Basilea awarded contract by BARDA of up to USD 89 million for the development of its novel antibiotic BAL30072
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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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* 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.
For further information, please contact:
+----------------------------------+--------------------------------+
| Media Relations | Investor Relations |
+----------------------------------+--------------------------------+
| Peer Nils Schröder, PhD | Barbara Zink, PhD, MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+----------------------------------+--------------------------------+
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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originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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