The Medicines Company Announces FDA Filing Acceptance of New Drug Application for Intravenous Antibiotic Carbavance® (meropenem-vaborbactam)
The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s new drug application (NDA) filing for Carbavance® (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTIs). The FDA does not currently plan to hold an advisory committee meeting to discuss the application.
The NDA filing is based on results from the pivotal Phase III TANGO 1 clinical trial in patients with cUTIs. As previously announced, the TANGO 1 trial met both FDA and European Medicines Agency (EMA) pre-specified primary endpoints. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients. Supporting the NDA are interim data from the ongoing TANGO 2 Phase III trial, which compares the safety, tolerability and efficacy of Carbavance with best available therapy in patients with selected serious infections due to confirmed or suspected carbapenem-resistant Enterobacteriaceae (CRE). The TANGO 2 trial is ongoing and the Company expects results to be available before the end of the third quarter of 2017.
“The exceptionally rapid development of Carbavance demonstrates the strong product discovery and development capabilities of The Medicines Company’s Infectious Disease Business, and reflects our commitment to making innovative antimicrobial products available to patients with the most serious drug-resistant infections,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We believe that Carbavance could be a promising and highly-differentiated treatment option for these patients and we look forward to continuing our dialogue with the FDA during its review process.”
Tony Kingsley, President and Chief Operating Officer of The Medicines Company added, “Reaching this point in the development of Carbavance reflects the focus, commitment and expertise of our Infectious Disease Business. Multiple studies support the potential for Carbavance to make a meaningful difference in the treatment of serious infections. If approved by the FDA, we will leverage our existing sales and distribution infrastructure to launch Carbavance in the U.S. market.”
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 cUTI, including those infections caused by bacteria resistant to currently-available carbapenems. Carbavance has been granted Fast Track status by the FDA for the treatment of cUTI 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 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.
In February 2014, the Company’s Infectious Disease Business was awarded a cost-sharing contract from 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), of which $55.8 million in federal funds have been obligated to date to support the development of Carbavance.
In September 2016, The Medicines Company entered into a new strategic partnership with BARDA 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. The Medicines Company was awarded $32 million in initial funding, and up to an additional $100 million (pending the availability of funding) over approximately five years, if all options to extend the partnership are exercised by BARDA. The initial $32 million award support a Phase IIIb trial of the Carbavance, 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.
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 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 Infectious Disease Business also has a leading pipeline of novel agents directed towards 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," “potential,” 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 the Company will make regulatory submissions for Carbavance on a timely basis, or at all; whether the Carbavance NDA and other regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; whether clinical trials for Carbavance 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; 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 October 27, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.