Cempra Pharmaceuticals, Inc.'s Solithromycin (CEM-101) Receives Qualified Infectious Disease Product Designation From the FDA
9/6/2013 9:44:37 AM
CHAPEL HILL, N.C., Sept. 6, 2013 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated oral Solithromycin (CEM-101), as a Qualified Infectious Disease Product (QIDP) for the indication of community-acquired bacterial pneumonia. The QIDP designation is expected to enable Cempra to benefit from certain incentives for the development of new antibiotics, including priority review, and a five year extension of new chemical entity (NCE) exclusivity. An oral formulation of solithromycin is currently being evaluated in a Phase 3 trial for the treatment of community-acquired bacterial pneumonia (CABP). Cempra is planning to initiate an intravenous-to-oral Phase 3 step-down Phase 3 trial during the second half of 2013.
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