Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Ur...
January 02 2018 - 08:01AM
-- Investigational drug has potential to treat
certain MDR gram-negative pathogens, including carbapenem-resistant
Enterobacteriaceae (CRE) --
Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical
company developing innovative antibacterials addressing multi-drug
resistant (MDR) gram-negative infections, today announced that the
U.S. Food and Drug Administration (FDA) has accepted for review the
Company’s New Drug Application (NDA) for plazomicin for the
treatment of complicated urinary tract infections (cUTI), including
pyelonephritis, and bloodstream infections (BSI) due to certain
Enterobacteriaceae in patients who have limited or no alternative
treatment options. FDA has granted the NDA Priority Review and set
a target action date under the Prescription Drug User Fee Act
(PDUFA) of June 25, 2018. Achaogen also intends to submit an
application for marketing authorization in the European Union (EU)
in 2018.
"The number of confirmed cases of CRE annually in the U.S. is at
least 70,000, and is projected to double by 2022,” said Blake Wise,
Achaogen's Chief Executive Officer. “We are excited about
plazomicin's potential to address certain multi-drug resistant
gram-negative infections and feel that plazomicin would be a
valuable new treatment option for patients with serious bacterial
infections, including those due to CRE and ESBL-producing
Enterobacteriaceae."
In its acceptance letter, the FDA has stated that it is
currently planning to hold an advisory committee meeting to discuss
this application. The NDA is supported by data from both the EPIC
and CARE clinical trials which evaluated the safety and efficacy of
plazomicin in patients with serious infections caused by
gram-negative pathogens, including extended-spectrum beta-lactamase
(ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE).
The FDA granted Breakthrough Therapy designation for plazomicin for
the treatment of bloodstream infections (BSI) caused by certain
Enterobacteriaceae in patients who have limited or no alternative
treatment options. Breakthrough Therapy designation was created by
the FDA to expedite the development and review of drugs that target
serious or life-threatening conditions. Plazomicin has also
received Qualified Infectious Disease Product (QIDP) designation
from the FDA which provides incentives for the development of
new antibiotics, including priority review and an additional five
years of market exclusivity.
About FDA Priority Review Designation A
Priority Review designation is given to drugs that offer major
advances in treatment, or provide a treatment where no adequate
therapy exists. The FDA goal for reviewing a drug with Priority
Review status is six months from the time the application is filed
by the FDA.
About Plazomicin Plazomicin was developed to
treat serious bacterial infections due to MDR Enterobacteriaceae,
including extended-spectrum beta-lactamase (ESBL) producing and
carbapenem-resistant Enterobacteriaceae (CRE), and has been
evaluated in two Phase 3 clinical trials, EPIC and CARE.
About Multi-Drug Resistant (MDR) Gram-Negative
Infections Multidrug resistant
gram-negative bacteria, including carbapenem-resistant
Enterobacteriaceae (CRE), are gram-negative bacteria that are
resistant to multiple antibiotics and pose a serious threat
for hospitalized patients. The problem is extensive and growing;
the Centers for Disease Control and Prevention (CDC) characterized
CRE as “nightmare bacteria” and an immediate public health threat
that requires “urgent and aggressive action”. The CDC characterized
ESBL-producing bacteria as a serious threat to public health.
Patients with MDR infections often have limited or inadequate
therapeutic options leading to high rates of mortality.
About Achaogen Achaogen is a late-stage
biopharmaceutical company passionately committed to the discovery,
development, and commercialization of innovative antibacterial
treatments for MDR gram-negative infections. Achaogen is developing
plazomicin, its lead product candidate, for the treatment of
serious bacterial infections due to MDR Enterobacteriaceae,
including carbapenem-resistant Enterobacteriaceae. Achaogen’s
plazomicin program has been funded in part with Federal funds from
the Biomedical Advanced Research and Development Authority, Office
of the Assistant Secretary for Preparedness and Response, Office of
the Secretary, Department of Health and Human Services, under
Contract No. HHSO100201000046C. The Company’s second product
candidate is C-Scape, an orally-administered
beta-lactam/beta-lactamase inhibitor combination. Achaogen has
other programs in early and late preclinical stages focused on
other MDR gram-negative infections and additional disease areas.
All product candidates, including plazomicin, are investigational
only and have not been approved for commercialization. For
more information, please visit www.achaogen.com.
Forward-Looking Statements This 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, Achaogen's expectations regarding potential
regulatory approval and label of plazomicin, Achaogen’s plans
regarding an application for marketing authorization in the
European Union, plazomicin’s potential to address certain MDR
infections, plazomicin’s potential to treat serious bacterial
infections, including those due to CRE and ESBL-producing
Enterobacteriaceae and Achaogen's 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 uncertainties inherent
in the preclinical and clinical development process; the
uncertainties of having an NDA accepted by the FDA, the risks and
uncertainties of the regulatory approval process; the risks and
uncertainties of commercialization and gaining market acceptance;
the risk when bacteria will evolve resistance to plazomicin or
C-Scape; Achaogen's reliance on third-party contract manufacturing
organizations to manufacture and supply its product candidates and
certain raw materials used in the production thereof; risk of third
party claims alleging infringement of patents and proprietary
rights or seeking to invalidate Achaogen's patents or proprietary
rights; and the risk that Achaogen's proprietary rights may be
insufficient to protect its technologies and product candidates.
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 Achaogen's
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 March 14, 2017 and its
Quarterly Report on Form 10-Q filed on November 8, 2017. 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. (NASDAQ:AKAO)
Investor and Media Contact: David ArringtonVice
President, Investor Relations and Corporate Communications
650.440.5856darrington@achaogen.com