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Valneva sells regulatory ‘fast pass’ for $103M

Vaccine maker Valneva on Monday said it has sold a priority review voucher to an undisclosed buyer for $103 million.

The voucher, a sort of regulatory fast pass, was awarded to Valneva by the Food and Drug Administration alongside its Nov. 9 approval of Ixchiq, the company’s vaccine to prevent disease caused by the chikungunya virus.

Valneva plans to invest the cash into Phase 3 testing of a Lyme disease vaccine it’s co-developing with Pfizer, and into additional trials of Ixchiq.

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

Ixchiq is approved for adults over the age of 18 and was the first shot for the prevention of chikungunya to gain clearance in the U.S. A mosquito-borne illness, Chikungunya can cause fever, joint pain and muscle pain. Valneva plans to begin selling the vaccine this year, and a Centers for Disease Control and Prevention is set to discuss recommendations for the shot this month.

Priority review vouchers were introduced to encourage development of drugs for diseases that might otherwise not get significant investment, such as rare pediatric conditions or, in this case, tropical maladies like chikungunya.

The vouchers, which can be sold or transferred, are used to shorten the FDA’s review of a new drug from 10 months to six — valuable time for companies seeking to gain a competitive advantage over market rivals. In recent years, the vouchers have typically sold for around $100 million.