PIPELINE

POWERED BY
PURPOSE

Every product candidate in our pipeline represents a major step in the right direction for patients and healthcare providers. Our teams have been hard at work to grow our portfolio of acute care and oncology treatments with the goal of improving lives through innovative therapies.

THE TEAMS
AT WORK

 

Medical and Operations

Woodcliff Lake, NJ

Jupiter, FL

Office of Pharmaceutical Development

Cambridge, MA

Eagle Pharmaceuticals Product Candidates and Pipeline Opportunities

CAL021

  • Novel first-in-class anti-toxin agent being developed for the treatment of severe community-acquired bacterial pneumonia
  • Global Phase 2 study underway
    • Approx. 276 patients expected
    • Approx. 120 centers in 22 countries expected
  • CAL02 will receive five years of marketing exclusivity upon approval if approved as an NCE (or three years without NCE designation)
  • Received FDA Fast-Track and Qualified Infectious Disease Product (QIDP) designations, which provide five years’ exclusivity extension (for a total potential of eight or ten years of exclusivity)
  • Interim analyses: Interim results expected during the first half of 2024

ENA-0012

  • ENA-001 is an investigational new chemical entity being developed by Eagle’s partner, Enalare, as an agnostic respiratory stimulant for multiple patient populations experiencing respiratory depression
  • Post-op respiratory depression
    • Enalare commenced fentanyl tox study in early 2023
    • Expect to start additional tox study as early as 3Q23
  • Community Drug Overdose (BARDA and NIH funding)
    • Executing toxicology studies with intramuscular formulation (IM)
    • Expect Phase 1 enrollment 2023
  • Apnea of Prematurity (Rare Pediatric Disease and Orphan Drug designations)
    • Completed animal proof of concept
    • Designing next set of animal studies and clinical pathway

EA-114

  • Novel and proprietary formulation of fulvestrant being developed for hormone-receptor-positive (HR+) metastatic breast cancer
  • Potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients
  • Positive Type C meeting with FDA in August 2023; agreed on a path forward to advance the clinical development of EA-114
  • Eagle plans to file a new drug application (“NDA”) for EA-114 in 2024

Docetaxel Injection Non-Alcohol Formula

Learn more about Docetaxel Injection, including boxed warning and approved indications in the full Prescribing Information

About Expanded Access for CAL02

At Eagle, we are committed to developing first-in-class treatments for patients with severe pneumonia and physicians who treat them.

CAL02 has been designed and is being developed as an adjunctive treatment for patients with severe pneumonia. We will conduct clinical studies to demonstrate the safety and efficacy of CAL02 and obtain regulatory approval, and ultimately make CAL02 available.

Before regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, such as CAL02, by participating in clinical trials and by ‘Expanded access,’ also referred to as compassionate use, ‘Early Access,’ and ‘Emergency Use.’ Patients who seek access to investigational medicines outside of an established clinical study and before health authority marketing authorization may wish to do so because standard treatments have failed, because they cannot tolerate already approved medicines, because they are unable to participate in a clinical study or because there are no comparable or satisfactory therapy options available outside of clinical trials. The primary purpose of expanded access is to use the investigational drug for patient treatment purposes rather than to gather data on safety, tolerability, and effectiveness.

Currently, Eagle Pharmaceuticals does not offer an expanded access program and does not accept expanded access requests outside of clinical trials. We believe that access to CAL02 should be limited to clinical trials until such time as its safety, tolerability and effectiveness for a particular indication has been determined and confirmed by regulatory authorities. Ongoing clinical trials can be found at www.clinicaltrials.gov, NCT05776004. Patient access to CAL02 outside of a clinical trial may interfere with the conduct of our ongoing and future clinical trials and may also disrupt the progress of our development program, which would, in turn, delay access to many patients in need.

Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access CAL02. If you have questions about Eagle’s expanded access policy, please contact Eagle at Eagle2202study@inclin.com. Please expect a response within five business days. In line with the 21ST Century Cures Act, Eagle may revise this policy at any time.

  1. Eagle Pharmaceuticals. Press Release, November 14, 2022. https://investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-announces-fda-acceptance-investigational.
  2. In August 2022, Eagle acquired a 17% equity stake in Enalare, with an option to purchase the remaining shares of Enalare upon achievement of specified milestones.
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