Basilea Pharmaceutica Ltd. announces that ceftobiprole (Zeftera), 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.
Dr. 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. The labelling reflects our conviction that Zeftera is an innovative broad-spectrum, first-line treatment which may be used before knowing the exact bacteria causing the infection. This marketing authorization signals the start of a new era for Basilea as we commercialize the first of a number of innovative compounds in our pipeline."
Basilea Pharmaceuticals Corp. will co-promote the drug in Canada under the trade name Zeftera with its local partner Janssen-Ortho, Inc. Ceftobiprole is currently under review by regulatory authorities in the US, the European Union, Australia, Russia, South Africa and Switzerland.
Zeftera (ceftobiprole medocaril for injection) is the first approved broad-spectrum anti-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. Ceftobiprole as a single intravenous agent has demonstrated broad-spectrum activity against many other Gram-positive as well as Gram-negative bacteria, frequently associated with community and hospital-acquired infections.
Health Canada has indicated Zeftera for: "The treatment of the following infections when caused by susceptible strains of the designated microorganisms in patients 18 years of age and older: Complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis caused by: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus aureus (including methicillin-resistant isolates), and Streptococcus pyogenes."
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International. Basilea Pharmaceutica Ltd. has also exercised its option to co-promote ceftobiprole in the US and in the major European markets together with Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the US and the respective Janssen-Cilag companies in Europe. Basilea maintains an option to co-promote the drug in Japan and China.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SWX Swiss Exchange. Basilea's integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs.