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News breaking: 2017-09-10

Teva To Present New Asthma and COPD Data at the 2017 European Respir..

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Teva To Present New Asthma and COPD Data at the 2017 European Respiratory Society (ERS) International Congress

New Analyses To Be Presented for Two Respiratory Therapies - CINQAERO®▼
(reslizumab) and DuoResp Spiromax®
(budesonide/formoterol fumarate dihydrate)

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that ten company-sponsored abstracts will be presented at the
2017 European Respiratory Society (ERS) International Congress in Milan,
Italy on September 9-13, 2017.
“Teva is honored to be a part of this esteemed international meeting as
we present compelling data on two important respiratory therapies that
we believe help to address the current needs of patients throughout the
world living with asthma and COPD,” said Alexandra Kropotova, MD, Vice
President, Clinical Development, Respiratory at Teva Pharmaceuticals.
“The data we will be presenting at ERS further demonstrate our ongoing
commitment to driving innovation and advancement of respiratory
medicines – specifically as it relates to the use of biologics and
developing devices designed to help address the issue of inhaler
technique errors.”
Showcasing A Targeted Biologic
Among the accepted abstracts, eight presentations focus on CINQAERO®
(reslizumab), a humanized interleukin-5 antagonist monoclonal antibody
for the treatment of severe eosinophilic asthma.
An abstract from Teva’s Health Economics and Outcomes Research (HEOR)
group will be presented during a late-breaking oral session and focuses
on a network meta-analysis which indirectly compares the relative
treatment effect on efficacy and safety of reslizumab to that of
Two additional abstracts of note will be presented via poster and
include post-hoc pooled analyses from two 52-week trials evaluating the
effect of reslizumab on reducing clinical asthma exacerbations (CAEs) as
well as improving lung function, asthma control and quality of life.
Highlighting Inhaler Technology
Teva will present HEOR data from its breath-actuated inhaler portfolio,
evaluating change in exacerbations, oral corticosteroid or antibiotic
use and respiratory related hospitalization or emergency department
visits after patients switched from Symbicort Turbuhaler®
(budesonide/formoterol fumarate dihydrate) to DuoResp Spiromax® (budesonide/formoterol
fumarate dihydrate).
Teva-sponsored data to be presented at the 2017 ERS International
Congress is as follows:
CINQAERO® (reslizumab)
#PA3970: A longitudinal follow-up of severe asthma patients
receiving reslizumab
This abstract will be presented as a poster presentation on
Tuesday, September 12, 2017 from 12:50-2:40 PM
#PA3972: Follow-up of patients with severe asthma receiving
reslizumab: an FEV1 analysis
This abstract will be presented as a poster presentation on
Tuesday, September 12, 2017 from 12:50-2:40 PM
#PA3960: Reslizumab for uncontrolled eosinophilic asthma in
patients who experienced a single exacerbation in the previous year:
sub-analysis of two phase 3 trials
This abstract will be presented as a poster presentation on
Tuesday, September 12, 2017 from 12:50-2:40 PM
#PA4690: Clinically meaningful FEV1 response with
reslizumab achieved early and sustained over 52 weeks
This abstract will be presented as a poster presentation on
Wednesday, September 13, 2017 from 8:30-10:30 AM
#PA4691: Reslizumab reduces severe exacerbations associated
with emergency department visit or hospitalization and improves
measures of lung function in patients on maintenance oral
corticosteroids (OCS) at baseline
This abstract will be presented as a poster presentation on
Wednesday, September 13, 2017 from 8:30-10:30 AM
Health Economics & Outcomes Research
#PA937: Real-life evaluation of budesonide/formoterol (DuoResp
Spiromax) for the management of asthma and COPD in the UK
This abstract will be presented as a poster presentation on
Sunday, September 10, 2017 from 12:50-2:40 PM
#OA2903: Reslizumab versus benralizumab in patients with
inadequately controlled asthma: a Bayesian Network Meta-analysis
This late-breaking abstract will be presented as an oral
presentation during the Update and New Perspectives in Airway
Diseases session on Monday, September 11, 2017 from 2:45-4:45 PM
#PA2626: Efficacy of reslizumab in adults with severe
eosinophilic asthma with ≥3 exacerbations in the previous year:
analyses at weeks 16 and 52 of two placebo-controlled phase 3 trials
This abstract will be presented as a poster presentation on
Monday, September 11, 2017 from 12:50-2:40 PM
#PA3889: Comparing asthma and COPD inhaler devices in real life
clinical practice in the UK: differences in training requirements and
This abstract will be presented as a poster presentation on
Tuesday, September 12, 2017 from 12:50-2:40 PM
#PA4687: Clinically meaningful improvements with reslizumab in
patient-reported outcomes and lung function in a sub-population
defined by the EU indication with ≥3 exacerbations
This abstract will be presented as a poster presentation on
Wednesday, September 13, 2017 from 8:30-10:30 AM
All abstracts are available on the ERS website, and can be accessed here.
Symbicort Turbuhaler® is a registered
trademark of the AstraZeneca group of companies.
About CINQAERO® (reslizumab)CINQAERO®
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. CINQAERO® binds to human
IL-5 and prevents it from binding to the IL-5 receptor, thereby reducing
eosinophilic inflammation.
CINQAERO® Important Safety Information
CINQAERO®▼ (reslizumab) 10mg/ml concentrate for solution for
infusion Abbreviated Prescribing Information. Presentation: Vial
containing either 25mg of reslizumab in 2.5ml or 100mg of reslizumab in
10ml (10 mg/ml). Indications: Add-on therapy in adult patients
with severe eosinophilic asthma inadequately controlled despite
high-dose inhaled corticosteroids plus another medicinal product for
maintenance treatment. Dosage and administration: CINQAERO should
be prescribed by physicians experienced in the diagnosis and treatment
of severe eosinophilic asthma. Intravenous infusion only. Should be
administered as a 20–50 minute intravenous infusion through a sterile,
non-pyrogenic infusion, single-use, low protein binding filter (0.2 μm).
Must not be administered as a bolus injection or as undiluted
concentrate. CINQAERO is intended for long-term treatment. Review
treatment at least annually based on disease severity and exacerbation
control. See SmPC for dilution instructions and administration. Adults
and Elderly: Based on body weight below 35kg or above 199kg; dose is
3mg/kg given once every four weeks. For patients body weight between
35kg and 199kg; refer to dosing in table 1 of SmPC. Children:
Not recommended in children and adolescents up to 17 years old. Renal
and Hepatic Impairment: No dose adjustment required. Contraindications:
Hypersensitivity to active substance or any excipients. Precautions
and warnings: Not to be used to treat acute asthma exacerbations.
Asthma-related symptoms or exacerbations may occur. Acute systemic
reactions, including anaphylactic reactions were observed during or
within 20 minutes after infusion. Patients should be monitored during
and for an appropriate time following administration. If an anaphylactic
reaction occurs, discontinue treatment immediately and permanently.
Patients with pre-existing helminth infections should be treated before
commencing CINQAERO therapy. If infection occurs during treatment,
temporary discontinuation of treatment should be considered.
Interactions: No formal drug interaction studies have been
performed. Pregnancy: Not recommended. Lactation:
Antibodies may be transferred to the newborns through milk. Not
recommended during the first few days after birth. See SmPC for further
information. Effects on ability to drive and use machines: Negligible
influence on the ability to drive and use machines. Adverse
reactions: Anaphylactic reaction, malignancies. Common: Blood
creatine phosphokinase increased. Consult the Summary of Product
Characteristics in relation to other side effects. Overdose:
Monitor for signs and symptoms of adverse effects and initiate
symptomatic treatment.
Please refer to the Summary of Product Characteristics (SmPC) for
full details of Prescribing Information.
About DuoResp Spiromax® (budesonide/formoterol
fumarate dihydrate)DuoResp Spiromax®
contains a combination of budesonide, an inhaled corticosteroid to treat
the underlying inflammation in asthma and COPD, and formoterol fumarate
dihydrate, a long-acting beta2-adrenergic agonist for the relief of
bronchoconstriction in asthma and COPD. With its design, the Spiromax®
inhaler incorporates a specific combination of features and provides
consistent drug delivery across inspiratory flow rates. DuoResp Spiromax®
received a positive opinion from the European Commission on the 29th of
April 2014, and is currently available to patients in multiple countries
across Europe.
About Teva RespiratoryTeva Respiratory develops and
delivers high-quality treatment options for respiratory conditions,
including asthma, COPD, cystic fibrosis and allergic rhinitis. The Teva
Respiratory portfolio is centred 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-activated 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 TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions used by approximately
200 million patients in over 60 markets 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 the world-leading innovative treatment for multiple
sclerosis as well as late-stage development programs for other disorders
of the central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 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 the potential benefits of CINQAERO® and DuoResp Spiromax®,
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:
the uncertainty of commercial success of CINQAERO® and DuoResp
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; the
uncertainty of clinical success and obtaining regulatory approvals and
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170906005787/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3) 926-7656orPR
Contacts:Iris Beck Codner, Israel, 972 (3) 926-7208Denise
Bradley, United States, 215-591-8974
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