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Basilea Pharmaceutica Ltd. (CH) - Basilea presents new efficacy data on BAL30072, its novel antibiotic against Gram-negative bacteria

Basel, Switzerland, May 18, 2009 - Data on Basilea Pharmaceutica Ltd.'s compounds including new results on its novel antibiotic BAL30072 presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID). The data on BAL30072 provide further evidence for its potent bactericidal activity in vitro against a broad range of clinical isolates of difficult-to-treat, multi-resistant Gram-negative bacteria.

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.

A potent single agent New research data presented at ECCMID by Bowker and co-authors confirm that BAL30072, as a single agent, has broad-spectrum in-vitro activity against many of the most difficult-to-treat, multi-resistant Gram-negative "superbugs", including common species of enteric bacteria, thus closing the activity gaps of currently available Gram-negative agents (Poster P1112).

Synergistic effects with carbapenems BAL30072 has been shown to have strong bactericidal activity in vitro against multi-resistant Gram-negative bacteria, including carbapenem-resistant strains. New in-vitro data presented at ECCMID show that the already low rate of resistance development to BAL30072 in difficult-to-treat bacilli such as P. aeruginosa and Acinetobacter spp. is further decreased when BAL30072 is combined with currently marketed Gram-negative antibiotics such as carbapenems. Concomitantly its bactericidal activity is increased in such a combination (P1110, P1111).

BAL30072's unrivaled in-vitro properties suggest that it has the potential to become a unique, novel treatment option for severe hospital infections caused by multi-resistant Gram-negative bacteria.

Posters on BAL30072 displayed at ECCMID Resistance Development Studies with the Novel Siderophore Monobactam BAL30072. - M Page, C Mueller, B Hofer, E Desarbre; P 1110

Bactericidal Effect of the Novel Siderophore Monobactam BAL30072. - M Page, C Mueller, B Hofer, E Desarbre; P 1111

In vitro Activity of a New Siderophore Monobactam BAL30072 Against ESBL Producing Enterobateriacae and Clinical Isolates of Enterobacter cloacae. - KE Bowker, TR Walsh, AP MacGowan; P 1112

BAL30072 - a trojan horse fighting resistance BAL30072 is a novel siderophore monobactam that exploits the natural nutrient uptake like a trojan horse. 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 the potent inhibition of Pseudomonas, Acinetobacter spp. and Enterobacter spp. BAL30072 also exhibits strong activity against Burkholderia spp. and Stenotrophomonas, two of the more difficult to treat Gram-negative pathogens.

Posters on Ceftobiprole displayed at ECCMID Comparative susceptibility of European Gram-negative pathogens to ceftobiprole, ceftazidime and cefepime. - H Seifert, M Dryden, A Quintana, J Laeuffer, P Okolo, I Morrissey; P 1033

Spectrum and potency of ceftobiprole against leading North American pathogens producing community- and hospital-acquired pneumonia (2005-2007). - H Sader, P Rhomberg, M Janechek, R Jones; P 1095

Antimicrobial activity of ceftobiprole, a novel anti-methicillin-resistant S. aureus cephalosporin, tested against skin and skin-structure infection pathogens (North America). - R Jones, H Sader, M Janechek, P Rhomberg; P 1096

In vitro activity of ceftobiprole against a group of well-characterized staphylococci. - S Borbone, F Campanile, D Bongiorno, S Jeddari, C Scuderi, S Stefani; P 1097

Comparative susceptibility of European Gram-positive pathogens to ceftobiprole, vancomycin, teicoplanin and linezolid. - FJ Schmitz, J Perry, R Zbinden, A Quintana, J Laeuffer, ML Cassettari, I Morrissey; P 1633

Posters on Isavuconazole displayed at ECCMID Is Aspergillus nidulans susceptible to all antifungal agents? In vitro activity of an updated panel of antifungal agents against 63 clinical isolates. - T Peláez, J Guinea, B Gama, R Flores, S Recio, M Torres-Narbona, P Muñoz, E Bouza; P 1297

In vitro antifungal activity of isavuconazole against 345 mucorales isolates, collected at eight study centers worldwide. - P Verweij, G Gonzalez, NP Wiederhold, C Lass-Flörl, P Warn, M Heep, MA Ghannoum, J Guinea; P 1298

Oral pharmacokinetics of isavuconazole in liver impairment due to cirrhosis. - AH Schmitt-Hoffmann, B Roos, E Peterfai, D Edwards, J Spickermann, M Heep; P 1665

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 (alitretinoin, ceftobiprole) and one investigational drug in phase III (isavuconazole). Toctino® (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 and Ukraine under the brand name ZEFTERA(TM) and in Switzerland under Zevtera(TM). Marketing applications for ceftobiprole were submitted in the U.S., 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.

Posted: May 2009