The U.S. government has exercised a $12.3 million option with Marinus Pharmaceuticals to manufacture the active pharmaceutical ingredient (API) for the anti-seizure drug ganaxolone.
The Department of Health and Human Services’ Biomedical Advanced Research and Development Authority signed off on the option under its ongoing cost-sharing contract with Marinus. The government inked the deal in 2020 in an effort to support the development of intravenous ganaxolone for the treatment of refractory status epilepticus (RSE).
Under terms of the contract, Marinus could reap about $51 million if all options are exercised.
The U.S. agency desires a treatment for RSE as a way to combat chemical warfare agents (organophosphare nerve agents) that can cause prolonged seizures that become more difficult to treat as they progress.
Producing and stockpiling the APIs needed to manufacture ganaxolone also fits into the government’s onshoring initiative, which could reduce the drug's API supply costs by more than 30%, the company said.
“We believe that this agreement is an important step forward in advancing the development of ganaxolone to potentially transform the treatment paradigm for status epilepticus, including in individuals exposed to nerve gas,” Scott Braunstein, M.D., Marinus’ chief executive, said in a statement.
Marinus restarted its phase 3 seizure clinical trials in early May after delays caused by clinical supply disruptions and the COVID-19 pandemic. It expects top-line results in the second half of 2023, a year later than its prior target of the second half of 2022.
The company said it’s planning a phase 3 RSE trial for European registration (RAISE II) that is expected to start in the second half of 2023.