Medicines Co. (MDCO) Receives $132M HHS Grant, Enters Partnership with BARDA for Gram-Negative Infections Antibiotics

September 21, 2016 7:31 AM EDT

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The Medicines Company (Nasdaq: MDCO) announced that it has entered into a new strategic partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), that will provide the Company with up to $132 million to support the development of new antibiotics to fight drug-resistant, gram-negative infections. The partnership was established under HHS’s Other Transactional Authority (OTA) and is a distinctive, flexible, portfolio-based approach to funding drug development. It is the first portfolio-based partnership between BARDA and a U.S. headquartered private-sector company.

Under the terms of the OTA agreement, BARDA will provide $32 million in initial funding, and up to an additional $100 million over approximately 5 years if all options to extend the partnership are exercised by BARDA. The initial $32 million award will 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 (HABP/VABP). The initial award, as well as funding provided under any subsequent options exercised by BARDA, will also support the advancement of additional antibiotics in The Medicines Company’s leading portfolio of new antibiotic drug candidates targeting drug resistant bacteria. In 2014, the Company’s Infectious Disease Business was also awarded a cost-sharing contract from BARDA, of which $55.8 million in federal funds have been obligated to date to support the development of Carbavance.

“The commitment of HHS and BARDA to establishing innovative structures to support the development of novel antimicrobial drugs demonstrates their leadership in combating the growing worldwide public threat of antibiotic resistance. The size and scope of The Medicines Company’s strategic relationship with BARDA reflects our successful track record of innovative antibiotic discovery and development, the strength of our commercialization capabilities and the breadth of our leading pipeline of novel, antibacterial drug candidates,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “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. We view this as a critical part of our mission to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers.”

Michael Dudley, PharmD, Senior Vice President, Head of R&D and Co-Leader of The Medicines Company’s Infectious Diseases Business, added, “Multidrug-resistant bacterial infections are widely-recognized as an urgent and growing threat to public health. 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. Our new partnership with BARDA will allow us to advance the next generation of urgently-needed antibiotics for the most serious drug-resistant infections, particularly those for which there are limited or no effective treatment options, and will provide flexibility to adjust our plans according to the most promising candidates and evolving drug-resistance priorities in the U.S. healthcare system.”

Antibiotic resistance, also known as antimicrobial drug-resistance (AMR), is a rapidly-growing threat in the United States and around the world. The U.S. Centers for Disease Control (CDC) estimates that, in the United States alone, more than two million infections and 23,000 deaths annually are caused by bacteria resistant to at least first-line treatments, with an estimated annual cost burden of $20 billion. Carbapenem-resistant Enterobacteriaceae (CRE) infections are one of the deadliest, with mortality rates reaching 40%. The CDC considers CRE as one of the top three most urgent drug-resistant infectious disease threats and the only one of the top three that causes systemic infections.

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