DUBLIN, Oct. 24, 2016 /PRNewswire/ -- Allergan plc (NYSE:
AGN), a leading global pharmaceutical company committed to
improving outcomes and meeting critical needs in infectious
diseases, will present new data from its anti-infectives portfolio
as a part of 23 presentations at the upcoming IDWeek 2016, taking
place Oct. 26-30, 2016, in
New Orleans.
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Presentations will feature microbiology, clinical and health
outcomes and economics data, including two oral presentations
evaluating patient risk factors for carbapenem-resistant
Enterobactericeae (CRE) and timing of appropriate therapy in
patients with serious infections, as well as other poster
presentations addressing the cost of infections due to multi-drug
resistant Gram-negative pathogens and acute bacterial skin and skin
structure infections (ABSSSI). Additional data will highlight
AVYCAZ® (ceftazidime and avibactam) clinical efficacy
and susceptibility in certain difficult-to-treat pathogens;
DALVANCE® (dalbavancin) pediatric safety and in
vitro activity in Gram-positive pathogens causing ABSSSI; and
TEFLARO® (ceftaroline fosamil) clinical outcomes and
in vitro activity in Gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus
(MRSA).
"The diverse range of data presented at IDWeek underscore the
burden to patients and the healthcare system that can result from a
variety of serious infections," said David
Nicholson, Ph.D., Chief R&D Officer, Allergan. "Allergan
remains committed to ongoing research and development of its
portfolio, as well as providing physicians with education and
surveillance data that may improve clinical outcomes for
patients."
The scheduled times and titles of all the presentations are as
follows:
Oral Presentations
Saturday, October 29, 10:56 –
11:09 a.m. CT
- Presentation #1794: Identification of Patients at Greatest
Risk for Carbapenem Resistance in Patients with Serious
Hospital‐Onset Infections Due to Enterobacteriaceae
Species
Saturday, October 29, 11:22 –
11:35 a.m. CT
- Presentation #1796: Does Timing of Receipt of Appropriate
Antimicrobial Therapy Make a Difference among Patients with
Serious Infections Due to Resistant Gram‐Negative
Pathogens?
Poster Presentations
AVYCAZ (ceftazidime and avibactam)
Thursday, October 27, 12:30 –
2 p.m. CT
- Poster #580: Evaluation of Avibactam Combined with
Beta-Lactams against Non-Tuberculous Mycobacteria
- Poster #703: Ceftazidime-Avibactam Antimicrobial Activity
and Spectrum When Tested Against Gram-Negative Organisms from
Pediatric Patients: Results from the INFORM Surveillance Program
(USA, 2011-2015)
Friday, October 28, 12:30 –
2 p.m. CT
- Poster #1324: In Vitro Activity of
Ceftazidime-Avibactam (CAZ-AVI) against Urinary Tract Infection
(UTI) and Intra-Abdominal Infection (IAI) Pathogens from
Latin America: Results of the
INFORM Surveillance Initiative
Saturday, October 29, 12:30 –
2 p.m. CT
- Poster #2044: Efficacy of Ceftazidime-Avibactam against
Multi-Drug Resistant Enterobacteriaceae and Pseudomonas
aeruginosa from the Phase 3 Clinical Trial Program
- Poster #1850: Antimicrobial Susceptibility of KPC-Producing
Enterobacteriaceae Stratified by Infection Site (USA, 2012-2015)
- Poster #1837: Ceftazidime-Avibactam Activity When Tested
against Gram-Negative Bacteria Isolated from Patients with
Pneumonia, Including Ventilator-Associated Pneumonia (VAP),
Hospitalized in United States
Medical Centers (2011-2015)
- Poster #1831: Antimicrobial Activity of
Ceftazidime-Avibactam Tested against Pseudomonas Aeruginosa
Isolates from USA Hospitals
Stratified by Site of Infection: Results from the INFORM
Surveillance Program, 2013-2015
DALVANCE (dalbavancin)
Friday, October 28, 12:30 –
2 p.m. CT
- Poster #1163: Necrotizing Fasciitis (NF) within the First 72
Hours after Presentation with Skin and Skin Structure
Infection
Saturday, October 29, 12:30 –
2 p.m. CT
- Poster #1834: Dalbavancin In Vitro Activity Obtained
against Gram-Positive Clinical Isolates Causing Osteomyelitis in
USA Hospitals (2011-2015)
- Poster #1970: Dalbavancin Pharmacokinetics and Safety in
Children 3 Months to 11 Years of Age
- Poster #1835: Activity of Dalbavancin Tested against
Gram-Positive Clinical Isolates Causing Skin and Skin Structure
Infections in Pediatric Patients from USA Hospitals (2014-2015)
TEFLARO (ceftaroline fosamil)
Friday, October 28, 12:30 –
2 p.m. CT
- Poster #1263: Clinical Use of Ceftaroline Fosamil for
the Treatment of Hospital-Acquired Pneumonia and
Ventilator-Associated Pneumonia
- Poster #1126: Clinical Use of Ceftaroline Fosamil for
the Treatment of Gram‐Positive Osteomyelitis
- Poster #1164: In vitro Activity of Ceftaroline against
Skin and Soft Tissue and Respiratory Pathogens Isolated from
Latin America
- Poster #1091: Clinical Use of Ceftaroline Fosamil for the
Treatment of Gram-Positive Bacteremia: CAPTURE Study
Experience
Saturday, October 29, 12:30 –
2 p.m. CT
- Poster #1846: Evaluation of the in vitro Activity of
Ceftaroline Tested against Clinical Bacterial Isolates from
USA hospitals: Results from 5
Years of the AWARE Surveillance Program (2011-2015)
Clinical and Health Outcomes and Economics Data
Thursday, October 27, 12:30 –
2 p.m. CT
- Poster #355: Association between Carbapenem Resistance and
Mortality among Adults Hospitalized with Serious Infections Due to
an Enterobacteriaceae spp: Results of a Systematic Literature
Review and Meta‐Analysis
- Poster #319: Outcome of Initial Antibiotic Treatments among
Hospitalized Patients with Hospital- and Healthcare-Associated
Bacterial Infections in Brazil:
Findings of the RECOMMEND Study
Friday, October 28, 12:30 –
2 p.m. CT
- Poster #1146: Economic Burden of Inpatient Stays for
Patients with Acute Bacterial Skin and Skin Structure Infections in
the United States: A Retrospective
Observational Analysis of Premier Hospital Admissions
- Poster #1145: Hospital Cost and Reimbursement for Acute
Bacterial Skin and Skin Structure Infections: A Retrospective
Observational Analysis of Admissions Using 2014 Medicare Claims
Data
Saturday, October 29, 12:30 –
2 p.m. CT
- Poster #2045: Clinical and Economic Burden of Multi-Drug
Resistant Pseudomonas sp. (MDRP) among Patients with Serious
Infections in U.S. Hospitals
Full abstracts can be found on the IDWeek website at
http://www.idweekinternational.com.
About AVYCAZ®
AVYCAZ is an antibiotic
developed to treat certain serious Gram-negative bacterial
infections. It consists of ceftazidime, a third-generation
cephalosporin and established treatment for serious Gram-negative
bacterial infections, and avibactam, a non-β lactam β-lactamase
inhibitor.
The addition of avibactam to ceftazidime protects ceftazidime
from breakdown by certain β-lactamases. AVYCAZ offers a
differentiated profile in the treatment of complicated
intra-abdominal infections (cIAI) (in combination with
metronidazole) and complicated urinary tract infections (cUTI)
caused by designated microorganisms in patients 18 years or older
through its in vitro activity against Enterobacteriaceae,
including those that produce certain extended-spectrum
beta-lactamases (ESBLs) and Klebsiella pneumoniae
carbapenemase (KPCs), 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
under the brand name AVYCAZ, while AstraZeneca holds the rights to
commercialize the combination in the rest of the world under the
brand name Zavicefta.
INDICATIONS AND USAGE
Complicated Intra-Abdominal Infections
(cIAI)
AVYCAZ® (ceftazidime and avibactam), in
combination with metronidazole, is indicated for the treatment of
complicated intra-abdominal infections (cIAI) caused by the
following susceptible Gram-negative microorganisms: Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis,
Enterobacter cloacae, Klebsiella oxytoca,
Citrobacter freundii complex, 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.
In the treatment of cUTI, as only limited clinical safety and
efficacy data for AVYCAZ are currently available, reserve AVYCAZ
for use in patients with cUTI who have limited or no alternative
treatment options.
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 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 of 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
in cIAI (incidence of ≥5% when used with metronidazole) were
diarrhea (8%), nausea (7%), and vomiting (5%). In cUTI, the most
common adverse reactions (incidence of ≥10%) were 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
30-minute, one-dose treatment option for acute bacterial skin and
skin structure infections (ABSSSI) that delivers a full course of
IV therapy. DALVANCE can be administered as either one 1500 mg dose
or as 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.
Allergan is in partnership with Angelini and Cardiome to market
dalbavancin outside of US. Angelini distributes dalbavancin
under the brand name Xydalba™ in several countries, which include
Italy, Spain, Poland, Portugal and many Eastern European countries,
including Russia and Turkey. Cardiome commercializes dalbavancin as
Xydalba in the U.K, Germany,
France, the Netherlands, Belgium, Nordic nations, certain other Western
European nations, various Middle Eastern nations and Canada.
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 community-acquired
bacterial pneumonia (CABP) and acute bacterial skin and skin
structure infections (ABSSSI) due to designated susceptible
pathogens. TEFLARO is a bactericidal cephalosporin with
activity against both Gram-positive and Gram-negative
pathogens. TEFLARO is indicated in adult and pediatric patients 2
months of age and older 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 ABSSSI. 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® (ceftaroline fosamil) is indicated in
adult and pediatric patients 2 months of age and older for the
treatment of acute bacterial skin and skin structure
infections (ABSSSI) caused by susceptible isolates of the
following Gram-positive and Gram-negative
microorganisms: Staphylococcus aureus (including
methicillin-susceptible and -resistant
isolates), Streptococcus
pyogenes, Streptococcus agalactiae,Escherichia
coli, Klebsiella pneumoniae, and Klebsiella
oxytoca.
- TEFLARO is also indicated in adult and pediatric patients 2
months of age and older for the treatment
of community-acquired bacterial pneumonia
(CABP) caused by susceptible 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 has 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
- In adults, 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 adult Phase 3 trials.
- In children, seroconversion from a negative to a positive
direct Coombs' test result occurred in 42/234 (17.9%) of patients
receiving TEFLARO and 3/93 (3.2%) of patients receiving comparator
drugs in the three pooled pediatric 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 Adults
- In the four pooled adult 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.
- The most common adverse reactions occurring in >2% of
patients receiving TEFLARO in the adult pooled Phase 3 clinical
trials were diarrhea (5%) nausea (4%), and rash (3%).
Adverse Reactions in Pediatrics
- In the three pooled pediatric clinical trials, serious adverse
reactions occurred in 10/257 (4%) of patients receiving TEFLARO and
3/102 (3%) of patients receiving comparator drugs. Treatment
discontinuation due to adverse reactions occurred in 10/257 (3.9%)
of patients receiving TEFLARO and 2/102 (2%) of patients receiving
comparator drugs with the most common adverse reaction leading to
discontinuation being rash in 2/257 (0.8%) of patients treated with
TEFLARO
- The most common adverse reactions occurring in ≥ 3% of patients
receiving TEFLARO in the pooled pediatric clinical trials were
diarrhea (8%), rash (7%), vomiting (5%), pyrexia (3%) and nausea
(3%).
Drug Interactions
- No clinical drug-drug interaction studies have been conducted
with TEFLARO. There is minimal potential for drug- drug
interactions between TEFLARO and CYP450substrates, inhibitors,
or inducers; drugs known to undergo active renal secretion; and
drugs that may alter renal blood flow.
Use in Specific Populations
- There have been no adequate and well-controlled studies with
TEFLARO in pregnant or nursing women.
- Safety and effectiveness in pediatric patients below the age of
2 months have not been established as no data are available.
- 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 adult patients with moderate
(CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30mL/min) renal
impairment and in patients with end-stage renal disease (CrCl
<15 mL/min). There is insufficient information to
recommend a dosage regimen for pediatric patients with CrCl < 50
ml/min/1.73m2.
- 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 plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceuticals, devices and biologic products for patients around
the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we
build bridges, power ideas, act fast and drive results for our
customers and patients around the world by always doing what is
right.
With commercial operations 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 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
and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016 (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:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Fran DeSena
(973) 517-3132
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SOURCE Allergan plc