- Corporate
Ceftobiprole
Ceftobiprole belongs to a well accepted class of antibacterial agents known as
cephalosporins that are used to treat serious life-threatening infections caused by
Gram-negative and Gram-positive bacteria. Ceftobiprole is a new drug for the
treatment of the increasing number of patients with severe methicillin-resistant Staphylococcus aureus (MRSA) infections.
Regulatory status
Ceftobiprole medocaril for injection is the first approved broad-spectrum
anti-MRSA antibiotic belonging to the cephalosporin class. Ceftobiprole as a
single intravenous agent has demonstrated broad-spectrum activity against a
wide range of difficult-to-treat Gram-positive and Gram-negative hospital and
community-acquired infections including MRSA.
Ceftobiprole is marketed in Canada
(ZEFTERA™) for the treatment of complicated
skin and skin structure infections (cSSSI), including non-limb threatening
diabetic foot infections without concomitant osteomyelitis; and in Switzerland
(Zevtera™) for the treatment of complicated skin and soft
tissue infections (cSSTI) including diabetic foot infections. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson&Johnson company. Basilea Pharmaceutica International Ltd. has exercised
its option to co-promote ceftobiprole in North America and in the major
European markets. Basilea maintains an option to co-promote ceftobiprole in
Japan and China.
About complicated skin infections
Complicated skin and soft tissue infections are among the most common
infections in the hospital setting. Staphylococcus aureus, a
Gram-positive microbe, is the predominant germ in skin infections. In
recent years methicillin resistant strains of S. aureus have become
increasingly common and have been associated with increased morbidity and
mortality. Patients with chronic wounds or those who have recently received
antibiotics may also be infected by Gram-negative microbes. This is
frequently the case for diabetic patients with foot infections. Treatment
of diabetic foot infections requires broad-spectrum intravenous antibiotics
and may include hospitalization and surgery. Broad-spectrum antibiotics
that cover resistant bacteria are often needed for the treatment of more
severe skin infections.
The need of new antibacterial agents
Each year approximately 5 million patients worldwide are treated for cSSSI.
An additional 5 million patients are treated for community-acquired pneumonia
(CAP) in hospitals and 2.5 million patients for hospital-acquired pneumonia
(HAP). With the rising incidence of MRSA, drug-resistant Streptococcus
pneumoniae and the threat of community-acquired MRSA (cMRSA), an
increasing number of patients with severe skin infections and pneumonia may
no longer respond to traditional antibiotic treatment. There is a growing
need for first-line broad-spectrum antibacterials that also cover resistant
bacteria.
Positive phase III data
Four pivotal phase III clinical studies were completed demonstrating
positive non-inferiority results as compared to standard treatment. These
data provide the basis for initial regulatory filings for the treatment
of cSSSI and planned follow-on filings for pneumonia including both, HAP
and CAP requiring hospitalization. Severe skin infections and pneumonia
account for a significant proportion of bacterial infections treated in
hospitals.
Ceftobiprole is specifically designed to bind the penicillin-resistant
targets in Gram-positive cocci, resulting in potent bactericidal activity
towards MRSA and penicillin-resistant Streptococcus pneumoniae
(PRSP). The antibiotic has demonstrated a broad-spectrum profile
targeting other Gram-positive as well as Gram-negative pathogens. In
addition, the antibiotic has shown a low potential to select for
resistance in vitro. Ceftobiprole is expected to combine the
well-established advantages of the cephalosporin antibiotic class with an
enhanced Gram-positive antibacterial spectrum.
© 2010 Basilea Pharmaceutica Ltd.
