The price for a priority review voucher keeps going up. In May of this year, the price was $245 million. Today, Abbvie bought one for $350 million from United Therapeutics.
The Priority Review Voucher program was introduced to encourage companies to develop drugs for rare pediatric conditions or neglected tropical diseases. If the company’s drug gets approved for a pediatric or neglected tropical disease, the FDA can give them a voucher that they can then use for future drug applications. A priority review designation by the FDA means the drug will be reviewed in 6 months instead of the standard 10 months. And the vouchers can be applied to ANY future drug application by the company. Normally, a priority review designation would only be given to a drug that is for a 'serious condition' and has demonstrated 'the potential to be a significant improvement in safety and effectiveness'.
The Priority Review Voucher is also transferable and that is what United Therapeutics decided to do with their voucher—sell it. And Abbvie believes that getting one of their drugs to market 4 months earlier is worth $350 million.
United Therapeutics received the Pediatric Disease Priority Review Voucher when dinutuximab was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease in March, 2015.
Upon closing of the transaction, United Therapeutics will receive $350 million in cash in exchange for the Priority Review Voucher. The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
In a press release, Roger Jeffs, PhD, president and co-CEO of United Therapeutics said, "We are very pleased to monetize our PPRV (Pediatric Priority Review Voucher), and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases."
The Price Continues to Rise
The $350 million that Abbvie will pay for the voucher is much higher than the $245 million
Sanofi paid Retrophin for its voucher earlier this year. And that price was higher than the $67.5 million and $125 million that Biomarin and Knight Therapeutics received for their vouchers last year from Regeneron
United Therapeutics Corporation Agrees to Sell Priority Review Voucher to AbbVie for $350 Million [news release]. United Therapeutics Corp. August 20, 2015. http://www.prnewswire.com/news-releases/united-therapeutics-corporation-agrees-to-sell-priority-review-voucher-to-abbvie-for-350-million-300130415.html
Image of money courtesy wikimedia commons. https://commons.wikimedia.org/wiki/File:VegasBitch198.jpg