DUBLIN, Jan. 29, 2016 /PRNewswire/ -- Allergan plc (NYSE:
AGN) today announced that it has entered into a global agreement
with AstraZeneca to develop and commercialize ATM-AVI, an
investigational, fixed-dose antibiotic combining aztreonam and
avibactam. Together, the two companies will evaluate the
combination to treat serious infections caused by metallo
βlactamase MBL-producing Gram-negative pathogens, a
difficult-to-treat sub-type of carbapenem-resistant
Enterobacteriaceae (CRE), for which there are currently very
limited treatments, thus presenting a new treatment option for
patients with MBL-producing pathogens. Under the terms of the
agreement, Allergan will maintain commercialization rights in the
U.S. and Canada and AstraZeneca
will maintain commercialization rights in all other countries.
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ATM-AVI is the first drug candidate to be developed under a
public-private partnership agreement between AstraZeneca and the
Biomedical Advanced Research and Development Authority (BARDA), a
part of the U.S. Department of Health and Human Services' Office of
the Assistant Secretary for Preparedness and Response (ASPR).
Announced in September 2015, the goal
of this strategic alliance is to develop a portfolio of drug
candidates over the next five years with dual uses in treating
illnesses caused by bioterrorism agents and antibiotic-resistant
infections.
"The rate of antibiotic resistance continues to increase
worldwide, representing a truly global threat that requires
collaboration and sustained commitment from industry and government
to develop solutions," said David
Nicholson, Executive Vice President, Global Brands Research
and Development, Allergan. "As a leader in anti-infectives, we are
dedicated to the ongoing research and development of innovative
products, like ATM-AVI, for patients with difficult-to-treat
infections who, today, have very few or no effective
options."
Aztreonam is not inactivated by MBLs, as a single agent it has
limited utility because the vast majority of MBL-producing
pathogens also express serine-β-lactamases that can inactivate it.
With avibactam's ability to inhibit many serine-β-lactamase
enzymes, aztreonam's activity is restored against pathogens that
co-produce MBLs and serine enzymes, thus presenting a new treatment
option for patients.
"This collaboration represents an important milestone in the
development of ATM-AVI. Antimicrobial resistance is a huge global
health challenge, which is increasingly at the forefront of the
public health agenda. We look forward to working with health
authorities to help bring this much-needed new treatment option to
patients," said Hans Sijbesma, Managing Director, Antibiotics
Business Unit, AstraZeneca.
The European Union's Innovative Medicines Initiative (IMI), a
partnership between the European Union and the European
pharmaceutical industry, is currently supporting the Phase 2
clinical study of ATM-AVI in Europe under a project called COMBACTE-CARE
and is joining. BARDA and AstraZeneca in supporting global phase 3
clinical development needed to apply for regulatory approval of
ATM-AVI.
About Allergan
Allergan plc (NYSE: AGN), headquartered
in Dublin, Ireland, is a unique,
global pharmaceutical company and a leader in a new industry
model—Growth Pharma. Allergan is focused on developing,
manufacturing, and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines, and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, health care
providers, and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
Forward-Looking Statement
Statements contained in this
press release that refer to future events or other non-historical
facts are forward-looking statements that reflect Allergan's
current perspective of existing trends and information as of the
date of this release. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements. It is important to note that Allergan's goals and
expectations are not predictions of actual performance. Actual
results may differ materially from Allergan's current expectations
depending upon a number of factors affecting Allergan's business.
These factors include, among others, the inherent uncertainty
associated with financial projections; the difficulty of predicting
the timing or outcome of FDA or other regulatory approvals or
actions, if any; the impact of competitive products and pricing;
market acceptance of and continued demand for Allergan's products;
difficulties or delays in manufacturing; costs and efforts to
defend or enforce intellectual property rights; the availability
and pricing of third party sourced products and materials;
successful compliance with governmental regulations applicable to
Allergan's facilities, products and/or businesses; and other risks
and uncertainties detailed in Allergan's periodic public filings
with the Securities and Exchange Commission, including but not
limited to Allergan's Annual Report on Form 10-K for the year ended
December 31, 2014, Quarterly Report
on Form 10-Q for the quarterly period ended June 30, 2015, Quarterly Report on Form 10-Q for
the quarter ended September 30, 2015,
and from time to time in Allergan's other investor communications.
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc