September 13, 2013

Basilea reports presentation of 19 posters at ICAAC on investigational anti-infectives isavuconazole, ceftobiprole, and BAL30072




Basel, Switzerland, September 13, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that 19 posters are being presented on the anti-infectives isavuconazole, ceftobiprole, and BAL30072 at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The conference is taking place from September 10 to 13, 2013 in Denver, USA.

Basilea's Chief Scientific Officer Dr. Laurenz Kellenberger commented: "Drug resistance is a major global healthcare concern with patients facing potentially life-threatening infections with few to no therapeutic options. The wealth of data presented on the activity of isavuconazole, ceftobiprole, and BAL30072 against resistant pathogens further substantiates the promising profiles of these innovative product candidates in addressing this unmet medical need. We expect topline data from two isavuconazole phase 3 studies to be available in the second half of 2013. In the same timeframe, we anticipate a regulatory decision on the European Marketing Authorization Application for ceftobiprole for the potential treatment of pneumonia in the hospital."

Presentations on isavuconazole further substantiate its broad antifungal coverage. Isavuconazole demonstrated potent activity against global collections of contemporary, clinically relevant pathogens causing invasive fungal disease. Activity against invasive pulmonary aspergillosis and mucormycosis was demonstrated in neutropenic animal models. In addition, synergistic action between isavuconazole and micafungin was observed in-vitro against Aspergillus spp.

A presentation showing a genotypic characterization of methicillin-resistant Staphylococcus aureus (MRSA) strains collected during the ceftobiprole pneumonia phase 3 studies confirmed that the isolates were representative of MRSA strains causing nosocomial infections worldwide. Additional posters highlight the potent synergistic activity of ceftobiprole with daptomycin in-vitro; against vancomycin-intermediate or daptomycin-resistant MRSA isolates; and against daptomycin-susceptible and vancomycin resistant enterococci.

Susceptibility data presented at ICAAC highlight the activity of Basilea's novel anti-Gram-negative antibiotic BAL30072 against important potential biodefense pathogens. In June, Basilea announced its contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the development of BAL30072.

Posters on isavuconazole

Pharmacodynamics (PD) of Isavuconazole (Isav) in a Murine Invasive Pulmonary Aspergillosis (IPA) Model Against Wildtype (WT) and Cyp51 Mutants - A. Lepak, K. Marchillo, J. Van Hecker, D.R. Andes; A-291

No Effect on Pharmacokinetic and Pharmacodynamic Parameters of Warfarin after Coadministration with Isavuconazole - T. Yamazaki, A. Desai, H. Pearlman, D. Kowalski, C. Lademacher, R. Townsend; A-448

Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of CYP3A4 Substrate Atorvastatin in Healthy Subjects - T. Yamazaki, H. Pearlman, D. Kowalski, C. Lademacher, A. Desai, R. Townsend; A-449

Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of CYP2B6 Substrate Bupropion in Healthy Subjects - A. Desai, H. Pearlman, T. Yamazaki, C. Lademacher, D. Kowalski, R. Townsend; A-450

Impact of Candida species on the Isavuconazole (ISA) Pharmacodynamic (PD) Target in an in vivo Neutropenic Murine Model of Invasive Candidiasis (IC) - A. Lepak, K. Marchillo, J. Van Hecker, D. Diekema, D.R. Andes; A-451

Pharmacokinetics and Efficacy of Isavuconazole for Treatment of Experimental Invasive Pulmonary Aspergillosis - R. Petraitiene, V. Petraitis, P.W. Moradi, G.E. Strauss, B.T. Huertas, A. Katragkou, E. Petraityte, L.L. Kovanda, J. Smart, W.W. Hope, T.J. Walsh; M-759

Isavuconazole Protects Immunosuppressed Mice from Rhizopus oryzae Infection - G. Luo, T. Gebremariam, H. Lee, J.E. Edwards, A.S. Ibrahim; M-787

In Vitro Activity of Antifungal Drugs against a Global Collection of 28 Clinical and Environmental Exserohilum Species Isolates - J.F. Meis, H. Madrid, I. Breuker, F. Hagen, G.S. De Hoog, A. Chowdhary; M-1350

Intra- and Interlaboratory Study of Antifungal Susceptibility Testing of Isavuconazole against Aspergillus Strains - M.A. Ghannoum, V. Chaturvedi, A. Espinel-Ingroff, A. Fothergill, R. Jones, L. Ostrosky-Zeichner, R. Rennie, T. Walsh; M-1351

In Vitro Interaction Between Isavuconazole and Micafungin or Amphotericin B against Medically Important Moulds - V. Petraitis, J. Meletiadis, P.W. Moradi, G.E. Strauss, L.L. Kovanda, R. Petraitiene, T.J. Walsh; M-1362

Isavuconazole Susceptibility in Triazole Resistant Aspergillus fumigatus - L. Gregson, J. Goodwin, A. Johnson, L. McEntee, C.B. Moore, M. Richardson, W.W. Hope, S.J. Howard; M-1365

Activity of Isavuconazole, Amphotericin B, and Micafungin Alone and in Combination against Exserohilum rostratum - P.W. Moradi, V. Petraitis, R. Petraitiene, G.E. Strauss, D.H. Larone, Y. Zhao, A. W. Forthergill, M. Ghannoum, M. Simitsopoulou, E. Roilides, D.P. Kontoyiannis, D.S. Perlin, T. J. Walsh; M-1372

In Vitro Activity of Isavuconazole compared with Itraconazole, Voriconazole, and Posaconazole in azole-resistant Aspergillus fumigatus - S. Seyedmousavi, A.J. Rijs, W.J. Melchers, J.W. Mouton, P.E. Verweij; M-1377

Activity of Isavuconazole and Comparator Antifungals Tested Against Contemporary (2012) Fungal Clinical Isolates Collected Worldwide - M. Castanheira, S.A. Messer, P.R. Rhomberg, R. Dietrich, R.N. Jones, M.A. Pfaller; M-1378
Posters on ceftobiprole

%fT>MIC Predicts the Microbiological Eradication at End of Treatment with Ceftriaxon or Ceftobiprole in Patients with Community Acquired Pneumonia - A.E. Muller, N. Punt, J.W. Mouton; A-472

Genotypic Characterization of Methicillin-resistant Staphylococcus aureus Strains Recovered from Pneumonia Clinical Trials for Ceftobiprole - R.E. Mendes, L.M. Deshpande, A.J. Costello, R.K. Flamm, R.N. Jones; C2-558

Ceftobiprole (BPR) and Ampicillin (AMP) Increase Daptomycin (DAP) Susceptibility in DAP Susceptible and Resistant and Vancomycin Resistant Enterococci (VRE) - B.J. Werth, K.E. Barber, K. Tran, M.J. Rybak; E-132

Activity of Ceftobiprole (BPR) Combination Regimens Against Multiple Strains of Staphylococcus aureus with Differing Resistance Phenotypes; K.E. Barber, B.J. Werth, C.E. Ireland, N.E. Stone, M.J. Rybak; E-138
Poster on BAL30072

In vitro Activity of BAL30072 against Biodefense Pathogens -J.R. Hershfield, L.L. Miller, S.A. Halasohoris, M.G. Page; F-1203

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About isavuconazole

Isavuconazole is an investigational intravenous and oral broad-spectrum antifungal, partnered with Astellas Pharma Inc., for the potential treatment of severe invasive and life-threatening fungal infections. It is currently in phase 3 of clinical development. Isavuconazole demonstrated 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 in-vitro activity against emerging and often fatal molds including those that cause mucormycosis. In clinical studies isavuconazole achieved predictable drug levels in patients, supporting reliable once-daily dosing and a switch from intravenous to oral administration. Isavuconazole received U.S. FDA fast-track and U.S. orphan drug designation.

About ceftobiprole

Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for the potential first-line empiric treatment of severe bacterial infections. It is currently under regulatory review in Europe for the potential treatment of pneumonia in the hospital. Ceftobiprole has demonstrated broad-spectrum activity against Gram-positive bacteria including methicillin-resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram-negative pathogens, including Enterobacteriaceae and Pseudomonas aeruginosa.

About BAL30072

BAL30072 is an intravenous bactericidal sulfactam antibiotic against multidrug-resistant Gram-negative bacterial infections, currently in phase 1 of clinical development. BAL30072 demon­strated in-vitro and in-vivo coverage of Gram-negative pathogens including multidrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. It has robust activity against common strains of resistant bacteria that produce antibiotic-inactivating enzymes including carba­penemases and metallo-beta-lactamases such as the New Delhi metallo-beta-lactamase 1 (NDM-1). In addition, BAL30072 has shown additive or synergistic activity with antibiotics from the carbapenem class. Basilea entered a contract with BARDA for up to USD 89 million in funding for the development of BAL30072.

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., 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.

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