Date: 2013-06-25
Type of information: Development agreement
Compound: BAL30072 (monosulfactam antibiotic)
Company: Basilea Pharmaceutica (Switzerland) Biomedical Advanced Research and Development Authority (BARDA- U.S. Department of Health and Human Services) (USA)
Therapeutic area: Infectious diseases
Type agreement: development
Action mechanism: BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo models demonstrated potent bactericidal activity against a broad range of multidrug-resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. It overcomes bacterial resistance by several mechanisms and is not easily destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum beta-lactamases (ESBLs), carbapenemases and the recently characterized New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance against many currently marketed antibiotics.
Disease: multidrug-resistant Gram-negative
Details: * On June 25, 2013, Basilea Pharmaceutica has announced 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.
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.
Financial terms: Under the terms of the contract, BARDA will provide funding of approximately $ 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 $ 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.
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