New Jersey biotech nets $50M+ BARDA contract for respiratory candidate

Eagle Pharmaceuticals is keeping an eye on Enalare Therapeutics’ lead respiratory candidate, and apparently, so is the US government.

The New Jersey-based biotech struck a deal with BARDA worth up to $50.3 million to develop the lead compound, dubbed ENA-001, the company announced on Tuesday. The candidate is designed to simulate breathing and is meant to be used in emergency cases when treating drug overdoses or respiratory depression post-surgery.

According to Enalare, the first phase of the contract will give it $6 million to complete any actions through its Phase I trial. The overall award, which will be based on several milestones in R&D and production, will give funding for toxicology, human trials, manufacturing and regulatory filings.

Herm Cukier

CEO Herm Cukier told Endpoints News in an email that the discussion to expand its relationship with BARDA started at the beginning of this year. The company has been a part of the DRIVe ReDIRECT (Repurposing Drugs in Response to Chemical Threats) program.

For the company to have a finished product, it will still take several years. The company is also planning for all the manufacturing to be done in the United States once that stage is reached.

“We are working with BARDA to have an approved drug available before the end of the decade and will seek all means to accelerate the timeline as possible,” Cukier said in an email to Endpoints.

This is not the first deal that Enalare has managed to receive. Last month, Eagle Pharmaceuticals placed a $25 million investment into the company, with a $12.5 million upfront payment, followed by an additional $12.5 million in six months. If the drug enters Phase II, which is supposed to kick off next year, and reaches a 50% enrollment in that trial, Eagle has the option to make two additional investments of $15 million each, and the option to acquire the biotech outright.

BARDA, while giving out major contracts to manufacturers to counter the monkeypox outbreak, has not been neglecting other diseases. Earlier this month, the San Diego-based biotech Arcturus Therapeutics won a $62.3 million award from BARDA to eventually push a candidate for influenza from the preclinical stages through to Phase I.

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