SOURCE: Basilea Pharmaceutica AG

September 14, 2007 13:10 ET

Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Community-acquired Pneumonia Requiring Hospitalization

BASEL, SWITZERLAND--(Marketwire - September 14, 2007) - Basilea Pharmaceutica Ltd. (SWX: BSLN) announced today that the ceftobiprole Phase III top-line study results in community-acquired pneumonia (CAP) patients requiring hospitalization met the primary endpoint of non-inferiority versus the study comparators.

Ceftobiprole is the first anti-MRSA (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin under evaluation for marketing authorization and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The 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 at the test-of-cure (TOC) visit in the clinically evaluable population was 86% for ceftobiprole and 87% for the comparators.

The microbiological eradication rates were 88% and 92% in the ceftobiprole and comparator arm, respectively. The clinical cure rate in the clinically evaluable patient population with moderate to severe pneumonia (defined as a score >90 on the PORT pneumonia severity index) was 89% and 81% for the ceftobiprole and comparator arms, respectively.

Ceftobiprole was generally well tolerated, with an adverse event profile consistent with that previously reported.

"We are delighted with these clinical results that show that ceftobiprole was as effective as the comparator regimen in these respiratory infections that were severe enough to require hospitalization. We believe that ceftobiprole may have the potential to become a useful therapeutic option to treat patients with community-acquired pneumonia, in particular in patients who require a broader antibiotic coverage", commented Dr. Anthony Man, CEO of Basilea.

Ceftobiprole is currently under review by Regulatory Authorities in the US, Europe and Canada for the treatment of complicated skin and skin structure infections.

About Community-acquired Pneumonia Requiring Hospitalization

Community-acquired pneumonia (CAP) is associated with high morbidity and mortality, with at least one third 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. MRSA is increasingly identified as a potential pathogen in community-acquired pneumonia.

About Ceftobiprole

Ceftobiprole, Basilea's lead antibacterial product, is the first of a new class of anti-MRSA broad-spectrum cephalosporin antibiotics. It is specially designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards 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. In addition, it has shown 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.

The efficacy and safety of ceftobiprole is currently being investigated in clinical trials in nosocomial pneumonia and in patients with febrile neutropenia.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Ortho-McNeil, Inc., 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 integrated biopharmaceutical company headquartered in Basel, Switzerland, listed on the SWX Swiss Exchange (SWX: BSLN). We focus on the discovery, development and commercialization of innovative medicines to satisfy high medical and patient needs in the hospital and specialty pharmaceutical setting. Basilea has a diversified product portfolio including novel treatments for resistant bacterial infections, systemic fungal infections and severe skin diseases. The highly competitive product pipeline comprises three late-stage product candidates and substantial early-stage programs. Basilea is currently building its sales and marketing organization in the U.S. and major European markets to promote alitretinoin and co-promote ceftobiprole upon approval.

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.

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