BASEL, SWITZERLAND--(Marketwire - October 05, 2012) - Basilea Pharmaceutica AG /
Basilea's European Marketing Authorization Application for ceftobiprole for
treatment of pneumonia accepted for review
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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
Application (MAA) for its novel investigational antibiotic ceftobiprole for
treatment of pneumonia in hospitals has been accepted for review under the
"We are very pleased that our ceftobiprole Marketing Authorization
has been accepted for review and look forward to working closely with the
European health authorities during the review process," stated Dr. Anthony
Chief Executive Officer of Basilea. "Basilea is committed to address the
threat of bacterial resistance against current antibiotics. Ceftobiprole is
next generation antibiotic from the well-studied class of cephalosporin
antibiotics with bactericidal activity against a broad spectrum of
relevant Gram-positive and Gram-negative pathogens that may cause
Ceftobiprole has activity against Gram-positive bacteria, including
resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and
penicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram-
pathogens, including Enterobacteriaceae and Pseudomonas aeruginosa."
The MAA submission is supported by two international, double-blind,
phase III studies assessing the efficacy and safety of first-line empiric
ceftobiprole versus single or combination drug comparators to treat
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.
acquired (nosocomial) pneumonia is one of the most common infections
the hospital, accounting for approximately 25% of all intensive care unit
infections, and is associated with significant mortality., Prompt
intervention with an appropriate broad-spectrum antibiotic treatment is
as best medical practice. In both diseases the increasing incidence of
bacteria is a major concern.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical
the therapeutic areas of bacterial infections, fungal infections and
targeting the medical challenge of rising resistance and non-response to
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,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future results, performance or achievements expressed or implied by
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
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,
clinical events as end points for clinical trials of ventilator-associated
pneumonia and hospital-acquired pneumonia. Clinical Infectious Diseases
2010; 51(S1): S120-S125.
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE