Achaogen Announces FDA Clearance and Launch of the Thermo Scientific QMS Plazomicin Immunoassay
December 10 2018 - 8:01AM
Achaogen, Inc. (NASDAQ: AKAO), a biopharmaceutical company
discovering, developing and commercializing innovative
antibacterial agents to address multi-drug resistant (MDR)
gram-negative infections, today announced that the Center for
Devices and Radiological Health (CDRH) of the U.S. Food and Drug
Administration (FDA) has provided clearance for the Thermo
Scientific QMS Plazomicin Immunoassay that provides a quantitative
measure of plazomicin in human plasma using automated clinical
chemistry analyzers. Results of the assay will be used to
assist in the management of patients receiving plazomicin therapy.
Plazomicin, marketed as ZEMDRI™ in the United States, was
approved by the U.S. Food and Drug Administration for the treatment
of adults with complicated urinary tract infections, including
pyelonephritis, due to certain Enterobacteriaceae.
“The QMS Plazomicin Immunoassay will enable therapeutic drug
management (TDM) which is critical to support the use of ZEMDRI in
a subset of the more than one million annual cases of multi-drug
resistant or recurrent complicated urinary tract infections in the
United States,” said Janet Dorling, Achaogen’s Chief Commercial
Officer. “This is an important milestone and we are excited
about the commercialization of the QMS Plazomicin immunoassay.”
Thermo Fisher Scientific and Achaogen jointly developed the QMS
Plazomicin immunoassay. Both companies entered into a
collaboration to develop an assay that would help healthcare
professionals make important dosing determinations regarding the
use of ZEMDRI for appropriate patients.
About AchaogenAchaogen is a biopharmaceutical
company passionately committed to the discovery, development, and
commercialization of innovative antibacterial treatments for MDR
gram-negative infections. Achaogen's first commercial product is
ZEMDRI, for the treatment of adults with complicated urinary tract
infections, including pyelonephritis, due to certain
Enterobacteriaceae. The Achaogen ZEMDRI program was funded in part
with federal funds from the Biomedical Advanced Research and
Development Authority (BARDA). The Company is currently developing
C-Scape, an orally-administered beta-lactam/beta-lactamase
inhibitor combination, which is also supported by BARDA. C-Scape is
investigational, has not been determined to be safe or efficacious,
and has not been approved for commercialization. For more
information, visit the Achaogen website at www.achaogen.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, the potential uses and advantages of ZEMDRI
(plazomicin), Achaogen’s strategic and commercial objectives and
the Achaogen pipeline of product candidates. Such forward-looking
statements involve known and unknown risks, uncertainties, and
other important factors that may cause Achaogen's actual results,
performance, or achievements to be materially different from any
future results, performance, or achievements expressed or implied
by the forward-looking statements. Such risks and uncertainties
include, among others, the risks and uncertainties of
commercialization and gaining market acceptance, uncertainties
inherent in the development process, the risks and uncertainties of
the regulatory approval process and the risk when bacteria will
evolve resistance to ZEMDRI. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the Achaogen business in general, see Achaogen’s
current and future reports filed with the Securities and Exchange
Commission, including its Annual Report on Form 10-K filed on
February 27, 2018, and its Quarterly Report on Form 10-Q filed on
November 8, 2018. Achaogen does not plan to publicly update or
revise any forward-looking statements contained in this press
release, whether as a result of any new information, future events,
changed circumstances, or otherwise.
Source: Achaogen, Inc© 2018 Achaogen, Inc. All Rights
Reserved.
Investor and Media Contact:Martin
ForrestAchaogen, Inc.mforrest@achaogen.com650-419-3920