Cempra sags as reviewers fret over Solithera worries

Cempra Inc. (NASDAQ:CEMP) plummeted $11.35 (61%) to $7.30 on Wednesday after FDA reviewers said hepatotoxicity findings from clinical studies of oral and IV Solithera solithromycin constitute a "genuine liver injury signal." The comments came in briefing documents released ahead of Friday's planned meeting of FDA's Antimicrobial Drugs Advisory Committee to discuss an NDA for the candidate to treat community acquired bacterial pneumonia (CABP).

The reviewers noted that hepatic events observed in Solithera's development program exceed those observed prior to FDA's 2004 approval of Ketek telithromycin from Sanofi (Euronext:SAN; NYSE:SNY), a structurally-related ketolide antibiotic. Post-marketing studies associated telithromycin with liver injury, including four liver-related deaths and one transplant, and FDA later curtailed its use in some indications (see BioCentury, Dec. 18, 2006)...