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Bavarian Nordic indgår aftale med Dynavax om markedsføring og distribution af HEPLISAV B hepatitis B vaccine i Tyskland

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KØBENHAVN, Danmark, 27. maj 2021 – Bavarian Nordic A/S (OMX: BAVA) har indgået aftale med Dynavax Technologies Corporation (Nasdaq: DVAX), en biofarmaceutisk virksomhed, der er fokuseret på udvikling og kommercialisering af nye vacciner, om markedsføring og distribution af deres HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] hepatitis B vaccine i Tyskland med forventet lancering i fjerde kvartal 2021.

I februar 2021 udstedte Europa-Kommissionen (EU) markedsføringstilladelse til HEPLISAV B til aktiv immunisering mod hepatitis B-virusinfektion (HBV) forårsaget af alle kendte undertyper af hepatitis B-virus hos voksne fra 18 år og opefter. HEPLISAV B er den eneste FDA- og EU-godkendte hepatitis B-vaccine, der muliggør færdigvaccination inden for en måned med blot to doser.

HEPLISAV B vil komplementere og styrke Bavarian Nordics kommercielle portefølje i Tyskland, og vil drage fordel af selskabets eksisterende markedsførings- og distributionsnetværk, der udover selskabets egne vacciner mod rabies og flåtbåren hjernebetændelse, vil håndtere Valnevas vacciner mod japansk hjernebetændelse og kolera som led i den fælles markedsførings- og distributionsaftale, der blev indgået sidste år. Det store overlap med den eksisterende målgruppe, der dækker praktiserende læger, bedriftslæger og rejsevaccinespecialister, passer strategisk godt til selskabet og rummer klare kommercielle synergier for den dedikerede salgsstyrke, som Bavarian Nordic har etableret i Tyskland.

Administrerende direktør i Dynavax, Ryan Spencer udtaler: “Vi ser frem til samarbejdet med Bavarian Nordic om kommercialiseringen af HEPLISAV B i Tyskland. Hepatitis B er er særdeles smitsom og potentielt dødelig virus med stigende infektionsrater og flere end 250 millioner smittede verden over. Heldigvis kan hepatitis B forebygges via effektiv vaccination. Med to doser, der kan gives over blot én måned samt en statistik signifikant højere beskyttelse (seroprotection) i head-to-head kliniske forsøg, rummer HEPLISAV B en unik mulighed for at imødegå de kendte udfordringer med at fuldføre vaccination og yder samtidig bedre beskyttelse end de tre doser, som indgår i sammenligningen.”

Administrerende direktør i Bavarian Nordic, Paul Chaplin udtaler: “Vi er glade for at kunne udvide vores kommercielle aktiviteter på det største EU-marked via markedsføring og distribution af et produkt, der komplementerer vores øvrige forretning, og vi ser frem til at bistå Dynavax med en succesrig markedslancering i Europa senere på året.”  

Om hepatitis B
Hepatitis B er en virussygdom i leveren, der kan udvikle sig til kronisk sygdom og føre til skrumpelever, leverkræft og død. Hepatitis B-virus er 50 til 100 gange mere smitsom end HIV,i og der er en stigning i smittetilfælde. Der er ingen kur mod hepatitis B, men effektiv vaccination kan forhindre sygdommen.

Hos voksne spredes hepatitis B gennem kontakt med inficeret blod og gennem ubeskyttet sex med en smittet person. Det amerikanske center for sygdomskontrol (CDC) anbefaler vaccination til personer med høj risiko for infektion som følge af deres job, livsstil, boligforhold og rejser til bestemte områder.ii Diabetespatienter er særligt sårbare over for infektion, hvorfor CDC anbefaler vaccination til voksne i alderen 19 til 59 med diabetes hurtigst muligt efter diagnosen er stillet, samt for personer i alderen 60 år og opefter med diabetes.iii Ca. 20 millioner amerikanske voksne har diabetes, og 1,5 millioner nye tilfælde af diabetes diagnosticeres hvert år. iv

About HEPLISAV B
HEPLISAV B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV B.

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full E.U. Prescribing Information for HEPLISAV B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to HEPLISAV B.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

Important U.S. Product Information
HEPLISAV B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

For full U.S. Prescribing Information for HEPLISAV B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV B. Hepatitis B has a long incubation period. HEPLISAV B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing its CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com

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 under navnet JYNNEOS®, også til beskyttelse mod abekopper. Vaccinen er desuden godkendt som koppevaccine i Europa under navnet IMVANEX® og i Canada under navnet IMVAMUNE®. Vores kommercielle produktportefølje består endvidere af to markedsledende vacciner: Rabipur®/RabAvert® mod rabies og Encepur® mod 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 ebolavaccinen MVABEA®, der er licenseret til Janssen Pharmaceutical Companies of Johnson & Johnson. Vi er desuden engageret i udviklingen af en næstegenerations COVID-19 vaccine baseret på en indlicenseret, kunstig viruslignende partikelteknologi. Vaccinekandidaten, ABNCoV2, undersøges for øjeblikket i kliniske forsøg. 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. 19 / 2021

i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm
ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm
iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf
iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

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