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www.fdanews.com/articles/208613-marinus-sells-priority-review-voucher-to-novo-nordisk-for-110-million

Marinus Sells Priority Review Voucher to Novo Nordisk for $110 Million

July 15, 2022

Marinus Pharmaceuticals has entered into an agreement with Novo Nordisk to sell its Rare Pediatric Disease priority review voucher for $110 million.

The FDA awarded Marinus the voucher last March when the company received the agency’s approval for Ztalmy (ganaxolone), an oral suspension for the treatment of seizures associated with a rare form of genetic epilepsy called cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.

Marinus said that the $110 million will allow it to advance its clinical pipeline, including two ongoing phase 3 trials, but also the commercial launch of Ztalmy.

The FDA offers priority review vouchers to drug sponsors as an incentive to develop treatments for rare pediatric diseases. But the tradable vouchers can then be used to secure a faster review of any drug. Novo Nordisk has not said how it plans to use the voucher.

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