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European regulators have delayed approval of Johnson & Johnson’s new antibiotic for skin infections, leading the firm’s Swiss partner in the drug’s development to launch legal action.
Ceftobiprole has been designed to treat complicated skin and soft tissue infections, including the deadly hospital superbug MRSA.
But the European Medicines Agency has delayed approval pending completion of what it called a “good clinical practice inspection”, involving the review of records at European hospitals and other sites where patient testing was conducted.
The product had previously been delayed by the US Food and Drug Administration after the watchdog said it also wanted to investigate clinical-investigator sites where the drug was tested on patients.
Following the repeated delays, Swiss firm Basilea Pharmaceutica is now attempting to claim financial damages and has submitted a request for arbitration to the Netherlands Arbitration Institute, including a demand for milestone payments.
Analyst Steve Brozak of WBB Securities said: “In this environment, for small biotechs, any delay is absolutely devastating.
“What is absolutely essential for Basilea is just one of many projects for Johnson & Johnson.”
Copyright Press Association 2009