The Medicines Company Announces BARDA Exercises Next Option on Contract for Support of the Development of CARBAVANCE® (meropenem/RPX7009) for Drug-Resistant Gram-Negative Pathogens

The Medicines Company

today announced that Rempex Pharmaceuticals, a wholly owned subsidiary, has been awarded the next option on a contract by the Biomedical Advanced Research and Development Authority (BARDA) to support the development of CARBAVANCE® (meropenem/RPX7009). CARBAVANCE is the combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor that is targeted for treatment of multi-drug resistant (MDR) gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE). The BARDA contract is a cost-sharing arrangement that includes clinical studies, non-clinical development activities, manufacturing, and associated regulatory activities designed to gain US approval of Carbavance for treatment of serious gram-negative infections. Carbavance is currently in Phase 3 development. The cost-share contract with BARDA was initiated in 2014 and extends over 5 years. The award of this third option brings the total commitment from BARDA to $53.8 million. If all options are exercised in the contract, it would bring the total value of the award to approximately $90 million. "We have enjoyed a very productive collaboration with BARDA", said Michael Dudley, PharmD, FIDSA, Senior Vice President and Head of Health Sciences Research and Development, and co-Leader of the Infectious Diseases Global Innovation Group. "We are grateful for the recognition of the excellent progress made in the development of CARBAVANCE, and the importance of advancing urgently needed new therapies for resistant bacteria by exercising the next option in our contract." Clive Meanwell, MD, PhD, CEO of The Medicines Company, added, "With acute and intensive care hospitals in the United States facing rapid and increasing antibacterial resistance, we appreciate the commitment of BARDA to Carbavance and the innovation it reflects from our R&D teams that are committed to saving lives, alleviating suffering and contributing to the economics of healthcare by addressing the important problem of antibiotic resistance."