The Medicines Company said today it will receive up to $132 million from the Biomedical Advanced Research and Development Authority (BARDA) toward developing new antibiotics to fight drug-resistant, gram-negative infections.
The strategic partnership is the first between BARDA and a drug developer based on building a portfolio rather than a single treatment, The Medicines Company said.
The Medicines Company will receive $32 million in initial funding, followed by up to an additional $100 million over approximately five years, if BARDA exercises all options to extend the partnership. The initial $32 million award is intended to support a Phase IIIb trial of the company’s investigational antibiotic, Carbavance® (meropenem-vaborbactam), for the treatment of gram-negative infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
The initial award, as well as funding provided under subsequent options exercised by BARDA, will also support the advancement of additional antibiotics in The Medicines Company’s portfolio of antibiotic drug candidates targeting drug-resistant bacteria, the company added.
“Our new portfolio-based partnership with BARDA demonstrates our continuing commitment to our infectious disease business and will enable us to accelerate the development of novel therapies to combat the rising threat of antimicrobial drug-resistance, while expanding our integrated discovery, development and commercialization platform,” Clive Meanwell, M.D., Ph.D., CEO of The Medicines Company, said in a statement.
The award is not BARDA’s first to The Medicines Company. To date, $55.8 million in federal funds have been obligated to support the development of Carbavance under a contract awarded to the company’s infectious disease business in 2014.
In June, The Medicines Company reported positive topline results from the Phase III TANGO1 trial of Carbavance in patients with complicated urinary tract infections, including statistical superiority over the combination of piperacillin and tazobactam.
“Existing support from BARDA has been integral to our rapid advancement of Carbavance from our discovery labs through a successful Phase III trial program, and has positioned us for an NDA submission in early 2017,” added Michael Dudley, PharmD, svp, head of R&D and co-leader of The Medicines Company’s infectious diseases business.