The French vaccine maker on Monday said it sold a priority review voucher, which was awarded by the FDA in November 2023 alongside an approval for its chikungunya vaccine, to an undisclosed buyer.
Pictured: Healthcare worker administering a vaccine into a patient’s arm/iStock, Tirachard
French vaccine maker Valneva has sold its priority review voucher secured from the FDA in November 2023, when it secured approval for its chikungunya vaccine, for the price of $103 million to an undisclosed buyer, the company announced on Monday.
Valneva CEO Thomas Lingelbach said that the funds would be “an important source of additional funding” and will go towards advancing its pipeline, which is developing vaccines against Lyme disease and Zika virus. Valneva’s sale of the priority review voucher comes on the heels of the FDA approving the company’s chikungunya vaccine Ixchiq, which was the first vaccine to get regulatory approval to prevent the disease.
“As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people’s lives,” Lingelbach said in a statement.
The tropical disease priority review voucher program gives priority review vouchers to the sponsors of product applications, according to Valneva. The voucher program intends to spur the development of drugs and biologics that will prevent or treat tropical diseases such as chikungunya or dengue fever. The vouchers themselves can be used to get a priority review of an application.
Valneva’s Ixchiq vaccine, approved in November, is cleared for people 18 and older who are at risk of the mosquito-borne virus. Data from last year’s Phase III trial showed that the vaccine had seroprotection rates of 98.6% for patients 18 to 64 years old and 100% in patients 65 and older. According to a Valneva financial update from December 2023, the vaccine will launch sometime in early 2024.
However, the company is not planning to rest on its laurels as it continues to develop the vaccine for younger ages. The company announced last month it had vaccinated the first participant in the Phase II trial for the vaccine in children at different dosing levels. As of now, there is no approved chikungunya vaccine for children.
Valneva also has competition in the chikungunya space, with Bavarian Nordic showing positive Phase III data for its vaccine back in August 2023.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
