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Basilea wins Canadian approval for new antibiotic

Basilea Pharmaceutica has announced that ceftobiprole, the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Health Canada authorizing the marketing of ceftobiprole for the treatment of complicated skin and soft tissue infections including diabetic foot infections.

Basilea Pharmaceuticals will co-promote the drug in Canada under the trade name Zeftera with its local partner Janssen-Ortho. Ceftobiprole is currently under review by regulatory authorities in the US, the EU, Australia, Russia, South Africa and Switzerland.

Zeftera (ceftobiprole medocaril for injection) is said to be the first approved broad-spectrum anti-Methicillin-resistant Staphylococcus aureus (MRSA)antibiotic belonging to the cephalosporin class. It 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.

Anthony Man, CEO of Basilea, said: “The availability of Zeftera is an important advance in the fight against infections due to potentially deadly bacteria, including MRSA and we are delighted by this first regulatory approval in Canada.”