Novartis buys priority review voucher - which drug?

Novartis buys priority review voucher from Pharming for discount price of $21M
By James Waldron
Jun 1, 2023 07:12am

When licensing Joenja to Pharming in 2019, Novartis secured the right to a “pre-agreed, contractually defined percentage of the PRV value.” (SeventyFour/iStock/Getty Images Plus)
Novartis has acquired a priority review voucher from Pharming for the bargain price of $21.1 million, thanks to some shrewd dealmaking dating back a few years.

The Dutch biotech was awarded the rare pediatric disease priority review voucher by the FDA back in March in connection with the approval of its activated phosphoinositide 3-kinase delta syndrome drug Joenja, also known as leniolisib.

If $21 million sounds like pretty good value for an accelerated review pass, that’s because it is. Novartis paid $100 million for a similar voucher from the opioid-crisis-crippled Mallinckrodt in July 2022, close to the $110 million Novo Nordisk paid Marinus Pharmaceuticals a month earlier.

The reason for the steep discount dates back to the original licensing agreement signed in August 2019 when Pharming acquired the rights to Joenja from Novartis. This gave the Swiss pharma the option to purchase the voucher for a “pre-agreed, contractually defined percentage of the PRV value,” the Amsterdam-based biotech explained in a June 1 release.

Priority review vouchers act as a regulatory token that can be redeemed for an accelerated review, shaving the review time of approval applications from 10 months to six. The question now is what asset Novartis will use the voucher for—Fierce Biotech had not received a response from the Big Pharma to a request for this information at the time of publication.

A 2020 government analysis of the voucher program found that in the 10 years since launch in 2009, more than half were sold off. The price of the sales ranged from $67 million to $350 million. Of the 31 vouchers that were issued from 2009 to 2019, 16 had been redeemed.

 

Expanded label for breast cancer drug or Zolgensma IT