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New efficacy data on Basilea's novel antibiotic against
multi-resistant Gram-negative bacteria presented at ICAAC |
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Basel, Switzerland, September 15, 2009 - Data on Basilea
Pharmaceutica Ltd.'s anti-infective compounds ceftobiprole,
isavuconazole and the novel antibiotic BAL30072 were presented at the
Annual Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in San Francisco. The data demonstrate that the
in-vitro potency of BAL30072 translates into high efficacy in in-vivo
models for respiratory tract infection (RTI), urinary tract infection
(UTI), septicemia and for soft tissue infection (STI) involving
multi-resistant Gram-negative "superbugs".
Multi-resistant Gram-negative 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.
New in-vitro data demonstrate BAL30072's activity against clinically
increasingly problematic multi-resistant Pseudomonas and
Acinetobacter spp. as well as against Burkholderia pseudomallei
(Poster F1-1478), a pathogen which causes increasing concern.
High efficacy as single agent in infection models
New research data presented at ICAAC reveal that BAL30072, as a
single agent, has robust in-vivo activity against many
multi-resistant Gram-negative "superbugs". Weiss and co-authors
demonstrated that BAL30072's strong bactericidal activity in vitro
translates into efficacy against Klebsiella pneumoniae and
Pseudomonas aeruginosa in RTI models comparable to that of the
therapeutic benchmark meropenem (Poster F1-1485). High activity was
also shown in models for STI against Acinetobacter baumannii by Russo
and co-authors (F1-1486). Further BAL30072 shows good efficacy
against Gram-negative pathogens in models for blood infection and for
UTI (Escherichia coli), (Posters F1-1483, F1-1484). The data from the
infection models confirm the compatibility and synergistic effects of
BAL30072 with carbapenems observed in a number of in-vitro studies
(Posters F1-1482, F1-1479, F1-1480).
BAL30072 - a Trojan horse fighting resistance
BAL30072 is a novel siderophore monobactam that acts like a "Trojan
horse" by exploiting natural nutrient uptake systems to gain access
to its target. Its unique pattern of penicillin-binding-protein
inhibition and its bactericidal mode of action confer potent in-vitro
activity against Gram-negative fermentors and non-fermentors. These
properties enable BAL30072 to overcome most of the genetically
defined factors of beta-lactam resistance. In addition to its potent
inhibition of Pseudomonas, Acinetobacter and Enterobacter spp.,
BAL30072 also exhibits strong activity against Burkholderia spp. and
Stenotrophomonas, two of the most difficult to treat Gram-negative
pathogens.
Posters on BAL30072 displayed at ICAAC 2009
In vitro activity of BAL30072 against Burkholderia pseudomallei. - T.
Mima, MGP Page, E Desarbre, HP Schweizer; F1-1478
Synergy between the siderophore monobactam BAL30072 and carbapenems
investigated by time-kill and checkerboard studies. - MGP Page, E
Desarbre, C Müller, B Hofer; F1-1479
Interactions between the siderophore monobactam BAL30072 and
carbapenems provides a powerful combination for addressing
multi-resistant organisms. - MGP Page, E Desarbre, C Müller, B Hofer,
C Dantier; F1-1480
In Vitro Potency of a Siderophore Monobactam BAL30072 (BAL) Against
Gram Negative Bacilli (GNB) with Defined beta-lactamase Enzymes. - KE
Bowker, AR Noel, TR Walsh, AP MacGowan; F1-1481
Meropenem (MEM) and BAL30072, a unique carbapenem-siderophore
monobactam combination with extended activity against multidrug (MDR)
resistant Acinetobacter baumannii. - AM Hujer, KM Hujer, E Desarbre,
MGP Page, and RA Bonomo; F1-1482
In vivo Gram-negative Activity of BAL30072 in a Mouse Septicemia
Model. - A. Schmitt-Hoffmann, K Gebhardt, A Brendle, P Fullhardt, D
Klauer, C Hofer, M Müller, MGP Page; F1-1483
Antibacterial activity of BAL30072, a siderophore monobactam
antibiotic, against E. coli in experimental urinary tract infection
in mice. - JM Andersen, CV Lundgren, MGP Page, N Frimodt-Møller;
F1-1484
Efficacy of BAL30072 in Experimental Respiratory Tract Infections. -
WJ Weiss, ME Pulse, P Nguyen, J Pierce, J Simecka, MGP Page; F1-1485
BAL30072 is active against Acinetobacter baumannii in a rat
soft-tissue infection model. - TA Russo, MGP Page, J Beanan, R.
Olson, AM Hujer, KM Hujer, A Endimiani and R. A. Bonomo; F1-1486
For further information please visit www.icaac.org
Ceftobiprole - good in-vitro activity against a wide range of
bacteria from clinical isolates across Europe and Canada
A series of posters add to the existing wealth of scientific evidence
on ceftobiprole's broad-spectrum activity against a wide range of
pathogens. Eight posters discuss the in-vitro activity of
ceftobiprole, a broad-spectrum anti-MRSA cephalosporin antibiotic,
against a range of Gram-positive and Gram-negative bacteria from
clinical isolates. The data presented demonstrate ceftobiprole's
strong in-vitro activity against staphylococci including
methicillin-resistant Staphylococcus aureus (MRSA), enterococci and
streptococci isolated from patients with severe infections such as
blood stream infections, complicated skin and skin structure
infections and hospital acquired pneumonia (Posters C2-137, E-191,
E-195, E-196, E-197, E-198, E-199, E-200).
Posters on ceftobiprole displayed at ICAAC 2009
Ceftobiprole is Superior to Vancomycin, Daptomycin, and Linezolid,
for the Treatment of Methicillin-Resistant Staphylococcus aureus
Experimental Endocarditis in Rabbits. - P Tattevin, L Basuino, BA
Diep, D Bauer, HF Chambers; B-053
Efficacy of Ceftobiprole, a Novel Cephalosporin Antibiotic in a Rat
Staphylococcus aureus Endocarditis (IE) Model: Microbiological and
Real-Time Bioluminescent Assessments. - YQ Xiong, AS Lynch, Y Li, W
Abdel Hady, K Bush, AS Bayer; B-054
Ceftobiprole Medocaril is an Effective Treatment against
Methicillin-Resistant Staphylococcus aureus (MRSA) Mediastenitis in a
Rat Model. - S Navon-Venezia, Y Barnea, B Kuzmenko, N Artzi, Y
Carmeli; B-1319
In Vitro Activities of Ceftobiprole, Daptomycin, Linezolid, and
Vancomycin against 461 Bacteremic Methicillin-Resistant
Staphylococcus aureus Isolated over a Period of 6 Years (2003-2008)
in a General Hospital in Madrid (Spain). - E Cercenado, M
Rodriguez-Creixems, A Eworo, M Marin, R Insa, E Bouza; C2-137
Comparative In Vitro Activity of Ceftobiprole against Gram-Positive
Cocci. - C Betriu, E Culebras, M Gomez, F Lopez, I Rodriguez-Avial,
JJ Picazo; E-191
In Vitro Activity of Ceftobiprole against Invasive Streptococcus
pneumoniae Isolated from Adult Patients. - E Rios, I Rodriguez-Avial,
C Betriu, JC Sanz, JJ Picanzo; E-195
In vitro Activities of Ceftobiprole and Comparators versus
Streptococcus pneumoniae (SPN) Isolated in Hospital Laboratories
across Canada: CANWARD 2007 and 2008. - AK Wierzbowski, JA Karlowsky,
DJ Hoban, GG Zhanel; E-196
In vitro Activity of Ceftobiprole against Methicillin-Resistant
Staphylococcus aureus isolated in intensive care units in Germany. -
U Frank, C Wilson, M Knigge; E-197
In vitro Activity of Ceftobiprole (BPR), Vancomycin (VAN, Teicoplanin
(TEI) and Linezolid (LIN) against Gram Positive Pathogens Circulating
in Twelve Countries. - M Cristino, R Kozlov, E Bouza, O Paniara, A
Quintana, JM Laeuffer, R Flamm, L Farmer, I Morrissey; E-198
Activity of Ceftobiprole (BPR), Vancomycin (VAN), Teicoplanin (TEI)
and Linezolid (LIN) against Contemporary S. aureus Including those
with High VAN MICs. - I Morrissey, F Schmitz, J Perry, R Zbinden, A
Quintana, R Flamm, M Cassettari; E-199
In Vitro Activity of Ceftobiprole against 10,035 Pathogens Obtained
from Patients in Canadian Hospitals: CANWARD 2007 and 2008. - G
Zhanel, M Decorby, P Lagace-Wiens, K Nichol, D Hoban, J Karlowsky;
E-200
Posters on isavuconazole displayed at ICAAC 2009
Pharmacokinetics of Isavuconazole in Liver Impairment due to
Hepatitis. - A Schmitt- Hoffmann, J. Spickermann, P. Thomann, B.
Roos; A1-588
Comparative In Vitro Activity of Isavuconazole (ISA) Against
Medically Important Yeasts and Moulds. - L Ostrosky-Zeichner, N
Inurria, J Rodriguez, E Chen, V Paetznick; M-1707
Susceptibility Assessment of Aspergillus terreus over an 18-Year
Period in a General Hospital. - T Peláez, B Gama, P Martin-Rabadán, L
Sanchez-Combronero, R Flores, L Alcalá, P Muõz, E Bouza; M-1714
For further information please visit www.icaac.org
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial, antifungal and oncology agents to fight drug
resistance and on the development of dermatology drugs. Basilea's
products are targeted to satisfy high medical and patient needs in
the hospital and specialty care setting.
The company owns a diversified portfolio including two commercialized
drugs (Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational
drug in phase III (isavuconazole). Toctino® (alitretinoin) is
marketed in the United Kingdom, Denmark and Germany and is approved
in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and
Spain. Alitretinoin has been recommended for approval in Italy and is
under regulatory review in Canada, Switzerland and 15 additional
European countries. Furthermore a phase III clinical trial on
alitretinoin for the treatment of severe chronic hand eczema is
ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM)
and in Switzerland under Zevtera(TM). Ceftobiprole is under
regulatory review in the U.S. and marketing applications are
submitted in the EU and several other countries. The company has set
up commercial organizations in UK, Denmark, Germany and Canada, while
it is building sales and marketing organizations in other countries
to commercialize alitretinoin and to co-promote ceftobiprole, subject
to approval.
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. |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | +41 61 606 1233 |
| +41 61 606 1460 | investor_relations@basilea.com |
| media_relations@basilea.com | |
+------------------------------------------------------------------+
This press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link:
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement. Copyright © Hugin AS 2009. All rights reserved.
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