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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.
 

SOURCE Allergan plc