Basilea: Promising Antibiotic for MRSA
Janssen-Cilag, a subsidiary of Johnson & Johnson, has submitted a marketing authorization application to the EMEA for ceftobiprole, a new cephalosporin developed by Basilea. The drug has demonstrated potent anti-MRSA activity and in vitro activity against difficult to treat gram-negative bacteria such as multi-drug resistant Pseudomonas, potentially making it an attractive treatment option.
The submission to the European Medicines Agency (EMEA) by Basilea’s license partner Janssen-Cilag is for the use of ceftobiprole in the treatment of complicated skin and soft tissue infections including diabetic foot infections. A new drug application was filed with the FDA in May for the same indication.
The marketing authorization application (MAA) includes data from two phase III trials (STRAUSS 1 and STRAUSS 2). These studies enrolled over 1600 patients, including those with diabetic foot infections caused by gram-negative and gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). In both trials, ceftobiprole achieved a high clinical cure rate compared to single drug or two-drug combination comparators, respectively. In addition, ceftobiprole was well tolerated demonstrating a safety profile consistent with the cephalosporin class of antibiotics.
Due to the rising rates of multi-drug resistant gram positive bacterial infections, the majority of either newly introduced or late stage developmental drugs target bacteria such as MRSA. Among such antibacterials launched since 2000, Pfizer’s Zyvox (linezolid) has been the most successful, owing to its parenteral and oral formulations. However, the market is becoming increasingly crowded with drugs such as daptomycin, launched in 2003, tigecycline, launched in 2005, as well as dalbavancin and telavancin, both expected in 2007, intensifying the competition.
Ceftobiprole, however, has the advantage of being a compound derived from a class of drugs (cephalosporins), and a predecessor, Rocephin (ceftriaxone), which physicians are very familiar with, representing a perceived safety advantage over other novel compounds. As an added benefit, preclinical studies also point to bactericidal activity against Pseudomonas, making it one of the very few drugs that are active against this particularly hard-to-treat gram-negative species.
If it can clearly demonstrate potency against such organisms, ceftobiprole will be seen as a product that can potentially cover a wide range of gram-positive and gram-negative organisms while providing the safety associated with the cephalosporin class, and may therefore prove to be a more attractive option for treatment of multi-drug resistant gram-positive and gram-negative bacteria. This is a key drug for Basilea’s prospects, and an approval would mark the first step in the Swiss biotech’s transition from a purely R&D focus to a commercial operation.