Print

AstraZeneca PLC (AZN) Granted Marketing Authorisation in Europe for ZINFORO  
8/28/2012 7:28:34 AM

LONDON, UK I August 28, 2012 I AstraZeneca today announced that the European Commission has granted Marketing Authorisation to 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). This makes ZINFORO™ the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause of serious and difficult to treat complicated skin infections*.

ZINFORO™ was designed to be different from previously approved cephalosporins and has a novel mode of action which results in bactericidal activity and broad coverage against common causative pathogens, such as Staphylococcus aureus, including MRSA, and Streptococci in cSSTI and Streptococcus pneumoniae and methicillin-susceptible Staphylococcus aureus (MSSA) in CAP.

The Marketing Authorization of ZINFORO™ is based on data from the Phase III clinical trial programme which included four pivotal registration trials, CANVAS 1 and 2 (cSSTI) and FOCUS 1 and 2 (CAP). These studies demonstrated consistent clinical efficacy in the treatment of cSSTI and CAP with the recognised tolerability profile of the cephalosporin class. The most common adverse reactions occurring in >/= 3% of patients treated with ZINFORO™ were diarrhoea, headache, nausea, and pruritus and were generally mild or moderate in severity.

ZINFORO™ also demonstrated clinical efficacy in vulnerable** patient groups, for example the elderly, or those with underlying comorbidities (such as diabetes mellitus or peripheral vascular disease in cSSTI or chronic obstructive pulmonary disease [COPD] or asthma in CAP]*. This may help to overcome some of the current treatment challenges faced by physicians when treating this patient population, who require an effective treatment without compromising on tolerability.

“We are delighted that ZINFORO™ has received regulatory approval across Europe and believe it will make a valuable contribution to addressing the significant unmet need for new antibiotics,” said Martin Mackay, President, R&D, AstraZeneca. “This is a key step in making ZINFORO™ more widely available to patients across the globe and we will work with the appropriate health authorities, formulary and protocol reviews, and clinicians to bring this new antibiotic to patients as soon as possible.”

In 2009, Forest Laboratories Inc. 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 European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 21 June 2012 and is applicable to all 27 Member States and the three European Economic Area countries of the European Union. NOTES TO EDITORS

* There is no experience with ZINFORO™ in the treatment in the following patient groups:

In cSSTI: the immunocompromised, patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients

In CAP: immunocompromised; patients with severe sepsis/septic shock, severe underlying lung disease; patients with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to MRSA; patients requiring intensive care; the available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of Streptococcus pneumoniae (PNSP). Caution is advised when treating such patients

** Vulnerable patients with co-morbidities are defined as those:

With a reduced ability to fight the infection or tolerate treatment In whom a resistant or difficult to treat pathogen is known or suspected Where there is an urgent need for action

These patients can pose additional treatment challenges for the physician.

About ZINFORO™

ZINFORO™ is a new intravenous cephalosporin antibiotic indicated for the treatment of adult patients with cSSTI or CAP.

ZINFORO™ is bactericidal and works by binding to and inhibiting penicillin-binding proteins (PBPs). PBPs are involved in bacterial cell wall synthesis and repair and their inhibition leads to reduced bacterial cell replication and/or cell death.

ZINFORO™ has been designed with a specific mode of action which contributes to its bactericidal activity against the common causative pathogens of cSSTI, and CAP and unlike other cephalosporins, shows a high affinity for particular PBPs in MRSA in cSSTI and Streptococcus pneumoniae in CAP?.

? No cases of CAP due to MRSA were enrolled into the studies; the available clinical data cannot substantiate efficacy against PNSP. ZINFORO™ is not active against strains of Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBLs) or Pseudomonas aeruginosa. In addition in vitro data in CAP indicate that the following atypical species are not susceptible to ceftaroline: Chlamydophila spp. Legionella spp. Mycoplasma spp.

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 (pneumonia) 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 is anticipated to be even more significant in the coming years.

CAP and cSSTI are commonly associated with considerable 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), a common cause of serious and difficult to treat complicated skin infections, affects 150,000 patients per year, resulting in attributable extra in-hospital costs of €380 million.

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

SOURCE: AstraZeneca


//-->