Basilea Pharmaceutica's European Marketing Authorization Application for ceftobiprole for the Treatment of Pneumonia Accepted for Review
Published: Oct 05, 2012
BASEL, SWITZERLAND--(Marketwire - October 05, 2012) - Basilea Pharmaceutica AG / Basilea's European Marketing Authorization Application for ceftobiprole for the treatment of pneumonia accepted for review . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, October 5, 2012 - Basilea Pharmaceutica Ltd. (SIX: BSLN) today reported that Basilea Pharmaceutica International Ltd. has received confirmation from European health authorities that the Marketing Authorization Application (MAA) for its novel investigational antibiotic ceftobiprole for the treatment of pneumonia in hospitals has been accepted for review under the decentralized procedure.
"We are very pleased that our ceftobiprole Marketing Authorization Application has been accepted for review and look forward to working closely with the European health authorities during the review process," stated Dr. Anthony Man, Chief Executive Officer of Basilea. "Basilea is committed to address the rising threat of bacterial resistance against current antibiotics. Ceftobiprole is a next generation antibiotic from the well-studied class of cephalosporin antibiotics with bactericidal activity against a broad spectrum of clinically relevant Gram-positive and Gram-negative pathogens that may cause pneumonia. Ceftobiprole has activity against Gram-positive bacteria, including methicillin- resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram- negative pathogens, including Enterobacteriaceae and Pseudomonas aeruginosa."
The MAA submission is supported by two international, double-blind, controlled phase III studies assessing the efficacy and safety of first-line empiric ceftobiprole versus single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired pneumonia.
About hospital-treated pneumonia
Community-acquired pneumonia is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics. Hospital- acquired (nosocomial) pneumonia is one of the most common infections acquired in the hospital, accounting for approximately 25% of all intensive care unit (ICU) infections, and is associated with significant mortality., Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is accepted as best medical practice. In both diseases the increasing incidence of resistant bacteria is a major concern.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and development operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd. the company focuses on innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and non-response to current treatment options.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward- looking statements contained herein as a result of new information, future events or otherwise.
This press release can be downloaded from www.basilea.com.
 Torres A and Rello J. Update in community-acquired and nosocomial pneumonia 2009. American Journal of Respiratory and Critical Care Medicine 2010; 181: 782-787.
 Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of hospital-acquired and ventilator-associated pneumonia. Clinical Infectious Diseases 2010; 51(S1): S48-S53.
 Muscedere JG, Day A and Heyland DK. Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clinical Infectious Diseases 2010; 51(S1): S120-S125.
Press release (PDF): http://hugin.info/134390/R/1646657/530673.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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