Basilea reports presentation of new data on investigational anti-infectives isavuconazole, ceftobiprole and BAL30072 at ICAAC

Dienstag, 11. September 2012 18:40

Basilea Pharmaceutica AG / Basilea reports presentation of new data on investigational anti-infectives isavuconazole, ceftobiprole and BAL30072 at ICAAC . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, September 11, 2012 - Basilea Pharmaceutica Ltd. (SIX:BSLN) today reported that new data on anti-infectives isavuconazole, ceftobiprole and BAL30072 are being presented at the 2012 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place from September 9 to 12, 2012, in San Francisco, USA.

Basilea's Chief Scientific Officer Dr. Laurenz Kellenberger commented: "The rising tide of multidrug-resistant bacteria and the still unacceptably high mortality related to serious infections highlight the urgent need for novel antimicrobials. The data presented at ICAAC further substantiate the promising profiles of these innovative product candidates for addressing this high unmet medical need."

Key presentations include the following:

Posters on isavuconazole

Isavuconazole (ISA) Pharmacodynamic (PD) Target Determination for C. albicans (CA) in an In Vivo Neutropenic Murine Model of Invasive Candidiasis (IC) - A. Lepak, K. Marchillo,
j. Cabezas, D.R. Andes; A-1931

In Vitro Activity of Isavuconazole against Cryptococcus Isolates - A Pooled Analysis from 3 Studies - J.I. Smart, M.E. Jones, L.L. Kovanda; M-331

Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of CYP3A4 Substrate Midazolam in Healthy Volunteers - A. Desai, N. Zadeikis, H. Pearlman, D. Kowalski,
R. Townsend; A-1936

In Vitro Activity of Isavuconazole against a Worldwide Collection of 237 Aspergillus terreus Isolates and Compared with 7 Other Aspergillus Active Antifungal Drugs Tested with EUCAST and CLSI Methodology - J.F. Meis, J.W. Mouton, J.P. Bouchara, A. Chakrabarti,
P. Gaustad, J.V. Guinea-Ortega, J. Houbraken, R.A. Samson, K. Grif, C. Lass-Floerl, C.H. Klaassen; M-332


Posters on ceftobiprole

%fT>MIC Predicts Probability of Microbiological Outcome in the Treatment of Nosocomial Pneumonia by Ceftobiprole - A.E. Muller, N. Punt, J.W. Mouton; A-624

Monte Carlo Simulations Based on Phase 1 Studies Predict Target Attainment of Ceftobiprole in Nosocomial Pneumonia Patients: A Validation Study - A. Muller, A.H. Schmitt-Hoffmann, N. Punt, J.W. Mouton; A-624a


Posters on BAL30072

In Vitro Activity of BAL30072 against Contemporary Clinical Isolates of Gram-Negative Bacteria (GNB) from New York City including Multidrug-Resistant (MDR) Isolates -
D. Landman, M. Singh, B. El-Imad, E. Miller, T. Win, J. Quale; F-841

Antimicrobial Activity of BAL30072, Alone and in Combination with Meropenem Tested Against Gram-Negative Bacteria Causing Serious Infections in Hospitals from China, India, Latin America and South East Asia-Pacific - P.R. Rhomberg, K.A. Fedler, R.K. Flamm,
R.N. Jones, H.S. Sader; E-193

Comparative Efficacy of BAL30072, Aztreonam, Meropenem and Ceftazidime and Effects of Dose Fractionation in a Murine Thigh Infection Model - J.K. gould, A. Sattar, G.M. Daws, L.J. Payne, J. Spikermann, W. StubbinGs, A. SchmiTt-HOffmanN, M.G.P. Page, P.a. Warn;

Urinary Antibacterial Activity of BAL30072 against Uropathogens After IV Administration - F.M.E. Wagenlehner, B. Blenk, C. Wagenlehner, H. Blenk, K.G. Naber; A-1285

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About isavuconazole

Isavuconazole is a novel intravenous and oral broad-spectrum antifungal. In collaboration with Astellas Pharma Inc., isavuconazole is being investigated in a phase III program for the treatment of severe invasive and life-threatening fungal infections. The drug demonstrated excellent in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as less prevalent but often fatal molds such as Zygomycetes spp. It has reliable and predictable dosing, allowing a switch from IV administration to a convenient once daily oral dose and has the potential to overcome many of the limitations of current treatment options.

About ceftobiprole

Ceftobiprole is a novel broad-spectrum antibiotic for the potential treatment of severe, multidrug-resistant bacterial infections. The drug has activity against a wide range of Gram-positive bacteria, including the MRSA 'superbug' and clinically relevant Gram-negative bacteria. Ceftobiprole has met the study endpoints in several phase III trials and has shown a typical cephalosporin safety profile. A Marketing Authorization Application has been submitted in Europe through the decentralized procedure.

About BAL30072

BAL30072 is a novel investigational bactericidal sulfactam antibiotic in phase I, specifically targeting multidrug-resistant Gram-negative bacteria. The innovative antibacterial drug has demonstrated broad in-vitro and in-vivo coverage of Gram-negative pathogens including multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii. It has robust activity against common strains of bacteria that produce antibiotic-inactivating enzymes including extended-spectrum beta-lactamases (ESBL) and metallo-beta-lactamases such as the New Delhi metallo-beta-lactamase 1 (NDM-1). In addition, BAL30072 has been shown to enhance the activity of antibiotics from the penem class.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Through the fully integrated research and development operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd. ("Basilea") the company focuses on innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and non-response to current treatment options.


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
Peer Nils Schröder, Ph.D.
Head Public Relations &
Corporate Communications
+41 61 606 1102
Barbara Zink, Ph.D., MBA
Head Corporate Development

+41 61 606 1233

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