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.

source：https://www.pharmaceutical-technology.com/news/valneva-sells-ixchiq-priority-voucher-for-103m-to-fuel-rd/