Even in the era of the FDA's Commissioner's National Priority Voucher (CNPV) program, Jazz Pharmaceuticals is showing that traditional priority review vouchers (PRVs) can catch a pretty penny.
In fact, the price of such vouchers has been climbing steadily in recent months, according to public disclosures surrounding the deals.
During Jazz's Tuesday presentation at the J.P. Morgan Healthcare Conference, the company revealed that it executed an agreement to sell the PRV gained in conjunction with last year's FDA approval of targeted brain cancer medicine Modeyso for $200 million. In March of last year, Jazz paid $935 million to purchase biopharma Chimerix and get ahold of the then-unapproved drug, called dordaviprone, which won its FDA approval several months later.
Half of the new proceeds will go to Jazz, the company said in the footnotes of the presentation. Jazz didn't reveal where the rest of the proceeds will go.
Jazz also did not disclose the purchaser of its PRV. The company's announcement comes after a series of other PRV sales last year that ranged between $150 million and $175 million.
Priority review vouchers allow drugmakers to cut months off of standard FDA reviews for their promising new products. For drugmakers eager to launch potentially lucrative new medicines, a six-month review afforded by a PRV can be worth the investment.
But a new twist to the FDA review landscape has been introduced in the form of the FDA's CNPV program. These controversial vouchers, handed out by the agency to companies addressing certain national priorities, enable one- to two-month reviews. They cannot be transferred between companies absent a buyout, however.
Already, pharma giants such as of Novo and Eli Lilly have been awarded CNPV vouchers, potentially shrinking the pool of traditional PRV buyers. Novo and Lilly are using their CNPV vouchers to potentially speed new obesity offerings to the market.