BASEL, SWITZERLAND--(Marketwired - June 25, 2013) -
Basilea Pharmaceutica AG /
Basilea awarded contract by BARDA of up to USD 89 million for the
its novel antibiotic BAL30072
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* BAL30072 current multiple ascending dose study reached maximum tolerated
* Further development, including combination studies with carbapenems,
under BARDA agreement
Basel, Switzerland, June 25, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the Biomedical Advanced Research and Development
(BARDA), a division within the U.S. Department of Health and Human
entered a contract with Basilea for the development of BAL30072, Basilea's
monosulfactam antibiotic, due to the drug's broad coverage against
multidrug-resistant Gram-negative pathogens including those that pose a
Under the terms of the contract, BARDA will provide funding of
USD 17 million over the initial agreement period of twenty-two months.
Subsequent options which may be exercised over a total six-year-period
bring the total value of the contract up to USD 89 million. Exercise of
options is conditioned upon successful completion of pre-defined
including microbiological, pre-clinical, clinical, manufacturing and
BAL30072 is being developed for the treatment of severe infections, such as
nosocomial pneumonia due to multidrug-resistant Gram-negative bacteria. To
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
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
has been demonstrated. Under the contract with BARDA, Basilea will now
to test in phase 1 safety and tolerability of BAL30072 also in combination
carbapenems. Basilea is continuing the profiling of BAL30072 to establish
optimal dosing regimens for clinical testing of combinations. The phase 1
development program, including studies in combination and in special
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
multidrug-resistant Gram-negative bacteria. The drug originated from our
portfolio of exciting research compounds addressing multiple mechanisms of
resistance. Our integrated research, development and manufacturing
is focused on making drugs that fight resistance available to patients.
the BARDA contract, we will move forward with the development of our
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
of synergistic or additive activity of BAL30072 in combination with
and its broad coverage of multidrug-resistant Gram-negative pathogens, the
has the potential of becoming an important treatment option for serious
infections, including hospital-acquired infections due to resistant
which are increasing in frequency. BAL30072 addresses the global concerns
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
BAL30072 is a novel monosulfactam antibiotic with bactericidal activity
multidrug-resistant Gram-negative bacteria. It has demonstrated broad
and in-vivo coverage of Gram-negative pathogens including
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
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
hospital-acquired pneumonia, complicated intra-abdominal infections or
complicated urinary tract infections.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the Company focuses on innovative pharmaceutical
the therapeutic areas of bacterial infections, fungal infections and
targeting the medical challenge of rising resistance and non-response to
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
events or otherwise.
This press release can be downloaded from www.basilea.com.
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE