— Expected to start a Phase 2 study in approximately 276 patients with severe community-acquired pneumonia at approximately 120 sites worldwide —

— Patient recruitment expected to begin as early as early 2023 —

— CAL02 is being developed as an adjunct to clinically indicated antibiotic treatment —

WOODCLIFF LAKE, NJ, November 14, 2022 (GLOBE NEWSWIRE) — Eagle Pharmaceuticals, Inc. EGRX (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved its investigational new drug application (“IND”) for CAL02, a novel, first-in-class, broad-spectrum antibiotic, -Virulence Agent for Adjunctive Treatment of Severe Community-Acquired Bacterial Pneumonia (“SCABP”).

The Phase 2 study is expected to begin in early 2023 with enrollment of approximately 276 patients with severe community-acquired pneumonia at approximately 120 sites worldwide.

“We are pleased that CAL02 IND has been accepted by the FDA and look forward to initiating the Phase 2 trial, which is expected in early 2023. We have already identified a pool of suitable sites in 22 countries which we believe could add up to approximately 120 sites worldwide,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “This is an exciting program and we believe it that CAL02 has the potential to improve the treatment regimen for patients with severe community-acquired pneumonia, as well as shorten disease duration and improve patient outcomes,” concluded Tarriff.

CAL02 may be eligible for ten years of regulatory exclusivity, including five years as a new chemical entity and five years as a qualified product for infectious diseases (“QIDP”) under the Generating Antibiotic Incentives Now (“GAIN”) Act. Eagle believes CAL02 may be eligible for Fast Track and Breakthrough Therapy status. In addition, Eagle believes that a CAL02 application for a new drug to treat SCABP may be a candidate for priority consideration. That…