1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say

 
• By Sue Sutter

Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.

Sanofi/Regeneron Pharmaceuticals Inc.’s $67.5 million purchase of a rare pediatric disease priority review voucher from BioMarin Pharmaceutical Inc. sets the first public price tag on what a four-month reduction in FDA review time is worth. However, it also renews questions about whether tropical disease vouchers can command as high a price as their pediatric voucher brethren.

The longer regulatory lead time needed for voucher redemption and limitations on the number of transfers have been seen as making tropical disease vouchers less appealing to potential buyers than...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.