Marinus Pharmaceuticals is using a priority review voucher granted four months ago as a financial life preserver, selling the accelerated review pass designated for rare pediatric diseases to Novo Nordisk for $110 million, according to a disclosure Thursday. The sale extends Marinus’ cash runway into the fourth quarter of 2023.
The voucher was given to Marinus in March after the approval of Ztalmy, a treatment for seizures related to a rare form of genetic epilepsy. But the company preferred instead to reinvest in its existing R&D effort, saying Thursday that the new proceeds would fund existing trials including two phase 3 studies in status epilepticus and tuberous sclerosis complex, respectively. The first of the two readouts from those trials is not expected until the second half of 2023.
Chief Financial Officer Steven Pfanstiel also said in a statement that the money would help pay for the commercial launch of Ztalmy, which is slated for this month. Although the sale nearly doubled Marinus’ available cash reserves, Wall Street did not seem particularly impressed, with Marinus’ shares down more than 6% from $5.55 to $5.20 as the markets opened Thursday.
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. It’s not immediately clear how Novo Nordisk will use it but spokesperson Allison Schneider said the company will decide in the “near future.”
Novo previously acquired a voucher from Medicines Development for Global Health in 2019. The company did not disclose then how much it had paid for the chance at a swift review.
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.
By Max Bayer
Source: fiercebiotech.com
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