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Bavarian Nordic har modtaget positiv anbefaling fra det Europæiske Lægemiddelagentur om udvidelse af godkendelsen af IMVANEX® til også at omfatte abekopper

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KØBENHAVN, Danmark, 22. juli 2022 – Bavarian Nordic A/S (OMX: BAVA) meddelte i dag, at Udvalget for Humanmedicinske Lægemidler (CHMP) under Det Europæiske Lægemiddelagentur (EMA) har vedtaget en positiv udtalelse, der anbefaler, at markedsføringstilladelsen for selskabets koppevaccine, IMVANEX®, udvides til også at omfatte beskyttelse af mennesker mod abekopper.

Data til at understøtte den positive udtalelse blev indsendt efter anmodning fra EMA's Emergency Task Force (ETF) i lyset af det nuværende udbrud af abekopper i flere lande.

Anbefalingen fra CHMP vil blive forelagt Europa-Kommissionen med henblik på endelig godkendelse snart.  Når den er udstedt af Kommissionen, vil den udvidede markedsføringstilladelse være gyldig i alle EU-medlemsstater samt i Island, Liechtenstein og Norge.

Paul Chaplin, administrerende direktør for Bavarian Nordic, udtaler: "Vi bifalder den fremskyndede gennemgang fra CHMP og anbefalingen om at udvide godkendelsen af vores vaccine til at omfatte beskyttelse mod abekopper i tråd med godkendelserne fra det amerikanske lægemiddelagentur (FDA) og Health Canada. Selv om vi allerede har leveret vores vaccine til mange europæiske lande under det nuværende udbrud af abekopper, herunder leverancer til det fælles EU-beredskabslager, der varetages af Den Europæiske Myndighed for Kriseberedskab og -indsats på Sundhedsområdet (HERA), er udvidelsen af godkendelsen medvirkende til at forbedre adgangen til vaccinen i hele Europa og styrke det fremtidige beredskab mod abekopper."

Om IMVANEX®
IMVANEX® (MVA-BN eller Modified Vaccinia Ankara-Bavarian Nordic) er en ikke-replikerende koppevaccine udviklet i samarbejde med den amerikanske regering for at sikre levering af en koppevaccine til hele befolkningen, inklusive immunkompromitterede personer, som ikke anbefales vaccination med traditionelle replikerende koppevacciner. Vaccinen blev godkendt af Europa-Kommissionen i 2013 til immunisering mod kopper hos voksne i alderen 18 år og opefter og har efterfølgende opnået myndighedsgodkendelser i Canada (markedsført under navnet IMVAMUNE® og USA (markedsført under navnet JYNNEOS®, hvor godkendelsen er blevet udvidet til at omfatte indikationen abekopper som den eneste vaccine, der har opnået denne til dato.

Bavarian Nordic har igangværende leveringskontrakter med USA og Canada og har leveret vaccinen til en række ikke-oplyste lande globalt som en del af deres nationale biologiske beredskaber. I de senere år er mindre mængder af vaccinen blevet leveret i forbindelse med sporadiske tilfælde af abekopper. I forbindelse med udbruddet af abekopper i 2022 har Bavarian Nordic samarbejdet med flere regeringer om at imødekomme efterspørgslen på vaccinen gennem en række leveringskontrakter og arbejder desuden på at sikre produktion af yderligere vacciner til at opfylde behovet på den mellemlange til lange bane.

Om Bavarian Nordic
Bavarian Nordic er et fuldt integreret vaccineselskab, der er fokuseret på udvikling, produktion og kommercialisering af livsvigtige vacciner. Vi er globalt førende inden for koppevacciner, og er mangeårig leverandør til den amerikanske regering af en ikke-replikerende koppevaccine, som er godkendt af de amerikanske sundhedsmyndigheder, også til beskyttelse mod abekopper. Vaccinen er desuden godkendt mod kopper og abekopper i Canada og som koppevaccine i Europa. Vores kommercielle produktportefølje består endvidere af markedsledende vacciner mod rabies og flåtbåren hjernebetændelse. Med udgangspunkt i vores virale vaccineplatform, MVA-BN®, har vi udviklet en bred portefølje af produktkandidater, der sigter mod at forbedre og beskytte liv ved at frigøre immunsystemets egne kræfter. Blandt andet har vi udviklet en ebolavaccine, der er licenseret til Janssen Pharmaceutical Companies of Johnson & Johnson. Vi er desuden engageret i udviklingen af en næstegenerations COVID-19 vaccine. For yderligere information besøg www.bavarian-nordic.com.

Udsagn om fremtiden
Denne meddelelse indeholder fremadrettede udsagn, som er forbundet med risici, usikkerheder og andre faktorer, hvoraf mange er uden for vores kontrol. Dette kan medføre, at faktiske resultater afviger væsentligt fra de resultater, som er omhandlet i ovennævnte fremadrettede udsagn. Fremadrettede udsagn omfatter udsagn vedrørende vores planer, mål, fremtidige begivenheder, præstation og/eller anden information, som ikke er historisk information. Alle fremadrettede udsagn skal udtrykkeligt vurderes i sammenhæng med de forbehold, der er taget eller henvist til i denne erklæring. Vi påtager os ingen forpligtelser til offentligt at opdatere eller revidere udsagn om fremtiden således, at disse afspejler efterfølgende begivenheder eller omstændigheder, undtagen i det omfang dette er foreskrevet ved lov.

Kontakt
Rolf Sass Sørensen, Vice President Investor Relations, Tlf. +45 61 77 47 43

Selskabsmeddelelse nr. 29 / 2022

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