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Microsoft word - 20080520 final pr cefto hcap @ats v 2.5 e.docPRESS RELEASE
Ceftobiprole shows high cure rates in patients
hospitalized with community-acquired pneumonia
Basel, Switzerland, May 20, 2008 - Basilea Pharmaceutica Ltd. (SWX:BSLN)
highlights the presentation of positive phase III results on ceftobiprole in the
treatment of community-acquired pneumonia (CAP) requiring hospitalization at
the International Conference of the American Thoracic Society (ATS). The
detailed analysis of previously announced top line results demonstrate high cure
rates in patients at risk for poor outcomes.
The randomized, double-blind phase III study compared clinical outcomes following the
treatment with ceftobiprole versus ceftriaxone with or without linezolid in patients hospitalized
with community-acquired pneumonia. The clinical cure rate in the clinically evaluable patient population with moderate to severe pneumonia was 87% for ceftobiprole and 88% for the comparator arm. In patients infected with Streptococcus pneumoniae, the most common pathogen in CAP, high cure rates were achieved with ceftobiprole (93%) and the comparator (89%). In the overall study population ceftobiprole met non-inferiority with a margin (delta) of 10%. Ceftobiprole achieved high cure rates in patients at risk for poorer outcomes such as elderly patients, patients with severe pneumonia, with systemic inflammatory response or with concomitant bloodstream infection. Ceftobiprole was effective in 93% of the clinically evaluable patients at age 75 or older (vs. 86% for the comparator). The cure rate in patients with class IV and V severity (PORT score) was 90% for ceftobiprole vs. 85% for the comparator. Patients with systemic inflammatory response syndrome were cured in 85% and 87% for ceftobiprole and comparator respectively, and 86% of patient with concomitant bloodstream infection were cured in both treatment arms. Ceftobiprole was generally well tolerated, with an adverse event profile consistent with that previously reported. “The results of this study confirm that ceftobiprole as a single drug was effective as a first-line therapy in the treatment of CAP requiring hospitalization, including those patients at risk of poorer outcome. We believe that ceftobiprole has the potential to become an important therapeutic option to treat patients with bacterial lung infections”, commented Dr. Anthony Man, CEO of Basilea. Ceftobiprole is being co-developed with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and it is currently under review by regulatory authorities in the US, the EU, Canada, Australia and in Switzerland for the treatment of complicated skin and skin structure Basilea Pharmaceutica Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com Ceftobiprole posters presented at ATS on Tuesday, May 20th 2008 Efficacy of Ceftobiprole compared to Ceftriaxone +/- Linezolid for the Treatment of Patients Hospitalized with Community-Acquired Pneumonia. SC Nicholson and co-authors. Efficacy of Ceftobiprole for the Treatment of Severely Ill Patients Hospitalized with Community-Acquired Pneumonia. SC Nicholson and co-authors. To view poster abstracts please visit www.abstracts2view.com/ats08/. About community-acquired pneumonia requiring hospitalization Community-acquired pneumonia is associated with high morbidity and mortality, with at least one fifth of cases requiring hospitalization. Despite a large number of antimicrobials available, it remains a significant cause of death in industrialized countries. CAP is caused by a variety of pathogens with their order of importance dependent on the location and population studied, Streptococcus pneumonia being the predominant pathogen with increasing incidence of CAP caused by multidrug-resistant Streptococcus pneumoniae (MDRSP). About ceftobiprole Ceftobiprole, Basilea’s lead antibacterial product, is a first-in-class anti-MRSA broad-spectrum cephalosporin antibiotic. It is specially designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). In clinical trials, ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram- positive and Gram-negative pathogens with potent activity against common bacterial respiratory pathogens including MDRSP. In addition, it has demonstrated a low potential to select resistance in vitro. In the trials, ceftobiprole was generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International. When approved, Ortho- McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, will market ceftobiprole in the U.S. and Janssen-Cilag companies will market the product in Europe and Asia. Basilea has exercised its co-promotion rights for ceftobiprole in North America and major European countries, and maintains an option to co-promote the drug in Japan and China. About Basilea Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea’s integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs. Basilea’s products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. The company owns a diversified portfolio including two pre-registration drugs and one phase-III investigational drug. The company is currently building its sales and marketing organization to promote alitretinoin and to co-promote ceftobiprole, subject to approval. Basilea Pharmaceutica Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com 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:
This press release can be downloaded from www.basilea.com Basilea Pharmaceutica Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com
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