Valneva sells FDA priority review voucher for chikungunya vaccine for $103m

Valneva has announced that it has sold its chikungunya virus (CHIKV) vaccine priority review voucher (PRV) it received from the US Food and Drug Administration (FDA) for $103m.

The FDA’s tropical disease PRV programme is aimed at encouraging the development of new drugs and biologics for the prevention and treatment of tropical diseases.

Chikungunya is a mosquito-borne viral disease caused by CHIKV, a togaviridae virus that is transmitted by Aedes mosquitoes. Symptoms include the acute onset of fever, debilitating joint or muscle pain, headache, nausea, rash and chronic arthralgia.

In up to 97% of people, infection leads to symptomatic disease after four to seven days following the mosquito bite.

In November 2023, Valneva was awarded a tropical disease PRV following the FDA’s approval of Ixchiq, a single-dose, live-attenuated vaccine indicated for the prevention of disease caused by CHIKV in individuals aged 18 years or older who are at increased risk of exposure to the virus.

The approval made Ixchiq the first-ever licenced CHIKV vaccine worldwide.

Following the sale, all proceeds will be invested into the French vaccine maker’s research and development (R&D) projects, which include the co-development of its phase 3 vaccine candidate against Lyme disease, VLA15.

In addition, proceeds will also go towards further clinical trials for its Ixchiq vaccine and the expansion of the company’s pipeline.

Thomas Lingelbach, chief executive officer, Valneva, said: “This non-dilutive capital provides an important source of additional funding to advance the continued development of our clinical pipeline,… [grow] our portfolio of vaccines [and address] unmet medical needs that have the potential to transform people’s lives.”

VLA15 is currently the most advanced Lyme disease vaccine candidate in clinical development. The ongoing phase 3 study is investigating the efficacy, safety and immunogenicity of VLA15 in participants aged five years or older across 50 sites in areas including Finland, Germany, the Netherlands, Poland, Sweden and the US.

In anticipation of the phase 3 trial, Pfizer announced it would invest €90.5m in Valneva to represent 8.1% of its share capital to support the development of the strategic Lyme partnership between the two companies, after announcing positive phase 2 paediatric results for the Lyme disease vaccine in April 2022.