Bavarian Nordic

{{Short description|Pharmaceutical company}}

{{Use dmy dates|date=August 2024}}

{{Infobox company

| name = Bavarian Nordic A/S

| logo = Bavarian Nordic logo.svg

| logo_size = 220px

| type = Public

| traded_as = {{Unbulleted list | {{OMX|CSE3333|BAVA}} | OMXC25CAP component{{cite web |url=https://se.investing.com/indices/omx-copenhagen-25-components |title=Archive.ph |access-date=8 September 2023 |archive-date=13 March 2022 |archive-url=https://archive.today/20220313071425/https://se.investing.com/indices/omx-copenhagen-25-components |url-status=bot: unknown}}{{Cite web |title=OMX Copenhagen 25 (OMXC25CAP) |url=https://indexes.nasdaqomx.com/docs/FS_OMXC25.pdf |website=Nasdaq OMX |archive-url=https://web.archive.org/web/20220313072035/https://indexes.nasdaqomx.com/docs/FS_OMXC25.pdf |archive-date=13 March 2022 |url-status=dead}}}} OTC Markets: [https://www.otcmarkets.com/stock/BVNRY/quote BVNRY]

| ISIN = {{ISIN|sl=n|pl=y|DK0015998017}}

| key_people = {{unbulleted list | Luc Debryune (chairman){{cite news |url=https://www.bavarian-nordic.com/about/leadership.aspx |title=Board of Directors |work=BN |accessdate=8 April 2024}} | Paul Chaplin (president and CEO){{cite news |url=https://www.bavarian-nordic.com/about/leadership.aspx |title=Executive Management |work=BN |accessdate=8 April 2024 |archive-date=17 July 2020 |archive-url=https://web.archive.org/web/20200717045220/https://www.bavarian-nordic.com/about/management.aspx |url-status=dead}} }}

| industry = Biotechnology

| products = Imvanex, Imvamune, Jynneos, Rabipur/RabAvert, Encepur, Vivotif, Vaxchora, Mvabea

| revenue = {{increase}} {{DKK|7.062 billion|link=yes}}

| revenue_year = 2023

| assets = {{increase}} {{DKK|14.373 billion|link=yes}}

| assets_year = 2023

| equity = {{increase}} {{DKK|10.340 billion|link=yes}}

| equity_year = 2023

| num_employees = {{increase}} 1.379 (2023)

| website = {{URL|https://bavarian-nordic.com}}

| foundation = {{start date and age|1994}}

| hq_location_city = Hellerup

| hq_location_country = Denmark{{cite web |title=Hellerup, Denmark |url=https://www.bavarian-nordic.com/about/locations/hellerup.aspx |publisher=Bavarian Nordic |access-date=6 December 2021 |archive-url=https://web.archive.org/web/20220313080019/https://www.bavarian-nordic.com/about/locations/hellerup.aspx |archive-date=13 March 2022}}

| footnotes ={{Cite web |url=https://www.bavarian-nordic.com/media/353977/bn_annual_report_2023.pdf |archive-url=https://web.archive.org/web/20240402113817/https://www.bavarian-nordic.com/media/353977/bn_annual_report_2023.pdf |archive-date=2 April 2024 |title=Annual Report 2023 |publisher=Bavarian Nordic |access-date=8 April 2024}}

}}

Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines. The company is headquartered in Hellerup, Denmark, with manufacturing facilities in Kvistgård, Denmark and {{ill|Thörishaus|de}} near Bern, Switzerland. The company has research and development facilities in Martinsried, Germany and San Diego, California, as well as offices in Zug, Switzerland, and Morrisville, North Carolina. The company uses viral vectors and virus-like particles in its research and development.

Technologies

= MVA-BN =

MVA-BN is a proprietary technology developed by Bavarian Nordic. It is derived from the Modified vaccinia Ankara virus. MVA-BN is characterized by the inability to replicate in human cells,{{Cite journal |date=9 January 2014 |title=IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine |journal=Expert Review of Vaccines |volume=8 |issue=1 |pages=13–24 |doi=10.1586/14760584.8.1.13 |pmid=19093767 |vauthors=Kennedy JS, Greenberg RN |pmc=9709931 |s2cid=35854977}} contrary to other vaccinia-based vaccines, which may replicate in humans, thus potentially causing severe and life-threatening side effects. Developed as the non-replicating smallpox and mpox vaccine, MVA-BN is approved in Canada as Imvamune,{{cite web |url=http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php |title=Products for Human Use. Submission #144762 |date=13 June 2014 |work=Register of Innovative Drugs |publisher=Health Canada |at=144762 (Submission Number) |archive-url=https://web.archive.org/web/20140617224429/http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php |archive-date=17 June 2014 |accessdate=26 June 2014}} in the European Union, as Imvanex,{{cite web |url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002596/human_med_001666.jsp&mid=WC0b01ac058001d124 |title=Imvanex |date=27 May 2016 |work=Human Medicines |publisher=European Medicines Agency |accessdate=12 June 2016 |archive-date=20 June 2018 |archive-url=https://web.archive.org/web/20180620154521/http://www.ema.europa.eu/ema//index.jsp?curl=pages%2Fmedicines%2Fhuman%2Fmedicines%2F002596%2Fhuman_med_001666.jsp&mid=WC0b01ac058001d124#authorisation |url-status=dead}} and the United States as

Jynneos.{{cite web |title=Jynneos |website=U.S. Food and Drug Administration (FDA) |date=24 September 2019 |url=https://www.fda.gov/vaccines-blood-biologics/jynneos |archive-url=https://web.archive.org/web/20191017060019/https://www.fda.gov/vaccines-blood-biologics/jynneos |archive-date=17 October 2019 |url-status=live |access-date=16 October 2019 |id=STN 125678}}{{PD-notice}}{{cite web |title=Smallpox Vaccine Supply & Strength |website=National Institute of Allergy and Infectious Diseases (NIAID) |date=26 September 2019 |url=https://www.niaid.nih.gov/diseases-conditions/smallpox-vaccine |archive-url=https://web.archive.org/web/20191017060706/https://www.niaid.nih.gov/diseases-conditions/smallpox-vaccine |archive-date=17 October 2019 |url-status=live |access-date=16 October 2019}}{{cite journal |vauthors=Greenberg RN, Hay CM, Stapleton JT, Marbury TC, Wagner E, Kreitmeir E, Röesch S, von Krempelhuber A, Young P, Nichols R, Meyer TP, Schmidt D, Weigl J, Virgin G, Arndtz-Wiedemann N, Chaplin P |title=A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN) in 56-80-Year-Old Subjects |journal=PLOS ONE |volume=11 |issue=6 |pages=e0157335 |year=2016 |pmid=27327616 |pmc=4915701 |doi=10.1371/journal.pone.0157335 |bibcode=2016PLoSO..1157335G |doi-access=free}} The vaccine was supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles.{{Citation needed|date=November 2024}}

The vaccine is being deployed worldwide to combat the 2022 mpox outbreak, leading to concerns over vaccine nationalism and hoarding by countries with pre-existing contracts.[https://healthpolicy-watch.news/exclusive-china-monkeypox-bavarian-nordics/ Exclusive: Closure of World's Only Manufacturing Plant for Monkeypox Vaccine Raises Questions About World's Ability to Meet Rising Demand]

Ebola vaccine development and production

The company has worked for several years with the NIAID{{cite web |url=http://id.bavarian-nordic.com/pipeline/filovirus.aspx |title=Infectious Diseases: Filovirus Vaccine |accessdate=29 October 2014 |publisher=Bavarian Nordic |archive-url=https://web.archive.org/web/20141030033953/http://id.bavarian-nordic.com/pipeline/filovirus.aspx |archive-date=30 October 2014 |url-status=dead}} on the development of a filovirus vaccine for Ebola and Marburg hemorrhagic fever diseases. In October 2014, following a successful pre-clinical demonstration of the combination vaccine regimen of its multivalent MVA-BN Filovirus vaccine and Crucell/Janssen's AdVac technology based on adenoviral vectors, Bavarian Nordic joined efforts with Crucell Holland B.V., one of the Janssen Pharmaceuticals companies of Johnson & Johnson to develop and manufacture this vaccine regimen intended for emergency use to help contain the outbreak in West Africa.{{cite web |url=http://id.bavarian-nordic.com/media/news.aspx?news=4241 |title=Bavarian Nordic Enters Licensing and Supply Agreement with Janssen on MVA-BN® Ebola Vaccine |date=22 October 2014 |accessdate=29 October 2014 |publisher=Bavarian Nordic |archive-url=https://web.archive.org/web/20141103063837/http://id.bavarian-nordic.com/media/news.aspx?news=4241 |archive-date=3 November 2014 |url-status=dead}}{{cite news |url=https://www.reuters.com/article/bavariannordic-brief-idUSWEA00GAP20141023 |title=BRIEF-Bavarian Nordic to expand collaboration with Janssen |work=reuters-brief |date=23 October 2014 |agency=Reuters |accessdate=29 October 2014 |archive-date=30 October 2014 |archive-url=https://web.archive.org/web/20141030034134/http://www.reuters.com/article/2014/10/23/bavariannordic-brief-idUSWEA00GAP20141023 |url-status=live}}{{cite news |url=http://bigstory.ap.org/article/20f65c2cde5e400f88f51f8a471d523a/jj-spend-200m-ebola-vaccine-program |title=Johnson & Johnson plans Ebola vaccine testing |date=22 October 2014 |agency=Associated Press |publisher=AP News |accessdate=29 October 2014 |url-status=dead |archiveurl=https://web.archive.org/web/20141031231349/http://bigstory.ap.org/article/20f65c2cde5e400f88f51f8a471d523a/jj-spend-200m-ebola-vaccine-program |archivedate=31 October 2014}} In January 2015, the company had produced the first 400,000 doses of the vaccine and the first clinical trial of the vaccine regimen was initiated in the UK, with additional trials planned in the US and Africa.{{cite news |url=https://www.reuters.com/article/us-health-ebola-vaccine-j-j-idUSKBN0KF0HH20150106 |title=J&J, Bavarian Nordic start clinical tests in Ebola vaccine race |date=6 January 2015 |agency=Reuters |accessdate=12 January 2015 |archive-date=13 January 2015 |archive-url=https://web.archive.org/web/20150113020402/http://www.reuters.com/article/2015/01/06/us-health-ebola-vaccine-j-j-idUSKBN0KF0HH20150106 |url-status=live}} It was approved for medical use in the European Union in July 2020.{{cite news |url=https://johnsonandjohnson.gcs-web.com/static-files/1c979f4f-cad3-4f8b-9a22-69aaac503570 |title=Johnson & Johnson Announces European Commission Approval for Janssen's Preventive Ebola Vaccine |date=1 July 2020 |agency=Reuters |accessdate=16 July 2020}}

Acquisitions

In October 2019, it was announced that Bavarian Nordic would acquire travel vaccines Rabipur(/Rabavert) for rabies and Encepur for tick-borne encephalitis (TBE) from GlaxoSmithKline (GSK).{{Cite web |url=http://www.pharmatimes.com/news/gsk_to_divest_rabipur,_encepur_to_bavarian_nordic_1313948 |title=GSK to divest Rabipur, Encepur to Bavarian Nordic |last=Smith |first=Anna |date=21 October 2019 |website=PharmaTimes |language=en |access-date=3 April 2020}}{{Cite web |url=https://www.gsk.com/en-gb/media/press-releases/gsk-agrees-to-divest-rabies-and-tick-borne-encephalitis-vaccines-to-bavarian-nordic/ |title=GSK agrees to divest rabies and tick-borne encephalitis vaccines to Bavarian Nordic {{!}} GSK|website=www.gsk.com|language=en-GB|access-date=3 April 2020}} In February 2023, it was announced that Bavarian Nordic would acquire travel vaccines Vivotif for typhoid fever and Vaxchora for cholera, in addition to a late-stage candidate for chikungunya, from Emergent BioSolutions.{{cite web |title=Bavarian Nordic scoops up Emergent's travel vaccines, manufacturing site in deal worth up to $380M |url=https://www.fiercepharma.com/manufacturing/after-jynneos-success-bavarian-nordic-hands-over-380m-emergents-typhoid-and-cholera |website=Fierce Pharma |access-date=20 February 2023}}

Marketed products and pipeline

Bavarian Nordic's marketed products and pipeline, as of July 2020.{{cite web |url=https://www.bavarian-nordic.com/what-we-do/pipeline.aspx |date=20 February 2020 |title=Pipeline |publisher=Bavarian Nordic |accessdate=14 July 2020}}{{cite web |url=https://www.bavarian-nordic.com/media/291506/2019-ar-en.pdf |title=Annual Report 2019, Pipeline (p.30) |publisher=Bavarian Nordic |accessdate=15 July 2020 |archive-url=https://web.archive.org/web/20200327154927/https://www.bavarian-nordic.com/media/291506/2019-ar-en.pdf |archive-date=27 March 2020 |url-status=dead }}

class="wikitable"
ProductIndicationPhaseRemark
ImvanexSmallpox, mpox and disease caused by vaccinia virusApproved EU 2013-07Liquid-frozen.
ImvamuneSmallpoxApproved Canada 2013-11Liquid-frozen.
JynneosSmallpox and mpoxApproved US 2019-09-24Liquid-frozen.
MVA-BN (freeze-dried)SmallpoxIIIPhase 3 clinical trials completed.
Rabipur/RabAvert(Pre-/post-exposure protection against) rabiesApprovedAcquisition completed on 31 December 2019. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020–25 – during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.{{Citation needed|date=November 2024}}
EncepurEuropean (Western) tick-borne encephalitis (TBE) virusApprovedAcquisition completed on 31 December 2019. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020–25 – during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.{{Citation needed|date=November 2024}}
MvabeaEbola and Marburg virusApproved EU 2020-07-01Licensed to Janssen. One dose of Janssen's primer Zabdeno (Ad26.ZEBOV) followed 8 weeks later by a dose of Bavarian Nordic's booster Mvabea® (MVA-BN Filo) collectively constitutes Janssen's Ebola vaccine regimen.
CHIKV VLPChikungunyaIIIPh3 topline results announced 6 August 2023.{{cite web |url=https://www.bavarian-nordic.com/investor/news/news.aspx?news=6816 |date=6 August 2023 |title=Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents |publisher=Bavarian Nordic |accessdate=2 May 2024}} Regulatory submissions planned for 2024.{{cite web |url=https://www.bavarian-nordic.com/what-we-do/pipeline/chikungunya.aspx |title=Chikungunya |publisher=Bavarian Nordic |accessdate=2 May 2024}}
MVA-BN WEVWestern equine encephalitis virusIPh1 topline results announced 8 June 2020.{{cite web |url=https://www.bavarian-nordic.com/investor/news/news.aspx?news=6058 |date=8 June 2020 |title=Bavarian Nordic Announces Topline Results from Phase 1 Clinical Trial of Equine Encephalitis Virus Vaccine |publisher=Bavarian Nordic |accessdate=15 July 2020}} A Phase 2 clinical study is planned for initiation in 2024.{{cite web |url=https://www.bavarian-nordic.com/what-we-do/pipeline/equine-encephalitis.aspx |title=Equine Encephalitis |publisher=Bavarian Nordic |accessdate=2 May 2024}}

Associations

Bavarian Nordic is a member of the Medical Countermeasures Coalition, a group of companies, academic institutions, and other organizations dedicated to building an effective medical countermeasure enterprise through sound public policy and strong public-private partnerships.{{cite web |title=Member Organizations |url=https://www.medicalcountermeasures.org/about-mcmc/#Members |website=Medical Countermeasures Coalition |access-date=2 May 2024}}

The company is a funding partner of the Bipartisan Commission on Biodefense,{{Cite web |title=Sponsors / Donors |url=https://biodefensecommission.org/sponsors-donors/ |url-status=live |archive-url=https://archive.today/20220529040043/https://biodefensecommission.org/sponsors-donors/ |archive-date=29 May 2022 |access-date=20 June 2022 |website=Bipartisan Commission on Biodefense |language=en-US}} and a former donor to the Bipartisan Policy Center.{{Cite web |year=2017 |title=2017 Annual Report |url=https://bipartisanpolicy.org/download/?file=%2Fwp-content%2Fuploads%2F2019%2F07%2FAnnual-Report-2017.pdf |url-status=live |archive-url=https://web.archive.org/web/20220707070050/https://bipartisanpolicy.org/download/?file=%2Fwp-content%2Fuploads%2F2019%2F07%2FAnnual-Report-2017.pdf |archive-date=7 July 2022 |access-date=7 July 2022 |website=Bipartisan Policy Center}}

References

{{Reflist}}