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Swissmedic accepts for review Basilea's ceftobiprole Marketing Authorization Application for the treatment of pneumonia

BASEL, Switzerland, Sept. 16, 2013 (GLOBE NEWSWIRE) --

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the Swiss regulatory authority Swissmedic has accepted the ceftobiprole Marketing Authorization Application for review. Ceftobiprole is an investigational broad-spectrum anti-MRSA (methicillin-resistant Staphylococcus aureus) antibiotic. The intended indication of ceftobiprole is for the treatment of hospital-acquired (nosocomial) pneumonia and community-acquired pneumonia in adults. Ronald Scott, Chief Executive Officer of Basilea, stated: "We are very pleased that Swissmedic will begin its review of our Marketing Authorization Application for ceftobiprole in pneumonia. Severe pneumonia is a condition associated with morbidity and mortality which is significantly increased when MRSA is a causative organism. Data has shown that ceftobiprole provides broad antibacterial coverage including MRSA and Gram-negative pathogens such as Pseudomonas. We are focused on working with Swissmedic to support their review of ceftobiprole." Basilea's submission dossier includes data from two international double-blind, randomized, controlled phase 3 studies in hospital-acquired pneumonia and community-acquired pneumonia. These studies compared the efficacy and safety of empiric ceftobiprole use versus standard-of-care single or combination antibiotic therapy. Ceftobiprole in pneumonia is currently under review with European regulatory authorities, with a decision anticipated in the second half of 2013. About ceftobiprole Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for the potential first-line empiric treatment of severe bacterial infections. Ceftobiprole has demonstrated broad-spectrum activity against Gram-positive bacteria, including methicillin-resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram-negative pathogens, including Enterobacteriaceae and Pseudomonas aeruginosa. About pneumonia treated in the hospital Community-acquired pneumonia is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.[1] Hospital- acquired pneumonia is one of the most common infections 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. The increasing incidence of bacteria resistant to many antibiotics is a major concern. About Basilea Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and development operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd., the company focuses on innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and non-response to current treatment options. 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, PhD | Barbara Zink, PhD, 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] Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Critical Care Clinics 2013; 29: 563-601. [2] Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of hospital-acquired and ventilator-associated pneumonia. Clinical Infectious Diseases 2010; 51: S48-S53. [3] Barbier F, Andremont A, Wolff M, Bouadma L. Hospital-acquired pneumonia and ventilator-associated pneumonia: recent advances in epidemiology and management. Current Opinion in Pulmonary Medicine 2013; 19: 216-228. Press release (PDF): http://hugin.info/134390/R/1729288/577711.pdf [HUG#1729288] Source:Basilea Pharmaceutica Ltd.