Basel, Switzerland--(Marketwire - July 30, 2012) - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced that it has submitted a Marketing Authorization Application (MAA)
under the European decentralized procedure for its novel investigational
antibiotic ceftobiprole, a broad-spectrum anti-MRSA (methicillin-resistant
Staphylococcus aureus) drug, for the treatment of pneumonia in hospitals.
Dr. Anthony Man, Chief Executive Officer of Basilea, stated: "The
the Marketing Authorization Application for ceftobiprole to treat patients
hospital with pneumonia is an important development milestone for this
innovative antibiotic. Ceftobiprole's antibacterial profile covers a broad
spectrum of clinically relevant Gram-positive and Gram-negative pathogens
may cause pneumonia, including MRSA and multidrug-resistant pneumococci."
The submission is supported by two international double-blind randomized
controlled phase III studies assessing the efficacy and safety of first-
empiric ceftobiprole versus single or combination drug comparators to treat
hospitalized community-acquired and hospital-acquired (nosocomial)
About hospital-treated pneumonia
Community-acquired pneumonia is a common condition with up to 60% of the
patients requiring hospital admission and intravenous antibiotics.
pneumonia is one of the most common infections acquired in the hospital,
accounting for approximately 25% of all intensive care unit (ICU)
and is associated with significant mortality., Prompt empiric
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
the SIX Swiss Exchange (SIX: BSLN). Basilea Pharmaceutica International
fully integrated research and development operations are focused on
antifungals and oncology drugs, targeting the medical challenge of
and non-response to current treatment.
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.
1. Torres A and Rello J. Update in community-acquired and nosocomial
2009. American Journal of Respiratory and Critical Care Medicine
2010; 181: 782-787
2. Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of
hospital-acquired and ventilator-associated pneumonia. Clinical
Diseases 2010; 51(S1): S48-S53
3. Muscedere JG, Day A and Heyland DK. Mortality, attributable mortality,
clinical events as end points for clinical trials of ventilator-
pneumonia and hospital-acquired pneumonia. Clinical Infectious Diseases
2010; 51(S1): S120-S125
Press release (PDF):
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE