Deals, Regulatory

What’s the big hurry, Novartis? Pharma giant scores a PRV shortcut for $130M

Novartis $NVS is moving up the ladder of Big Pharma companies with the most aggressive development groups in the industry. Today we learned that the Basel-based giant paid $130 million to buy a priority review voucher from Ultragenyx $RARE.

That figure marks a tick up from the last PRV deal for $125 million, helping set a market floor for a regulatory shortcut that has been valued (by AbbVie) as high as $350 million.

Remarkably, this is Novartis’ second PRV. They bagged a voucher last September with the approval of Kymriah, the first CAR-T t0 hit the market.

Novartis isn’t saying what it plans to do with the voucher, good for an automatic 6-month snap review for a new drug application, four months faster than the standard review. That would be “premature,” says a spokesperson for Novartis.

Novartis has a few big late-stage programs where they could use either of their PRVs. One top possibility:

  • RTH258 is looking to go head-to-head with Regeneron’s Eylea as quickly as possible. Regeneron, meanwhile, just filed for an approval of an easier quarterly dosing schedule in response, so Novartis has good reason to hustle.

Or maybe Novartis, which spends $9 billion a year on R&D, just wants to keep one in the bank for future use.

Ultragenyx got the rare pediatric PRV with the approval of Mepsevii, which has inspired only modest peak sales projections as the biotech lines up what it hopes will be a much bigger OK for burosumab.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Clinical Scientist
Molecular Templates Jersey City, NJ
Manufacturing Associate - GMP Upstream
Molecular Templates Austin, TX
Director, Regulatory Affairs
Molecular Templates Jersey City, NJ
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Manufacturing Associate - GMP Downstream
Molecular Templates Austin, TX

Visit Endpoints Careers ->