Basilea submits European Marketing Authorization Application of ceftobiprole for the treatment of pneumonia
Basilea Pharmaceutica AG /
Basilea submits European Marketing Authorization Application of ceftobiprole for
the treatment of pneumonia
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Basel, Switzerland, July 30, 2012 - Basilea Pharmaceutica Ltd. (SIX:BSLN) today
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 submission of
the Marketing Authorization Application for ceftobiprole to treat patients in
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 that
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-line
empiric ceftobiprole versus single or combination drug comparators to treat
hospitalized community-acquired and hospital-acquired (nosocomial) 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.[1] 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.[2],[3] 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.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Basilea Pharmaceutica International Ltd.'s
fully integrated research and development operations are focused on antibiotics,
antifungals and oncology drugs, targeting the medical challenge of resistance
and non-response to current treatment.
Disclaimer
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.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations@basilea.com | investor_relations@basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
References
1. 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
2. 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
3. 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/1630332/522448.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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