BASEL, Switzerland, Dec. 20, 2005 (PRIMEZONE) -- With new evidence of its potency against methicillin-resistant Staphylococcus aureus (MRSA) and broad spectrum of activity, ceftobiprole; in late-stage development by Basilea Pharmaceutica Ltd (SWX:BSLN) and Johnson & Johnson PRD, is the highlight of the session "New Beta Lactams" at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington DC, USA.
Page et al., (F-1157) describe how ceftobiprole rapidly attacks MRSA to achieve its potent activity (Von Eiff et al., E-314; Ednie & Appelbaum, E-306) against these bacteria, which are the most common cause of hospital infections. Additional data confirm that it is very difficult for MRSA to become resistant to ceftobiprole (Bogdanovic & Appelbaum, F-1163).
Furthermore, Schmitt-Hoffmann et al. (B-2007) demonstrate the excellent tissue penetration and powerful anti-MRSA activity of ceftobiprole in pre-clinical testing of osteomyelitis, difficult to treat bone infections.
Heep et al. (E-308) and Queenan & Bush (C1-55) demonstrate that ceftobiprole is very stable to the hydrolytic action of cephalosporinases and shows a low potential for induction of resistance in Gram-negative pathogens such as Enterobacter cloacae.
Other posters show that ceftobiprole has potent activity against a wide range of Gram-negative pathogenic bacteria (Applebaum & Smith, E-304; Pankuch et al., E-305; Clark et al., E-316, Amsler et al., E-313; Kresken et al., E-311).
"The posters at this year's conference confirm Basilea's position as a leader in anti-bacterial research, generating anti-infective drugs addressing the increasing medical need associated with resistance," commented Prof. Jutta Heim, Chief Scientific Officer of Basilea.
"With ceftobiprole progressing well in late-stage development for the treatment of severe bacterial infections and our water-soluble azole entering phase III, we show our continued commitment and ability to develop anti-infective drugs with strong competitive profiles," stated Dr. Rienk Pypstra, Chief Development Officer of Basilea.
Scientific data concerning ceftobiprole presented at ICAAC 2005
Friday, 16 December 2005
C1-55
Ceftobiprole: Effect on AmpC Beta-Lactamase Induction and Resistance Frequency in Gram-Negative Bacteria A. M. QUEENAN, K. BUSH; Johnson & Johnson Pharmaceutical Res. and Dev. L.L.C., Raritan, NJ.
E-304
MIC Values of Ceftobiprole and Comparators towards Haemophilus influenzae and Moraxella catarrhalis P. C. APPELBAUM, K. SMITH; Hershey Med. Ctr., Hershey, PA.
E-305
Time-Kill Activities of Ceftobiprole and Eight other Agents against H. influenzae and M. catarrhalis G. PANKUCH, G. LIN, P. C. APPELBAUM; Hershey Med. Ctr., Hershey, PA.
E-306
Antistaphylococcal Kill Kinetics of Ceftobiprole and Comparators L. M. EDNIE, P. C. APPELBAUM; Hershey Med. Ctr., Hershey, PA.
E-308
Induction of AmpC Beta-Lactamases in Enterobacter cloacae Triggers Resistance to Extended Spectrum Cephalosporins, but not to Cefepime and Ceftobiprole M. HEEP, C. GEIER, B. HOFER, C. DANTIER, M. G. P. PAGE; Basilea Pharmaceutica, Basel, Switzerland.
E-310
Activity of Ceftobiprole and other Beta-Lactams against Streptococcus pneumoniae U.S. Clinical Isolates with Defined Substitutions in Penicillin-Binding Proteins (PBP) PBP1a, PBP2b, and PBP2x T. A. DAVIES, K. BUSH; Johnson & Johnson Pharmaceutical Res. & Dev. L.L.C., Raritan, NJ.
E-311
In Vitro Activity of Ceftobiprole (BAL9141) in Combination with Ciprofloxacin, Levofloxacin, Amikacin, and Tobramycin against Clinical Isolates of Pseudomonas aeruginosa M. KRESKEN1, M. HEEP 2; 1Antiinfectives Intelligence GmbH, Bonn, Germany, 2Basilea Pharmaceutica Ltd., Basel, Switzerland.
E-313
In Vitro Susceptibility of Ceftobiprole against Non-Fermenting Clinical Isolates K. M. AMSLER, K. BUSH, E. WIRA, B. FOLENO; Johnson & Johnson Pharmaceutical Res. & Dev. L.L.C., Raritan, NJ.
E-314
Antistaphylococcal Activity of Ceftobiprole (BAL9141) C. VON EIFF, A. W. FRIEDRICH, K. BECKER, G. PETERS; University of Muenster, Muenster, Germany.
E-316
Low Propensity of Ceftobiprole to Select for Resistant Mutants of H. influenzae and M. catarrhalis C. CLARK, T. BOGDANOVICH, L. M. EDNIE, P. C. APPELBAUM; Hershey Med. Ctr., Hershey, PA.
Saturday, 17 December 2005
F-1157
Interaction of Ceftobiprole with a Purified Soluble Form of Staphylococcus epidermis PBP 2' M. G. P. PAGE, P. CASPERS, M. KANIA; Basilea Pharmaceutica, Basel, Switzerland.
F-1163
Staphylococcal Single-Step Resistance Selection Studies with Ceftobiprole and Comparators T. BOGDANOVICH, P. C. APPELBAUM; Hershey Med. Ctr., Hershey, PA.
Sunday, 18 December 2005
D-1647
In Vitro Susceptibility Testing Guidelines for Ceftobiprole (BAL9141) Using CLSI Disk Diffusion and Broth Microdilution MIC Methods R. N. JONES1, 2, H. S. SADER 1, T. R. FRITSCHE 1; 1JMI Lab., North Liberty, IA, 2Tufts Univ. Sch. of Med., Boston, MA.
Monday, 19 December 2005
B-2007
Distribution of Ceftobiprole in Bone Matrix and Bone Marrow in a Rabbit MRSA Osteomyelitis Model SCHMITT-HOFFMANN1, L. YIN 2, J. CALHOUN 2, J. THOMAS 2, S. SHAPIRO 1, J. SPICKERMANN 1; 1Basilea Pharmaceutica, Basel, Switzerland, 2Univ. of Missouri Sch. Med., Columbia, MO
About Ceftobiprole
Ceftobiprole (BAL5788), Basilea's lead antibacterial product, is the first of a new class of broad-spectrum anti-MSRA cephalosporin antibiotics that was 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 not only has a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens, but has also shown a low potential to induce 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). After successful completion of enrollment into the first phase III STRAUSS trial (Study of Resistant Staphylococcus Aureus Skin and Skin Structure Infections), focusing on Gram-positive infections, Basilea and its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. commenced a second complicated skin infection trial targeting both Gram-positive and Gram-negative bacterial infections, including patients with diabetic foot infections. Ceftobiprole is also currently in phase III clinical trials in nosocomial pneumonia.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag AG International, a Johnson & Johnson company. Ortho-McNeil Pharmaceutical, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate company, Janssen-Cilag, will market the product in Europe, Japan and China. Basilea has retained an option to co-promote ceftobiprole in North America, major European countries, Japan and China.
About Basilea
Basilea Pharmaceutica Ltd. (SWX:BSLN) is a biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea was founded in October 2000 to discover, develop and bring innovative medicines to the market. The company's fully integrated research and development operations are currently focused on new anti-bacterial and anti-fungal agents to fight drug resistance as well as on dermatology drugs.
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