DUBLIN, Sept. 16, 2015 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced that its infectious disease portfolio
will be featured in 24 abstracts highlighting new data at the
Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) 2015, which takes place from September 17-21, 2015 in San Diego.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
Allergan will present data from studies further evaluating: the
antimicrobial activity against certain gram negative isolates and
pharmacokinetics of AVYCAZ™ (ceftazidime-avibactam); in-vitro
activity and susceptibility testing methodologies for
DALVANCE® (dalbavancin) (ABSSSI); and the microbiologic
activity, pharmacodynamics and efficacy of TEFLARO®
(ceftaroline fosamil) for the treatment of acute skin and skin
structure infections (ABSSSI).
"The data presented at ICAAC represent our commitment to
developing important therapies and powerful tools to improve
outcomes for patients and the healthcare system," said David Melnick, vice president, clinical
development, anti-infectives, Allergan. "Allergan is committed
to bringing to market new innovations for significant and urgent
medical needs at the earliest possible time."
The scheduled times and titles of the presentations are as
follows:
AVYCAZ™ (ceftazidime-avibactam)
Friday, September 18, 12:00 p.m. – 2:00
p.m.
- Efficacy of ceftazidime-avibactam in the rat intra-abdominal
abscess model against a meropenem-resistant isolate of Klebsiella
pneumoniae carrying blaKPC-2 (poster B-070)
- Trends in β-lactamase occurrence in USA
hospitals during the 2012-2014-period and activity of
ceftazidime-avibactam (CAZ-AVI) against a large collection of
β-lactamase (BL) producing isolates (poster
C-137)
- Ceftazidime-avibactam activity tested against aerobic
Gram-negative organisms Isolated from intra-abdominal infections in
United States (USA) hospitals (2012-2014) (poster
C-140)
- In vitro antibacterial activity of
ceftazidime-avibactam (CAZ-AVI) tested against contemporary
Pseudomonas aeruginosa: (PSA) isolates from United States (USA) medical centers by census region (poster
C-143)
- Ceftazidime-avibactam activity tested against
ceftazidime-non-susceptible Citrobacter spp., Enterobacter spp.,
Serratia marcescens, and Pseudomonas aeruginosa from United States medical centers (2011-2014)
(poster C-148)
- In vitro activity of ceftazidime-avibactam (CAZ-AVI) against
Carbapenem-resistant Enterobacteriaceae (CRE) isolated from
Latin-American and Asia-Pacific Countries in 2014 (poster
C-150)
- ß-lactamase characterization of Enterobacteriaceae (ENT)
baseline pathogens from Phase 3 trials of ceftazidime-avibactam
(CAZ-AVI) (poster C-181)
- Comparative evaluation of ceftazidime-avibactam MIC testing
with Etest® CZA256 and CLSI broth microdilution methods
(poster D-189)
Saturday, September 19,
12:00 p.m. – 1:00
p.m.
Sunday, September 20, 11:00 a.m. – 1:00
p.m.
- Single-dose pharmacokinetics (PK) of ceftazidime-avibactam
(CAZ-AVI) in hospitalized pediatric patients (poster
G-1205)
Monday, September 21, 9:00 a.m. – 9:15
a.m.
- Exploring the inactivation mechanism by avibactam (AVI) of
an inhibitor-resistant Carbapenemase, PenA from Burkholderia
multivorans (Bm) (oral)
- Inhibitory activity of avibactam against selected
ß-lactamases expressed in an isogenic Escherichia coli strain
(oral)
DALVANCE® (dalbavancin)
Friday, September 18, 12:00 p.m. – 2:00
p.m.
- Facility factors that influence decision to admit or
discharge patients with acute bacterial skin and skin structure
infection (ABSSSI) (poster S-427)
Sunday, September 20, 11:00 a.m. – 1:00
p.m.
- Dalbavancin prevents biofilm formation by
methicillin-susceptible and -resistant Staphylococcus aureus
(poster C-1070)
- Evaluation of dalbavancin MIC test strip compared to broth
>microdilution MIC for relevant gram-positive isolates
(poster D-1138)
- Evaluation of dalbavancin non-susceptible MIC results
obtained against clinical trial and (2011-2014) surveillance
isolates (poster D-1175)
- Multicenter study of antimicrobial (AM) treatment in
admitted (ADM) vs. not admitted (NADM) patients with acute
bacterial skin and skin structure infection (ABSSSI) (poster
S-1334)
TEFLARO® (ceftaroline fosamil)
Saturday, September 19,
11:00 a.m. – 1:00 p.m.
- Ceftaroline fosamil 600 mg every 8 h for the treatment of
ABSSSI due to Staphylococcus aureus with ceftaroline MICs of 4 mg/L
(poster A-455)
- Ceftaroline fosamil 600 mg every 12 h (q12h) can provide
adequate exposure against Staphylococcus aureus with ceftaroline
MICs ≤2 mg/L in ABSSSI (poster A-456)
- Pharmacodynamics of ceftaroline against Proteus mirabilis
pre-clinical clinical correlates (poster A-472)
- In vitro activity of ceftaroline and key comparators against
a recent global collection of Gram-positive blood isolates
(poster C-552)
- Interaction of ceftaroline with clinically-relevant
beta-lactamases (poster C-624a)
Sunday, September 20, 11:00 a.m. – 1:00
p.m.
- Dose Confirmation for Ceftaroline Fosamil in Pediatric
Patients with Acute Bacterial Skin and Skin Structure Infections
(ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP) (poster
A-958)
- Impact of disease severity on ceftaroline pharmacokinetics
(PK) in patients with ABSSSI: Phase III COVERS trial (poster
A-966)
- Three-year analysis of ceftaroline activity against
Staphylococcus aureus from Latin
America based on specimen source and length of patient
stay (poster C-1059)
Full abstracts can be found on the ICAAC website
at http://www.icaac.org/.
About AVYCAZ™
INDICATIONS AND USAGE
As only limited clinical safety
and efficacy data for
AVYCAZ™ (ceftazidime-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 aeruginosain 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 AVYCAZ, avibactam‑containing products,
ceftazidime, 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 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 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 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 the 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,
and Streptococcus anginosus group
(including S. anginosus, S. intermedius, S.
constellatus).
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 (5.5%), headache (4.7%),
and diarrhea (4.4%).
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 two-dose regimen
for DALVANCE is 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® (ceftaroline
fosamil)
TEFLARO® is a broad-spectrum
bactericidal cephalosporin with activity against both gram-positive
pathogens and gram-negative pathogens. TEFLARO is
indicated for the treatment of CABP, including cases caused
by Streptococcus pneumoniae bacteremia, and
ABSSSI, including cases caused by MRSA. In clinical trials, TEFLARO
was generally well-tolerated with an adverse event profile
consistent with the cephalosporin class of antibiotics.
Forest 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 (including 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 antibacterials. Before therapy with TEFLARO is
instituted, careful inquiry about previous hypersensitivity
reactions to other cephalosporins, penicillins, or carbapenems
should be made. If this product is to be given to a penicillin- or
other beta-lactam-allergic patient, caution should be exercised
because cross sensitivity among beta-lactam antibacterial agents
has been clearly established.
- If an allergic reaction to TEFLARO occurs, the drug should be
discontinued. Serious acute hypersensitivity (anaphylactic)
reactions require emergency treatment with epinephrine and other
emergency measures that may include airway management, oxygen,
intravenous fluids, antihistamines, corticosteroids, and
vasopressors as clinically indicated.
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
events 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 events 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 events 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
- 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 see the full Prescribing Information for TEFLARO 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 Quarterly Report on Form 10-Q for
the quarter ended March 31, 2015 (such periodic public
filings having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
|
Investors:
|
|
Lisa
DeFrancesco
|
|
(862)
261-7152
|
|
|
|
Media:
|
|
Mark
Marmur
|
|
(862)
261-7558
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-anti-infective-portfolio-highlighted-in-24--abstracts-at-icaac-2015-300143845.html
SOURCE Allergan plc