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Basilea Pharmaceutica (BSLN.SW) Submits European Marketing Authorization Application of Ceftobiprole for the Treatment of Pneumonia



7/30/2012 9:13:57 AM

Basel, Switzerland--(Marketwire - 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.

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

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

[HUG#1630332]


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Head Public Relations &
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+41 61 606 1102
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Head Corporate Development
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