TKO: EMA rejects Ph3 ceftobiprole data, J&J bails

Today marks a TKO for Switzerland's Basilea.

Fresh concerns over the reliability of late-stage clinical data used by Switzerland's Basilea to back the new superbug antibiotic ceftobiprole caused regulators at the European Medicines Agency to drop their earlier recommendation in its favor. That move followed a decision by U.S. regulators to reject Basilea's pitch for an approval after questioning the data late last year. And its commercial partner J&J followed that one-two punch this morning with a decision to hand the whole program back to Basilea.

According to the EMA, good clinical practices had not been followed at some of the sites where the antibiotic was being tested. "Although the study results suggested that the medicine was beneficial to patients, the CHMP was concerned about how reliable the results were," the panel says in a statement.  

The earlier delays on the program led Basilea to file a claim against its partner J&J, saying that the big pharma company was responsible for the holdup. Today, the Swiss company says it's reviewing "all strategic options."

- here's the press release on the EMA decision
- here's the release on J&J's latest move
- and here's the Reuters story

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