The Medicines Company MDCO today announced enrollment of the first
patient in its Phase 3 clinical trial program for CARBAVANCE™
(meropenem/RPX7009), an investigational intravenous antibiotic under
development for the treatment of serious bacterial infections due to
gram-negative bacteria, particularly KPC (Klebsiella pneumoniae
carbapenemase)-producing carbapenem-resistant Enterobacteriaceae (CRE).
CARBAVANCE ^ is a combination of the carbapenem antibiotic, meropenem,
combined with RPX7009, the first of a novel class of beta-lactamase
inhibitors. Beta-lactamase inhibitors are agents that inhibit bacterial
enzymes, which destroy beta-lactam antibiotics and result in resistance to
first line as well as "last defense" antimicrobials used in hospitals.
Gram-negative bacterial infections are widely considered to be one of the
largest areas of unmet medical need, as these pathogens are growing
increasingly resistant to existing therapies with few antibiotics in
development.
“We are excited to be initiating our two clinical trials with CARBAVANCE,”
said Jeff Loutit, Vice President and Chief Medical Officer for Infectious
Disease Care at The Medicines Company. “RPX7009 was developed specifically to
have activity against KPC producing strains of CRE, and meropenem is a
carbapenem with a proven track record of efficacy and safety. We believe
CARBAVANCE, upon approval, has the potential to provide health care
professionals and patients with a new option for the treatment of serious
gram-negative infections.”
The first CARBAVANCE clinical trial is designed to evaluate the efficacy,
safety and tolerability of CARBAVANCE in approximately 850 patients with
complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). The
second trial is designed to evaluate the safety, efficacy and tolerability of
CARBAVANCE in approximately 150 patients with suspected or known serious
infections due to CRE across multiple indications.
Results from both CARBAVANCE Phase 3 trials are expected in 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. “With acute and intensive care
hospitals around the world facing rapid and increasing antibacterial
resistance, the development of CARBAVANCE is the type of innovation we need as
physicians to address such a threat,” stated Keith S. Kaye, M.D., M.P.H.,
Professor of Internal Medicine and Infectious diseases at Wayne State
University School of Medicine, Corporate Director of Infection Prevention,
Hospital Epidemiology and Antimicrobial Stewardship at the Detroit Medical
Center.
In January 2014, the U.S. Food and Drug Administration (FDA) designated
CARBAVANCE as a Qualified Infectious Disease Product (QIDP). 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 of the product for intravenous use in six indications. These
include complicated urinary tract and intra-abdominal infections,
hospital-acquired bacterial pneumonia/ventilator-associated bacterial
pneumonia, and febrile neutropenia. 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.
In February 2014, the CARBAVANCE program, through our subsidiary Rempex
Pharmaceuticals, 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. On October 30, 2014, BARDA awarded Rempex the
second option, bringing the total commitment to date by BARDA to $37.8
million. The BARDA contract (HHSO100201400002C) is a cost-sharing arrangement
that includes non-clinical development activities, clinical studies,
manufacturing, and associated regulatory activities designed to gain US
approval of CARBAVANCE for treatment of serious gram-negative infections.
Studies are also planned to assess the potential usefulness of CARBAVANCE for
treatment of certain gram-negative bioterrorism agents.
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