The Medicines Company Announces Completion of Patient Enrollment in Phase 3 TANGO 1 Study of CARBAVANCE® (meropenem-vaborbactam) for Treatment of Complicated Urinary Tract Infections (cUTI)
The Medicines Company (NASDAQ:MDCO) has announced the completion of patient enrollment in the Phase 3 TANGO 1 study of CARBAVANCE® (meropenem-vaborbactam), an investigational agent being developed for the treatment of complicated urinary tract infections (cUTI). TANGO 1 was initiated in the fourth quarter of 2014 under a cost-share agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of CARBAVANCE. Top-line data are expected in the second half of 2016.
“As we announce today the completion of enrollment in this critical Phase 3 study, sooner than originally forecasted, CARBAVANCE continues to move quickly through product development,” said Clive Meanwell, MD, PhD, Chief Executive Officer, The Medicines Company. “CARBAVANCE is targeted at the most deadly and insidious of bacterial threats, namely CRE. We look forward to sharing results from the TANGO 1 study in the near future.”
CARBAVANCE is the combination of the carbapenem antibiotic, meropenem, with the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), that is being developed for the treatment of gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).
“Completion of patient enrollment in the TANGO 1 trial in patients with cUTI, along with Fast Track designation for potential indications in cUTIs, are important milestones in the accelerated development program for CARBAVANCE,” said Michael Dudley, PharmD, Senior Vice President, Head of Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. “Support from BARDA has allowed us to continue delivering on our commitment to advance new antimicrobial drugs to address the most serious and urgent drug-resistant infections. It is patients with limited treatment options that CARBAVANCE is intended to help. Timely and helpful guidance from the FDA and European regulators has also been instrumental in enabling execution of an efficient Phase III program.”
TANGO 1 is investigating the safety, tolerability and efficacy of CARBAVANCE in patients with cUTIs or acute pyelonephritis compared to that for piperacillin/tazobactam. Approximately 550 patients were to be randomly assigned (1:1) to receive either CARBAVANCE or piperacillin/tazobactam each given intravenously for up to 10 days. Patients in both arms who met protocol-defined criteria of improvement could be switched to oral levofloxacin after a minimum of 5 days of IV therapy.
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 and is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.
CARBAVANCE was designed to address gram-negative bacteria that produce new 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 antimicrobial resistance threat.
About TANGO Clinical Trials
There are currently two ongoing TANGO (Targeting Antibiotic Non-susceptible Gram-negative Organisms) Phase 3 clinical trials. In addition to TANGO 1, 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. Study subjects with cUTI, nosocomial pneumonia, intra-abdominal infections and/or bacteremia will be randomly assigned (2:1) to CARBAVANCE or "best available therapy" for up to 14 days.
About FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigational agent CARBAVANCE (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI). The FDA Fast Track designation is designed to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.
About BARDA Contract
In February 2014, the CARBAVANCE program was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) that included an initial commitment of $19.8 million and subsequent option periods over 5 years that, if completed, would bring the total value of the award to approximately $90 million to support the development of CARBAVANCE. BARDA awarded the second option on October 31, 2014 and a third option on October 1, 2015, bringing the total commitment to date by BARDA to $55.8 million. The BARDA contract is a cost-sharing arrangement that includes non-clinical development activities, clinical studies, manufacturing, and associated regulatory activities.
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 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, US and Zurich, Switzerland.
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," "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,, 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 May 9, 2016 , which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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Krishna Gorti, M.D., 973-290-6122
Vice President, Investor Relations