Eagle swoops down to nab chunk of BARDA-backed Enalare Therapeutics

Eagle Pharmaceuticals isn’t leaving M&A to larger birds of prey in the biopharma kingdom, swooping down to take a piece of Enalare Therapeutics and its lead asset, ENA-001.

The cost for Eagle to spread its wings comes in the form of a $55 million bet in Enalare, with the opportunity to fully acquire the company later, the two companies announced Tuesday. The first $25 million will be paid upfront with the remaining $30 million contingent on Enalare successfully launching ENA-001 into phase 2 trials and achieving 50% enrollment. Eagle also has the option to gobble all remaining Enalare shares at a later date, to the tune of $100-$175 million plus royalties.

Eagle's interest centers on Enalare’s agnostic respiratory stimulant, ENA-001, currently in development for post-operative respiratory depression, community drug overdose and apnea of prematurity, a breathing condition impacting newborns. Phase 1 data released in June found that the med reversed respiratory depression caused by anesthesia.

The potential of the drug to reverse hypoventilation motivated the U.S. government to chip in with a contract from the Biomedical Advanced Research and Development Authority (BARDA) in April 2021 to repurpose the therapy for opioid overdoses. Enalare expects to enter clinical trials for this use in the first half of 2023.

“Without added headcount or expense, Eagle will be able to rely on our experienced and highly regarded team as we move onto phase 2 and 3 trials, which we believe will successfully demonstrate ENA-001's ability to improve patient respiratory capacity,” said Enalare CEO Herm Cukier. 

Eagle estimates the asset will be ready for commercial launch in 2026, years off an initial estimate teased by Enalare. A corporate presentation from October 2020 projected that ENA-01 would be ready to hit the market to treat both opioid overdoses and infection-related respiratory distress in 2022. 

The critical care opportunity presented by ENA-01 fits into Eagle’s existing pipeline, which includes FDA-approved Barhemsys to treat post-operative nausea and surgical sedation med Byfavo. Eagle CEO Scott Tariff said the equity and potential acquisition fortifies the company’s ambitions of being a “diversified, branded pharmaceutical company with long-duration assets in acute care.”