DUBLIN, April 8, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company committed to
developing new treatment options for infectious diseases, today
announced that new data from its anti-infective portfolio will be
featured in 20 abstracts during the upcoming European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID),
April 9-12, 2016 in Amsterdam.
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Data from these studies will further evaluate treatment patterns
and clinical outcomes of AVYCAZ® (ceftazidime and
avibactam) against difficult-to-treat complicated intra-abdominal
infections (cIAI) and complicated urinary tract infections (cUTI)
caused by designated susceptible Gram-negative isolates, clinical
outcomes for patients with acute bacterial skin and skin structure
infections (ABSSSI) treated with single-dose DALVANCE®
(dalbavancin) therapy in outpatient settings and in vitro
activity and clinical outcomes for TEFLARO® (ceftaroline
fosamil) in patients with complicated skin and soft tissue
infections (cSSTI), community-acquired bacterial pneumonia (CAP),
concurrent bacteremia and methicillin-resistant Staphylococcus
aureus (MRSA).
David Melnick, M.D., Vice
President, Clinical Development, Anti-Infectives, Allergan,
will also present data from an analysis of six Phase 3 studies of
TEFLARO for the treatment of patients with cSSTI or CAP and
concurrent bacteremia on Tuesday, April 12, at 12:30 p.m. CET. AstraZeneca—who jointly developed
AVYCAZ with Allergan—will also present data on an abstract
detailing clinical data results for AVYCAZ.
"Over the last several months, Allergan has led the way in
anti-infective research and innovation, providing physicians with
the tools they need to address the challenges of serious
infections, including those caused by difficult-to-treat
pathogens," said David Nicholson,
Ph.D., President and Executive Vice President, Global R&D,
Allergan. "This data demonstrates our continued commitment to the
ongoing evaluation and development of therapies for patients in
greatest need, including those with the most serious infections who
have limited or no available treatment options."
Ceftazidime and avibactam is being jointly developed with
AstraZeneca. Allergan holds the rights to commercialize ceftazidime
and avibactam in North America,
while AstraZeneca holds the rights to commercialize the combination
in the rest of the world.
Allergan plc (formerly Forest Laboratories) obtained the
worldwide rights (excluding Japan, where Takeda
Pharmaceuticals holds rights) to TEFLARO in 2007 when it
acquired Cerexa, Inc., a privately held biopharmaceutical
company. In August 2009, Forest
Laboratories and AstraZeneca entered into a definitive
collaboration agreement to co-develop and commercialize ceftaroline
fosamil in all markets outside the U.S., Canada and Japan.
Allergan and Angelini are in a partnership to distribute
dalbavancin as the brand name Xydalba™ in several countries, which
include Italy, Spain, Poland, Portugal and many Eastern European countries,
including Russia and Turkey.
Angelini is a private international group leader in the
health and wellness and basic commodities sectors. Pharmaceutical
is the core business of the group, representing more than 50
percent of the Angelini group's €1.5 billion 2015 revenue. The
pharma division is focused mainly on pain relief, inflammation,
CNS, anti-infectives and gynecology, with a strong position
also in the OTC market.
The scheduled times and titles of the presentations are as
follows:
AVYCAZ (ceftazidime and avibactam)
Saturday, April 9, 3:30 p.m. - 4:30 p.m. CET (Central European
Time)
- In vitro activity of ceftazidime-avibactam and comparators
against pseudomonas aeruginosa from Europe 2012–2014 (Poster presentation -
P0297)
- Activity of ceftazidime-avibactam against
carbapenem-non-susceptible Enterobacteriaceae isolated from
patients in Europe 2012–2014
(Poster presentation - P0332)
- β-lactamase characterization of baseline
Enterobacteriaceae from Phase 3 trials of ceftazidime-avibactam
(CAZ-AVI) for the treatment of complicated urinary tract infections
(cUTIs) (Poster presentation - P0333)
- Activity of ceftazidime-avibactam against
carbapenem-non-susceptible Enterobacteriaceae with and without
additional ESBL and/or class C β-lactamases isolated
from a global surveillance program, 2012–2014 (Poster
presentation - P0334)
- Activity of ceftazidime-avibactam against clinical and
isogenic laboratory Pseudomonas aeruginosa isolates expressing
combinations of most relevant β-lactam resistance
mechanisms (Poster presentation - P0335)
Sunday, April 10, 1:30 p.m. – 2:30 p.m.
CET
- Evaluation of ceftazidime-avibactam gradient strip MIC,
broth microdilution MIC and 10-4 disk methods for
Enterobacteriaceae and Pseudomonas aeruginosa (Poster
presentation - P0799)
Sunday, April 10, 2:30 p.m. – 3:30 p.m.
CET
- Efficacy of ceftazidime-avibactam against
ceftazidime-resistant Gram-negative pathogens: a pooled analysis
from the ceftazidime-avibactam clinical trial programme
(Oral presentation - O287)
- Presenter: Angela
Wardman, Senior Medical Scientist, Antibiotics
Business Unit, AstraZeneca
Monday, April 11, 1:30 p.m. – 2:30 p.m.
CET
- Activity of ceftazidime/avibactam against Enterobacteriaceae
producing extended-spectrum beta-lactamases and acquired AmpC
beta-lactamases, including those lacking porin expression
(Poster presentation - P1315)
Tuesday, April 12, 12:30 p.m. – 1:30 p.m.
CET
- Evaluating treatment patterns and clinical outcomes among
hospitalized patients with complicated urinary tract infection
(cUTI) based on an interim analysis in Europe and Russia of the RECOMMEND Study (Poster
presentation - P1477)
- Investigating the healthcare resource utilization associated
with complicated urinary tract infections in three phase 3 trials
for ceftazidime-avibactam (Poster presentation -
P1484)
ePosters, Available Saturday, April
9 – Tuesday, April 12
- Clinical outcomes associated with initial antibiotic therapy
among hospitalized patients with complicated intra-abdominal
infection (cIAI) based on interim analysis in Europe and Russia of the RECOMMEND Study (ePoster
presentation - EV0222)
- A mathematical model for predicting the development of
bacterial resistance based on the relationship between the level of
antimicrobial resistance and the volume of antibiotic
consumption (ePoster presentation -
EV0342)
- In-vitro activity of ceftazidime, ceftaroline and aztreonam
alone and in combination with avibactam against nosocomial
bloodstream Enterobacteriaceae isolates in Russia (ePoster presentation -
EV0632)
DALVANCE (dalbavancin)
Monday, April 11, 12:30 p.m. - 1:30 p.m. CET
- Treatment of acute bacterial skin and skin structure
infection (ABSSSI) with single dose dalbavancin in an outpatient
setting (Poster presentation - P0901)
Monday, April 11, 1:30 p.m. - 2:30 p.m. CET
- Intrapulmonary and plasma concentrations of dalbavancin in
healthy adults after a single 1500 mg infusion (Poster
presentation - P1198)
TEFLARO (ceftaroline fosamil)
Saturday, April 9, 3:30 p.m. - 4:30 p.m. CET
- Antimicrobial activity of ceftaroline against a collection
of methicillin-resistant Staphylococcus aureus (MRSA) isolates
collected in 2013-2014 at the Geneva University Hospitals (HUG)
(Poster presentation - P0192)
Monday, April 11, 3:30 p.m. - 4:30 p.m. CET
- Comparative activities of ceftaroline and ceftriaxone
against bacterial pathogens associated with community-associated
respiratory infections (Poster presentation -
P1347)
- Activity of ceftaroline tested against Staphylococcus
collected from a nationwide study in Spain in 2014 (Poster presentation
- P1348)
- In vitro antimicrobial activity of ceftaroline against
coagulase-negative Staphylococci: Global report from the Assessing
Worldwide Antimicrobial Resistance Evaluation (AWARE) 2012-2014
Program (Poster presentation - P1350)
Tuesday, April 12, 12:30 p.m. - 1:30 p.m. CET
- Ceftaroline fosamil for the treatment of patients with cSSTI
or CAP and concurrent bacteraemia: analysis of six Phase III
trials (Oral presentation - EP0087)
- Presenter: David Melnick,
M.D., Vice President, Clinical Development, Anti-Infectives,
Allergan
Full abstracts can be found on the ECCMID website
at http://www.eccmid.org/.
About AVYCAZ®
AVYCAZ is an antibiotic
developed to treat certain serious Gram-negative bacterial
infections. It consists of ceftazidime, a third-generation
cephalosporin, that is an established and respected treatment for
serious Gram-negative bacterial infections, and avibactam, a non-β
lactam β-lactamase inhibitor.
The determination of efficacy of AVYCAZ was supported in part by
the previous findings of the efficacy and safety of ceftazidime for
the treatment of cIAI and cUTI. The contribution of
avibactam to AVYCAZ was primarily established in
vitro and in animal models of infection. AVYCAZ
was studied in two Phase 2 randomized, blinded, active-controlled,
multicenter trials, one each in cIAI and cUTI. These trials
were not designed with any formal hypotheses for inferential
testing against the active comparators.
The addition of avibactam to ceftazidime protects ceftazidime
from breakdown by certain β-lactamases. AVYCAZ offers a
differentiated profile in the treatment of cIAI (in combination
with metronidazole) and cUTI caused by designated microorganisms
through its in vitro activity against Enterobacteriaceae,
including those that produce certain ESBL and KPC, and
difficult-to-treat Pseudomonas aeruginosa.
Ceftazidime and avibactam is being jointly developed with
AstraZeneca. Allergan holds the rights to commercialize ceftazidime
and avibactam in North America,
while AstraZeneca holds the rights to commercialize the combination
in the rest of the world.
INDICATIONS AND USAGE
As only limited clinical safety
and efficacy data for AVYCAZ (ceftazidime and avibactam) are
currently available, reserve AVYCAZ for use in patients who have
limited or no alternative treatment options.
Complicated Intra-Abdominal Infections (cIAI)
AVYCAZ,
in combination with metronidazole, is indicated for the treatment
of complicated intra-abdominal infections (cIAI) caused by the
following susceptible microorganisms: Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii,
Enterobacter cloacae, Klebsiella oxytoca and Pseudomonas
aeruginosa in patients 18 years or older.
Complicated Urinary Tract Infections (cUTI), including
Pyelonephritis
AVYCAZ is indicated for the treatment of
complicated urinary tract infections (cUTI) including
pyelonephritis caused by the following susceptible microorganisms:
Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri,
Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii,
Proteus spp., and Pseudomonas aeruginosa in patients 18
years or older.
Usage
To reduce the development of drug-resistant
bacteria and maintain the effectiveness of AVYCAZ and other
antibacterial drugs, AVYCAZ should be used only to treat infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
AVYCAZ is contraindicated in
patients with known serious hypersensitivity to the components of
AVYCAZ (ceftazidime and avibactam), avibactam‑containing products,
or other members of the cephalosporin class.
WARNINGS AND PRECAUTIONS
- In a Phase 3 complicated intra-abdominal infections (cIAI)
trial, clinical cure rates were lower in a subgroup of patients
with baseline creatinine clearance (CrCL) of 30 to less than or
equal to 50 mL/min compared to those with CrCL greater than 50
mL/min. The reduction in clinical cure rates was more marked in
patients treated with AVYCAZ plus metronidazole compared to
meropenem-treated patients. Clinical cure rates in patients with
normal renal function/mild renal impairment (CrCL greater than 50
mL/min) was 85% (322/379) with AVYCAZ plus metronidazole vs 86%
(321/373) with meropenem, and clinical cure rates in patients with
moderate renal impairment (CrCL 30 to less than or equal to 50
mL/min) was 45% (14/31) with AVYCAZ plus metronidazole vs 74%
(26/35) with meropenem. Within this subgroup, patients treated with
AVYCAZ received a 33% lower daily dose than is currently
recommended for patients with CrCL 30 to less than or equal to 50
mL/min. Monitor CrCL at least daily in patients with changing renal
function and adjust the dosage of AVYCAZ accordingly.
- Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions and serious skin reactions have been reported in patients
receiving beta-lactam antibacterial drugs. Before therapy with
AVYCAZ is instituted, careful inquiry about previous
hypersensitivity reactions to other cephalosporins, penicillins, or
carbapenems should be made. Exercise caution if this product is to
be given to a penicillin or other beta-lactam-allergic patient
because cross sensitivity among beta-lactam antibacterial drugs has
been established. Discontinue the drug if an allergic reaction to
AVYCAZ occurs.
- Clostridium difficile-associated diarrhea (CDAD) has been
reported for nearly all systemic antibacterial drugs, including
AVYCAZ, and may range in severity from mild diarrhea to fatal
colitis. Careful medical history is necessary because CDAD has been
reported to occur more than 2 months after the administration of
antibacterial drugs. If CDAD is suspected or confirmed,
antibacterials not directed against C. difficile should be
discontinued, if possible.
- Seizures, nonconvulsive status epilepticus, encephalopathy,
coma, asterixis, neuromuscular excitability, and myoclonia have
been reported in patients treated with ceftazidime, particularly in
the setting of renal impairment. Adjust dosing based on creatinine
clearance.
- Prescribing AVYCAZ in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS
- The most common adverse reactions (incidence of ≥10% in either
indication) were vomiting (14%), nausea (10%), constipation (10%),
and anxiety (10%).
Please see full Prescribing Information for AVYCAZ at
www.avycaz.com.
About
DALVANCE®
DALVANCE for
injection is a second-generation, semi-synthetic lipoglycopeptide,
which consists of a lipophilic side-chain added to an enhanced
glycopeptide backbone. DALVANCE is the first and only IV
antibiotic approved for the treatment of ABSSSI with a two-dose
regimen of 1000 mg followed one week later by 500 mg, each
administered over 30 minutes. DALVANCE demonstrates
bactericidal activity in vitro against a range of
Gram-positive bacteria, such as Staphylococcus
aureus (including methicillin-resistant, also known as
MRSA, strains) and Streptococcus pyogenes, as well
as certain other streptococcal species. On May 23,
2014, the FDA approved DALVANCE for the treatment of adult
patients with acute bacterial skin and skin structure infections
(ABSSSI) caused by susceptible Gram-positive bacteria, including
methicillin-resistant Staphylococcus aureus (MRSA).
INDICATION AND USAGE
DALVANCE (dalbavancin) for
injection is indicated for the treatment of adult patients with
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-susceptible and methicillin-resistant strains),
Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus dysgalactiae, Streptococcus anginosus group
(including S. anginosus, S. intermedius, S.
constellatus) and Enterococcus faecalis
(vancomycin-susceptible strains).
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of DALVANCE and other antibacterial
agents, DALVANCE should be used only to treat infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DALVANCE is contraindicated in
patients with known hypersensitivity to dalbavancin.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity
(anaphylactic) and skin reactions have been reported with
glycopeptide antibacterial agents, including DALVANCE.
Exercise caution in patients with known hypersensitivity to
glycopeptides due to the possibility of
cross-sensitivity. If an allergic reaction occurs,
treatment with DALVANCE should be discontinued.
Infusion-related Reactions
Rapid intravenous infusion
of DALVANCE can cause reactions, including flushing of the upper
body, urticaria, pruritus, and rash.
Hepatic Effects
ALT elevations with DALVANCE
treatment were reported in clinical trials.
Clostridium difficile-associated
Diarrhea
Clostridium difficile-associated diarrhea
(CDAD) has been reported with nearly all systemic antibacterial
agents, including DALVANCE, with severity ranging from mild
diarrhea to fatal colitis. Evaluate if diarrhea occurs.
Development of Drug-resistant Bacteria
Prescribing
DALVANCE in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS
The most common adverse
reactions in patients treated with DALVANCE were nausea (4.7%),
headache (3.8%), and diarrhea (3.4%).
USE IN SPECIFIC POPULATIONS
- There have been no adequate and well-controlled studies with
DALVANCE in pregnant or nursing women. DALVANCE should only be used
if the potential benefit justifies the potential risk in these
populations.
- In patients with renal impairment whose known creatinine
clearance is less than 30 mL/min and who are not receiving
regularly scheduled hemodialysis, the recommended regimen of
DALVANCE is 1125 mg, administered as a single dose, or 750 mg
followed one week later by 375 mg. No dosage adjustment is
recommended for patients receiving regularly scheduled
hemodialysis, and DALVANCE can be administered without regard to
the timing of hemodialysis.
- Caution should be exercised when prescribing DALVANCE to
patients with moderate or severe hepatic impairment (Child-Pugh
Class B or C) as no data are available to determine the appropriate
dosing in these patients.
Please see full prescribing information for DALVANCE
at www.dalvance.com.
ABOUT TEFLARO®
TEFLARO was first approved by the U.S. FDA in October 2010 for the treatment of adults with
CABP and ABSSSI due to designated susceptible
pathogens. TEFLARO is a bactericidal cephalosporin with
activity against both Gram-positive and Gram-negative
pathogens. TEFLARO is indicated for the treatment of CABP,
including cases caused by Streptococcus pneumoniae, and
ABSSSI, including cases caused by
methicillin-resistant Staphylococcus
aureus (MRSA). TEFLARO is the first and only cephalosporin
with activity against MRSA. In clinical trials, TEFLARO was
generally well-tolerated with an adverse event profile consistent
with the cephalosporin class of antibiotics. TEFLARO has been
administered in over 2.3 million days of therapy, treating more
than 350,000 patients.
Allergan plc (formerly Forest Laboratories) obtained the
worldwide rights (excluding Japan, where Takeda
Pharmaceuticals holds rights) to TEFLARO in 2007 when it
acquired Cerexa, Inc., a privately held biopharmaceutical
company. In August 2009, Forest Laboratories and
AstraZeneca (NYSE:AZN) entered into a definitive collaboration
agreement to co-develop and commercialize ceftaroline fosamil in
all markets outside the U.S., Canada and Japan.
INDICATIONS AND USAGE
TEFLARO is indicated for the treatment of acute ABSSSI caused by
susceptible bacterial isolates of the following Gram-positive and
Gram-negative microorganisms: Staphylococcus
aureus (methicillin-susceptible and -resistant
isolates) Streptococcus pyogenes, Streptococcus
agalactiae, Escherichia coli, Klebsiella
pneumoniae and Klebsiella oxytoca.
TEFLARO is also indicated for the treatment of CABP caused by
susceptible bacterial isolates of the following Gram-positive and
Gram-negative microorganisms: Streptococcus
pneumoniae (including cases with concurrent
bacteremia), Staphylococcus
aureus (methicillin-susceptible isolates
only), Haemophilus influenzae, Klebsiella pneumoniae,
Klebsiella oxytoca and Escherichia coli.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of TEFLARO and other antibacterial
drugs, TEFLARO should be used to treat only ABSSSI or CABP that are
proven or strongly suspected to be caused by susceptible
bacteria.
Appropriate specimens for microbiological examination should be
obtained in order to isolate and identify the causative pathogens
and to determine their susceptibility to ceftaroline. When culture
and susceptibility information are available, they should be
considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
IMPORTANT SAFETY INFORMATION
Contraindications
- TEFLARO is contraindicated in patients with known serious
hypersensitivity to ceftaroline or other members of the
cephalosporin class. Anaphylaxis and anaphylactoid reactions have
been reported with ceftaroline.
Warnings and Precautions
Hypersensitivity Reactions
- Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions and serious skin reactions have been reported with
beta-lactam antibacterial drugs. Before therapy with TEFLARO is
instituted, careful inquiry about previous hypersensitivity
reactions to other cephalosporins, penicillins, or carbapenems
should be made. Maintain clinical supervision if this product is to
be given to a penicillin- or other beta-lactam-allergic patient,
because cross sensitivity among beta-lactam antibacterial agents
has been clearly established.
- If an allergic reaction to TEFLARO occurs, discontinue TEFLARO
and institute appropriate treatment and supportive measures.
Clostridium difficile-Associated
Diarrhea
- Clostridium difficile-Associated Diarrhea (CDAD) has
been reported for nearly all systemic antibacterial agents,
including TEFLARO, and may range in severity from mild diarrhea to
fatal colitis. Careful medical history is necessary because CDAD
has been reported to occur more than 2 months after the
administration of antibacterial agents. If CDAD is suspected or
confirmed, antibacterials not directed against C. difficile
should be discontinued, if possible.
Direct Coombs' Test Seroconversion
- Seroconversion from a negative to a positive direct Coombs'
test result occurred in 120/1114 (10.8%) of patients receiving
TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs
in the four pooled Phase 3 trials. No adverse reactions
representing hemolytic anemia were reported in any treatment group.
If anemia develops during or after treatment with TEFLARO,
drug-induced hemolytic anemia should be considered. If drug-induced
hemolytic anemia is suspected, discontinuation of TEFLARO should be
considered and supportive care should be administered to the
patient if clinically indicated.
Development of Drug-Resistant Bacteria
- Prescribing TEFLARO in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
Adverse Reactions
- In the four pooled Phase 3 clinical trials, serious adverse
reactions occurred in 98/1300 (7.5%) of patients receiving TEFLARO
and 100/1297 (7.7%) of patients receiving comparator drugs.
Treatment discontinuation due to adverse reactions occurred in
35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of
patients receiving comparator drugs with the most common adverse
reactions leading to discontinuation being hypersensitivity for
both treatment groups at a rate of 0.3% in the TEFLARO group and
0.5% in the comparator group.
- No adverse reactions occurred in greater than 5% of patients
receiving TEFLARO. The most common adverse reactions occurring in
>2% of patients receiving TEFLARO in the pooled Phase 3 clinical
trials were diarrhea, nausea, and rash.
Drug Interactions
- No clinical drug-drug interaction studies have been conducted
with TEFLARO. There is minimal potential for drug-drug interactions
between TEFLARO and CYP450
substrates, inhibitors, or inducers; drugs known to undergo active
renal secretion; and drugs that may alter renal blood flow.
Use in Specific Populations
- TEFLARO has not been studied in pregnant women. Therefore,
TEFLARO should only be used during pregnancy if the potential
benefit justifies the potential risk to the fetus.
- It is not known whether ceftaroline is excreted in human milk.
Because many drugs are excreted in human milk, caution should be
exercised when TEFLARO is administered to a nursing woman.
- Safety and effectiveness in pediatric patients have not been
established.
- Because elderly patients, those ≥65 years of age, are more
likely to have decreased renal function and ceftaroline is excreted
primarily by the kidney, care should be taken in dose selection in
this age group and it may be useful to monitor renal function.
Dosage adjustment for elderly patients should therefore be based on
renal function.
- Dosage adjustment is required in patients with moderate (CrCl
>30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal
impairment and in patients with end-stage renal disease (CrCl
<15 mL/min).
- The pharmacokinetics of ceftaroline in patients with hepatic
impairment have not been established.
Please also see the full Prescribing Information
at www.TEFLARO.com.
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. 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;
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, 2015 (certain of such periodic public
filings having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
|
|
(862)
261-7152
|
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Media:
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Mark
Marmur
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(862)
261-7558
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SOURCE Allergan plc