Cempra Reports QIDP Designation For Solithromycin - Quick Facts

(RTTNews) - Cempra Inc. (CEMP) announced the U.S. 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 exclusivity.

An oral formulation of solithromycin is currently being evaluated in a Phase 3 trial for the treatment of community-acquired bacterial pneumonia. Cempra is planning to initiate an intravenous-to-oral Phase 3 step-down Phase 3 trial during the second half of 2013.