Basilea Pharmaceutica has revealed that partner Johnson & Johnson is asking Europe’s regulators to look again at the recently-rejected antibiotic ceftobiprole.
Last month the European Medicines Agency’s Committee For Medicinal Products for Human Use adopted a negative opinion on ceftobiprole to treat complicated skin and soft-tissue infections. The panel actually backed the superbug drug in November 2008 but took the unusual step of halting the authorisation process on ceftobiprole, also known as Zeftera/Zevtera “pending completion and assessment of Good Clinical Practice inspections”.
Now, J&J’s Janssen-Cilag subsidiary has requested a re-examination of the negative opinion and according to current CHMP guidelines, a final opinion could be issued by the agency within four to five months.
Basilea has been irked by the way J&J handled the submission of the drug both in Europe and the USA and has a damages claim pending against the healthcare giant. After the CHMP’s rejection, a deal was then struck whereby J&J would return global rights for ceftobiprole to Basilea.
Under the terms of that agreement, there will be a one-year transition period during which J&J is required to fulfill all its obligations “including but not limited to development, manufacturing and commercialisation”. After that, the companies need to agree on a “transition plan that ensures proper management of ongoing clinical and regulatory activities…and allows for an efficient handover at no cost to Basilea”.
