Basilea Pharmaceutica said that the US FDA has issed a warning letter to Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) related to ceftobiprole clinical trials, for the treatment of complicated skin and skin structure infections.
The Warning Letter relates to observations from FDA sponsor and clinical site inspections conducted during the first part of 2008.
Consistent with Basilea’s earlier press releases, the Warning Letter asserts that there was a failure to ensure proper monitoring of the studies as well as deficiencies in study conduct.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic. It is marketed in Canada (ZEFTERA) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis. In Switzerland, (Zevtera) is marketed for the treatment of complicated skin and soft tissue infections (cSSTI), including diabetic foot infections without concomitant osteomyelitis.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International and Cilag GmbH International, a Johnson & Johnson company.