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Basilea's European Marketing Authorization Application for ceftobiprole for the treatment of pneumonia accepted for review

October 5, 2012 - Basel, Switzerland

Basilea Pharmaceutica AG /Basilea's European Marketing Authorization Application for ceftobiprole forthetreatment 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 receivedconfirmation from European health authorities that the MarketingAuthorizationApplication (MAA) for its novel investigational antibiotic ceftobiprole forthetreatment of pneumonia in hospitals has been accepted for review under thedecentralized procedure.

"We are very pleased that our ceftobiprole Marketing AuthorizationApplicationhas been accepted for review and look forward to working closely with theEuropean health authorities during the review process," stated Dr. AnthonyMan,Chief Executive Officer of Basilea. "Basilea is committed to address therisingthreat of bacterial resistance against current antibiotics. Ceftobiprole isanext generation antibiotic from the well-studied class of cephalosporinantibiotics with bactericidal activity against a broad spectrum ofclinicallyrelevant Gram-positive and Gram-negative pathogens that may causepneumonia.Ceftobiprole has activity against Gram-positive bacteria, includingmethicillin-resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) andpenicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram-negativepathogens, including Enterobacteriaceae and Pseudomonas aeruginosa."

The MAA submission is supported by two international, double-blind,controlledphase III studies assessing the efficacy and safety of first-line empiricceftobiprole versus single or combination drug comparators to treathospitalizedcommunity-acquired and hospital-acquired pneumonia.

About hospital-treated pneumonia

Community-acquired pneumonia is a common condition with up to 60% of thepatients requiring hospital admission and intravenous antibiotics.[1]Hospital-acquired (nosocomial) pneumonia is one of the most common infectionsacquired inthe hospital, accounting for approximately 25% of all intensive care unit(ICU)infections, and is associated with significant mortality.[2],[3] Promptempiricintervention with an appropriate broad-spectrum antibiotic treatment isacceptedas best medical practice. In both diseases the increasing incidence ofresistantbacteria is a major concern.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, andlisted onthe SIX Swiss Exchange (SIX: BSLN). Through the fully integrated researchanddevelopment operations of its Swiss subsidiary Basilea PharmaceuticaInternational Ltd. the company focuses on innovative pharmaceuticalproducts inthe therapeutic areas of bacterial infections, fungal infections andoncology,targeting the medical challenge of rising resistance and non-response tocurrenttreatment options.


This communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition,performanceor achievements of Basilea Pharmaceutica Ltd. to be materially differentfromany future results, performance or achievements expressed or implied bysuchforward-looking statements. Basilea Pharmaceutica Ltd. is providing thiscommunication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, futureevents or otherwise.

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[1] Torres A and Rello J. Update in community-acquired and nosocomialpneumonia2009. American Journal of Respiratory and Critical Care Medicine2010; 181: 782-787.

[2] Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes ofhospital-acquired and ventilator-associated pneumonia. Clinical InfectiousDiseases 2010; 51(S1): S48-S53.

[3] Muscedere JG, Day A and Heyland DK. Mortality, attributable mortality,andclinical events as end points for clinical trials of ventilator-associatedpneumonia and hospital-acquired pneumonia. Clinical Infectious Diseases2010; 51(S1): S120-S125.

Press release (PDF):

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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE


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