Johnson & Johnson said Wednesday the U.S. Food and Drug Administration rejected its new-drug application for ceftobiprole, an antibiotic for the treatment of complicated skin and skin-structure infections, including diabetic-foot infections.
J&J's Pharmaceutical Research & Development unit said the FDA in a letter said the company needs to conduct additional audit work of clinical-investigator sites and to address specific questions related to site monitoring. J&J and its partner Swiss-based Basilea Pharmaceutica Ltd. are reviewing the FDA's letter and said they will continue to work with the agency to resolve any issues.
The companies initially asked for approval of the drug in May of 2007, but in March of this year the FDA asked for more information on the drug candidate. It has already been approved in Canada and Switzerland and an advisory committee in Europe has recommended approval in the European Union for the treatment of skin and soft-tissue infections.
Ceftobiprole is a broad-spectrum therapy to treat an antibiotic-resistant germ called MRSA that has been most commonly found in hospitals. Basilea said on its Web site that the rising incidence of methicillin-resistant staphylococcus aureus has focused attention on the need for a broad spectrum of antibacterials that also cover resistant bacteria.
Shares of Basilea fell 55.50 ($46.39) Swiss francs, or 36.6 percent, to 96 francs ($80.24), in Switzerland trading Wednesday. Shares of Johnson & Johnson slipped 43 cents to close at $58.27.
