Basilea off on FDA complete response
Basilea Pharmaceutica AG (SIX:BSLN) fell CHF11.70 (15%) to CHF64.45 on Wednesday after FDA issued a complete response letter for an NDA from partner Johnson & Johnson (NYSE:JNJ) for ceftobiprole to treat complicated skin and skin structure infections (cSSSIs). According to Basilea, FDA said data from two Phase III trials of ceftobiprole are unreliable based on inspections and audits of about one third of the trial's sites. The agency recommended the company conduct two additional Phase III trials as well as a clinical pharmacology study. The complete response follows an August warning letter, in which FDA concluded that J&J had not adhered to the agency's regulations governing the conduct of clinical trials. It is the second complete response letter for the compound, with FDA issuing the first in November 2008; FDA issued an approvable letter for the compound in March 2008. ...