[November 07, 2016] |
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Teva Highlights Growing Respiratory Portfolio at the 2016 American College of Allergy, Asthma & Immunology Annual Scientific Meeting
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that ten company-sponsored abstracts will be presented at the
2016 American College of Allergy, Asthma & Immunology (ACAAI) Annual
Scientific Meeting in San Francisco, California on November 10-14, 2016.
Data for presentation include results from three Phase III studies and
one Phase I study of fluticasone propionate/salmeterol (FS) RespiClick®,
a fixed-dose combination inhaled corticosteroid (ICS) and long-acting
beta agonist (LABA) delivered via Teva's RespiClick®
breath-actuated, multi-dose dry powder inhaler (MDPI) and for
fluticasone propionate (Fp) RespiClick® an ICS monotherapy
also delivered via the RespiClick® device. This will be the
first presentation of the Phase III clinical trial results for FS
RespiClick® and Fp RespiClick®, which are
currently under review with the U.S. Food & Drug Administration for the
treatment of adolescent and adult patients with asthma. Abstracts of
note include two poster presentations examining the efficacy and safety
of Fp RespiClick® and FS RespiClick® at varying
doses compared to placebo, and a poster presentation evaluating
long-term safety of both products in asthmatic patients.
In addition, a retrospective, observational study pertaining to Teva's
rescue medication, ProAir® HFA (albuterol sulfate) Inhalation
Aerosol from its Health Economics & Outcomes Research division will be
presented via oral presentation. The study evaluated the impact of
rescue inhalers with integrated dose counters (IDC (News - Alert)), specifically ProAir®
HFA, on healthcare utilization among asthmatic patients. Results
from the study show how IDCs significantly contributed to improved
outcomes for asthmatic patients while also reducing respiratory-related
healthcare utilization, specifically hospitalizations and emergency
department visits.
"We look forward to presenting new data and analyses for a number of
products in our growing respiratory portfolio at the ACAAI Annual
Scientific Meeting as we continue our work to help address the needs of
people living with respiratory disease," said Tushar Shah, MD, Senior
Vice President, Teva Global Respiratory Research and Development. "When
it comes to asthma, there is not a one-size-fits-all approach for
treatment. Whether enhancing delivery device technology, enabling
patients to track remaining doses in an inhaler with an integrated dose
counter, or developing targeted biologic therapies, Teva is committed to
developing and delivering therapies that will help patients across the
severity spectrum better manage their illness."
The following Teva-sponsored data will be presented at the 2016 ACAAI
Annual Meeting:
Fluticasone Propionate/Salmeterol RespiClick®
and Fluticasone Propionate RespiClick®
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P148: Long-term Safety of Fluticasone Propionate and
Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers in
Asthmatic Patients
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Friday, November 11, 2016 at 3:40 p.m. on Monitor 8
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P149: Fluticasone Propionate and Fluticasone
Propionate/Salmeterol Multi-dose Dry Powder Inhaler Pharmacokinetics
in Patients With Persistent Asthma
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Friday, November 11, 2016 at 3:50 p.m. on Monitor 8
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P139: Fluticasone Propionate And Fluticasone
Propionate/Salmeterol Multi-dose Dry Powder Inhalers Compared With
Placebo for Persistent Asthma
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Sunday, November 13, 2016 at 10:15 a.m. on Monitor 7
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P142: Fluticasone Propionate and Fluticasone
Propionate/Salmeterol Delivered via Multi-dose Dry Powder Inhalers for
Persistent Asthma
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Sunday, November 13, 2016 at 12:50 p.m. on Monitor 8
ProAir RespiClick® (albuterol sulfate)
Inhalation Powder
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P152: Robust Performance of a Multi-dose Dry Powder Inhaler
With Albuterol Sulfate Under Various Misuse Scenarios
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Friday, November 11, 2016 at 4:20 p.m. on Monitor 8
ProAir® HFA (albuterol sulfate) Inhalation
Aerosol
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O024 Healthcare Utilization in Asthma Patients Using Albuterol
Hydrofluoroalkane Inhalation Aerosol With/Without an Integrated Dose
Counter
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This abstract will be orally presented on November 13, 2016 at
3:15 p.m. in Room 3024
Beclomethasone dipropionate HFA BAI (News - Alert)
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P150: Evaluation of Beclomethasone Dipropionate (80 and 160
mcg/day) Delivered via Breath Actuated Inhaler for Persistent Asthma
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Friday, November 11, 2016 at 4:00 p.m. on Monitor 8
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P143: Beclomethasone Dipropionate Pharmacokinetics Delivered by
Breath Actuated Inhaler and Metered Dose Inhaler in Healthy Subjects
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Sunday, November 13, 2016 at 1:00 p.m. on Monitor 7
CINQAIR®/CINQAERO® (reslizumab)
Injection
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P154: Indirect Comparison of Exacerbation Rates Among Patients
Treated with Reslizumab Compared to Omalizumab and Mepolizumab
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Friday, November 11, 2016 at 4:40pm on Monitor 8
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P155: Higher binding affinity and in vitro potency of
reslizumab for interleukin-5 compared with mepolizumab
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This abstract will be presented during Asthma, Other Lower Airway
Disorders on Saturday, November 12, 2016 at 10:50 am on Monitor 8
About Teva Respiratory Teva Respiratory develops and
delivers high-quality treatment options for respiratory conditions,
including asthma, COPD and allergic rhinitis. The Teva Respiratory
portfolio is centered on optimizing respiratory treatment for patients
and healthcare providers through the development of novel delivery
systems and therapies that help address unmet needs. The company's
respiratory pipeline and clinical trial program are based on drug
molecules delivered in proprietary dry powder formulations and
breath-actuated device technologies, as well as a targeted biologic
treatment for severe asthma. Through research and clinical development,
Teva Respiratory continually works to expand, strengthen and build upon
its treatment portfolio to positively impact the lives of the millions
of patients living with respiratory disease.
About CINQAIR® (reslizumab) Injection CINQAIR
(reslizumab) Injection is an interleukin-5 antagonist monoclonal
antibody (IgG4 kappa) indicated for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, and with an
eosinophilic phenotype.
Limitations of Use: CINQAIR is not indicated for:
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treatment of other eosinophilic conditions
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relief of acute bronchospasm or status asthmaticus
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
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Anaphylaxis has been observed with CINQAIR infusion in 0.3% of
patients in placebo-controlled clinical studies. Anaphylaxis was
reported as early as the second dose of CINQAIR.
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Anaphylaxis can be life-threatening. Patients shoul be observed
for an appropriate period of time after CINQAIR administration by a
healthcare professional prepared to manage anaphylaxis. Discontinue
CINQAIR immediately if the patient experiences signs or symptoms of
anaphylaxis.
CONTRAINDICATIONS
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CINQAIR is contraindicated in patients who have known hypersensitivity
to reslizumab or any of its excipients.
WARNINGS AND PRECAUTIONS
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Acute Asthma Symptoms or Deteriorating Disease: CINQAIR should
not be used to treat acute asthma symptoms or acute exacerbations. Do
not use CINQAIR to treat acute bronchospasm or status asthmaticus.
Patients should seek medical advice if their asthma remains
uncontrolled or worsens after initiation of treatment with CINQAIR.
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Malignancy: In placebo-controlled clinical studies, 6/1028
(0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant
neoplasm reported compared to 2/730 (0.3%) patients in the placebo
group. The observed malignancies in CINQAIR-treated patients were
diverse in nature and without clustering of any particular tissue
type. The majority of malignancies were diagnosed within less than six
months of exposure to CINQAIR.
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Reduction of Corticosteroid Dosage: No clinical studies have
been conducted to assess reduction of maintenance corticosteroid
dosages following administration of CINQAIR. Do not discontinue
systemic or inhaled corticosteroids abruptly upon initiation of
therapy with CINQAIR. Reductions in corticosteroid dose, if
appropriate, should be gradual and performed under the supervision of
a physician. Reduction in corticosteroid dose may be associated with
systemic withdrawal symptoms and/or unmask conditions previously
suppressed by systemic corticosteroid therapy.
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Parasitic (Helminth) Infection: Eosinophils may be involved in
the immunological response to some helminth infections. Treat patients
with pre-existing helminth infections before initiating CINQAIR. If
patients become infected while receiving treatment with CINQAIR and do
not respond to anti-helminth treatment, discontinue treatment with
CINQAIR until infection resolves.
ADVERSE REACTIONS
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Adverse reactions that occurred at =2% incidence and more commonly
than in the placebo group included 1 event: oropharyngeal pain (2.6%
vs. 2.2%).
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Elevated baseline creatine phosphokinase (CPK) was more frequent in
patients randomized to CINQAIR (14%) versus placebo (9%). Transient
CPK elevations in patients with normal baseline CPK values were
observed more frequently with CINQAIR (20%) versus placebo (18%)
during routine laboratory assessments.
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Myalgia was reported in 1% (10/1028) of patients in the CINQAIR 3
mg/kg group compared to 0.5% (4/730) of patients in the placebo group.
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Immunogenicity: In placebo-controlled studies, a treatment-emergent
anti-reslizumab antibody response developed in 53/983 (5.4%) of
CINQAIR-treated patients (3 mg/kg). The antibody responses were of low
titer and often transient. There was no detectable impact of the
antibodies on the clinical pharmacokinetics, pharmacodynamics,
clinical efficacy, and safety of CINQAIR.
Please
click here for full Prescribing Information
About ProAir® RespiClick (albuterol sulfate)
Inhalation PowderProAir® RespiClick (albuterol sulfate)
Inhalation Powder is indicated in patients 4 years of age and older for
the treatment or prevention of bronchospasm with reversible obstructive
airway disease and for the prevention of exercise-induced bronchospasm.
IMPORTANT SAFETY INFORMATION
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ProAir RespiClick® (albuterol sulfate) Inhalation Powder is
contraindicated in patients with hypersensitivity to albuterol or
patients with a severe hypersensitivity to milk proteins. Rare cases
of hypersensitivity reactions, including urticaria, angioedema, and
rash have been reported after the use of albuterol sulfate. There have
been reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
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ProAir RespiClick® can produce paradoxical bronchospasm
that may be life-threatening. Discontinue ProAir RespiClick®
and institute alternative therapy if paradoxical bronchospasm occurs
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Need for more doses of ProAir RespiClick® than usual may be
a marker of acute or chronic deterioration of asthma and requires
reevaluation of treatment
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ProAir RespiClick® alone may not be adequate to control
asthma in many patients. Early consideration should be given to adding
anti-inflammatory agents, e.g., corticosteroids
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ProAir RespiClick®, like other beta-adrenergic
agonists, can produce clinically significant cardiovascular effects in
some patients, as measured by heart rate, blood pressure, and/or
symptoms. If such effects occur, the drug may need to be discontinued
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ProAir RespiClick®, as with all sympathomimetic amines,
should be used with caution in patients with cardiovascular disorders
(especially coronary insufficiency, cardiac arrhythmias, and
hypertension), convulsive disorders, hyperthyroidism, and diabetes
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Fatalities have been reported in association with excessive use of
inhaled sympathomimetic drugs in patients with asthma. Do not exceed
the recommended dose
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Immediate hypersensitivity reactions may occur. Discontinue ProAir
RespiClick® immediately
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ProAir RespiClick® may produce significant hypokalemia in
some patients, which has the potential to produce adverse
cardiovascular effects. The decrease is usually transient, not
requiring supplementation
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Potential drug interactions can occur with beta-blockers, diuretics,
digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants
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In controlled studies of ProAir RespiClick® in patients 12
years of age and older, adverse events that occurred at an incidence
rate of at least 1% and greater than placebo included back pain (2% vs
1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus
headache (1% vs <1%), and urinary tract infection (1% vs <1%)
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In controlled studies of ProAir RespiClick® in patients 4
to 11 years of age, adverse events that occurred at an incidence rate
of at least 2% and greater than placebo included nasopharyngitis (2%
vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)
Please
click here for Full Prescribing Information
About ProAir® HFA (albuterol sulfate)
Inhalation AerosolProAir® HFA (albuterol sulfate)
Inhalation Aerosol is indicated in patients 4 years of age and older for
the treatment or prevention of bronchospasm with reversible obstructive
airway disease and for the prevention of exercise-induced bronchospasm.
IMPORTANT SAFETY INFORMATION
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Inhaled albuterol sulfate can produce paradoxical bronchospasm that
may be life-threatening. It should be recognized that paradoxical
bronchospasm, when associated with inhaled formulations, frequently
occurs with the first use of a new canister
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Fatalities have been reported in association with excessive use of
inhaled sympathomimetic drugs in patients with asthma
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ProAir HFA, as with all sympathomimetic amines, should be used with
caution in patients with cardiovascular disorders (especially coronary
insufficiency, cardiac arrhythmias, and hypertension), convulsive
disorders, hyperthyroidism, and diabetes
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Potential drug interactions can occur with beta-blockers, diuretics,
digoxin, or monoamine oxidase inhibitors, and tricyclic
antidepressants.
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Do not exceed the recommended dose
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Adverse events, which occurred at an incidence rate of at least 3%
with ProAir HFA, include headache, tachycardia, pain, dizziness,
pharyngitis, and rhinitis
Please
click here for full Prescribing Information
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world's largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management's current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to integrate Allergan plc's worldwide generic
pharmaceuticals business ("Actavis Generics") and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following the Actavis Generics acquisition, we will
have significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from investments in our pipeline of specialty
and other products; our ability to identify and successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions as
well as credit risks; the effectiveness of our patents, confidentiality
agreements and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products; adverse effects
of political or economic instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; the impact of continuing consolidation of our distributors
and customers; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; our potential exposure to
product liability claims that are not covered by insurance; any failure
to recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; significant impairment
charges relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting reliance
on access to the capital markets; potentially significant increases in
tax liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the "SEC (News - Alert)"). Forward-looking statements speak only as of the
date on which they are made and we assume no obligation to update or
revise any forward-looking statements or other information, whether as a
result of new information, future events or otherwise.
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