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Cempra, Inc.
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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