Basilea falls on ceftobiprole delay
Basilea (SWX:BSLN) fell CHF55.50 (37%) to CHF96 on Wednesday after FDA issued a complete response letter for an NDA from Basilea partner Johnson & Johnson (NYSE:JNJ) for ceftobiprole to treat complicated skin and skin structure infections (cSSSIs), including diabetic foot infections. The letter comes two months after J&J submitted a complete response to a March approvable letter for the broad spectrum anti-MRSA cephalosporin antibiotic. According to Basilea, FDA said further resolution of "deficiencies of study conduct" was necessary and that there was a "failure to ensure proper monitoring" of studies of the compound.
Basilea said the agency requested additional clinical site audits, information about J&J's clinical quality assurance programs, and a new audit plan that addresses deficiencies in monitoring CROs. FDA said it could not review the data in J&J's complete response until data integrity issues were resolved. It gave the pharma one year to respond, according to Basilea. ...