SOURCE: Basilea Pharmaceutica AG

April 13, 2010 01:31 ET

New data on compounds in Basilea's anti-infective portfolio

BASEL, SWITZERLAND--(Marketwire - April 13, 2010) -

Basilea Pharmaceutica AG / New data on compounds in Basilea's anti-infective portfolio processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, April 13, 2010 - Basilea Pharmaceutica Ltd. announces that new data on the antibacterial compounds BAL30072 and ceftobiprole as well as the antifungal drug isavuconazole were presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna. Basilea's innovative and balanced anti-infective portfolio addresses priority concerns in the treatment of serious infections.

Multi-resistant Gram-negative and Gram-positive 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.

BAL30072 - potent activity against multi-resistant Gram-negative bacteria

BAL30072 is a novel siderophore sulfactam antibiotic. Its unique pattern of penicillin-binding-protein inhibition and its bactericidal mode of action confer potent in-vitro and in-vivo activity against Gram-negative bacteria. Pathogens such as Pseudomonas spp. and Acinetobacter spp. as well as the enterobacteria Escherichia coli and Klebsiella pneumoniae are increasingly multi-resistant and difficult-to-treat Gram-negative "superbugs". BAL30072 overcomes most mechanisms of resistance to currently marketed beta-lactam antibiotics found in these bacilli.

New research data presented at ECCMID by Miriagou and co-authors show that BAL30072 demonstrates in-vivo efficacy against clinical metallo-beta-lactamase producing isolates of E. coli and K. pneumoniae, resistant to several antibiotics (poster P 1240). Furthermore, data from Carmeli and co-authors showing BAL30072's strong in-vitro and in-vivo activity against extended-spectrum-beta-lactamase producing E. coli was selected for an oral presentation at ECCMID's "New antibacterial agents" session (O 376).

BAL30072 has previously been shown to have potent antibacterial activity in vitro against multi-resistant Gram-negative bacteria, including carbapenem-resistant strains. New in-vivo data demonstrate that co-administration with meropenem enhances BAL30072's activity against resistant Gram-negative bacteria (E. coli, K. pneumoniae), including strains that are not susceptible to BAL30072 and meropenem as single agent, respectively (P 1240).

Basilea expects to initiate a phase I clinical development program for the investigation of BAL30072 in humans in the second half of 2010.

Ceftobiprole - preserves human intestinal flora

Ceftobiprole is a broad-spectrum cephalosporin antibiotic exhibiting activity against a wide spectrum of Gram-positive bacteria, including the 'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae as well as many clinically important Gram-negative bacteria, including Pseudomonas spp. Broad-spectrum antibiotic treatment frequently negatively impacts the normal intestinal microflora.

As a result, it may facilitate colonization by new potentially pathogenic strains or enable microorganisms already present in the normal intestinal flora to develop resistance. Panagiotidis and co-authors presented new data showing that ceftobiprole has no significant impact on intestinal flora of healthy volunteers (P 1226).


Oral presentation on BAL30072 at ECCMID

BAL30072, a new sulfactam with excellent in vitro and in vivo activity against Escherichia coli producing extended-spectrum beta-lactamases. - S. Navon-Venezia, O. Hermesh, B. Kuzmenko, M. Page, Y. Carmeli; O 376

Posters on BAL30072 displayed at ECCMID

Efficacy of BAL30072, alone and combined with meropenem, against VIM-producing enterobacteria in a murine thigh infection model. - V. Miriagou, C. Papagiannitsis, S. Kotsakis, A. Zioga, E. Siatravani, A. Loli, E. Tzelepi, L. Tzouvelekis, M. Donzelli, J. Spickermann, M. Page; P 1240

The role of iron transport in the activity of the siderophore sulfactam BAL30072 against Pseudomonas aeruginosa. - M. Page, C. Müller, B. Hofer, E. Desarbre, J. Dreier, F. Vidal; P 1241

Oral presentation on ceftobiprole at ECCMID

In vitro synergism between ceftobiprole and vancomycin against methicillin-resistant and glycopeptide-intermediate Staphylococcus aureus. - J.M. Entenza, J. Vouillamoz, A. Bizzini, M. Giddey, J. Bille, P. Moreillon; O 39

Posters on ceftobiprole displayed at ECCMID

Trends in ceftobiprole susceptibility among 2001-2008 consecutive methicillin-resistant Staphylococcus aureus blood isolates. - Y. Golan, L. McDermott, D.R. Snydman; P 939

Effect of ceftobiprole on the normal human intestinal microflora. - G. Panagiotidis, T. Bäckström, C. Asker-Hagelberg, M. Rashid, A. Weintraub, C.E. Nord; P 1226

Susceptibility of Gram-negative pathogens to ceftobiprole, ceftazidime and cefepime isolated from centres in Austria, Germany and Switzerland. - H. Seifert, S. Gatermann, W. Pfister, C. Poehlmann, S. Huhulescu, K. Muehlemann, J. Laeuffer, S. Decker-Burgard, M. Cassettari, I. Morrissey; P 1269

Ceftobiprole activity when tested against clinical bacterial pathogens from Europe, 2009. - D. Farrell, G. Moet, H. Sader, S. Putnam, R. Jones; P 1875

Posters on isavuconazole displayed at ECCMID

Antifungal susceptibility of yeasts isolated from patients with fungaemia: comparison of the E-test on direct blood samples and CLSI M27-A3. - J. Guinea, S. Recio, P. Escribano, T. Peláez, M. Torres-Narbona, M. Rodríguez- Créixems, C. Sánchez-Carrillo, E. Bouza; P 838

Can isavuconazole MICs for yeasts be read after 24 hours of incubation? - J. Guinea, P. Escribano, S. Recio, T. Peláez, E. Bouza; P 839

In vitro activity of isavuconazole against clinical non-Candida yeast isolates determined by E-test and CLSI M27-A3. - J. Guinea, S. Recio, P. Escribano, T. Peláez, E. Bouza; P 840

For further information please visit www.congrex.ch/ECCMID2010

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SWISS: BSLN). Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.

The company owns a broad and diversified portfolio. Basilea is marketing Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in ten additional European countries as well as in Canada and has been recommended for approval in 12 further European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.

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.

For further information, please contact:

+-----------------------------------+-------------------------------------+
|Media Relations                    |Investor Relations                   |
+-----------------------------------+-------------------------------------+
|Adesh Kaul                         |Barbara Zink, Ph.D., MBA             |
|Head Public Relations &            |Head Corporate Development           |
|Corporate Communications           |                                     |
|+41 61 606 1460                    |+41 61 606 1233                      |
|media_relations@basilea.com        |investor_relations@basilea.com       |
+-----------------------------------+-------------------------------------+

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[HUG#1402786]

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Basilea Pharmaceutica AG

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