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Feb 5, 2014

BARDA to Fund Development of Rempex Antimicrobial

  • Rempex Pharmaceuticals, a wholly owned subsidiary of The Medicines Company, has been awarded a BARDA contract worth up to $90 million to support the development of Carbavance, a combination of a carbapenem antibiotic with a beta-lactamase inhibitor for treatment of multidrug resistant gram-negative infections.

    The BARDA contract is a cost-sharing arrangement that includes nonclinical development activities, clinical studies, manufacturing, and associated regulatory activities designed to gain U.S. approval of Carbavance for treatment of serious gram-negative infections. Studies are also planned to assess the potential usefulness of Carbavance for treatment of certain gram-negative bioterrorism agents.

    The contract includes an initial commitment of $19.8 million and subsequent option periods over five years that, if completed, would bring the total value of the award to approximately $90 million.

    The Medicines Company acquired Rempex Pharmaceuticals two months ago. Among the drug candidates of interest to The Medicines Company was Carbavance, which is expected to enter registration studies in 2014, having already completed Phase I dose-escalation studies. Last year, Rempex presented preclinical data in which Carbavance showed promising activity against key gram-negative pathogens, including E. coli, Klebsiella sp., Acinetobacter sp., and Pseudomonas aeruginosa.

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