PEG) based bowel preparation for colonoscopy in adults. It is the first lower-volume bowel preparation to show superior segmental cleansing of the colon vs. standard of care.[1]

PLENVU®iscurrentlyavailableinmainlandEurope(exceptFranceandSweden)andAustraliaviaNorgine,inSouthKoreaviaitspartnerKoreaPharmaandintheUSAviaitspartnerSalixPharmaceuticals.[2]ForfurtherinformationonPLENVU®intheEUvisitwww.expertiseincolonoscopy.com/plenvu

NotestoEditors:

AboutPLENVU®

PLENVU®,PowderforOralSolution(PEG3350,SodiumAscorbate,SodiumSulfate,AscorbicAcid,SodiumChloride,andPotassiumChloride),isindicatedinadultsforbowelcleansingpriortoanyprocedurerequiringacleanbowel.

AboutColorectalCancerandcolonoscopy

Colorectalcanceristhesecondmostcommoncauseofcancer-relatedmortalityworld-wide.[3]Colorectalcancerislargelypreventable,withearlydetectionbeingassociatedwitha90%curerate.[4]Colonoscopyisaneffectivemethodforcolorectalcancerscreeningandhasbeenshowntoreduceboththeincidenceandmortalityofcolorectalcancerwhenappliedinthegeneralpopulation.Inadequatepre-colonoscopybowelcleansingreducesthediagnosticaccuracyofcolonoscopy,particularlyforthedetectionofsmallerlesionsandsessile(slightlyflattened)polyps.Thismayresultinrepeatedprocedures,therebypotentiallyincreasingpatientburden,resourcerequirementandcostsandcanpossiblydelaytheinitiationoftreatment.[5],[6],[7]

AboutNorgine

NorgineisaleadingEuropeanspecialistpharmaceuticalcompanythathasbeenbringingtransformativemedicinestopatientsforoveracentury.Ourcommitmenttotransformingpeople'slivesdriveseverythingwedoandourEuropeanexperience,fullyintegratedinfrastructureandexceptionalpartnershipapproachenablesustoquicklyapplycreativesolutionstobringlife-changingmedicinestopatientsthattheymaynototherwisebeabletoaccess.Norgineisproudtohavehelped22millionpatientsaroundtheworldin2019andgeneratedEUR419millioninnetproductsales,agrowthof6%over2018.

Norginehasadirectpresencein14Europeancountries,aswellasAustraliaandNewZealand.Wealsohaveastrongglobalnetworkofpartnershipsinnon-Norginemarkets.Weareaflexibleandfullyintegratedpharmaceuticalbusiness,withmanufacturing(Hengoed,WalesandDreux,France),thirdpartysupplynetworksandsignificantproductdevelopmentcapabilities,inadditiontooursalesandmarketinginfrastructure.Thisenablesustoacquire,developandcommercialisespecialistandinnovativeproductsthatmakearealdifferencetothelivesofpatientsaroundtheworld.

In2012,NorgineestablishedNorgineVentures,acomplementarybusinesswhichsupportsinnovativehealthcarecompaniesthroughtheprovisionofdebt-likefinancinginEuropeandtheUS.Formoreinformation,pleasevisithttp://www.norgineventures.com/.

NORGINEandthesaillogoaretrademarksoftheNorginegroupofcompanies.

Followus@norgine

AboutFaesFarma

Foundedin1933,FaesFarmaisaSpanishpharmaceuticalcompanywithwideinternationalexperiencethatresearches,producesandmarketspharmaceuticalproductsandrawmaterials,exportingthemtomanycountries.

Theidentityofthecompanyisdefinedbyanunwaveringsearchofexcellence,theconstantpursuitofamaximumpharmacologicalqualityofallitsproductsandtheconsequentefforttoalwaysofferhighlyeffectivesolutionsforpatientsinselectedtherapeuticareasamongwhichgastroenterologyisoneofthemostimportantforthecompany,aswellasallergytreatments.

FaesFarmaoperatesinmanycountries,employingmorethan1.200people.Itsheadquarters,manufacturingandR&DcentrearelocatedinLeioa,(Bizkaia).FaesFarmaalsohasfacilitiesinMadridandsubsidiariesinPortugal,LaboratoriosVitoria,inBarcelona,DiafarmLaboratoriesandalsoinItaly,France,Chile,México,Colombia,Peru,EcuadorandNigeria.

AboutAspen

Aspenisaleadingglobalplayerinspecialty,brandedandgenericpharmaceuticalswithanextensivebasketofproductsthatprovidetreatmentforabroadspectrumofacuteandchronicconditionsexperiencedthroughallstagesoflife.

Withanacknowledgedpresenceofnearly2decadesinthepharmaceuticalsector,Aspenremainscommittedtoitscorevaluesofprovidingqualityandeffectivehealthcaresolutionstomillionsofpatientsinmorethan150countries,withitscorefocusbeingintheThrombosis,AnaestheticandHighPotency&Cytotoxictherapeuticcategories.

Aspenhasastrongpresenceinbothemerginganddevelopedcountries.ItsemergingmarketfootprintincludesSub-SaharanAfrica,LatinAmerica,China,SouthEastAsia,EasternEuropeandtheCommonwealthofIndependentStates,comprisingRussiaandtheformerSovietRepublics.ItisalsoaleadingpharmaceuticalcompanyindevelopedcountriesincludingAustraliaandmostnotablyinWesternEurope.

Aspenoperateswithanestablishedbusinesspresenceinapproximately50countriesspanning6continentsandemploysmorethan10,000people.TheGroupoperates26manufacturingfacilitiesacross18sites.AspenholdsinternationalmanufacturingapprovalsfromsomeofthemoststringentglobalregulatoryagenciesincludingtheFDA,TGAandEMA.Aspen'smanufacturingcapabilitiesarescalabletodemandandcoverawidevarietyofproduct-typesincludingoralsoliddose,liquids,semi-solids,steriles,biologicals,APIsandinfantnutritionals.

Withamarketcapitalisationofapproximately$10billion,AspenisthelargestpharmaceuticalcompanylistedontheJSELimited(sharecode:APN)andranksamongstthetop20listedcompaniesonthisexchange.Formoreinformationvisit:http://www.aspenpharma.com/

AboutSwixxBioPharmaAG

Swixxnowoperatesfully-ownedsubsidiariesacrossCentralandEasternEurope,offeringcoveragefromMoscowtoPragueandfromTallinntoSofia.Netsalesin2019were143millionEurosandin2020shouldreach225millionEuros.Establishedin2014,Swixxhasgatheredoutstandingspecialtypharmaceutical,raredisease,medicaldeviceandOTC/consumerhealthcaretalentunderoneroof.Thecompanyspecializesinrepresentingresearch-basedpharmaceutical,biotech,orphan,medicalequipmentandself-carebrands.FormoreinfoaboutSwixx,pleasevisit:www.swixxbiopharma.com

References

[1] Repici A., Amlani B., Uebel P., Schreiber S. Superior high-quality colon cleansing with 1L NER1006 versus sodium picosulfate + magnesium citrate, 2L polyethylene glycol + ascorbate, or oral sulfate solution: Post hoc pooled analysis of three randomised phase 3 clinical trials. #P0159. Monday 22 October. 12:30 - 13:30 CET. UEGW 2018

[2] In Austria, Spain and the Netherlands it is known as PLEINVUE® rather than PLENVU® March 2018. Available at: https://www.medicines.org.uk/emc/medicine/31722. Accessed June 2018.

[3]World Health Organisation. https://www.who.int/news-room/fact-sheets/detail/cancerLast accessed February 2020

[4] American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html Last accessed February 2020

[5] Bechtold ML, Mir F, Puli SR et al. Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization. Ann Gastroenterol 2016; 29: 137 - 146

[6] Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467

[7] Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664 - 2669

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Rückfragen & Kontakt:

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

Eleni Fistikaki +44 (0)1895-826227 or +44 (0)7825-389477

contact@norgine.com

www.norgine.com

Media contacts for Faes Farma: Soraya Gonzalez
accionistas@faesfarma.com

Media contacts for Aspen: Shauneen Beukes
sbeukes@aspenpharma.com

Media contacts for Swixx: Maja Boskovic. +381-11-4426-321
Maja.Boskovic@swixxbiopharma.com

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