Marinus Pharma Shares Up After Deal for Rare Pediatric Disease Priority Review Voucher
July 14 2022 - 8:23AM
Dow Jones News
By Michael Dabaie
Marinus Pharmaceuticals Inc. shares were higher premarket
Thursday after the pharmaceutical company agreed to sell its Rare
Pediatric Disease Priority Review Voucher for $110 million, a move
the company said will strengthen its financial position.
In a Securities and Exchange Commission filing, Marinus said it
was selling the voucher to Novo Nordisk Inc.
Its shares rose 4.9% to $5.82 premarket.
The company received the voucher in March 2022 under a U.S. Food
and Drug Administration program to encourage the development of
treatments for rare pediatric diseases. Marinus was awarded the
voucher when it received approval of Ztalmy oral suspension CV for
the treatment of seizures associated with CDKL5 deficiency
disorder, a rare form of genetic epilepsy, in patients two years of
age and older.
"Upon completion, the sale of the PRV will significantly
strengthen Marinus' financial position, which we believe extends
our cash runway into the fourth quarter of 2023" and allow the
company to maintain momentum advancing its pipeline, including the
two Phase 3 trials in status epilepticus and tuberous sclerosis
complex, and focus on the commercial launch of Ztalmy, Marinus
Chief Financial Officer Steven Pfanstiel said.
Under the FDA program, a voucher is issued to the sponsor of a
rare pediatric disease product application and entitles the holder
to priority review of a single new drug application or biologics
license application. The sponsor can choose to sell or transfer the
voucher upon approval of the rare pediatric disease product
application.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
July 14, 2022 08:08 ET (12:08 GMT)
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