New Antibiotics are Needed for Multi-drug Resistant Gram-Negative Infections
Patients with multi-drug resistant (MDR) infections often have limited or inadequate therapeutic options leading to high rates of mortality. We believe the greatest unmet medical needs lie among infections due to MDR gram-negative bacteria, where the problem is extensive and growing and the industry pipeline of drug candidates is sparse.
The World Health Organization has declared antibiotic resistance a threat to global health security
|2 MILLION||23,000||8 MILLION||20 BILLION|
|People per year in the U.S. become infected with antibiotic resistant bacteria||People die each year as a direct result of antibiotic resistant infections||Additional days in the hospital as a result of antibiotic resistant infections||Dollars is the annual cost resulting from antibiotic resistant infections in the U.S.|
Antibiotic resistance threats in the United States, 2013
By 2050, antimicrobial resistance is projected to result in ~10 million deaths per year and a global loss in Gross Domestic Product of more than $100 trillion
Review on Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations.
Review on Antimicrobial Resistance 2014.
Carbapenem-Resistant Enterobacteriaceae Pose an Urgent Threat to Patients
The need for new antibiotics to treat carbapenem-resistant-Enterobacteriaceae (CRE) is particularly acute. In 2013, the CDC labeled CRE as “nightmare bacteria” and indicated that CRE pose a public health threat requiring “urgent and aggressive action.” These bacteria are commonly multi-drug resistant, exhibiting resistance to not only carbapenems, but also to nearly all antibiotics commonly used to treat gram-negative infections, including cephalosporins, beta-lactam/beta-lactamase inhibitor combinations, fluoroquinolones, and currently marketed aminoglycosides.
Resistance to carbapenems is alarming because these drugs are one of the last lines of defense against resistant gram-negative infections. Most CRE express enzymes called carbapenemases which break down the carbapenem antibiotic molecule before it can kill the bacteria. Due to the lack of effective therapies, CRE infections are associated with significant mortality.
Department of Health & Human Services (HHS) Support
The U.S. Department of HHS supports the development of novel antibacterials through the Biomedical Advanced Research and Development Authority (BARDA) and their Broad Spectrum Antimicrobials (BSA) Program. In 2010, we entered into a contract with BARDA, under which BARDA committed funding of $124.3 million for the development of plazomicin. In 2017, we entered into a new contract with BARDA, under which BARDA has committed funding up to $18 million for the development of C-Scape.