Teva to Present New Respiratory Data at the 2016 Academy of Allergy, Asthma and Immunology Annual Meeting
03 Mars 2016 - 2:00PM
Business Wire
Positive Data Reported For Teva’s Targeted
Biologic; and Pediatric Data on Breath-Actuated, Dry-Powder
Short-Acting Beta-Agonist (SABA) Inhaler
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that five company-sponsored abstracts will be presented
at the 2016 Academy of Allergy, Asthma and Immunology (AAAAI)
Annual Meeting in Los Angeles, California on March 4-7, 2016.
Teva will present results from several analyses of data from the
pivotal Phase III clinical trial program for reslizumab, an
investigational humanized anti-interleukin-5 (IL-5) monoclonal
antibody (mAb) for add-on maintenance treatment of severe asthma
with an eosinophilic phenotype. The first oral presentation will
highlight results from an analysis that examined the effect of
reslizumab on clinical asthma exacerbations in patients with
chronic sinusitis and/or nasal polyps in addition to inadequately
controlled asthma and elevated blood eosinophils. The second oral
session will present results from a pooled analysis that evaluated
the efficacy of reslizumab in patients aged 65 years and older with
asthma and elevated blood eosinophils. The poster presentation will
highlight further analysis of quality of life data in patients with
inadequately controlled asthma and elevated blood eosinophils
treated with reslizumab.
Additional data to be presented include two poster presentations
of pediatric data on ProAir RespiClick® (albuterol sulfate)
Inhalation Powder, a breath-actuated, multi-dose, dry-powder,
short-acting beta-agonist (SABA) inhaler. Among the presentations
is a dose-ranging efficacy and safety study in which the treatment
was compared to both albuterol hydrofluoroalkane (HFA) Inhalation
Aerosol and placebo in pediatric patients (ages 4-11) with
asthma.
“The AAAAI Annual Meeting provides Teva with an exciting
opportunity to showcase the important work being done to support
our goal of bringing additional options, such as reslizumab and
ProAir RespiClick®, to asthma patients,” said Tushar Shah, MD,
Senior Vice President, Teva Global Respiratory Research and
Development. “This data highlights our continued commitment to
developing medicines, technologies and solutions to help address
the unmet needs of patients across the spectrum of respiratory
diseases.”
The following Teva-sponsored data will be presented at the 2016
AAAAI Annual Meeting:
Reslizumab
- #283: Efficacy of reslizumab
with asthma, chronic sinusitis with nasal polyps and elevated blood
eosinophils
- This abstract will be presented during
the Asthma Featured Biologics session from 2:15 PM to 2:30 PM on
Saturday, March 5, 2016
- #44: Improvements in asthma
quality of life questionnaire (AQLQ) domains with reslizumab in
patients with inadequately controlled asthma and elevated blood
eosinophils
- This abstract will be presented as a
poster during the Asthma Therapy I: Biologics session from 9:45 AM
to 10:45 AM on Saturday, March 5, 2016
- #284: Efficacy of reslizumab in
older patients (≥ 65 years) with asthma and elevated blood
eosinophils: results from a pooled analysis of two phase 3,
placebo-controlled trials
- This abstract will be presented during
the Asthma Featured Biologics session from 2:30 PM to 2:45 PM on
Saturday, March 5, 2016
ProAir® RespiClick (albuterol sulfate)
Inhalation Powder
- #681: Dose ranging efficacy and
safety study of albuterol multidose dry powder inhaler (MDPI) vs
albuterol hydrofluoroalkane (HFA) and placebo MDPI in children with
asthma
- This abstract will be presented via
poster from 9:45 AM to 10:45 AM on Monday, March 7, 2016
- #686: Efficacy and safety of albuterol multidose dry
powder inhaler (MDPI) versus placebo in children with asthma
- This abstract will be presented via poster from 9:45 AM to
10:45 AM on Monday, March 7, 2016
All abstracts have been published in an online supplement to the
February issue of The Journal of Allergy and Clinical
Immunology.
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 Reslizumab
Reslizumab is an investigational humanized interleukin-5 (IL-5)
antagonist IgG4K monoclonal antibody (mAb), for add-on maintenance
treatment of severe asthma in patients with an eosinophilic
phenotype. IL-5 is the most selective eosinophil cytokine known 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. Reslizumab binds to human IL-5
and prevents it from binding to the IL-5 receptor, thereby reducing
eosinophilic inflammation. Reslizumab has been submitted to and is
currently under review by the U.S. Food and Drug Administration
(FDA), European Medicines Agency (EMA) and Health Canada.
About ProAir® RespiClick (albuterol sulfate)
Inhalation Powder
ProAir® RespiClick (albuterol sulfate) Inhalation Powder is
indicated in patients 12 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
- Do not use ProAir® RespiClick
(albuterol sulfate) Inhalation Powder if you are allergic to
albuterol sulfate, lactose, or milk proteins. Report any red, itchy
bumps on your skin, swelling around the lips or eyes, or rash to
your healthcare professional.
- If your symptoms become significantly
worse when you use ProAir® RespiClick, seek medical attention
immediately. This may indicate either a worsening of your asthma or
a reaction to the medication. Either of these could be
life-threatening.
- Do not increase your dose or
take extra doses of ProAir® RespiClick without first talking to
your healthcare professional.
- Before using ProAir® RespiClick, be
sure to tell your healthcare professional if you have a heart,
blood, thyroid or seizure disorder, high blood pressure, diabetes,
are pregnant or planning to become pregnant, or are breastfeeding
or planning to breastfeed.
- ProAir® RespiClick can cause
significant heart-related side effects, such as an increase in
pulse, blood pressure and/or related symptoms. If you have a heart
condition, your healthcare professional will determine if ProAir®
RespiClick is right for you.
- Make sure your healthcare professional
knows all the medicines you are taking – especially other inhaled
medicines, other asthma medicines, heart and blood pressure
medicines and drugs that treat depression – because some medicines
may interfere with how well your asthma medicines work.
- Common side effects in patients taking
ProAir® RespiClick include back pain, body aches and pains, upset
stomach, sinus headache, and urinary tract infection.
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
1,000 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.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 consummate the acquisition of Allergan
plc’s worldwide generic pharmaceuticals business (“Actavis
Generics”) and to realize the anticipated benefits of such
acquisition (and the timing of realizing such benefits); the fact
that following the consummation of the Actavis Generics
acquisition, we will be 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 we will incur to finance the Actavis Generics acquisition;
the fact that for a period of time following the consummation of
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").
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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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orUnited StatesRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR:IsraelIris
Beck Codner, 972 (3) 926-7687orUnited StatesDenise Bradley,
215-591-8974orUnited StatesNancy Leone, 215-284-0213
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