BASEL, SWITZERLAND--(Marketwire - September 19, 2011) -
Basilea Pharmaceutica AG /
New clinical and preclinical data on Basilea's novel antibiotic BAL30072
multidrug-resistant Gram-negative superbugs presented at ICAAC
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Basel, Switzerland, September 19, 2011 - Detailed results from the
first phase I study with Basilea's novel antibiotic BAL30072 were presented
the 51(st) Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) in Chicago, USA. Additional preclinical data underline the strong
bactericidal activity and broad coverage of BAL30072 against
multidrug-resistant Gram-negative bacteria. Also, further data on Basilea's
anti-MRSA broad-spectrum antibiotic ceftobiprole are presented.
Multidrug-resistant Gram-negative bacteria such as Pseudomonas aeruginosa
Acinetobacter baumannii are causing growing concern as they have become
resistant to most marketed antibiotics, leaving only few or no therapeutic
Basilea's BAL30072, a beta-lactam antibiotic of the sulfactam class, has
potential to play an essential role in the therapy of life-threatening
infections caused by such multidrug-resistant as it is not easily destroyed
bacterial enzymes which cause resistance against many currently marketed
antibiotics. BAL30072 has demonstrated bactericidal activity against
range of Gram-negative superbugs.
BAL30072 - a novel sulfactam antibiotic against multidrug-resistant
Favorable data from the first phase I study, a double-blind, randomized,
placebo-controlled, single ascending dose study demonstrate the excellent
profile of BAL30072. In the study, no clinically relevant drug-related
events were observed at any dose level and no dose-limiting toxicities were
identified. BAL30072 displayed predictable linear pharmacokinetics with low
inter-subject variability, in line with preclinical data and in accordance
the favorable beta-lactam class profile. (Posters A2-572, F1-145 and
second, multiple ascending dose phase I study with BAL30072 has been
initiated and is anticipated to be completed in the first part of 2012.
Further in vitro data presented at ICAAC highlight the potent activity
of BAL30072 especially against difficult-to-treat multidrug-resistant
Data about the strong activity of BAL30072 against multi-resistant
bacteria carrying the gene for the NDM-1 enzyme (New Delhi
metallo-beta-lactamase) that leads to resistance towards almost all of the
antibiotics were presented. The test panel included clinical isolates from
recent outbreak of NDM-1 positive Acinetobacter baumannii in the UK. The
activity of BAL30072 as a single agent was enhanced by combination with
meropenem, suggesting potential synergy. (Poster E-722)
Bacteria resistant against carbapenems, the current most broadly active
against Gram-negative pathogens, are an emerging threat. The potent
BAL30072 against carbapenem-resistant Gram-negative bacteria is therefore
BAL30072 demonstrated the most potent activity against carbapenem-resistant
Gram-negative bacteria in a head-to-head comparison with meropenem and
aztreonam. In addition, BAL30072 demonstrated bactericidal activity in
meropenem- and aztreonam-resistant strains.
Basilea's Head of Biology, Prof. Malcolm Page, was invited to give an oral
presentation on BAL30072 and other beta-lactams titled "Monocyclic
scaffolds for treatment of multidrug-resistant infections" (Presentation
as part of the symposium "Investigational drugs worth waiting for to treat
Posters on BAL30072 at ICAAC 2011
Pharmacokinetics and Safety of the Novel Sulfactam Antibiotic BAL30072
Single Ascending Dose Infusions in Healthy Volunteers - A. SCHMITT-
ROOS, J. MAARES, J. SAUER, J. SPICKERMANN, I. MEYER, A. KAUFHOLD; A2-572
BAL30072: A Novel Monocyclic Sulfactam Antibiotic - Preclinical
Properties - A. SCHMITT-HOFFMANN, K. GEBHARDT, M. WIND, P. HARGREAVES, D.
KLAUER, A. BRENDLE, A. SERAFYN, C. SCHLAEFLE, H. GRUNWALD, C. BUCHER, J.
BAL30072: A Novel Monocyclic Sulfactam Antibiotic - Preclinical Safety
Properties - A. SCHMITT-HOFFMANN, C. BUCHER, J. SPICKERMANN, H. URWYLER;
Activity of the Novel Sulfactam BAL30072, Alone and in Combination with
Meropenem, Against Diverse Gram-Negative Isolates Carrying NDM-1 Beta-
Gene - T. R. WALSH, J. WEEKS, M. TOLEMAN, R. HOWE, M. WOOTTON, V. DANIEL,
STUBBINGS, M. E. JONES; E-722
Bactericidal Activity of BAL30072 Compared to Other Agents against
Multi-Resistant Gram-Negative Bacteria by Time-Kill - G. A. PANKUCH, C.
CLARK, G. LIN, W. STUBBINGS, P. C. APPELBAUM, K. KOSOWSKA-SHICK; E-737
Expression of Fe-Uptake Systems in Pseudomonas aeruginosa PAO1 and
Susceptibility to the Siderophore Sulfactam BAL30072 - T. KOEHLER, M. G. P.
PAGE, C. VAN DELDEN; F1-144
For further information please visit www.icaac.org
Ceftobiprole - a novel broad-spectrum anti-MRSA antibiotic targeting
Gram-positive and Gram-negative bacteria for the treatment of severe
as hospital-acquired pneumonia
Furthermore, additional preclinical data on Basilea's anti-MRSA
antibiotic ceftobiprole are presented at ICAAC.
Ceftobiprole is a novel broad-spectrum cephalosporin antibiotic, tested in
several phase III studies, for the first-line treatment of severe
multidrug-resistant bacterial infections. It has demonstrated activity
against a wide
range of Gram-positive bacteria, including the methicillin-resistant
Staphylococcus aureus (MRSA) superbug, as well as clinically-relevant
Gram-negative bacteria such as Pseudomonas aeruginosa, against which
a broader spectrum than other drugs, for example piperacillin/tazobactam or
Posters on ceftobiprole at ICAAC 2011
Comparison of In Vitro Activity of Ceftobiprole (BPR) with Ceftriaxone
Ceftazidime (TAZ), and Cefepime (FEP) Against Isolates of Rapidly Growing
Microbacteria (RGM) and Nocardia (NOC) - R. J. WALLACE JR., B. A.
K. KRIEL, T. MARTIN, L. BRIDGE, R. VASIREDDY; E-118
Investigating Ceftobiprole (Cef) Alone and in Combination with Daptomycin
Linezolid (Lin) and Vancomycin (Van) Against Methicillin-Resistant
Staphylococcus aureus (MRSA) in an In Vitro Infection Model - N. ALKURDI,
A. KUMAR, R. ARIANO, S. ZELENITSKY; E-1335
New Cephalosporins against Gram-Positive and Gram-Negative Bacteria Have No
Significant Ecological Impact on the Human Intestinal Microflora - M.
RASHID, A. WEINTRAUB, C. NORD; K-1415
For further information please visit www.icaac.org
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SWISS: BSLN). Basilea Pharmaceutica International
fully integrated research and development operations are focused on
antifungals and oncology drugs, as well as on the development of
drugs, targeting the medical challenge of resistance and non-response to
treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only
treatment for adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids, in Denmark, Finland, France, Germany, Norway,
Switzerland and the United Kingdom and has appointed distributors for
in other selected European markets, Canada, Israel, Mexico and the Republic
Korea. A phase III clinical program on alitretinoin for the treatment of
chronic hand eczema is ongoing in the U.S.
For its phase III compound isavuconazole, a potential best-in-class azole
antifungal for the treatment of life-threatening invasive fungal
company has entered into a license, co-development and co-promotion
with Astellas Pharma Inc.
In addition, Basilea is developing ceftobiprole, a late-stage novel
(methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin
antibiotic, for the first-line treatment of potentially life-threatening
resistant bacterial infections. Ceftobiprole has a broad coverage of both
Gram-positive bacteria, including MRSA, and many clinically important
bacteria such as Pseudomonas spp.
Basilea's BAL30072, a novel antibiotic for the treatment of resistant
Gram-negative infections, and the oncology drug BAL101553 for the treatment
drug-resistant cancers are in phase I clinical testing.
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,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future results, performance or achievements expressed or implied by
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,
events or otherwise.
This press release can be downloaded from www.basilea.com.
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Basilea Pharmaceutica AG
P.O Box Basel Switzerland
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