New Data To Be Presented Show Reduction in ER Visits and
Hospitalizations in Patients with Varying
Levels of Disease Severity Following Use of Two Asthma Therapies
JERUSALEM--(BUSINESS WIRE)--May 17, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that eight company-sponsored abstracts will be presented at
the 2017 American Thoracic Society (ATS) International Conference in
Washington, D.C. on May 19-24, 2017.
Data to be presented include three abstracts on CINQAIR®
(reslizumab) Injection, an interleukin-5 antagonist monoclonal antibody
(IgG4 kappa) approved by the U.S. Food and Drug Administration (FDA) for
add-on maintenance treatment of patients with severe asthma aged 18
years and older, and with an eosinophilic phenotype.
One abstract, to be presented via oral presentation, is based on a
post-hoc pooled analysis of two phase 3, 52-week placebo-controlled
trials from the BREATH program looking at the efficacy of CINQAIR in two
populations: (1) adult patients with severe asthma (GINA steps 4 and 5)
and (2) adult patients with severe asthma and ≥2 exacerbations in the
previous year to study start. Two additional abstracts, both accepted
for poster presentation, will explore the efficacy of CINQAIR®
in patients eligible for treatment with omalizumab and the time between
first dose and reduction in blood eosinophil levels, respectively.
Three abstracts from the company’s Health Economics and Outcomes
Research (HEOR) group will also be presented, two of which focus
primarily on the impact of severe uncontrolled asthma. The real world
data presented in these abstracts highlight the unmet clinical, economic
and quality of life burdens that persist with standard of care
treatment. The third and final HEOR abstract will explore whether
patients with asthma and/or chronic obstructive pulmonary disorder
(COPD) experienced lower healthcare resource utilization when using
ProAir® HFA with a dose counter compared to the same product
without.
Teva will also present an abstract on ProAir® HFA (albuterol
sulfate) Inhalation Aerosol which examines the proportion of
asthma-related Emergency Department (ED) visits made by adults who ran
out of their short-acting beta-agonist (SABA) inhaler before the ED
visit.
Finally, Teva will present one abstract comparing in-clinic vs at-home
handheld spirometry testing as observed in one of the clinical trials
for the investigational beclomethasone dipropionate breath-actuated
inhaler (BAI).
“We are pleased to present data from our respiratory portfolio at this
year’s ATS International Conference, which brings together leaders and
innovators at the forefront of respiratory care,” said Tushar Shah, MD,
Head, Late Stage Development at Teva Pharmaceuticals. “Asthma remains a
critical public health issue, responsible for nearly two million ER
visits annually1, making it imperative
for our company to remain focused on developing treatment options that
address these issues and unmet needs. The data presented at ATS
reinforce the advancements we’ve made in the area of respiratory by
highlighting the importance of device technologies as well as clinical
outcomes such as reducing ER visits and hospitalizations.”
The following Teva-sponsored data will be presented at the 2017 ATS
International Conference:
CINQAIR® (reslizumab) Injection
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Abstract #7676: Impact of Reslizumab on Healthcare Resource
Utilization in Adult Patients with Severe Eosinophilic Asthma
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This abstract will be presented as an oral presentation during
Mini Symposium A94: Improving Asthma Management: Research at the
Forefront session from 4 to 4:15 p.m. on May 21, 2017
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Poster #613/Abstract #5984: Efficacy of Reslizumab in Asthma
Patients Eligible for Omalizumab Treatment
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This abstract will be presented as a poster during Poster
Discussion Session B101:Advances in Asthma from 2:15 to 4:15 p.m.
on May 22, 2017
-
Poster #1007/Abstract #7629: Early Decreases in Blood
Eosinophil Levels with Reslizumab
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This abstract will be presented as a poster during Thematic Poster
Session B32: Therapeutic Trials in Asthma from 9:15 a.m. to 4:15
p.m. on May 22, 2017
ProAir® HFA (albuterol sulfate) Inhalation
Aerosol
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Poster #501/Abstract #8401: Emergency Department Patients with
Asthma Exacerbation Who Ran Out of Their Inhaled Short-Acting
β-Agonists: A Multicenter Study in Boston
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This abstract will be presented as a poster during Discussion
Session B25: Asthma Epidemiology: Exacerbations, Admissions,
Readmissions and ED Visits from 9:15 to 11:15 a.m. on May 22, 2017
Beclomethasone dipropionate Breath-Actuated Inhaler (BAI)
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Poster #1022/Abstract #8221: Analysis of the Relationship
Between Handheld and Clinic-Based Spirometry Measurements in a
Randomized, Double-blind, Placebo-Controlled Study of Beclomethasone
Dipropionate via Breath-Actuated Inhaler for Persistent Asthma
-
This abstract will be presented as a poster during Thematic Poster
Session B32: Therapeutic Trials in Asthma from 9:15 a.m. to 4:15
p.m. on May 22, 2017
Health Economics & Outcomes Research
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Poster #702/Abstract #10481: Impact of Integrated Dose Counter
on Healthcare Utilization and Disease Control in Medicare Patients
with Asthma and/or Chronic Obstructive Pulmonary Disease Using
Albuterol Sulfate Inhalation Aerosol (ProAir® HFA)
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This abstract will be presented as a poster during the ISAM/ATS
Pre-Conference Presentation from 1 to 4 p.m. on May 20, 2017 and
during the B23-Novel Epidemiology, Management, and Outcomes in
Asthma session from 9:15 to 11:15 a.m. on May 22, 2017
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Poster #1049/Abstract #5974: Burden of Disease of Severe
Uncontrolled Asthma: A European Study
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This abstract will be presented as a poster during Thematic Poster
Session B38: Asthma: A Panoramic View from 9:15 a.m.to 4:15 p.m.
on May 22, 2017
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Poster #1048/Abstract #5890: Poor Asthma Control Despite
Medication Use in Patients with Severe Symptoms and Elevated
Eosinophil Levels
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This abstract will be presented as a poster during Thematic Poster
Session B38: Asthma: A Panoramic View from 9:15 a.m. to 4:15 p.m.
on May 22, 2017
About CINQAIR® (reslizumab) Injection
CINQAIR® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa). IL-5 is the most selective
eosinophil-active cytokine and plays a major role in the maturation,
activation and survival of eosinophils. In asthma patients, the
eosinophilic phenotype is associated with compromised lung function,
more frequent symptoms, and increased risk of exacerbations. CINQAIR®
binds to human IL-5 and prevents it from binding to the IL-5 receptor,
thereby reducing eosinophilic inflammation.
CINQAIR is a prescription medicine used with other asthma medicines for
the maintenance treatment of asthma in people aged 18 years of age and
older whose asthma is not controlled with the current asthma medicines.
When added to other medicines for asthma, CINQAIR helps prevent severe
asthma attacks (exacerbations) and can improve your breathing.
-
CINQAIR is not used to treat other problems caused by eosinophils.
-
CINQAIR is not used to treat sudden breathing problems.
Important Safety Information
What is the most important information I should know about
CINQAIR® (reslizumab) Injection?
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CINQAIR® can cause serious side effects, including:
-
Serious allergic reactions (anaphylaxis). Serious allergic
reactions can happen right after you receive your CINQAIR®
infusion. These reactions can cause death. Allergic reactions
sometimes do not happen right away. Your healthcare provider will
watch you during and after you receive your CINQAIR®
infusion for any signs of a reaction. Tell your healthcare
provider right away if you have any of the following symptoms that
may be associated with an allergic reaction:
-
Breathing problems
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Paleness
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Flushing
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Skin rash (hives)
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Itching
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Swelling of your face, lips, mouth, or tongue
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Symptoms of low blood pressure (fainting, dizziness, light
headedness, confusion, fast heart beat)
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Nausea or abdominal discomfort
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Do not receive CINQAIR® if you are allergic to
reslizumab or any of the ingredients in CINQAIR®.
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Before receiving CINQAIR®, tell your healthcare provider
about all of your medical conditions, including if you:
-
Are taking oral or inhaled corticosteroid medicines. Do not stop
taking your corticosteroid unless your healthcare provider tells
you to stop. This may cause other symptoms that were controlled by
the corticosteroid medicine to come back.
-
Have or have had cancer (malignancy).
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Have a parasitic (helminth) infection.
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Are pregnant or plan to become pregnant. It is not known if CINQAIR®
will harm your unborn baby. Tell your healthcare provider if you
become pregnant during your treatment with CINQAIR®.
-
Are breastfeeding or plan to breastfeed. It is not known if CINQAIR®
passes into your breast milk. You and your healthcare provider
should decide if you will receive CINQAIR® and
breastfeed. Talk to your healthcare provider about the best way to
feed your baby if you receive CINQAIR®.
-
Do not stop taking your other asthma medicines unless your healthcare
provider tells you to.
-
What are the possible side effects of CINQAIR®?
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CINQAIR® may cause serious side effects, including:
-
See “What is the most important information I should know
about CINQAIR®?”
-
Abnormal growth of cells or tissue in your body that may not
be cancer (malignancy)
-
The most common side effects of CINQAIR® include throat
pain.
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These are not all the possible side effects of CINQAIR®.
-
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please
click here for Full Prescribing Information
About ProAir® HFA (albuterol sulfate)
Inhalation Aerosol
ProAir® 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
-
If your symptoms become significantly worse when you use ProAir® HFA,
contact your doctor immediately. This may indicate either a worsening
of your asthma or a reaction to the medication, which may rarely occur
with the first use of a new canister of ProAir® HFA. Either
of these could be life-threatening.
-
What to tell your doctor before using ProAir® HFA: If you
have a heart, blood, or seizure disorder, high blood pressure,
diabetes, or an overactive thyroid, be sure to tell your doctor. Also
make sure your doctor knows all the medications you are taking –
especially heart medications and drugs that treat depression – because
some medications may interfere with how well your asthma medications
work. Do not exceed the recommended dose.
-
Side effects associated with ProAir® HFA included headache,
rapid heartbeat, pain, dizziness, and irritation of the throat and
nose.
Please
click here for Full Prescribing Information
About Beclomethasone dipropionate Breath-Actuated Inhaler (BAI)
Beclomethasone dipropionate Breath-Actuated Inhaler (BAI) is a systemic
corticosteroid delivered via BAI aerosol. Teva has filed an New Drug
Application (NDA) with the FDA seeking approval for the maintenance
treatment of asthma as a prophylactic therapy in patients four years of
age and older, and for the treatment of asthma patients who require
systemic corticosteroid administration, where adding beclomethasone
dipropionate may reduce or eliminate the need. A response from the FDA
is expected in the second half of 2017.
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 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 1,000
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding Teva respiratory products, which are based on management’s
current beliefs and expectations and are subject to substantial risks
and uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from that
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
relating to:
-
our specialty medicines business, including: the potential benefits
of our respiratory portfolio.; competition for our specialty products,
especially Copaxone®, our leading medicine,
which faces competition from existing and potential additional generic
versions and orally-administered alternatives; our ability to achieve
expected results from investments in our product pipeline; competition
from companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
-
our business and operations in general, including: our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third party
information technology systems or breaches of our data security; the
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
-
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”), including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov
and www.tevapharm.com.
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 contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
statements.
1. United States Environmental Protection Agency. Asthma Facts. March
2013.http://www.epa.gov/asthma/pdfs/asthma_fact_sheet_en.pdf.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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