Basilea/J&J's ceftobiprole approved in Canada

Basilea Pharmaceutica's ceftobiprole (Zeftera) has been approved by Health Canada for the treatment of complicated skin and soft tissue infections including diabetic foot infections. The Swiss originator will co-promote the predicted blockbuster, first-in-class broad-spectrum anti-methicillin resistant Staphyloccocus aureus cephalosporin with partner, US health care major Johnson & Johnson.

The intravenous agent is specially designed to bind the penicillin-resistant targets in many Gram-positive bacteria of the cocci-type, resulting in bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae. Earlier this year (Marketletter March 24), the US Food and Drug Administration issued an "approvable" letter for ceftobiprole. According to Lehman Brothers analysts, the issues raised by the agency could delay the drug's approval by up to 12 months. Their new expected US launch date for the compound in cSSSI is now second-half 2009 but expect the letter to have limited impact to a filing in pneumonia.