Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party.
The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.
Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale.
One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia.
The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient recruitment and testing due to “Good Clinical Practices (GCP) violations” by a third-party contractor Care Access. The contract research organisation (CRO) later challenged these allegations and an FDA investigation found no misconduct by Care Access. However, the programme received a setback with the companies delaying the planned submission of a biologics licence application to the FDA and a marketing authorisation application to the European Medicines Agency by one year to 2026.
Valneva also plans to use the funds to conduct additional clinical trials for Ixchiq and to expand its clinical pipeline. In December 2023, the 24-month follow-up results from the Phase IIIb trial (NCT04838444), following inoculation Ixchiq show that 97% of the 316 healthy adult subjects in the study had neutralising antibody titers above the seroresponse threshold.
The FDA grants new priority review vouchers to a company when a drug for neglected tropical disease for rare paediatric disease or material threat medical countermeasure is approved. But there is no guarantee that a voucher will be awarded. bluebird bio missed out on gaining an FDA priority voucher through this mechanism for its sickle cell gene therapy, Lyfgenia (lovotibeglogene autotemcel), after the agency stated that the company was ineligible due to the therapy’s active ingredient already being used in the company’s FDA approved beta-thalassemia gene therapy Zynteglo (betibeglogene autotemcel).
The FDA priority review vouchers reduce the FDA review time of a drug application from the usual ten months to six months. Vouchers do not need to be used by the company that received them and can be sold to raise funds.
