Basilea Pharmaceutica AG : Basilea awarded contract by BARDA of up to USD 89
million for the development of its novel antibiotic BAL30072
Basilea Pharmaceutica AG / Basilea awarded contract by BARDA of up to USD 89
million for the development of its novel antibiotic BAL30072 . Processed and
transmitted by Thomson Reuters ONE. The issuer is solely responsible for the
content of this announcement.
*BAL30072 current multiple ascending dose study reached maximum tolerated
*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
Under the terms of the contract, BARDA will provide funding of approximately
USD17 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 USD89million. 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 phase1 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
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.
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.
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
This press release can be downloaded from www.basilea.com.
Press release (PDF)
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(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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