Valneva SE

Valneva SE
Company typeSocietas Europaea
Euronext Paris: VLA
CAC Mid 60
ISINFR0004056851
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]

Background

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.[citation needed]

Products

Released vaccines

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]

Failed developments

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

Main article: Valneva COVID-19 vaccine

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

Valneva and dynavax technologies[16] had 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 pre-ordered 60 million doses.[12][13] The trials were supported by the UK National Institute for Health Research and four British universities.[15] Due to government support, Valneva would 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]

In September 2021, Valneva announced that the UK government had cancelled their vaccine order.[20] The cancellation reason was not officially given, but seemed to be related to difficulties getting building materials due to Brexit[21] and not vaccine quality.

On 14 April 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so.[22]

On 17 May 2022 the European Commission cancelled its advance purchase agreement for the vaccine which would have seen Valneva provide 60 million doses over two years.[23]

Other vaccines under development

Valneva is also working on four other vaccines:[citation needed]

On 20 June 2022, American biotech firm Pfizer announced a 90.5 million euro ($95.24 million) investment, buying an 8.1% stake in Valneva as part of a partnership to tackle Lyme disease.[26]

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. ^ "Valneva, Dynavax Inks $1.5 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. ^ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva".
  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. 14 January 2021. Retrieved 18 January 2021.
  19. ^ Yeomans, Emma. "Scotland factory to produce Valneva Covid vaccine". The Times. Retrieved 18 January 2021.(Subscription required.)
  20. ^ "UK scraps Covid-19 vaccine deal with French firm Valneva". BBC News. 13 September 2021.
  21. ^ "U.K. Threw Covid Vaccine Maker Under Bus over Contract, Valneva CEO Says". Bloomberg.com. 24 November 2021.
  22. ^ "Regulatory approval of COVID-19 Vaccine Valneva". GOV.UK. Retrieved 2022-04-14.
  23. ^ Dunleavy, Kevin (2022-05-17). "Valneva's COVID-19 vaccine faces uncertain future after Europe cancels supply contract". Fierce Pharma. Retrieved 2022-06-21.
  24. ^ Malhi, Sabrina (10 November 2023). "FDA approves first vaccine against mosquito-borne virus chikungunya". The Washington Post. Retrieved 13 November 2023.
  25. ^ Sorgho, Olivier (27 November 2023). "Valneva says EU regulator accepts its chikungunya vaccine application". Reuters. Retrieved 27 November 2023.
  26. ^ "Pfizer to buy 8.1% stake in French vaccines company Valneva". The Economic Times. Retrieved 2022-06-21.