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Bavarian Nordic

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Bavarian Nordic A/S
Company typePublic
OTC Markets: BVNRY
ISINDK0015998017
IndustryBiotechnology
Founded1994; 30 years ago (1994)
Headquarters
Hellerup
,
Denmark[3]
Key people
ProductsImvanex, Imvamune, Jynneos, Rabipur/RabAvert, Encepur, Vivotif, Vaxchora, Mvabea
RevenueIncrease 7.062 billion kr. (2023)
Total assetsIncrease 14.373 billion kr. (2023)
Total equityIncrease 10.340 billion kr. (2023)
Number of employees
Increase 1.379 (2023)
Websitebavarian-nordic.com
Footnotes / references
[6]

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 Thörishaus [de] near Bern, Switzerland.[3] 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

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MVA-BN

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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,[7] 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,[8] in the European Union, as Imvanex,[9] and the United States as Jynneos.[10][11][12] The vaccine was supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles.[citation needed]

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.[13]

Ebola vaccine development and production

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The company has worked for several years with the NIAID[14] 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.[15][16][17] 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.[18] It was approved for medical use in the European Union in July 2020.[19]

Acquisitions

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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).[20][21] 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.[22]

Marketed products and pipeline

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Bavarian Nordic's marketed products and pipeline, as of July 2020.[23][24]

Product Indication Phase Remark
Imvanex Smallpox, mpox and disease caused by vaccinia virus Approved EU 2013-07 Liquid-frozen.
Imvamune Smallpox Approved Canada 2013-11 Liquid-frozen.
Jynneos Smallpox and mpox Approved US 2019-09-24 Liquid-frozen.
MVA-BN (freeze-dried) Smallpox III Phase 3 clinical trials completed.
Rabipur/RabAvert (Pre-/post-exposure protection against) rabies Approved Acquisition 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]
Encepur European (Western) tick-borne encephalitis (TBE) virus Approved Acquisition 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]
Mvabea Ebola and Marburg virus Approved EU 2020-07-01 Licensed 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 VLP Chikungunya III Ph3 topline results announced 6 August 2023.[25] Regulatory submissions planned for 2024.[26]
MVA-BN WEV Western equine encephalitis virus I Ph1 topline results announced 8 June 2020.[27] A Phase 2 clinical study is planned for initiation in 2024.[28]

Associations

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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.[29]

The company is a funding partner of the Bipartisan Commission on Biodefense,[30] and a former donor to the Bipartisan Policy Center.[31]

References

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  1. ^ "Archive.ph". Archived from the original on 13 March 2022. Retrieved 8 September 2023.{{cite web}}: CS1 maint: bot: original URL status unknown (link)
  2. ^ "OMX Copenhagen 25 (OMXC25CAP)" (PDF). Nasdaq OMX. Archived from the original (PDF) on 13 March 2022.
  3. ^ a b "Hellerup, Denmark". Bavarian Nordic. Archived from the original on 13 March 2022. Retrieved 6 December 2021.
  4. ^ "Board of Directors". BN. Retrieved 8 April 2024.
  5. ^ "Executive Management". BN. Archived from the original on 17 July 2020. Retrieved 8 April 2024.
  6. ^ "Annual Report 2023" (PDF). Bavarian Nordic. Archived from the original (PDF) on 2 April 2024. Retrieved 8 April 2024.
  7. ^ Kennedy JS, Greenberg RN (9 January 2014). "IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine". Expert Review of Vaccines. 8 (1): 13–24. doi:10.1586/14760584.8.1.13. PMC 9709931. PMID 19093767. S2CID 35854977.
  8. ^ "Products for Human Use. Submission #144762". Register of Innovative Drugs. Health Canada. 13 June 2014. 144762 (Submission Number). Archived from the original on 17 June 2014. Retrieved 26 June 2014.
  9. ^ "Imvanex". Human Medicines. European Medicines Agency. 27 May 2016. Archived from the original on 20 June 2018. Retrieved 12 June 2016.
  10. ^ "Jynneos". U.S. Food and Drug Administration (FDA). 24 September 2019. STN 125678. Archived from the original on 17 October 2019. Retrieved 16 October 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ "Smallpox Vaccine Supply & Strength". National Institute of Allergy and Infectious Diseases (NIAID). 26 September 2019. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  12. ^ 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 (2016). "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". PLOS ONE. 11 (6): e0157335. Bibcode:2016PLoSO..1157335G. doi:10.1371/journal.pone.0157335. PMC 4915701. PMID 27327616.
  13. ^ Exclusive: Closure of World's Only Manufacturing Plant for Monkeypox Vaccine Raises Questions About World's Ability to Meet Rising Demand
  14. ^ "Infectious Diseases: Filovirus Vaccine". Bavarian Nordic. Archived from the original on 30 October 2014. Retrieved 29 October 2014.
  15. ^ "Bavarian Nordic Enters Licensing and Supply Agreement with Janssen on MVA-BN® Ebola Vaccine". Bavarian Nordic. 22 October 2014. Archived from the original on 3 November 2014. Retrieved 29 October 2014.
  16. ^ "BRIEF-Bavarian Nordic to expand collaboration with Janssen". reuters-brief. Reuters. 23 October 2014. Archived from the original on 30 October 2014. Retrieved 29 October 2014.
  17. ^ "Johnson & Johnson plans Ebola vaccine testing". AP News. Associated Press. 22 October 2014. Archived from the original on 31 October 2014. Retrieved 29 October 2014.
  18. ^ "J&J, Bavarian Nordic start clinical tests in Ebola vaccine race". Reuters. 6 January 2015. Archived from the original on 13 January 2015. Retrieved 12 January 2015.
  19. ^ "Johnson & Johnson Announces European Commission Approval for Janssen's Preventive Ebola Vaccine". Reuters. 1 July 2020. Retrieved 16 July 2020.
  20. ^ Smith, Anna (21 October 2019). "GSK to divest Rabipur, Encepur to Bavarian Nordic". PharmaTimes. Retrieved 3 April 2020.
  21. ^ "GSK agrees to divest rabies and tick-borne encephalitis vaccines to Bavarian Nordic | GSK". www.gsk.com. Retrieved 3 April 2020.
  22. ^ "Bavarian Nordic scoops up Emergent's travel vaccines, manufacturing site in deal worth up to $380M". Fierce Pharma. Retrieved 20 February 2023.
  23. ^ "Pipeline". Bavarian Nordic. 20 February 2020. Retrieved 14 July 2020.
  24. ^ "Annual Report 2019, Pipeline (p.30)" (PDF). Bavarian Nordic. Archived from the original (PDF) on 27 March 2020. Retrieved 15 July 2020.
  25. ^ "Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents". Bavarian Nordic. 6 August 2023. Retrieved 2 May 2024.
  26. ^ "Chikungunya". Bavarian Nordic. Retrieved 2 May 2024.
  27. ^ "Bavarian Nordic Announces Topline Results from Phase 1 Clinical Trial of Equine Encephalitis Virus Vaccine". Bavarian Nordic. 8 June 2020. Retrieved 15 July 2020.
  28. ^ "Equine Encephalitis". Bavarian Nordic. Retrieved 2 May 2024.
  29. ^ "Member Organizations". Medical Countermeasures Coalition. Retrieved 2 May 2024.
  30. ^ "Sponsors / Donors". Bipartisan Commission on Biodefense. Archived from the original on 29 May 2022. Retrieved 20 June 2022.
  31. ^ "2017 Annual Report" (PDF). Bipartisan Policy Center. 2017. Archived (PDF) from the original on 7 July 2022. Retrieved 7 July 2022.
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