The ceftobiprole saga isn't finished yet. Basilea Pharmaceutica said this morning that J&J subsidiary Janssen-Cilag International has asked European regulators to re-examine their rejection of a marketing application for the superbug antibiotic ceftobiprole, a troubled program that has endured despite bickering partners and a cloud now hovering over its clinical trial process.
Last month the European Committee for Medicinal Products for Human Use rejected the application to market the treatment for complicated skin and soft tissue infections. Regulators at the EMA had pulled an earlier recommendation after concluding that good clinical practices weren't followed at some of the sites. And late last year U.S. regulators had also questioned the data submitted for the antibiotic.
J&J, which had been fending off accusations by Basilea that it was responsible for a delay in gaining an approval, had responded by handing the rights to the program back to Basilea. And Basilea CEO Anthony Man said that the company was reviewing all its options in light of J&J's decision to terminate its license. One of those options evidently included a new pitch to regulators, even with low odds of any quick success. Basilea says that a final opinion could arrive in four or five months.
- here's Basilea's release for more info