Valneva SE
 | |
| Company type | Societas Europaea |
|---|---|
| Euronext Paris: VLA
CAC Mid 60 Nasdaq: VALN | |
| ISIN | FR0004056851 |
| Industry | Biotechnology |
| Predecessor | Merger of Intercell AG and Vivalis SA |
| Founded | 2013 |
| Headquarters | , |
Key people | Thomas Lingelbach (CEO), Frédéric Grimaud (Chairman of the supervisory board) |
| Products | Development of vaccines |
| Website | www |
Valneva SE is a speciality vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. The company current market three proprietary travel vaccines.
Revenues from its growing commercial business help fuel the continued advancement of its vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva 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
[edit]Founded in 2013 through the merger of Austrian company Intercell AG and French company Vivalis SA, Valneva is publicly traded on Euronext Paris (ticker:VLA) and Nasdaq (ticker:VALN).[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
[edit]Licensed vaccines
[edit]Valneva markets the following licensed vaccines:
- IXIARO® - a vaccine for the prevention of Japanese encephalitis, notably approved in the United States, Europe, Canada and Australia)[6]
- DUKORAL® - an oral vaccine authorized for use in the European Union and Australia to protect against cholera and in Canada, Switzerland, New Zealand, and Thailand to protect against cholera and ETEC, the leading cause of travelers' diarrhea.[7]
- IXCHIQ® - a single-shot vaccine approved for the prevention of chikungunya virus infection. It is currently licensed in Europe for people aged 12 years and older and in other countries (United States, Canada, the United Kingdom and Brazil) for individuals aged 18 and older. Label extension applications are under review in the U.S., the UK and Canada to potentially extend the use of IXCHIQ® to adolescents 12 to 17 years of age. In May 2025, Valneva announced that the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended a pause in the use of IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows and earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and similar decision by the European Medicines Agency (EMA) to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation.
COVID-19 vaccine
[edit]Valneva, in collaboration with Dynavax Technologies[8] developed an inactivated inactivated whole virus vaccine whole-virus COVID-19 COVID-19 vaccine, VLA2001,[9] which was the first COVID-19 vaccine worldwide to receive full marketing authorization from the European Medicine Agency. In light of reduced order volume linked to the decline of the COVID-19 pandemic, Valneva suspended manufacturing of the vaccine in August 2022.
Vaccines under development
[edit]Valneva's research and development pipeline includes the only Lyme disease vaccine candidate (VLA15) in advanced clinical development, which is partnered with Pfizer, as well as the world's most clinically advanced tetravalent Shigella vaccine candidate, and proprietary vaccine candidates against the Zika virus and other global public health threats.
- VLA15 - a Phase 3 vaccine targeting Borrelia, the bacterium that causesLyme disease, under development in collaboration with Pfizer. It is the only vaccine candidate against Lyme disease currently undergoing late-stage clinical trials. Pfizer is currently executing the Phase 3 field efficacy study, VALOR (Vaccine Against Lyme for Outdoor Recreationists). Enrollment in the trial was completed in December 2023, and the primary vaccination series was completed in July 2024. Participants will be monitored for the occurrence of Lyme disease cases and first data is expected at the end of 2025. Pfizer aims to submit a Biologics License Application (BLA) to the U.S. FDA and Marketing Authorization Application (MAA) to the European Medicines Agency in 2026, subject to positive Phase 3 data. If VLA15 is approved and commercialized, Valneva will be eligible to receive $143 million in initial milestones from Pfizer, plus ongoing sales royalties ranging from 14% to 22% and an additional $100 million in cumulative sales milestones. VLA15 targets the six most prevalent serotypes, or variations, of Borrelia in the United States, where approximately 476,000 people are diagnosed with Lyme disease each year and in Europe, where at least a further 200,000 cases occur annually.
Pfizer invested €90.5 million ($95.24 million) in Valneva in June 2022, buying an 8.1% stake at Valneva for this project.[10]
- S4V2 - a Phase 2 tetravalent bioconjugate vaccine candidate against shigellosis, a diarrheal infection caused by Shigella bacteria, under development in collaboration with LimmaTech. Shigellosis is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,00 deaths are attributed to Shigella each year, particularly among children in Low-and-Middle-Income Countries (LMICs). No approved Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO). In October 2024, the FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need. Two Phase 2 studies, a Phase 2b Human Challenge Study (CHIM) and an infant study are currently ongoing and sponsored by LimmaTech. Subject to positive Phase 2 results, Valneva will assume responsibility for all further development.
- VLA1601 - a novel adjuvanted inactivated vaccine candidate against the mosquito-borne disease caused by the Zika virus (ZIKV). In March 2024, Valneva initiated a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA1601. Sentinel recruitment and vaccinations have been completed, and results from the trial are expected in 2025.
Zika virus transmission persist in several countries in the Americas and in other endemic regions, such as India and parts of Africa. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available and, as such, Zika remains a public health threat and is included int he FDA's Tropical Disease Priority Review Voucher Program. A vaccine against ZIKV could be a valuable addition to Valneva's portfolio against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®.
References
[edit]- ^ "Manufacturing and Services". Valneva. Retrieved 11 January 2021.
- ^ "Marketing and Distribution". Valneva. Retrieved 11 January 2021.
- ^ "Valneva Expands its Commercial Operations with the Opening of its French Commercial Office". Valneva. 9 January 2020. Retrieved 11 January 2021.
- ^ "Vivalis to Buy Intercell AG in European Biotech Merger for $174 Million". BioSpace. 17 December 2012. Retrieved 2 February 2021.
- ^ "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.
- ^ "Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed)". European Medicines Agency. 5 June 2009. Retrieved 25 April 2017.
- ^ "Dukoral, cholera vaccine (inactivated, oral)". European Medicines Agency. 30 April 2009. Retrieved 25 April 2017.
- ^ "Valneva, Dynavax Inks $1.5 Billion COVID-19 Vaccine Supply Deal with UK".
- ^ "VLA2001 COVID-19 Vaccine". Precision Vaccinations. 31 December 2020. Retrieved 11 January 2021.
- ^ "Pfizer to buy 8.1% stake in French vaccines company Valneva". The Economic Times. Retrieved 2022-06-21.
