Basilea awarded contract by BARDA of up to USD 89 million for the development of its novel antibiotic BAL30072

Basilea awarded contract by BARDA of up to USD 89 million for the development 
of its novel antibiotic BAL30072 
BASEL, SWITZERLAND -- (Marketwired) -- 06/25/13 --  Basilea
Pharmaceutica AG / Basilea awarded contract by BARDA of up to USD 89
million for the development of its novel antibiotic BAL30072 .
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solely responsible for the content of this announcement. 
* BAL30072 current multiple ascending dose study reached maximum
tolerated  dose  * Further development, including combination studies
with carbapenems, planned
 under BARDA agreement Basel, Switzerland,
June 25, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced
today that the Biomedical Advanced Research and Development
Authority
(BARDA), a division within the U.S. Department of Health
and Human Services, has entered a contract with Basilea for the
development of BAL30072, Basilea's novel
monosulfactam antibiotic,
due to the drug's broad coverage against multidrug-resistant
Gram-negative pathogens including those that pose a biothreat. 
Under the terms of the contract, BARDA will provide funding of
approximately
USD 17 million over the initial agreement period of
twenty-two months. Subsequent options which may be exercised over a
total six-year-period would
bring the total value of the contract up
to USD 89 million. Exercise of these
options is conditioned upon
successful completion of pre-defined milestones,
including
microbiological, pre-clinical, clinical, manufacturing and
associated
regulatory activities. 
BAL30072 is being developed for the treatment of severe infections,
such as nosocomial pneumonia due to multidrug-resistant Gram-negative
bacteria. To date,
Basilea has conducted a single ascending dose,
double-blind, randomized, placebo-controlled trial and double-blind,
randomized, placebo-controlled dose-ranging studies with multiple
ascending doses in healthy volunteers assessing
the pharmacokinetics,
safety and tolerability of BAL30072. For the current multiple
ascending dose study, the maximum tolerated dose has been reached.
Consistent with previous findings the dose-limiting factor was
reversible elevated liver enzyme levels. 
In pre-clinical in-vitro and in animal studies, an additive or
synergistic activity of BAL30072 when combined with antibiotics from
the carbapenem class
has been demonstrated. Under the contract with
BARDA, Basilea will now continue
to test in phase 1 safety and
tolerability of BAL30072 also in combination with
carbapenems.
Basilea is continuing the profiling of BAL30072 to establish
the
optimal dosing regimens for clinical testing of combinations. The
phase 1 development program, including studies in combination and in
special patient
populations, will continue in 2014. 
Ronald Scott, Basilea's Chief Executive Officer, commented: "BAL30072
is a potent, bactericidal antibiotic covering a broad range of
clinically relevant
multidrug-resistant Gram-negative bacteria. The
drug originated from our portfolio of exciting research compounds
addressing multiple mechanisms of drug
resistance. Our integrated
research, development and manufacturing organization
is focused on
making drugs that fight resistance available to patients. Through
the
BARDA contract, we will move forward with the development of our
innovative
antibiotic BAL30072, advancing a medical countermeasure
for a potential biological threat to national security and public
health." 
Prof. Achim Kaufhold, Basilea's Chief Medical Officer added: "Given
the evidence
of synergistic or additive activity of BAL30072 in
combination with carbapenems
and its broad coverage of
multidrug-resistant Gram-negative pathogens, the drug
has the
potential of becoming an important treatment option for serious
infections, including hospital-acquired infections due to resistant
pathogens
which are increasing in frequency. BAL30072 addresses the
global concerns of
antibiotic resistance and also has a potential
role in biodefense, treating infections caused by potential
biowarfare agents." 
BARDA is a division within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and Human
Services. 
About BAL30072 
BAL30072 is a novel monosulfactam antibiotic with bactericidal
activity against
multidrug-resistant Gram-negative bacteria. It has
demonstrated broad in-vitro
and in-vivo coverage of Gram-negative
pathogens including multidrug-resistant
Pseudomonas aeruginosa and
Acinetobacter baumannii. It has robust activity against common and
resistant pathogens including those that produce
antibiotic-inactivating enzymes such as metallo-beta-lactamases
including the New Delhi metallo-beta-lactamase 1 (NDM-1). In addition,
BAL30072 has been shown to enhance the activity of antibiotics from
the carbapenem class. Due to its potent
antimicrobial activity
against a broad range of clinically relevant and resistant
Gram-negative bacteria, BAL30072 has the potential to play an
important role in the therapy of serious and life-threatening
infections such as hospital-acquired pneumonia, complicated
intra-abdominal infections or complicated urinary tract infections. 
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
oncology,
targeting the medical challenge of rising resistance and
non-response to current
treatment options. 
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. 
This press release can be downloaded from www.basilea.com. 
Press
release (PDF): http://hugin.info/134390/R/1711719/567944.pdf 
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1711719] 
For further information, please contact: 
Media Relations 
Peer Nils Schroeder, PhD
Head Public Relations &
Corporate Communications
+41 61 606 1233
media_relations@basilea.com 
Investor Relations 
Barbara Zink, PhD, MBA
Head Corporate Development
41 61 606 1233
investor_relations@basilea.com
 
 
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