Basilea says that its soon-to-be ex-partner Johnson & Johnson is to discontinue sales of the antibiotic Zevtera in Switzerland following problems it has had elsewhere in getting the drug approved.
J&J’s Janssen-Cilag unit has asked Swissmedic to withdraw its sales licence for Zevtera (ceftobiprole) based on “the unfavorable assessments of the marketing authorisation applications” in the USA and the European Union. The product was approved in Switzerland in November 2008 for the treatment of complicated skin and soft tissue infections.
J&J has also put in requests for withdrawals of marketing applications in Russia, Ukraine and Azerbaijan, the remaining countries in which ceftobiprole is currently approved.
However the road to approval has been tough elsewhere. At the beginning of the year, the US Food and Drug Administration rejected Zevtera because data from two studies was found to be “unreliable or unverifiable”. A month later, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion on the superbug drug, having originally backed approval.
Basilea, which has put in a damages claim against J&J, noted that the rights to Zevtera are being transferred back. The Basel-based group added that the decision to discontinue sales of the drug in the Swiss market “does not preclude the submission of a new application for marketing authorisation in the future”.
