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

Friday, 22 June 2012

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.


About cSSTI and CAP

Complicated Skin and Soft tissue Infections (cSSTI) are difficult-to-treat infections of the skin and underlying soft tissues such as fascia and muscle layers e.g. deep soft tissue abscesses, cellulitis and surgical site infections. cSSTIs are among the most common antibiotic treated infections in the hospital setting and represent approximately 12% of all antibiotic-treated hospital patients in Europe.

Community Acquired Pneumonia (CAP) is an acute infection of the lungs in a patient who has not been exposed to a hospital or long-term care facility. The estimated incidence of CAP is between two and 12 cases per 1000 inhabitants in Europe each year. The annual incidence of CAP in the elderly has been estimated to be four-times that of younger populations, and with an expected 30% of the European population reaching ‘elderly’ status by 2060, the burden of CAP will be even more significant in the coming years.

CAP and cSSTI can be associated with morbidity, mortality, resource use and healthcare costs and despite the availability of a variety of antibiotics to treat CAP and cSSTI, studies show that many patients do not receive effective first-line empiric treatment.

In addition, emerging antimicrobial resistance is a global concern.

Across Europe, methicillin-resistant Staphylococcus aureus (MRSA), the most common cause of cSSTI, affects 150,000 patients per year, resulting in attributable extra in-hospital costs of €380 million.

The European Antimicrobial Resistance Surveillance Network report that in Streptococcus pneumoniae, the most common cause of CAP, 25-50% of isolates are non-susceptible to penicillin (PNSP).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.


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