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Valneva's R&D team gets $103M funding boost courtesy of priority review voucher sale

Vaccine maker Valneva is giving its R&D unit a $103 million gift courtesy of selling an FDA priority review voucher for tropical disease.

The French company received the voucher from the FDA in November 2023 in return for getting Ixchiq over the line as the first chikungunya vaccine approved in the U.S. and the world.

At the time, Valneva said it intended to monetize the voucher “to help finance its R&D programs.” The company confirmed today that a buyer has been found. The $103 million in proceeds from the sale will be invested into R&D projects, including a phase 3 vaccine against Lyme disease in partnership with Pfizer, more trials of Ixchiq and “the expansion of the company’s clinical pipeline.”

Valneva had originally planned to sell the voucher before the end of 2023 and revised down its financial guidance for the year at the end of December 2023 to reflect that the voucher was still waiting on the shelf. The company had expected R&D expenses for the full year to fall somewhere between 60 million euros ($64.5 million) and 70 million euros ($74.3 million), suggesting an influx of an additional $103 million could go a long way to secure its upcoming R&D ambitions.

In the end, the sale price fell within the 90 million to 110 million euro ($96.8 million to $118.3 million) range the company had been hoping for.

“This non-dilutive capital provides an important source of additional funding to advance the continued development of our clinical pipeline,” CEO Thomas Lingelbach said in this morning’s release. “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.”

Priority review vouchers act as regulatory tokens that can be redeemed for an accelerated review, shaving the review time of approval applications from 10 months to six. Valneva did not reveal the identity of the voucher’s new owner in its Feb. 5 release.

A 2020 government analysis of the voucher program found that in the 10 years since launch in 2009, more than half were sold off. The price of the sales ranged from $67 million to $350 million. Of the 31 vouchers that were issued from 2009 to 2019, 16 had been redeemed. 

https://www.fiercebiotech.com/biotech/valnevas-rd-team-get-103m-funding-boost-courtesy-priority-review-voucher-sale

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