Novartis just paid $100 million for an FDA priority review voucher, buying it off the struggling generics maker, Mallinckrodt.
PRVs can be redeemed to have any drug candidate reviewed under priority review — which gets an FDA decision in six months as opposed to the standard 10 months — or they can or they can be sold to another company. The agency offers three different types of vouchers: rare pediatric disease, medical countermeasure and tropical disease. Between 2014 and 2019, the FDA awarded 25 PRVs, 17 of them under the rare pediatric disease program.
Mallinckrodt initially earned the voucher from the FDA approval of StrataGraft last June, a treatment for deep partial thermal burns. Developed with help from BARDA, StrataGraft is considered a medical countermeasure.
As outlined in the recent SEC filing, Novartis will pay $65 million to the company, and $35 million to the General Unsecured Claims Trustee for the PRV.
Selling off PRVs has proved to be quite lucrative. Earlier this year, BridgeBio signed a definitive agreement with an 'undisclosed purchaser' to sell its rare pediatric disease PRV for $110 million.