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AZ's superbug antibiotic Zinforo cleared by EC

The infections it treats include those caused by the MRSA superbug

AstraZeneca headquarters

Approval of a new antibiotic is a pretty rare occurrence these days, so a green light in the EU for a novel intravenous cephalosporin developed by AstraZeneca (AZ) is something of a cause for celebration.

Zinforo (ceftaroline fosamil) has been cleared as a treatment for adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP), including those caused by the superbug methicillin-resistant Staphylococcus aureus (MRSA).

The new antibiotic is the first cephalosporin to be approved as a monotherapy in Europe with efficacy against MRSA, according to AZ, which notes that the drug was designed to work in a different way to other cephalosporins on the market.

The drug is bactericidal and works by binding to and inhibiting penicillin-binding proteins (PBPs), which are essential for bacterial cell wall synthesis and repair.

Zinforo was launched under the Teflaro brand name last year in the US, where it is sold by Forest Laboratories, and is considered a big advance because - in addition to its activity against MRSA - it can also be used alongside other antibacterials to treat infections caused by unusual pathogens such as pseudomonas or acinetobacter species.

It has also demonstrated clinical efficacy in vulnerable patient groups, for example the elderly, or those with underlying comorbidities such as diabetes, peripheral vascular disease, chronic obstructive pulmonary disease (COPD) or asthma.

In clinical trials, Zinforo demonstrated similar efficacy to vancomycin combined with aztreonam in cSSTI, with clinical cure rates of around 85 per cent.

Forest Labs originally acquired ceftaroline when it bought Cerexa in a $480m deal in 2006, and granted AZ exclusive worldwide commercial rights to the drug outside the US, Canada and Japan in 2009. The Teflaro brand achieved sales of around $22m in the US last year and is growing fast, with Forest predicting it will add around $65m to its coffers in fiscal 2012.

AZ's head of R&D Martin Mackay said that Zinforo "will make a valuable contribution to addressing the significant unmet need for new antibiotics".

29th August 2012

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