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Eagle Pharmaceuticals Takes Equity Stake in Enalare Therapeutics
Friday 12 August 2022

US-based Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) has inked an agreement to make an equity investment of USD 25m in clinical-stage privately held biopharmaceutical company Enalare Therapeutics Inc, the company said.

Enalare is focused on developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions.

The investment also includes an exclusive option for Eagle to acquire all remaining issued and outstanding Enalare stock upon the achievement of development milestones as set forth in the agreement.

As part of the transaction, Eagle will invest up to approximately USD 55m, which is expected to occur over the next two years subject to the achievement by Enalare of certain milestones on an agreed upon timeline.

The investment consists of an upfront investment of USD 25m, USD 12.5m now and USD 12.5 to be paid in six months, and two potential follow-on equity investments of USD 15m each contingent upon the commencement of the ENA-001 Phase 2 clinical trial, and the ENA-001 Phase 2 clinical trial reaching 50% enrollment.

Eagle and Enalare have also entered into an agreement providing Eagle the option to acquire the all remaining Enalare shares for an aggregate purchase price ranging from USD 100-USD 175m 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 transaction is expected to provide Eagle with products protected by intellectual property rights, including composition of matter patents, which potentially provide patent term into the mid-2030s to the early 2040s.

The company believes these products have the potential to address significant unmet medical needs for millions of patients worldwide suffering from acute respiratory depression, including those in the hospital post-operative care setting, those experiencing community drug overdose, and preterm infants suffering a common condition known as Apnea of Prematurity.

Enalare's lead compound, ENA-001, is an investigational, one-of-a-kind NCE designed as an agnostic respiratory stimulant.

ENA-001 is also being developed in an Intramuscular Formulation in partnership with the Biomedical Advanced Research and Development Authority for the potential use in patients experiencing drug overdose in a community setting and as a potential medical countermeasure for mass casualty events.

This effort is also supported via a grant from the National Institute on Drug Abuse (NIDA: award number R44DA057133), a division of the National Institutes of Health.

Enalare is planning to complete the required preclinical activities with the IM formulation in the near term and to begin human clinical studies in the first half of next year.

In addition, Enalare is developing ENA-001 for the treatment of Apnea of Prematurity, a condition commonly affecting infants born preterm in which they experience shallow or intermittent stoppage of breathing.

Persistent AoP can cause near- and long- term neurological development risks to the infant. ENA-001 has received Rare Pediatric Disease designation from the US Food and Drug Administration in the treatment of AoP, which potentially provides for a priority review voucher if the product is approved for this indication.

Enalare is currently executing an animal proof-of-concept study with ENA-001 in the treatment of AoP and expects to further pursue orphan drug designation and initiate human clinical trials.

ENA-001 is an investigational new chemical entity being developed by Enalare for multiple potential indications, including the prevention and treatment of post-operative respiratory depression.

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.

If approved, ENA-001 would offer new treatment options for physicians, emergency responders, and caregivers addressing acute respiratory depression across multiple patient populations in multiple settings.

Enalare Therapeutics Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions, including community drug overdose, post-operative respiratory depression, and apnea of prematurity.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise.
Date Published: 12/08/2022