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 benralizumab.
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 preference
- 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 Spiromax®;
- 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170906005787/en/
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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