Allergan : to Present New Data from its Anti-Infectives Portfolio at ASM Microbe 2016 in Boston

DUBLIN, June 13, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company committed to the research and development of new treatments for infectious diseases, today announced that new data from its anti-infectives portfolio will be featured in 14 presentations at the upcoming ASM Microbe, June 16-20, 2016, in Boston-an inaugural meeting integrating the American Society for Microbiology's (ASM) general meeting and Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) annual meeting.

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Ten of the presentations will feature AVYCAZ(ceftazidime and avibactam) data, highlighting its antimicrobial activity against certain difficult-to-treat Gram-negative pathogens. This includes data from the International Network for Optimal Resistance Monitoring (INFORM) program, one of the largest ongoing pathogen surveillance programs in the United States. Two presentations will evaluate the one-dose administration of DALVANCE (dalbavancin) in patients with acute bacterial skin and skin structure infections (ABSSSI), including data in the intravenous drug user (IVDU) population, and two address the in vitro activity of TEFLARO (ceftaroline fosamil) against a variety of Gram-positive pathogens, including Staphylococcus aureus.

'With the threat of difficult-to-treat infections on the rise, Allergan continues to develop new treatments and evolve existing therapies to address the challenges of these serious pathogens,' said David Nicholson, Ph.D., Chief R&D Officer, Allergan. 'These data inform the ongoing research and development of our entire anti-infective portfolio and further support our mission to provide physicians with the right tools to fight serious infections caused by Gram-negative and Gram-positive pathogens, for which limited treatment options are currently available.'

The scheduled times and titles of the presentations are as follows:

AVYCAZ (ceftazidime and avibactam)

Saturday, June 18, 12:45 p.m. - 2:45 p.m. ET (Eastern Time)

• Activity of ceftazidime-avibactam against Pseudomonas aeruginosa Isolated from patients in Latin America, Asia/Pacific and Middle-East/Africa 2012-2014
• Activity of ceftazidime-avibactam (CAZ-AVI) against OXA-48-carrying Enterobacteriaceae isolated from a global surveillance program 2012-2014
• Activity of ceftazidime-avibactam against carbapenem-non-susceptible Enterobacteriaceae from Latin America, Asia/Pacific and Middle East/Africa, 2012-2014

Sunday, June 19, 12:30 p.m. - 2:30 p.m. ET

• Ceftazidime-avibactam (CAZ-AVI) activity tested against eleven Enterobacteriaceae (ENT) species producing KPC enzymes

Monday, June 20, 12:30 p.m. - 2:30 p.m. ET

• Activity of ceftazidime-avibactam (CAZ-AVI) against ESBL positive Enterobacteriaceae (ENTB) and CAZ-resistant Pseudomonas aeruginosa from urinary tract infections (UTI) in Asia/South Pacific, Europe, Middle East/Africa and Latin America in the 2013 INFORM surveillance program
• Comparison of ceftazidime-avibactam (CAZ-AVI) exposure and PK/PD target attainment (TA) across patient subgroups
• Activity of ceftazidime-avibactam tested against clinical isolates of antimicrobial resistant Pseudomonas aeruginosa (PSA) from United States (USA) medical centers (2012-2014)
• Antimicrobial activity of ceftazidime-avibactam and comparator agents when tested against bacterial isolates causing infection in cancer patients (2012-2014)
• Ceftazidime-avibactam antimicrobial activity when tested against Gram-negative bacteria isolated from intensive care unit (ICU) patients with pneumonia (2012-2014)
• Antibacterial activity of avibactam combinations against recent carbapenemase-producing Enterobacteriaceae clinical isolates

DALVANCE (dalbavancin)

Friday, June 17, 12:30 p.m. - 2:30 p.m. ET

• Treatment of acute bacterial skin and skin structure infection (ABSSSI) with single dose dalbavancin in the intravenous drug user (IVDU) population

Monday, June 20, 12:30 p.m. - 2:30 p.m. ET

• Multi-site evaluation of dalbavancin and vancomycin MIC test strip compared to broth microdilution MIC

TEFLARO (ceftaroline fosamil)

Saturday, June 18, 12:45 p.m. - 2:45 p.m. ET

• Activity of ceftaroline against Staphylococcus aureus from pediatric, adult and elderly patients
• Activity of ceftaroline and comparators against Staphylococcus spp. and Streptococcus spp. from patients with blood stream infections (BSI): AWARE 2014 surveillance program

Full abstracts can be found on the ASM Microbe website at http://www.asmmicrobe.org/.

About AVYCAZ

AVYCAZ is an antibiotic developed to treat certain serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation cephalosporin and an established and respected 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 through its in vitro activity against Enterobacteriaceae, including those that produce certain extended-spectrum lactam β-lactamases (ESBL) and Klebsiella pneumoniae carbapanemase (KPC), and difficult-to-treat Pseudomonas aeruginosa.

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 DALVANCEDALVANCE 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 regiment 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 ABSSSI caused by susceptible Gram-positive bacteria, including 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 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 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/1.73m.
• 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, healthcare 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 March 31, 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