Basilea Pharmaceutica AG : Basilea reports presentation of 19 posters at ICAAC
on investigational anti-infectives isavuconazole, ceftobiprole, and BAL30072
Basilea Pharmaceutica AG / Basilea reports presentation of 19 posters at ICAAC
on investigational anti-infectives isavuconazole, ceftobiprole, and BAL30072 .
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responsible for the content of this announcement.
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
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.
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.
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.
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
For further information please visit www.icaac.org.
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
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.
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
Acinetobacterbaumannii 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 USD89million in funding for the development of BAL30072.
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.
For further information, please contact:
Media Relations Investor Relations
Peer Nils Schröder, PhD Barbara Zink, PhD, MBA
Head Public Relations & Head Corporate Development
+41 61 606 1102 +41 61 606 1233
This press release can be downloaded from www.basilea.com.
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