Marinus Pharmaceuticals ( NASDAQ: MRNS ) said the Biomedical Advanced Research and Development Authority (BARDA) exercised its first contract option worth ~$12.3M, to support U.S. onshoring of manufacturing capabilities for seizure therapy ganaxolone active pharmaceutical ingredient (API).
The option was exercised under Marinus' ongoing cost-share contract with BARDA awarded in 2020 to help develop intravenous (IV) ganaxolone to treat refractory status epilepticus (RSE) — a condition where a seizure lasting longer than 5 minutes or there is more than one seizure within 5 minutes, despite treatment.
Total potential funding under the contract is ~$51M, which includes up to $21M in previously approved base-period funding, today's ~$12.3M, and up to $18M across two additional option periods, the company said in a Sept. 22 press release.
Marinus has an ongoing phase 3 trial in RSE called RAISE, and a complementary planned phase 3 RSE trial, dubbed RAISE II, for European registration which is expected to begin in H2 2023.
The company expects results from the RAISE trial in H2 2023.
BARDA is part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services.
MRNS +2.55% to $6.84 premarket Sept. 22
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US government uses contract option for Marinus' seizure therapy ganaxolone