FDA Grants Fast Track Status for Investigational Antibiotic CARBAVANCE® (meropenem-vaborbactam)

11 Apr 2016
  • TANGO Phase 3 Clinical Trials Underway for cUTI and Serious Bacterial Infections Due to Confirmed or Suspected Carbapenem-resistant Enterobacteriaceae (CRE)

PARSIPPANY, N.J. --(BUSINESS WIRE)--Apr. 11, 2016-- The Medicines Company (NASDAQ:MDCO) today announced that 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). 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).

"We are excited about the potential to accelerate the regulatory evaluation for our novel investigational agent and potentially provide a new option for patients in the battle against gram-negative bacteria, including CRE, for which there is an unmet need," said Michael Dudley, PharmD, Senior Vice President and Head of Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. "The Medicines Company is committed to developing an innovative portfolio of antimicrobial drugs to tackle the most serious and urgent drug-resistant infections. The FDA Fast Track designation is an important regulatory process to help us meet that goal."

CARBAVANCE, an investigational agent not approved for commercial use in any market, is administered as a fixed combination by IV infusion. There are currently two ongoing TANGO (Targeting Antibiotic Non-susceptible Gram-negative Organisms) Phase 3 clinical trials. TANGO 1 is a randomized controlled trial in patients with cUTIs, and results are expected in the second half of 2016.

Antibiotic resistance in gram-negative bacteria has increased markedly in the last decade, leaving clinicians and critically ill patients few choices for treatment. The CDC has designated CRE as an urgent antimicrobial resistance threat. This has created an urgent need for new agents that has been recognized worldwide by health authorities.

In January 2014 , the FDA designated CARBAVANCE® as a Qualified Infectious Disease Product (QIDP) for cUTIs, intra-abdominal infections, HABP/VABP, and febrile neutropenia. The QIDP designation provides CARBAVANCE priority review by the FDA , eligibility for the FDA's "fast track" status, and an additional five years of exclusivity upon approval. The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012.

About Fast Track Designation

FDA's 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 $53.8 million . The BARDA contract is a cost-sharing arrangement that includes non-clinical development activities, clinical studies, manufacturing, and associated regulatory activities.

About TANGO 1 and TANGO 2

TANGO I is investigating the safety, tolerability, and efficacy of CARBAVANCE in patients with cUTIs or acute pyelonephritis compared to that for piperacillin/tazobactam. Approximately 500 study subjects will be randomly assigned (1:1) to receive either CARBAVANCE IV or piperacillin/tazobactam each given intravenously for up to 10 days. Subjects in both arms who meet protocol-defined criteria of improvement can be switched to oral levofloxacin after a minimum of 5 days of IV therapy.

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. Approximately 150 study subjects with cUTI, nosocomial pneumonia and/or bacteremia will be randomly assigned (2:1) to CARBAVANCE® IV or "best available therapy" for up to 14 days.

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 .

Forward-looking Statements

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 annual report on Form 10-K filed with the SEC on February 29, 2016 , which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

Source: The Medicines Company

The Medicines Company
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