Deals, FDA

How much is an FDA shortcut worth to drug developers hustling to an OK? Holding steady at $125M, cash

The market for priority review vouchers is holding steady at $125 million per deal.

That’s what BioMarin just received for its PRV, sold off to an unidentified buyer looking to slash 4 months off of a regular drug review. And it’s close to twice what the company reaped in 2014 when they sold their first PRV to Regeneron $REGN for $67.5 million.

BioMarin $BMRN got the PRV handed to it for the recent approval of Brineura for late infantile neuronal ceroid lipofuscinosis type 2, or CLN2. And they plan to use the $100 million they’ll clear in profit to fund the pipeline work at BioMarin.

There’s no word from BioMarin who bought the PRV, and we may never find out. But you’ll hear loud and clear when this regulatory card is played.

The PRV market — created by Congress to incentivize new drugs for certain niche markets — remains a curious sideshow in biopharma. The FDA has voiced its full throated dislike for the program, with regulators telling lawmakers that they don’t like the hurry-up schedule manufacturers can buy.

But the big players still love the PRV. GSK bought one — possibly from a disgraced Marathon — for $130 million and then used it to jump well ahead of Gilead in their race to the market with a new HIV combo therapy. Their early approval landed a week ago.

Gilead, no slouch when it comes to a late-stage development race, bagged Sarepta’s PRV for $125 million, helping set the market baseline rate that still prevails.

Ultragenyx $RARE has the latest PRV to hit the streets, so to speak. It was the 12th PRV for a rare pediatric drug OK.


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