Eagle Pharmaceutics Inc. EGRX said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product (QDIP) and Fast-Track Designation for CAL02, a treatment for severe community-acquired bacterial pneumonia (SCABP) as an add-on therapy to standard of care. The former designation will entitle the company to an additional eight to 10 years of regulatory exclusivity if the product is approved. Eagle also believes CAL02 is a new chemical entity, which would result in five years of marketing exclusivity. The latter underscores the significant unmet medical need in treating SCABP, a global illness that is associated with high morbidity and mortality, despite the availability of vaccines and antibiotics. Woodcliff Lake, N.J.-based Eagle is currently evaluating CAL02 in a Phase 2 trial where it’s being administered intravenously in addition to standard of care. The trial aims to enroll about 2l76 patients with SCABP worldwide. The QIDP designation was created in 2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. The stock has fallen 36% in the year to date, while the S&P 500 has gained 11%.
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