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
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
- Abstract #7676: Impact of
Reslizumab on Healthcare Resource Utilization in Adult Patients
with Severe Eosinophilic Asthma
- 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
- Poster #613/Abstract #5984:
Efficacy of Reslizumab in Asthma Patients Eligible for Omalizumab
Treatment
- 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
- 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
- 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
- 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)
- 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
- 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)
- 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
- Poster #1049/Abstract #5974:
Burden of Disease of Severe Uncontrolled Asthma: A European Study
- 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
- Poster #1048/Abstract #5890:
Poor Asthma Control Despite Medication Use in Patients with Severe
Symptoms and Elevated Eosinophil Levels
- 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?
- 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
- Paleness
- Flushing
- Skin rash (hives)
- Itching
- Swelling of your face, lips, mouth, or
tongue
- Symptoms of low blood pressure
(fainting, dizziness, light headedness, confusion, fast heart
beat)
- Nausea or abdominal discomfort
- Do not receive CINQAIR® if you are
allergic to reslizumab or any of the ingredients in CINQAIR®.
- 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).
- Have a parasitic (helminth)
infection.
- 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®?
- 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.
- 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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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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