Allergan to Present New Data from its Anti-Infectives Portfolio at IDWeek 2016 in New Orleans

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.

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SOURCE Allergan plc

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