On September 27, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") and Enalare Therapeutics Inc. ("Enalare") reported that Enalare has secured a contract for up to $50.3 million from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services (contract number 75A50122C00072) (Press release, Eagle Pharmaceuticals, SEP 27, 2022, View Source [SID1234621441]). In partnership with BARDA, ENA-001 is being developed in an intramuscular ("IM") formulation for potential use in patients experiencing community drug overdose and as a potential medical countermeasure for mass casualty events.
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The contract is awarded in stages based on the achievement of established milestones and deliverables and provides funding for Enalare to perform pre-clinical toxicology studies, human clinical studies, drug and device manufacturing, and submission of the regulatory file to the U.S. Food and Drug Administration ("FDA") for a formulation of ENA-001 suitable for community use. The first phase of the contract, which provides approximately $6.0 million to complete activities through the initial Phase 1 study, coincides with grant support from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health.
"Respiratory depression can be life threatening. This award provides critical non-dilutive funding to Enalare to accelerate the development of an IM formulation for ENA-001, which could potentially enable more rapid deployment in emergency situations. The pre-clinical work is going very well, and the BARDA contract provides support along the development and regulatory pathway toward FDA approval of ENA-001 for use in the United States. We believe this is a promising opportunity to address a serious, unmet issue in our society, and adds further to our enthusiasm for our agreement with Enalare," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
"We are pleased to expand our partnership with BARDA on the development of ENA-001 – a novel compound with a unique mechanism of action as an agnostic respiratory stimulant," said Herm Cukier, President and CEO of Enalare Therapeutics. "ENA-001’s rapid and proven ventilatory stimulation, irrespective of the cause of the respiratory depression, is critical for effective post-exposure therapy given the urgency for treatment and the unknowns associated with many chemical threats. Drug overdoses continue to ravage our communities, and with this new contract, we can accelerate our efforts to achieve our mutual goal of developing an innovative and rapid treatment for respiratory depression in a variety of settings," concluded Cukier.
The new award builds on an existing partnership between Enalare and the BARDA DRIVe ReDIRECT (Repurposing Drugs in Response to Chemical Threats) program. During that project, Enalare performed work to develop a formulation of ENA-001 that is suitable for intramuscular administration, which is much preferred for emergency use in the community.
The funding is provided via Biomedical Advanced Research and Development Authority to support the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population.
In August 2022, Eagle made an equity investment of $12.5 million in Enalare, with a commitment to invest another $12.5 million six months later and two potential follow-on equity investments of $15 million each contingent upon (i) the commencement of the ENA-001 Phase 2 clinical trial, and (ii) the ENA-001 Phase 2 clinical trial reaching 50% enrollment. Eagle also has the option to acquire the remaining Enalare shares for an aggregate purchase price ranging from $100-$175 million plus royalty rights ranging from 9%-12% on all future global net sales of any Enalare product, paid to the ex-Eagle holders of Enalare shares at the time of acquisition.
The development of ENA-001 is also supported by the National Institute on Drug Abuse ("NIDA") of the National Institutes of Health ("NIH") under award number R44DA057133. The content of this document is the responsibility of its authors and does not necessarily represent the official views of the National Institutes of Health.
About ENA-001
Enalare’s lead compound, ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant. The compound has a novel mechanism of action that affects ventilation via the peripheral chemoreceptor pathways in the carotid body. It utilizes the body’s own ventilation control system to beneficially influence breathing and has been shown to be effective and well tolerated in five human studies to date. With its novel mechanism of action and based on findings to date, it could potentially improve the lives of those impacted by several life-threatening conditions, including community drug overdose, post-operative respiratory depression, and apnea of prematurity. ENA-001 is an investigational compound and is not approved for use by the FDA.