|United's Roger Jeffs|
The cost of a priority review voucher for the FDA keeps going up. AbbVie is forking over a record $350 million to acquire a voucher from United Therapeutics, giving them an option at shaving four months off the agency's standard 10-month review process.
There's no immediate word from AbbVie ($ABBV) about which of their late-stage drugs will get the voucher, but at a cost of $87.5 million a month, the pharma company clearly has a potential blockbuster in mind. AbbVie and Roche are hustling the cancer drug venetoclax--which already has a breakthrough drug designation--to the FDA for an accelerated review, with more late-stage therapies in the pipeline to pick from.
The FDA is using the vouchers to help encourage R&D for pediatric and tropical diseases, handing out the vouchers for new approvals in those two fields. And every deal brings a new record price tag.
Sanofi ($SNY) and Regeneron ($REGN) drew considerable attention for their decision to pay the now bargain basement price of $67.5 million for a priority review voucher that allowed them to leapfrog Amgen on the first FDA approval for a PCSK9 cholesterol drug. Gilead ($GILD) scored a voucher for $125 million and then used it to accelerate a new HIV combo. And Sanofi fed the inflationary cycle with its $245 million voucher deal with Retrophin last May.
AbbVie has good reason to demonstrate a sense of urgency. The company is heavily dependent on Humira for most of its income and has to diversity its product portfolio as quickly as possible.
In this case, United ($UTHR) gets to cash in on its approval of Unituxin, a new drug for rare cases of neuroblastoma.
"We are very pleased to monetize our PPRV, and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases," said
- here's the release