Basilea Announces Submission of Marketing Authorization Application in Europe by Janssen-Cilag International NV for Ceftobiprole, a Novel Anti-MRSA Broad-spectrum Cephalosporin

Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today the submission of a Marketing Authorization Application to the European Medicines Agency (EMEA) for ceftobiprole by its license partner Janssen-Cilag International NV, a Johnson & Johnson company. This submission is for the use of ceftobiprole in the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections. Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin antibiotic to complete Phase III clinical trials.
This Marketing Authorization Application (MAA) of ceftobiprole for the treatment of complicated skin and soft tissue infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative, Gram-positive and methicillin-resistant Staphylococcus aureus (MRSA) pathogens. In both multinational, double-blind, randomized phase III studies, ceftobiprole achieved a high clinical cure rate compared to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.

Dr. Anthony Man, CEO of Basilea commented, “We have been delighted at the exciting, robust clinical data we have seen in the pivotal clinical trials for these complicated skin infections. Today’s MAA submission as well as the recent NDA filing in the USA reflect our view that ceftobiprole could play an important role globally in the future management of important medical problems posed by MRSA”.

A milestone payment of approximately CHF 12 million is associated with the MAA filing acceptance.

Ceftobiprole is currently in clinical phase III testing in hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) and in hospitalized patients with community-acquired pneumonia (CAP) with anticipated completion in the second half of the year.