New efficacy data on Basilea's novel antibiotic against multi-resistant Gram-negative bacteria presented at ICAAC

Sep 15, 2009 (Hugin via COMTEX) -- BPMUF | Quote | Chart | News | PowerRating -- Basel, Switzerland, September 15, 2009 - Data on Basilea Pharmaceutica Ltd.'s anti-infective compounds ceftobiprole, isavuconazole and the novel antibiotic BAL30072 were presented at the Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. The data demonstrate that the in-vitro potency of BAL30072 translates into high efficacy in in-vivo models for respiratory tract infection (RTI), urinary tract infection (UTI), septicemia and for soft tissue infection (STI) involving multi-resistant Gram-negative "superbugs".

Multi-resistant Gram-negative bacteria are appearing with increasing frequency in hospitals around the world and are causing a growing therapeutic problem. Infections caused by multi-resistant bacilli have been associated with prolonged hospital stays, higher healthcare costs and increased mortality, particularly when initial antibiotic therapy does not provide coverage of the causative pathogen.

New in-vitro data demonstrate BAL30072's activity against clinically increasingly problematic multi-resistant Pseudomonas and Acinetobacter spp. as well as against Burkholderia pseudomallei (Poster F1-1478), a pathogen which causes increasing concern.

High efficacy as single agent in infection models New research data presented at ICAAC reveal that BAL30072, as a single agent, has robust in-vivo activity against many multi-resistant Gram-negative "superbugs". Weiss and co-authors demonstrated that BAL30072's strong bactericidal activity in vitro translates into efficacy against Klebsiella pneumoniae and Pseudomonas aeruginosa in RTI models comparable to that of the therapeutic benchmark meropenem (Poster F1-1485). High activity was also shown in models for STI against Acinetobacter baumannii by Russo and co-authors (F1-1486). Further BAL30072 shows good efficacy against Gram-negative pathogens in models for blood infection and for UTI (Escherichia coli), (Posters F1-1483, F1-1484). The data from the infection models confirm the compatibility and synergistic effects of BAL30072 with carbapenems observed in a number of in-vitro studies (Posters F1-1482, F1-1479, F1-1480).

BAL30072 - a Trojan horse fighting resistance BAL30072 is a novel siderophore monobactam that acts like a "Trojan horse" by exploiting natural nutrient uptake systems to gain access to its target. Its unique pattern of penicillin-binding-protein inhibition and its bactericidal mode of action confer potent in-vitro activity against Gram-negative fermentors and non-fermentors. These properties enable BAL30072 to overcome most of the genetically defined factors of beta-lactam resistance. In addition to its potent inhibition of Pseudomonas, Acinetobacter and Enterobacter spp., BAL30072 also exhibits strong activity against Burkholderia spp. and Stenotrophomonas, two of the most difficult to treat Gram-negative pathogens.

Posters on BAL30072 displayed at ICAAC 2009 In vitro activity of BAL30072 against Burkholderia pseudomallei. - T. Mima, MGP Page, E Desarbre, HP Schweizer; F1-1478

Synergy between the siderophore monobactam BAL30072 and carbapenems investigated by time-kill and checkerboard studies. - MGP Page, E Desarbre, C Muller, B Hofer; F1-1479

Interactions between the siderophore monobactam BAL30072 and carbapenems provides a powerful combination for addressing multi-resistant organisms. - MGP Page, E Desarbre, C Muller, B Hofer, C Dantier; F1-1480

In Vitro Potency of a Siderophore Monobactam BAL30072 (BAL) Against Gram Negative Bacilli (GNB) with Defined beta-lactamase Enzymes. - KE Bowker, AR Noel, TR Walsh, AP MacGowan; F1-1481

Meropenem (MEM) and BAL30072, a unique carbapenem-siderophore monobactam combination with extended activity against multidrug (MDR) resistant Acinetobacter baumannii. - AM Hujer, KM Hujer, E Desarbre, MGP Page, and RA Bonomo; F1-1482

In vivo Gram-negative Activity of BAL30072 in a Mouse Septicemia Model. - A. Schmitt-Hoffmann, K Gebhardt, A Brendle, P Fullhardt, D Klauer, C Hofer, M Muller, MGP Page; F1-1483

Antibacterial activity of BAL30072, a siderophore monobactam antibiotic, against E. coli in experimental urinary tract infection in mice. - JM Andersen, CV Lundgren, MGP Page, N Frimodt-Moller; F1-1484

Efficacy of BAL30072 in Experimental Respiratory Tract Infections. - WJ Weiss, ME Pulse, P Nguyen, J Pierce, J Simecka, MGP Page; F1-1485

BAL30072 is active against Acinetobacter baumannii in a rat soft-tissue infection model. - TA Russo, MGP Page, J Beanan, R. Olson, AM Hujer, KM Hujer, A Endimiani and R. A. Bonomo; F1-1486

For further information please visit www.icaac.org

Ceftobiprole - good in-vitro activity against a wide range of bacteria from clinical isolates across Europe and Canada A series of posters add to the existing wealth of scientific evidence on ceftobiprole's broad-spectrum activity against a wide range of pathogens. Eight posters discuss the in-vitro activity of ceftobiprole, a broad-spectrum anti-MRSA cephalosporin antibiotic, against a range of Gram-positive and Gram-negative bacteria from clinical isolates. The data presented demonstrate ceftobiprole's strong in-vitro activity against staphylococci including methicillin-resistant Staphylococcus aureus (MRSA), enterococci and streptococci isolated from patients with severe infections such as blood stream infections, complicated skin and skin structure infections and hospital acquired pneumonia (Posters C2-137, E-191, E-195, E-196, E-197, E-198, E-199, E-200).

Posters on ceftobiprole displayed at ICAAC 2009 Ceftobiprole is Superior to Vancomycin, Daptomycin, and Linezolid, for the Treatment of Methicillin-Resistant Staphylococcus aureus Experimental Endocarditis in Rabbits. - P Tattevin, L Basuino, BA Diep, D Bauer, HF Chambers; B-053

Efficacy of Ceftobiprole, a Novel Cephalosporin Antibiotic in a Rat Staphylococcus aureus Endocarditis (IE) Model: Microbiological and Real-Time Bioluminescent Assessments. - YQ Xiong, AS Lynch, Y Li, W Abdel Hady, K Bush, AS Bayer; B-054

Ceftobiprole Medocaril is an Effective Treatment against Methicillin-Resistant Staphylococcus aureus (MRSA) Mediastenitis in a Rat Model. - S Navon-Venezia, Y Barnea, B Kuzmenko, N Artzi, Y Carmeli; B-1319

In Vitro Activities of Ceftobiprole, Daptomycin, Linezolid, and Vancomycin against 461 Bacteremic Methicillin-Resistant Staphylococcus aureus Isolated over a Period of 6 Years (2003-2008) in a General Hospital in Madrid (Spain). - E Cercenado, M Rodriguez-Creixems, A Eworo, M Marin, R Insa, E Bouza; C2-137

Comparative In Vitro Activity of Ceftobiprole against Gram-Positive Cocci. - C Betriu, E Culebras, M Gomez, F Lopez, I Rodriguez-Avial, JJ Picazo; E-191

In Vitro Activity of Ceftobiprole against Invasive Streptococcus pneumoniae Isolated from Adult Patients. - E Rios, I Rodriguez-Avial, C Betriu, JC Sanz, JJ Picanzo; E-195

In vitro Activities of Ceftobiprole and Comparators versus Streptococcus pneumoniae (SPN) Isolated in Hospital Laboratories across Canada: CANWARD 2007 and 2008. - AK Wierzbowski, JA Karlowsky, DJ Hoban, GG Zhanel; E-196

In vitro Activity of Ceftobiprole against Methicillin-Resistant Staphylococcus aureus isolated in intensive care units in Germany. - U Frank, C Wilson, M Knigge; E-197

In vitro Activity of Ceftobiprole (BPR), Vancomycin (VAN, Teicoplanin (TEI) and Linezolid (LIN) against Gram Positive Pathogens Circulating in Twelve Countries. - M Cristino, R Kozlov, E Bouza, O Paniara, A Quintana, JM Laeuffer, R Flamm, L Farmer, I Morrissey; E-198

Activity of Ceftobiprole (BPR), Vancomycin (VAN), Teicoplanin (TEI) and Linezolid (LIN) against Contemporary S. aureus Including those with High VAN MICs. - I Morrissey, F Schmitz, J Perry, R Zbinden, A Quintana, R Flamm, M Cassettari; E-199

In Vitro Activity of Ceftobiprole against 10,035 Pathogens Obtained from Patients in Canadian Hospitals: CANWARD 2007 and 2008. - G Zhanel, M Decorby, P Lagace-Wiens, K Nichol, D Hoban, J Karlowsky; E-200

Posters on isavuconazole displayed at ICAAC 2009 Pharmacokinetics of Isavuconazole in Liver Impairment due to Hepatitis. - A Schmitt- Hoffmann, J. Spickermann, P. Thomann, B. Roos; A1-588

Comparative In Vitro Activity of Isavuconazole (ISA) Against Medically Important Yeasts and Moulds. - L Ostrosky-Zeichner, N Inurria, J Rodriguez, E Chen, V Paetznick; M-1707

Susceptibility Assessment of Aspergillus terreus over an 18-Year Period in a General Hospital. - T Pelaez, B Gama, P Martin-Rabadan, L Sanchez-Combronero, R Flores, L Alcala, P Muoz, E Bouza; M-1714

For further information please visit www.icaac.org

About Basilea Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology 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 commercialized drugs (Toctino(R), ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug in phase III (isavuconazole). Toctino(R) (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional European countries. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM) and in Switzerland under Zevtera(TM). Ceftobiprole is under regulatory review in the U.S. and marketing applications are submitted in the EU and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to 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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SOURCE: Basilea Pharmaceutica AG

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