Valneva Secures $103 Million Funding to Advance Tropical Disease Treatments and Vaccines

Valneva Announces Significant Funding Boost

Valneva, a leading specialty vaccine company, has recently secured $103 million in non-dilutive capital to support the development of its clinical pipeline for tropical disease products and vaccines. The CEO, Thomas Lingelbach, views this funding as a crucial source for propelling their clinical pipeline forward. This significant development underlines the company's commitment to addressing tropical diseases and advancing the development of essential vaccines and treatments.

Sale of the Priority Review Voucher

According to the company's press release, Valneva has sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million. This funding will be invested directly into the company's R&D projects, including the co-development of its Phase 3 vaccine candidate against Lyme disease and additional clinical trials for its chikungunya vaccine, IXCHIQ. The Priority Review Voucher Program is designed to incentivize the development of new drugs and biologics for the prevention and treatment of tropical diseases.

Focus on Chikungunya Vaccine

Chikungunya is a mosquito-borne viral disease with high morbidity. There is a global need for vaccines against chikungunya, with the market estimated to exceed $500 million annually by 2032. Valneva's vaccine, IXCHIQ, is a live attenuated vaccine indicated for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is the first of its kind to gain approval in the U.S., and Valneva plans to begin selling the vaccine this year.

Priority Review Vouchers: Accelerating Drug Development

The tropical Disease Priority Review Voucher Program by the FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria. The vouchers can be sold or transferred and are used to shorten the FDA's review of a new drug from 10 months to six, providing a competitive advantage in the market. These vouchers were introduced to encourage development of drugs for diseases that might otherwise not receive significant investment, such as rare pediatric conditions or tropical diseases like chikungunya.

Future Plans for Valneva

With the funding from the sale of the voucher, Valneva plans to invest in Phase 3 testing of a Lyme disease vaccine co-developed with Pfizer and additional trials of Ixchiq. This cash injection provides non-dilutive capital for the development of Valneva's clinical pipeline, helping the company to continue its mission to develop, manufacture, and commercialize prophylactic vaccines for infectious diseases addressing unmet medical needs.