Basilea reports presentation of new data on anti-infective drug candidates addressing drug resistance

Basilea reports presentation of new data on anti-infective drug candidates 
addressing drug resistance 
BASEL, SWITZERLAND -- (Marketwired) -- 04/29/13 --  Basilea
Pharmaceutica AG / Basilea reports presentation of new data on
anti-infective drug candidates addressing drug resistance 
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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
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:
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 (P 983). 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
significant morbidity and mortality. 
Other presentations further support isavuconazole's broad spectrum of
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 (P 1001). In addition,
isavuconazole was reported to be active against
recently identified
emerging pathogenic yeast Candida africana (P 1079) as well
basidiomycete molds, which are associated with respiratory infections
(O 167). 
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 (P
1629). 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 (P 1628). 
In addition, ceftobiprole demonstrated potent activity similar to
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 (P 1627). Cefepime and ceftazidime are
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 (P 904). 
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 (P 1626, P 1625). Ceftobiprole was
several-fold more active against Streptococcus pneumoniae
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
Enterobacteriaceae and Pseudomonas aeruginosa. 
BAL30072 - a novel sulfactam antibiotic with bactericidal activity
against multidrug-resistant Gram-negative bacteria that is currently
in phase 1 clinical
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 (P 908).
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 (P

|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; P 983         |
|                                                                         |
|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; P 1001              |
|                                                                         |
|Molecular characterisation of germ tube-positive Candida species with    |
|special reference to Candida africana - C. SHARMA, S. WANKHEDE, A.       |
1079               |
|                                                                         |
|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; O 167                        |
|                                                                         |
|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; P 1629                                                            |
|                                                                         |
|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; P 1628                  |
|                                                                         |
|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; P 1627                                                       |
|                                                                         |
|%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; P 904                  |
|                                                                         |
|Activity of ceftobiprole tested against pathogens associated with        |
|community-acquired bacterial pneumonia in Europe - R.K. FLAMM, H.S.      |
|SADER, R.N. JONES; P 1626                                                |
|                                                                         |
|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; P 1625                                   |
|                                                                         |
|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; O 182                                |
|                                                                         |
|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; P 908                    |
|                                                                         |
|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; P 1631 |

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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
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
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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