By Chris Wack

 

Marinus Pharmaceuticals Inc. said it has submitted a new-drug application to the U.S. Food and Drug Administration for the use of its lead product candidate ganaxolone to treat seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy.

The pharmaceutical company said an NDA filing notification letter from the FDA is expected before the end of the third quarter.

If the NDA is accepted for filing by the FDA, this will enable the company to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management LP on or before Dec. 31, it said.

Marinus said the NDA includes a request for priority review, which, if granted, accelerates the timing of the FDA's goal for review of the application to six months following the end of the 60-day filing review period rather than the standard 10 month review.

Marinus also said it has entered into an agreement with Orion Corp. where Orion received exclusive rights to commercialize the oral and intravenous dose formulations of ganaxolone in the European Economic Area, U.K. and Switzerland for CDKL5 deficiency disorder, tuberous sclerosis complex and refractory status epilepticus.

Under the agreement, Orion will pay Marinus $30 million in cash as an upfront fee, Marinus said.

Marinus is eligible to receive up to an additional $115 million in R&D reimbursement and cash milestone payments based on specific clinical and commercial achievements, as well as tiered royalty payments based on net sales ranging from the low double digits to the high teens for the oral programs and the low double digits to the low 20s for the IV program, the company said.

Marinus shares were up 6% to $15.98 in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 03, 2021 07:48 ET (11:48 GMT)

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