Anglo-Swedish drug maker AstraZeneca plc (AZN: Quote,AZN.L) said Friday that European regulators have recommended approval of the company's new antibiotic Zinforo, for the treatment of adult patients with serious skin infections or community acquired pneumonia.
The European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion, recommending the approval of Zinforo or ceftaroline fosamil.
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 a new intravenous cephalosporin antibiotic for the treatment of adult patients with complicated Skin and Soft Tissue Infections or cSSTI, or Community Acquired Pneumonia or CAP.
The drug 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. This includes difficult to treat strains such as methicillin-resistant Staphylococcus aureus or MRSA in cSSTI and Streptococcus pneumoniae in CAP.
AstraZeneca said that the CHMP reviewed data from the Phase III clinical trial programs that included four pivotal registration trials, CANVAS 1 and 2 for cSSTI, and FOCUS 1 and 2 for CAP.
According to the company, clinical data demonstrated that Zinforo was effective and well tolerated in adult patients aged 18 years or above with cSSTI or CAP, including those patients with underlying co-morbidities.
cSSTIs are estimated to cause over 1.3 million hospitalizations per year in Europe. Similarly, about one million people are hospitalized in Europe each year with CAP.
Across Europe, MRSA, the most common cause of cSSTI, affects 150,000 patients per year, resulting in attributable extra in-hospital costs of 380 million euros.
Martin Mackay, President of R&D, AstraZeneca said, "We are pleased with this recommendation for Zinforo, which we believe may make a valuable contribution in the fight against drug-resistant infection."
In 2009, Forest Laboratories grated AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for ceftaroline fosamil, excluding U.S., Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name Teflaro in the U.S. in March 2011.
AstraZeneca said it has made regulatory submissions in several countries where it has commercialization rights, and further submissions are planned in 2012.
In Friday's regular session, AZN is trading at $43.35, up $0.34 or 0.79 percent on a volume of 155,190 shares.
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by RTT Staff Writer
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