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)
Sunday, June 19, 12:30 p.m. – 2:30 p.m. ET
Monday, June 20, 12:30 p.m. – 2:30 p.m. ET
DALVANCE (dalbavancin)
Friday, June 17, 12:30 p.m. - 2:30 p.m. ET
Monday, June 20, 12:30 p.m. - 2:30 p.m. ET
TEFLARO (ceftaroline fosamil)
Saturday, June 18, 12:45 p.m. - 2:45 p.m. ET
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
ADVERSE REACTIONS
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 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
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
IMPORTANT SAFETY INFORMATION
Contraindications
Warnings and Precautions
Hypersensitivity Reactions
Clostridium difficile-Associated Diarrhea
Direct Coombs' Test Seroconversion
Development of Drug-Resistant Bacteria
Adverse Reactions in Adults
Adverse Reactions in Pediatrics
Drug Interactions
Use in Specific Populations
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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