The Interagency Task Force on Antimicrobial Resistance was initiated in 1999 following a congressional hearing on the topic "Antimicrobial Resistance: Solutions to a Growing Public Health Problem."
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
National Institutes of Health (NIH)
From the 2012 Action Plan -
"NIH currently supports clinical trials aimed at identifying ways to reduce the use of licensed antibacterials in both community and healthcare settings. These trials focus on areas of greatest antimicrobial drug exposure, such as pneumonia ... and employ strategies to reduce use, such as shorter courses of antimicrobial treatment ..."
NB: the longer bacteria are exposed to an antibiotic, the greater the opportunity for resistant strains to develop.
With that federal objective in mind - from Lewis during his latest presentation -
"IV amikacin is used to treat this patient population right now. You can't get enough amikacin into the lung through IV to successfully address this disease".
In the US alone over a million people each year are hospitalized with pneumonia - and currently treated with antibiotics delivered via the bloodstream.
Anybody assuming that the FDA has no reason to approve Arikace for anything other than CF and NTM is completely overlooking its strategic importance to the federal task force. From the 10-K -
"In 2012, we entered into a cooperative research and development agreement (CRADA) with National Institutes of Allergy and Infectious Diseases (NIAID) to evaluate the safety and efficacy of ARIKACE in patients with NTM lung disease ... NIAID agreed to provide biostatistical advisory input in connection with the phase 2 NTM study. If we decide not to continue with the commercialization of ARIKACE in NTM, NIAID will have the right to complete the clinical trial. Further NIAID may elect to pursue its rights to obtain license rights to certain inventions made under the CRADA."
The following info on carbapenem-resistant Enterobacteriaceae (CRE) offers good reason for believing that the Federal Task Force views Arikace as an important weapon in the war against antimicrobial resistance -
"Last month, the CDC warned of a growing prevalence of carbapenem-resistant Enterobacteriaceae, or CRE, at U.S. hospitals.
CRE, which belong to a family of gram-negative bacilli bacteria are nightmare bacteria because it is resistant to even the strongest antibiotic available and patients are left with potentially untreatable infections, said Tom Frieden, Director of the Centers for Disease Control and Prevention, last month.
A new report, published online on April 18 in Clinical Infectious Diseases says that there are only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli, or GNB, bacteria. ... Even if approved - will these drugs be effective against the most resistant bugs that everyone is worried about?"
I posted the following a while back from a study on NDM-1 Enterobacteriaceae. Note that whereas all isolates were resistant to carbapenems, 87.5% remained susceptible to amikacin -
Objective: New Delhi metallo-beta-lactamase-1 (NDM-1) was reported in India and the United Kingdom in August 2010.
The first case of NDM-1 in this hospital was detected in October 2010 ..... From October 2010 to October 2011, we detected 7 NDM-1 patients with no overseas travel in last 2 years.
We detected 8 NDM-1 bacteria in 6 patients from clinical cultures (6 in urine, 1 in bile) and 1 from contact screening; 5 were Escherichia coli, 2 Klebsiella pneumoniae (KP) and 1 Enterobacter cloacae.
All isolates were resistant to all tested carbapenems, cephalosporins, penicillin-inhibitor combinations, and ciprofloxacin; 100% were susceptible to polymyxin B, 87.5% to amikacin, and 25% to gentamycin and ciprofloxacin. Three cases of urinary infections were cured with amikacin or polymyxin B.