DUBLIN, Nov. 11, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced the U.S. Food and Drug Administration
(FDA) has granted Qualified Infectious Disease Product (QIDP)
Designation and Fast Track Designation for ATM-AVI (aztreonam and
avibactam), for the treatment of complicated intra-abdominal
infections (cIAI), complicated urinary tract infections (cUTI), and
hospital-acquired bacterial pneumonia (HABP)/ventilator-associated
bacterial pneumonia (VABP). ATM-AVI is an investigational,
fixed-dose, intravenous combination antibiotic under development
globally.
"The rate of antibiotic resistance is increasing worldwide and
there are limited options available to patients with these
challenging and life-threatening infections, underscoring the need
for the pharmaceutical industry and government to work together to
bring forward new potential treatment options," said David Nicholson, EVP and Chief R&D Officer,
Allergan. "The QIDP Designation shows the importance of ATM-AVI for
treating serious or life-threatening infections, and the Fast Track
Designation allows us to work even closer with the FDA to bring
patients a new treatment faster."
The QIDP designation provides certain incentives for the
development of new antibiotics, including priority review and
eligibility for the FDA's Fast Track Designation, and a five-year
regulatory exclusivity extension. The Fast Track Designation is
designed to facilitate the development, and accelerate the review
of drugs to treat serious conditions that do not have sufficient
treatment options.
ATM-AVI has activity against metallo β-lactamase (MBL)-producing
Gram-negative pathogens, for which there are currently very limited
treatmentoptions. Although aztreonam is not inactivated by metallo
beta-lactamases (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. When combined with
avibactam's ability to inhibit many serine-β-lactamases ,
aztreonam's activity is restored against pathogens that co-produce
MBLs and serine enzymes, thus presenting a new treatment for
patients with these infections. ATM-AVI is currently in Phase III
trials.
ATM-AVI is being jointly developed with Pfizer. Allergan holds
the rights to commercialize ATM-AVI in North America, while Pfizer holds the rights
to commercialize this investigational therapy in the rest of the
world.
ATM-AVI is a drug candidate under development and supported by
public-private partnerships between Pfizer and the Biomedical
Advanced Research and Development Authority (BARDA)*, and between
Pfizer and the European Union's Innovative Medicines Initiative
(IMI) – a partnership between the European Union and the European
pharmaceutical industry, under a project called
COMBACTE-CARE (Combating Bacterial Resistance in Europe – Carbapenem Resistance)**. Allergan's
anti-infective portfolio also includes
AVYCAZ ® (ceftazidime and avibactam),
TEFLARO ® (ceftaroline fosamil),
DALVANCE ® (dalbavancin) and
MONUROL ® (fosfomycin tromethamine).
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
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 on existing trends and
information as of the date of this release. 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 difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; 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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2019. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
*This project has been funded in whole or in part with Federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under OTA number
HHSO100201500029C.
**This research project receives support from the Innovative
Medicines Initiative Joint Undertaking under grant agreement no
115620 resources of which are composed of financial contribution
form the European Union Seventh Framework Programme (FP7/2007-2013)
and EFPIA companies in kind contribution.
CONTACTS:
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Allergan:
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Investors:
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Manisha Narasimhan,
PhD
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(862)
261-7488
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Media:
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Lisa Brown
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(862)
261-7320
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SOURCE Allergan plc