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Valneva SE

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Valneva SE
Company typeSocietas Europaea
Euronext: VLA
IndustryBiotechnology
Predecessormerger of Intercell and Vivalis SA
Founded2013
Headquarters
Saint-Herblain
,
France
Key people
Thomas Lingelbach (CEO), Frédéric Grimaud (Chairman of the supervisory board)
ProductsDevelopment of vaccines
Websitewww.valneva.com

Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden and Vienna, Austria, with other offices in France, Canada and the United States.[1][2][3]

Valneva was founded in 2013 through the merger of Austrian company Intercell and French company Vivalis SA.[4][5] It has been listed since 28 May 2013 on the Euronext Paris in Paris and used to be listed on the Vienna Stock Exchange.

Products

Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia)[6] and Dukoral, a vaccine against cholera (approved in Europe and Australia).[7]

Some of its candidates have failed in clinical trials: VLA43, a therapeutic vaccine against Pseudomonas aeruginosa,[8] V710, a therapeutic vaccine against Staphylococcus aureus (in collaboration with Merck),[9] and IC41, therapeutic vaccine against hepatitis C.[10]

COVID-19 vaccine development

Main article: VLA2001

Valneva along with dynavax technologies[11] developed a candidate inactivated whole virus vaccine against COVID-19, VLA2001[12] derived from its Ixiaro vaccine, which is undergoing a Phase 1/2 trial in the United Kingdom.[13][14] The Phase 1/2 trial has 150 participants testing three dose levels for safety, tolerability, and immunogenicity. The trial is expected to be complete by 15 February 2021, with full reporting completed by August 2021.[15]

Valneva and dynavax technologies[16] has reached an agreement with the UK government to provide up to 100 million doses to be manufactured at its facility in Livingston, Scotland. The UK government has pre-ordered 60 million doses.[12][13] The trials are being supported by the UK National Institute for Health Research and four British universities.[15] Due to government support, Valneva will progress immediately into Phase 3 trials and develop production capacity before the full evaluation of the Phase 1/2 trial, rather than the traditional slower sequential approach which has lower financial risk.[17]

The company manufacturing facility in Livingston, Scotland produces the VLA2001 vaccine.[18][19]

Other developing vaccines

Valneva is also working on four other vaccines :

References

  1. ^ "Manufacturing and Services". Valneva. Retrieved 11 January 2021.
  2. ^ "Marketing and Distribution". Valneva. Retrieved 11 January 2021.
  3. ^ "Valneva Expands its Commercial Operations with the Opening of its French Commercial Office". Valneva. 9 January 2020. Retrieved 11 January 2021.
  4. ^ "Vivalis to Buy Intercell AG in European Biotech Merger for $174 Million". BioSpace. 17 December 2012. Retrieved 2 February 2021.
  5. ^ "Vivalis announces that the Intercell AG Extraordinary General Meeting has approved the proposed merger of equals with Vivalis SA to create Valneva SE". GlobeNewswire. 28 February 2013. Retrieved 2 February 2021.
  6. ^ "Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed)". European Medicines Agency. 5 June 2009. Retrieved 25 April 2017.
  7. ^ "Dukoral, cholera vaccine (inactivated, oral)". European Medicines Agency. 30 April 2009. Retrieved 25 April 2017.
  8. ^ "Valneva writes off hospital-acquired infection vaccine following PhII/III miss". FierceBiotech, Questex LLC. 2016-09-01. Retrieved 2017-04-25.
  9. ^ "Merck ends trial of Intercell's MRSA vaccine". Reuters. 2011-06-08. Retrieved 2017-04-25.
  10. ^ "Intercell Hepatitis C Vaccine Meets Primary Endpoints". FDA News. 22 August 2007. Retrieved 15 August 2008.
  11. ^ https://www.fdanews.com/articles/199049-valneva-dynavax-inks-15-billion-covid-19-vaccine-supply-deal-with-uk
  12. ^ a b "VLA2001 COVID-19 Vaccine". Precision Vaccinations. 31 December 2020. Retrieved 11 January 2021.
  13. ^ a b "Covid: Clinical trials begin for Valneva vaccine". BBC News. 16 December 2020. Retrieved 11 January 2021.
  14. ^ "Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate". Valneva SE. 16 December 2020. Retrieved 18 December 2020.
  15. ^ a b "Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults". clinicaltrials.gov. U.S. National Library of Medicine. 30 December 2020. Retrieved 11 January 2021.
  16. ^ https://valneva.com/press-release/valneva-and-dynavax-announce-commercial-supply-agreement-for-inactivated-adjuvanted-covid-19-vaccine/
  17. ^ Nawrat, Allie (6 August 2020). "Q&A with Valneva: UK Government scales up Covid-19 manufacturing". Pharmaceutical Technology. Retrieved 11 January 2021.
  18. ^ "Biotech Valneva: European Union to buy '30 million doses of unique West Lothian Covid-19 vaccine'". Edinburgh News. Retrieved 18 January 2021.
  19. ^ "Scotland factory to produce Valneva Covid vaccine". The Times. Retrieved 18 January 2021.(Subscription required.)
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