Just one month after the approval of Zycubo for Menkes disease, Fortress Biotech has announced an agreement to sell its “Rare Pediatric Disease Priority Review Voucher” (PRV) for a record-breaking $205 million. This figure surpasses the $200 million milestone set by Jazz Pharmaceuticals last month, confirming a robust upward trend in the market value of these regulatory assets.
A PRV is a specialized FDA mechanism designed to incentivize research into rare diseases. Possessing this voucher allows pharmaceutical companies to shorten the review period for a new drug from the standard 10 months to approximately 6 months. For potential “blockbuster” drugs, reaching the market four months earlier can translate into a commercial advantage worth hundreds of millions of dollars, justifying the increasingly steep acquisition costs.
This transaction occurs as the FDA advances a new initiative called the “Commissioner’s National Priority Voucher,” which offers ultra-fast reviews of just one to two months. Despite the introduction of these new voucher types, the value of traditional PRVs continues to soar, serving as a vital revenue stream for biotech firms like Fortress to reinvest in further research and development.
Source: https://www.fiercepharma.com/pharma/fortress-sells-fda-voucher-205m-after-zycubo-approval-last-month