Shares in Basilea are down this morning after regulators in Europe said they could not recommend approval for the antibiotic ceftobiprole, having previously backed the drug.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing authorisation application for ceftobiprole, filed by Basilea’s partner Johnson & Johnson unit Janssen-Cilag, for the treatment of complicated skin and soft tissue infections.

The superbug drug was filed as long ago as June 2007 and actually received a positive opinion from the CHMP in November 2008. However the EMEA says it “ took the unusual step” of halting the authorisation process on ceftobiprole “pending completion and assessment of Good Clinical Practice inspections”.

Those inspections showed that the Phase III studies supporting the MAA had not been conducted in compliance with GCP in some sites and the CHMP says that, although the study results suggested that the medicine was beneficial to patients, it was “concerned about how reliable the results were”. The CHMP’s stance echoes the one taken by the US Food and Drug Administration which has already delayed a decision on approval of the drug, also known as Zeftera/Zevtera, and the agency sent a warning letter to J&J last August accusing the company of “lax oversight” in its role as sponsor of two clinical studies.

The FDA’s misgivings led to Basilea increasing a damages claim against J&J submitted in February 2009 as part of a request for arbitration under the companies' licence agreement for ceftobiprole. The Swiss firm says it is now “reviewing all strategic options to protect the interests of the company and its shareholders”.
At 10.50am this morning (UK time) Basilea’s shares were down 2.3% to 65.35 Swiss francs.