Eagle Pharma, Enalare: ENA-001 Gets FDA Orphan Drug Designation To Treat Apnea Of Prematurity

Eagle Pharmaceuticals, Inc. (EGRX) and Enalare Therapeutics Inc. announced Monday that the U.S. Food and Drug Administration has granted Orphan Drug Designation to ENA-001 for the treatment of Apnea of Prematurity or AoP.

AoP is a development disorder attributed to immaturity of the pulmonary system characterized by either cessation of breathing for more than 20 seconds or cessation of breathing that lasts less than 20 seconds but is accompanied by either bradycardia or hypoxemia. The condition affects approximately 25% of all preterm infants.

ENA-001 is a new chemical entity with a novel mechanism of action as an agnostic respiratory stimulant. It has previously been granted Rare Pediatric Disease Designation for the treatment of Apnea of Prematurity by the FDA with eligibility for a priority review voucher.

The compound is also being developed for post-operative respiratory depression and community drug overdose.

Herm Cukier, President and CEO of Enalare Therapeutics, said, "This is an important milestone that builds on the Rare Pediatric Designation granted by the FDA for ENA-001 last December. Currently, pharmacologic treatment for these neonates is typically limited to caffeine or other methylxanthines. We are eager to advance this program and bring improved options for the preterm infants facing this challenging respiratory condition."

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. The company also agreed to make two potential follow-on equity investments of $15 million each, contingent upon the commencement of the ENA-001 Phase 2 clinical trial, as well as 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 of the National Institutes of Health under award number R44DA057133.

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