US BARDA contracts onshore manufacture of nerve agent treatment
The agreement between Marinus Pharmaceuticals and the US Biomedical Advanced Research and Development Authority (BARDA) was agreed in 2020, which provided the latter government department with three options to provide funding to the development of ganaxolone.
With BARDA exercising the first of its options, it will provide $12.3m (€12.6m) of funds to develop manufacturing capabilities for the active pharmaceutical ingredient (API) in the US.
BARDA has an interest in aiding the manufacture of API in the US because ganaxolone is being investigated to treat seizures that are not stopped by first-line anticonvulsants, such as in the case of nerve agent-induced refractory seizures.
In the situation of a mass-exposure situation, current anticonvulsants may be less effective at stopping seizures due to the potential for delayed delivery. As ganaxolone works through a different mechanism, the potential treatment may be able to treat seizures when other drugs are not effective – or potentially utilized in combination with existing therapies.
Outlining BARDA’s interest in the API, Scott Braunstein, CEO of Marinus, stated, “We remain committed to advancing this critical workstream and look forward to continued collaboration with BARDA to expand the government’s medical countermeasure capabilities in the event of a chemical attack.”
Marinus is in line to receive a total of approximately $51m, which consists of a $21m grant previously provided by the department and the eventuality that all three options are exercised by BARDA.
Regarding creating a manufacturing structure for the API itself, the company stated that the funding would enable it to create a second, domestic manufacturing source. In addition, the company expects that the onshoring effort could reduce the cost of supply of the API by more than 30%.
Marinus is currently putting ganaxolone through Phase III trials, and has an additional Phase III study planned for European registration that is expected to begin in the second half of 2023. The US section of the trials is being part-funded by federal government support from BARDA.
The actual condition for which the drug is being tested is status epilepticus, a condition that is characterized by prolonged or repetitive seizures if treatment is delayed or ineffective. It is estimated to affect 150,000 individuals in the US each year.
The company has stated that the treatment has the opportunity to become the standard of care for treating such seizures, if approved.
BARDA’s support for companies that are working in areas deemed to be important, in terms of national health or national emergencies, is not unusual. The department has previously signed a smallpox drug stockpiling contract, and also played a role in providing support to COVID-19 services during the height of the pandemic.