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 In a late-stage study, CARE, involving patients with serious
infections due to carbapenem-resistant enterobacteriaceae (CRE),
treatment with the drug, plazomicin, resulted in lower mortality
rates or serious complications, compared with colistin therapy, one
of the few antibiotics still used to treat CRE.
CRE is relatively rare, but the U.S. Centers for Disease Control and
Prevention has deemed it a "nightmare bacteria" because it spreads
easily, is increasingly resistant to existing antibiotics, and can
kill up to half of its victims.
Data shows there were about 65,000-75,000 cases of CRE in the United
States last year, the company said on a conference call with
analysts.
In a separate late-stage trial called EPIC, plazomicin was found to
be as effective as the broad spectrum antibiotic, meropenem, in
patients with complicated urinary tract infections (cUTI) and acute
pyelonephritis, Achaogen said.
A cUTI is associated with an underlying condition, which increases
the risk of failing therapy. Pyelonephritis typically occurs when
bacteria migrate from the bladder to the kidney, infecting the
organ.
Achaogen said it planned to submit a marketing application,
including data from both studies, to the U.S. Food and Drug
Administration in the second half of 2017 and the European Medicines
Agency in 2018.
The biotech company's shares jumped to $9.25 in morning trading on
Monday. Up to Friday's close, Achaogen's stock had fallen 8.54
percent since the start of the year.
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William Blair's Katherine Xu has forecast peak plazomicin sales of
$270 million for cUTI and $70 million for CRE in 2031, if approved,
in a client note published in November.
The plazomicin program is funded in part with an up to $103.8
million contract from the Biomedical Advanced Research and
Development Authority, or BARDA, a unit of U.S. Department of Health
and Human Services.
Antimicrobial resistant, or superbug, infections, kill hundreds of
thousands of people a year and has been described by the World
Health Organization as "one of the biggest health challenges of the
21st century."
(Reporting by Natalie Grover in Bengaluru; Editing by Anil D'Silva
and Martina D'Couto)
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