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 (NASDAQ:MDCO) 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."
CARBAVANCE®, an investigational agent not approved for commercial use in any market, is a combination of meropenem and RPX7009 administered as a fixed combination by IV infusion and is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems. There are currently two Phase 3 clinical trials, TANGO 1 and TANGO 2, which are ongoing. TANGO I is investigating CARBAVANCE’s safety, tolerability, and efficacy in patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP) compared to that for piperacillin/tazobactam. The second Phase 3 trial (TANGO 2) is comparing CARBAVANCE’s safety, tolerability, and efficacy with best available therapy in patients with serious infections due to confirmed or suspected CRE. CARBAVANCE® was designed to address resistant gram-negative bacteria that produce beta-lactamase enzymes that have spread in the US 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 US and are classified by the US Centers for Disease Control and Prevention (CDC) to be an urgent microbial resistance threat. CARBAVANCE® has been designated as a qualified infectious disease product (QIDP) by the US FDA.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements 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," “hopes,” and “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 our product candidates, including CARBAVANCE ®, will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether the BARDA contract remains in effect and the Company is able to comply with its requirements, 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 SEC on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.