BASILEA REPORTS 92% CLINICAL CURE RATES FOR CEFTOBIPROLE.



Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin to demonstrate efficacy in a large clinical trial in patients infected with staphylococcal infections, including methicillin-resistant Staphylococcus aureus (MRSA). Data presented support ceftobiprole's potent anti-MRSA activity with clinical cure rates of 92%. Extensive in vitro data presented reaffirm the enhanced broad-spectrum of activity including Gram-negative pathogens. Ceftobiprole is being developed in collaboration with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The detailed results of the first comparative phase III trial of ceftobiprole confirm the positive top-line efficacy and safety results initially communicated in March of this year. Ceftobiprole demonstrated high cure rates in patients with complicated skin and skin structure infections due to Gram- positive pathogens. Overall cure rates in the clinically evaluable population were 93.3% and 93.5% for ceftobiprole and vancomycin, respectively. Cure rates in the clinically evaluable population with MRSA infections were 91.8% and 90.0% for ceftobiprole and vancomycin, respectively. In contrast to vancomycin, ceftobiprole has in vitro microbiological activity against a broad spectrum of Gram-positive and Gram-negative pathogens. In this trial, all Gram-positive and most of the Gram-negative baseline pathogens cultured were demonstrated to be sensitive to ceftobiprole in vitro (E-0118, K-772). Ongoing phase III studies for ceftobiprole target infections caused by Gram-positive and Gram-negative pathogens.

The data further underscored that ceftobiprole was well tolerated in both treatment groups with few serious treatment-related adverse events and few discontinuations of therapy due to treatment-related adverse events. The overall number of non-serious treatment-emergent adverse events was similar. There was more mild taste disturbance and nausea seen in the ceftobiprole arm, and vancomycin-treated patients tended to have more skin rashes and disturbed renal function.

Additional to this Phase III trial, multiple microbiology studies, both in vitro and in vivo, were presented which highlighted the potent in vitro activity of ceftobiprole against clinically relevant Gram-positive pathogens (E-0113, E-0114, C2-1143) including staphylococci recovered from bone and joint infections (E-0119) as well as from patients with endocarditis (E-0118) supporting the potential use of ceftobiprole in those high medical need areas.

When testing Enterococcus faecalis isolates harboring any of the clinically observed resistance, including resistance to beta-lactams, glycoproteins or aminoglycosides, ceftobiprole showed excellent in vitro bactericidal activity. Together with the findings in a mouse peritonitis model (B-1125) these data indicate that ceftobiprole has promising activity against multi-drug resistant E. faecalis.

Additionally, data from large national surveillance studies of relevant clinical isolates confirm the broad spectrum of ceftobiprole and its in vitro microbiological activity. In three separate surveillance studies (E-0112, E-0115, E-0117) ceftobiprole was amongst the most potent cephalosporins against Enterobacteriaceae and Pseudomonas -- the most common Gram-negative bacterial pathogens associated with hospital-acquired infections -- explained in part by its enhanced affinity for the penicillin-binding protein 2 (PBP2) in pseudomonads (C1-0933).

"The data presented at ICAAC indicate the potential of ceftobiprole as a novel agent for empirical treatment of infections where MRSA is suspected. These results reinforce our view that ceftobiprole is a promising novel antibiotic to treat serious infections," stated Rienk Pypstra, MD, chief development officer of Basilea.

About Ceftobiprole

Ceftobiprole (BAL5788), Basilea's lead antibacterial product is the first cephalosporin antibiotic with both anti-MRSA and broad-spectrum activity in late-stage clinical trials. It is specially designed to bind to the penicillin-resistant targets in Gram-positive cocci, resulting in potent bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens. In addition it has shown a low potential to select for resistance in vitro.

The FDA granted ceftobiprole fast-track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species and for a second indication in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole showed positive, top-line phase III results in a first complicated skin infection study (STRAUSS I). The drug is currently also being studied in a second complicated skin infection trial (STRAUSS II) targeting both Gram-positive and Gram-negative bacterial infections, including patients with diabetic foot infections; and in phase III clinical trials in nosocomial pneumonia (CHOPIN studies) and in patients hospitalized with community-acquired pneumonia.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson company. Ortho-McNeil, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate Janssen-Cilag companies will market the product in Europe and Asia. Basilea has maintained an option to co-promote ceftobiprole in North America, major European countries, Japan and China.

About Basilea

Basilea Pharmaceutica Ltd. (SWX:BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's fully 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 setting. The company owns a diversified product portfolio including three products for severe medical indications in late stages of clinical development.

For more information, visit http://www.basilea.com.

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