BARDA Exercises First Contract Option With Marinus Pharma For Its Epilepsy Candidate

Vandana Singh
1 min read
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In this article:

  • Marinus Pharmaceuticals Inc (NASDAQ: MRNS) announced that the Biomedical Advanced Research and Development Authority (BARDA) exercised its first contract option, valued at approximately $12.3 million, to support U.S. onshoring of the manufacturing capabilities for ganaxolone active pharmaceutical ingredient (API).

  • This contract option was exercised under Marinus' ongoing cost-share contract with BARDA awarded in 2020 to support the development of intravenous (IV) ganaxolone for refractory status epilepticus (RSE).

  • Total potential BARDA funding under the contract if all options are exercised is approximately $51 million.

  • Related: Marinus Pharma Delays Status Epilepticus, IV Ganaxolone Clinical Trials Into 2023.

  • In addition to enabling a second, domestically sourced manufacturing capability for ganaxolone API, the onshoring initiative has the potential to drive a greater than 30% reduction in API supply cost.

  • Marinus has an ongoing Phase 3 clinical trial in RSE (the RAISE trial) and a complementary planned Phase 3 RSE trial for European registration (RAISE II) expected to begin in the second half of 2023.

  • Topline results for the RAISE trial are expected in the second half of 2023.

  • Ganaxolone development in the RAISE trial is partly funded with federal funds under the BARDA contract.

  • Price Action: MRNS shares are down 3.00% at $6.47 on the last check Thursday.

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