The Medicines Company (NASDAQ:MDCO) today 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.
About CARBAVANCE® (meropenem-vaborbactam)
Carbavance, an investigational agent not approved for commercial use in any market, is a combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by IV infusion. It is being developed to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. Carbavance has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act.
Carbavance was designed to address gram-negative bacteria that produce new beta-lactamase enzymes that have spread in the United States and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) in the United States and are classified by the U.S. Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat.
About The Infectious Disease Business
The Medicines Company’s Infectious Disease Business is committed to bringing life-saving antimicrobial products to patients with the most serious drug-resistant infections— infections caused by “super bugs” which are no longer treatable with available antibiotics. The Infectious Disease Business encompasses basic research and drug discovery focused on bacterial mechanisms of drug resistance; drug development focused on the most threatening bacterial diseases; and a distribution and commercial infrastructure that serves the leading hospitals and healthcare facilities in the United States. The business is currently developing Carbavance® (meropenem-vaborbactam) to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. A pivotal Phase III clinical trial for Carbavance was successfully completed in 2016. Since 2014, our team has successfully developed and launched two antibiotics against serious infections: Orbactiv® (oritavancin) for treatment of acute bacterial skin and skin-structure infections in adults, including those due to methicillin-resistant Staphylococcus aureus (MRSA) and a new formulation of Minocin® (minocycline) for injection, which is among the few FDA-approved agents for the treatment of infections due to Acinetobacter sp., a serious antimicrobial resistance threat. For more information on these products, including their respective prescribing information, please see www.orbactiv.com and www.minociniv.com. The business also has a leading pipeline of novel agents that address existing and emerging multidrug-resistant bacteria.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by an overriding purpose—to save lives, alleviate suffering and contribute to the economics of healthcare. The Company’s mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in three critical therapeutic areas: serious infectious disease care, cardiovascular care and surgery and perioperative care. The Company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland.
Forward Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether BARDA, HHS and the Company will perform as expected under the new OTA agreement; whether clinical trials for our product candidates will advance in the clinical process on a timely basis or at all or succeed in achieving their specified endpoints; whether physicians, patients and other key decision makers will accept clinical trial results; whether the Company will make regulatory submissions for its product candidates, including Carbavance, on a timely basis or at all; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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Last updated on: 21/09/2016
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