Discontinuation of sale of ceftobiprole in Switzerland

Janssen-Cilag AG, the holder of the Marketing Authorization in Switzerland, has requested Swissmedic to withdraw the marketing authorization of Zevtera™ and will discontinue sale of Zevtera™ as of September 17, 2010. This action is being taken based on the unfavorable assessments of the marketing authorization applications for ceftobiprole in the United States and the European Union.

Physicians are advised to allow all patients on Zevtera™ to complete their course of therapy and not to initiate treatment of new patients. Zevtera™ was authorized in Switzerland in November 2008 for the treatment of cSSTI. There have been no safety observations that would be in conflict with the approved label of Zevtera™.

The decision to discontinue sale of the product in the Swiss market does not preclude the submission of a new application for marketing authorization in the future. Corresponding requests for the withdrawal of Marketing Authorizations are being submitted to health authorities by a respective Janssen-Cilag company holding the Marketing Authorization in Russia, Ukraine and Azerbaijan, the remaining countries in which ceftobiprole is currently approved.

Contact
Adesh Kaul Head Public Relations & Corporate Communications +41 61 606 1460 media_relations@basilea.com