Basilea Pharmaceutica AG : Basilea reports presentation of new data on
anti-infective drug candidates addressing drug resistance
Basilea Pharmaceutica AG / Basilea reports presentation of new data on
anti-infective drug candidates addressing drug resistance . Processed and
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content of this announcement.
Basel, Switzerland, April 29, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
reported today that new data on drug candidates from its development pipeline
were presented at the European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) held in Berlin, Germany, from April 27 to 30.
The accelerating development of antibiotic resistance in Gram-positive
bacteria as well as the emergence of multidrug-resistant Gram-negative
pathogens are major global healthcare problems. In addition, mortality rates
associated with invasive fungal disease in immunocompromized patients, such as
cancer or transplant patients, remain high despite current therapies resulting
in a need for novel antifungal drugs.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "Infections
with drug-resistant bacteria are estimated to claim each year more than
100,000 lives in Europe and America. Basilea is one of the few companies
worldwide committed to address the problem of growing resistance against
currently available antibiotics and antifungals. The data presented at ECCMID
on the antifungal isavuconazole and the two antibiotics ceftobiprole and
BAL30072 further substantiate the promising profiles of these innovative
product candidates for addressing high unmet medical need."
Isavuconazole - a novel intravenous and oral broad-spectrum antifungal for the
potential treatment of severe invasive and life-threatening fungal infections,
currently in phase 3 clinical testing and partnered with Astellas Pharma Inc.
In a pooled analysis of eight studies undertaken in Europe and the U.S.,
isavuconazole exhibited potent in-vitro activity against clinically relevant
Candida isolates with reduced susceptibility to fluconazole (P983).
Fluconazole is currently recommended as first-line treatment of infections
with Candida yeasts, which are the most common cause of invasive fungal
disease in humans and a major cause of bloodstream infections in hospitalized
patients associated with significant morbidity and mortality.
Other presentations further support isavuconazole's broad spectrum of activity
against clinically relevant yeasts and molds. In a study of a large series of
Cryptococcus neoformans clinical isolates causing lung infections in Asian
patients, isavuconazole demonstrated the highest activity of all antifungals
tested (P1001). In addition, isavuconazole was reported to be active against
recently identified emerging pathogenic yeast Candida africana (P1079) as
well as basidiomycete molds, which are associated with respiratory infections
Ceftobiprole - a novel broad-spectrum anti-MRSA antibiotic under regulatory
review in Europe for pneumonia treated in the hospital
To monitor the spectrum and potency of antibiotics, several European
surveillance studies were conducted from 2008 through 2010. Results from
in-vitro testing of ceftobiprole against these large collections of clinically
relevant isolates were presented. Ceftobiprole was highly potent against
methicillin-resistant Staphylococcus aureus (MRSA), including strains with
decreased susceptibility to commonly used anti-MRSA antibiotics daptomycin,
linezolid and vancomycin (P1629). Furthermore, ceftobiprole was shown to be
highly potent against a large collection of European Gram-positive clinical
isolates comprising staphylococci, streptococci and enterococci, including
strains resistant to commonly used antibiotics for the treatment of
Gram-positive infections (P1628).
In addition, ceftobiprole demonstrated potent activity similar to ceftazidime
and cefepime when tested against a large collection of clinically relevant
Gram-negative pathogens, specifically Enterobacteriaceae and Pseudomonas
aeruginosa, collected in Europe during 2008 to 2010 (P1627). Cefepime and
ceftazidime are two commonly used broad-spectrum cephalosporin antibiotics
which, however, lack anti-MRSA activity that ceftobiprole offers in addition
to its broad Gram-positive and Gram-negative spectrum.
An analysis of data from the randomized, double-blind phase 3 clinical study
with ceftobiprole for the treatment of hospital-acquired pneumonia showed that
clinical outcome at the test-of-cure visit was associated with exposure to the
drug during treatment (P904).
Ceftobiprole is currently under regulatory review in Europe for the treatment
of pneumonia in the hospital. Data presented at ECCMID demonstrate the potent
in-vitro activity of ceftobiprole against leading pathogens associated with
community-acquired and hospital-acquired pneumonia (P1626, P1625).
Ceftobiprole was several-fold more active against Streptococcus pneumoniae
than ceftriaxone and cefepime, two antibiotics commonly used for the treatment
of pneumonia. In addition, the drug exhibited potent activity against a broad
spectrum of Gram-positive and Gram-negative pathogens associated with
hospital-acquired bacterial pneumonia, including MRSA, penicillin-resistant
Streptococcus pneumoniae, Enterobacteriaceaeand Pseudomonas aeruginosa.
BAL30072 - a novel sulfactam antibiotic with bactericidal activity against
multidrug-resistant Gram-negative bacteria that is currently in phase 1
The innovation of Basilea's antibiotic BAL30072 was highlighted in an oral
presentation at ECCMID. BAL30072, alone or in combination with meropenem
exhibited excellent in-vitro and in-vivo activity against a broad range of
clinically relevant multidrug-resistant Gram-negative pathogens such as
Acinetobacter baumannii and Pseudomonas aeruginosa, including isolates with
resistance against meropenem or the last resort antibiotic colistin (O 182).
In an in-vivo infection model it was demonstrated that BAL30072 was well
tolerated and highly effective against multidrug-resistant E. coli, Klebsiella
pneumoniae and Pseudomonas aeruginosa, including isolates expressing the NDM-1
metallo-beta lactamase encoding gene. BAL30072 displayed rapid in-vivo
bactericidal activity (P908). BAL30072 in combination with meropenem showed
strong synergistic interaction, resulting in a rapid bactericidal activity
against NDM-1 positive strains expressing multiple additional beta-lactamases
Posters on isavuconazole
In-vitro activity of isavuconazole against Candida isolates from the EU and
USA with reduced susceptibility to fluconazole: a pooled analysis from eight
studies - J.I. Smart, M.E. Jones, L.L.Kovanda; P983
Microsatellite-typing of 458 Indian Cryptococcus neoformans var. grubii
isolates and in-vitro susceptibility analysis - A. CHOWDHARY, F. HAGEN, A.
PRAKASH, S. KATHURIA, C.H.W.KLAASSEN, J.F. MEIS; P1001
Molecular characterisation of germ tube-positive Candida species with special
reference to Candida africana - C. SHARMA, S. WANKHEDE, A. PRAKASH, P. KUMAR
SINGH, S. KATHURIA, A. CHOWDHARY; P1079
Molecular identification of clinically-significant non-sporulating
basidiomycete moulds - P.KUMAR SINGH, S. KATHURIA, K. AGARWAL, P. ROY, G.
SYBREN DE HOOG, J.F. MEIS, A.CHOWDHARY; O167
Posters on ceftobiprole
Activity of ceftobiprole against methicillin-resistant Staphylococcus aureus
including strains with reduced susceptibility to daptomycin, linezolid, and
vancomycin - R.K. FLAMM, R.E.MENDES, H.S. SADER, R.N. JONES; P1629
Activity of ceftobiprole tested against clinical isolates of staphylococci and
streptococci from European surveillance (2008-2010) - R.K. FLAMM, H.S. SADER,
J.M. STREIT, R.N. JONES; P1628
Activity of ceftobiprole tested against Gram-negative clinical isolates from
European medical centres - R.K. FLAMM, H.S. SADER, J.M. STREIT, R.N. JONES;
%fT>MIC (minimum inhibitory concentration) predicts probability of clinical
outcome in the treatment of nosocomial pneumonia by ceftobiprole - A.E.
Muller, N. Punt, J.W. Mouton; P904
Activity of ceftobiprole tested against pathogens associated with
community-acquired bacterial pneumonia in Europe - R.K. FLAMM, H.S. SADER,
R.N. JONES; P1626
Activity of ceftobiprole tested against pathogens associated with
hospital-acquired bacterial pneumonia in Europe - R.K. FLAMM, H.S. SADER, J.M.
STREIT, R.N. JONES; P1625
Oral presentation on BAL30072
In-vivo efficacy of the novel monosulfactam BAL30072 alone and in combination
with meropenem against clinically important Gram-negative pathogens - W.
WEISS, M. PULSE, P.NGUYEN, J. PIERCE, D. VALTIERRA, K. PETERSON, J. SIMECKA,
W. STUBBINGS; O182
Posters on BAL30072
Efficacy of BAL30072 in murine thigh infection models of multi-resistant
Gram-negative bacteria - J.K. GOULD, A. SATTAR, P. THOMMES, L.J. PAYNE, W.
STUBBINGS, J. SPICKERMANN, G. DAWS, P. WARN; P908
BAL30072 combined with meropenem exhibits synergistic bactericidal activity
against clinical New Delhi metallo beta-lactamase (NDM-1)-positive
Enterobacteriaceae - J. WEEKS, W. STUBBINGS, T.R. WALSH; P1631
For further information please visit www.congrex.ch/eccmid2013.
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
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