Basilea Pharmaceutica AG has entered into an exclusive worldwide agreement with Cilag AG International, a Johnson & Johnson company, to develop, manufacture and market ceftobiprole, Basilea's novel broad-spectrum cephalosporin antibiotic that has activity against methicillin-resistant Staphylococcus aureus (MRSA).

Ceftobiprole is in phase III clinical trials in complicated skin and skin structure infections and hospital-acquired pneumonia trials are in preparation. Both indications have been granted fast track designation by the US FDA.

Under the terms of the agreement, Basilea will receive a substantial upfront payment and is eligible for additional payments on achievement of pre-specified clinical, regulatory and sales milestones. Upfront and milestone payments may together total up to 370 million Swiss Francs. Basilea will also receive significant double-digit royalties on worldwide sales. Ortho-McNeil Pharmaceutical, Inc., another Johnson & Johnson company, will market ceftobiprole in the US and its affiliate companies, known as Janssen-Cilag, will market the product outside the US. Basilea has retained an option to co-promote ceftobiprole in the US, in major European countries, Japan and China. Ortho-McNeil's research affiliate, Johnson & Johnson Pharmaceutical Research and Development, L.L.C., will develop ceftobiprole in collaboration with Basilea, the release said.

Ceftobiprole is the first of a new class of broad-spectrum anti-MSRA cephalosporin antibiotics that was specially designed to bind to the novel penicillin-resistant proteins in Gram-positive cocci, resulting in potent bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP).

In March 2003, the FDA granted ceftobiprole fast track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species. In June 2004, FDA granted fast track designation for a second indication for the treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia due to suspected or proven MRSA.