The EC cleared AstraZeneca’s Zinforo™ ( ceftaroline fosamil) intravenous antibiotic for the treatment of adults with complicated skin and soft tissue infections (cSSTI) or community acquired pneumonia (CAP). The firm says the drug is the only cephalosporin monotherapy approved in Europe that has demonstrated clinical efficacy against MRSA.
AstraZeneca licensed worldwide (excluding the U.S., Canada, and Japan) commercial rights and co-exclusive development rights to ceftaroline fosamil from Forest Laboratories in 2009. The drug was launched by Forest in the U.S. under the tradename Teflaro® in March 2011. Teflaro is similarly approved by FDA for the treatment of adults with CAP and acute bacterial skin and skin structure infections. Last month Forest reported Teflaro sales $9.4 million for the first quarter of fiscal 2013. Sales in the fourth quarter of 2012 were $7.9 million.
Clearance of the Zinforo in Europe was based on data from a Phase III trial program including four pivotal registrational studies, Canvas 1 and 2 in patients with cSSTI, and Focus 1 and 2 in patients with CAP. Zinforo was also effective in vulnerable patient groups including the elderly, or those with relevant underlying comorbidities including diabetes, peripharl vascular disease, COPD, or asthma.
AstraZeneca says Zinforo has a mechanism of action that differs from other approved cephalosporins. The drug is designed to inhibit penicillin-binding proteins (PBPs) involved in bacterial cell wall synthesis and repair, including PBPs found in MRSA-related cSSTI, and Streptococcus pneumoniae CAP.