Zinforo receives positive CHMP opinion in the European Union for the treatment of patients with serious skin infections or community acquired pneumonia

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Zinforo (ceftaroline fosamil), a new intravenous cephalosporin antibiotic for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

Ceftaroline fosamil is the first monotherapy antibiotic to combine the established tolerability of the cephalosporin class, with effective coverage of a range of bacteria responsible for serious skin infections and pneumonia, including difficult to treat strains such as methicillin-resistant Staphylococcus aureus (MRSA) in cSSTI and Streptococcus pneumoniae in CAP.

The CHMP reviewed data from the Phase III clinical trial programmes which included four pivotal registration trials, CANVAS 1 and 2 (cSSTI) and FOCUS 1 and 2 (CAP). Clinical data demonstrated that Zinforo was effective and well tolerated in adult patients (≥18 years of age) with cSSTI or CAP, including those patients with underlying co-morbidities.

cSSTI and CAP are infections commonly associated with considerable morbidity and mortality, and represent a major challenge to health care systems. cSSTIs are estimated to cause over 1.3 million hospitalisations per year in Europe. Similarly, approximately one million people are hospitalised in Europe each year with CAP.

“We are pleased with this recommendation for Zinforo, which we believe may make a valuable contribution in the fight against drug-resistant infection,” said Martin Mackay, President, R&D, AstraZeneca. “We remain one of the few companies still committed to novel antibiotic research, with one of the world’s largest antibacterial pipelines and many strong partnerships to address this significant unmet medical need.”

In 2009, Forest Laboratories granted AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for ceftaroline fosamil, excluding US, Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name Teflaro® in the US in March 2011.

“The CHMP positive opinion to recommend approval of Zinforo is an important step in bringing to the global market new treatment options for patients suffering from serious bacterial infections, particularly in view of increasing resistance,” said Marco Taglietti, MD, President Forest Research Institute.

AstraZeneca has made regulatory submissions in a number of countries where it has commercialisation rights and further submissions are planned in 2012.