Janssen-Cilag submits application for ceftobiprole approval

Swiss integrated biopharmaceutical company Basilea has announced that Janssen-Cilag has submitted a marketing authorisation application with the Swiss regulatory authority for ceftobiprole as a treatment for diabetic foot infections and other complicated skin and soft tissue infections (cSSTI).

The compound is currently being developed through an exclusive worldwide partnership agreement between Cilag and Basilea Pharmaceutica.

“Swissmedic had previously granted accelerated assessment of the marketing authorisation application – Beschleunigtes Zulassungsverfahren – for ceftobiprole for the treatment of complicated skin and soft tissue infections,” the company reports.

Basilea adds that the compound is currently being reviewed by regulatory bodies in the European Union, in addition to those in the US and Canada.

Cilag joined the Johnson & Johnson family of companies in 1959, while its marketing divisions joined with Janssen Pharmaceutica in the 1990s to form Janssen-Cilage.

The company’s non-marketing activities remain active under the Cilag name, with the firm conducting research and development, manufacturing and international services in Switzerland.

In May 2007, Astellas Pharma announced the submission of a marketing authorisation application with the European Medicines Agencies for a potential treatment for cSSTI known as telavancin, a compound co-developed with Theravence.

The firm reports that in phase III clinical trials, the compound has achieved its primary endpoint of non-inferiority when administered to patients with methicillin-resistant Staphylococcus aureus infection.