JERUSALEM--(BUSINESS WIRE)--Nov. 4, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced that
three company-sponsored abstracts will be presented at the 2015 Annual
Scientific Meeting of the American College of Allergy, Asthma and
Immunology (ACAAI) in San Antonio, Texas on November 5-9, 2015.
Data to be presented include a Phase III study examining the long-term
effects of reslizumab on asthma-related quality of life (AQLQ) in asthma
patients previously enrolled in reslizumab safety and efficacy studies.
Reslizumab is an investigational humanized anti-interleukin-5 (IL-5)
monoclonal antibody (mAb) for the treatment of asthma in patients with
elevated blood eosinophils who are inadequately controlled on an inhaled
corticosteroid (ICS)-based regimen.
Additional data to be presented include a real-world analysis of symptom
control, treatment satisfaction and quality of life measures in patients
with perennial allergic rhinitis currently treated with QNASL®
(beclomethasone dipropionate) Nasal Aerosol. A third abstract to be
presented includes data evaluating the pharmacokinetic, pharmacodynamic
and safety profiles of ProAir RespiClick® (albuterol sulfate)
Inhalation Powder and ProAir® HFA (albuterol sulfate)
Inhalation Aerosol in pediatric patients (ages 6-11) with asthma.
“Teva is committed to delivering and further developing therapies to
help meet the needs of the millions of people who suffer from
respiratory diseases,” said Tushar Shah, MD, Senior Vice President, Teva
Global Respiratory Research and Development. “The ACAAI Annual
Scientific Meeting provides an important forum for Teva to showcase our
scientific findings. This year we are pleased to present data from
across our respiratory portfolio and pipeline in the areas of asthma and
allergic rhinitis.”
The following data will be presented during poster sessions on Saturday,
November 7 and Sunday, November 8 at the Henry B. Gonzalez Convention
Center and Grand Hyatt Hotel:
Reslizumab
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#P26: Long-term effect of reslizumab on asthma-related quality
of life (AQLQ) in asthma patients (pts) previously enrolled in
reslizumab safety and efficacy studies
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This abstract will be presented from 3:30 PM to 4:30 PM on
Saturday, Nov. 7 and from 7:30 AM to 8:30 AM on Sunday, Nov. 8
QNASL® (beclomethasone dipropionate) Nasal
Aerosol
-
#P271: Real-World Effects of Beclomethasone Dipropionate Nasal
Aerosol in Patients With Perennial Allergic Rhinitis: 6-Month Results
-
This abstract will be presented from 3:30 PM to 4:30 PM on
Saturday, Nov. 7 and from 7:30 AM to 8:30 AM on Sunday, Nov. 8
ProAir® RespiClick (albuterol sulfate)
Inhalation Powder
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#P49: Pharmacokinetics and Pharmacodynamics of Albuterol
Multidose Dry Powder Inhaler and Albuterol Hydrofluoroalkane
Administered to Children With Asthma
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This poster will be presented from 3:30 PM to 4:30 PM on Saturday,
Nov. 7 and from 7:30 AM to 8:30 AM on Sunday, Nov. 8
Abstracts will be published in a supplement to the November issue of Annals
of Allergy, Asthma & Immunology and will also be available
online beginning Nov. 6.
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 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 inadequately controlled 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 monoclonal antibody developed
to target interleukin-5 (IL-5). IL-5 is a key cytokine shown to play a
crucial role in the maturation, activation and survival of eosinophils,
which are a type of white blood cell that are present at elevated levels
in the lungs, airways (sputum), and blood of many asthmatics. Evidence
shows that eosinophils play an active role in the pathogenesis of the
disease. Increased levels of eosinophils in the sputum and blood have
been shown to positively correlate with disease severity and increased
risk of asthma exacerbations. Reslizumab is thought to act by binding
circulating IL-5 and preventing IL-5 from interacting with its receptor.
Reslizumab has been submitted for and is currently under review by the
U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA)
and Health Canada.
About QNASL®
QNASL® (beclomethasone dipropionate) Nasal Aerosol is a
prescription medication that treats seasonal and year-round nasal
allergy symptoms in patients 4 years of age and older.
Important Safety Information
-
In clinical studies, nosebleeds and nose ulcers were more common in
patients treated with QNASL Nasal Aerosol than patients who received
placebo. Some nosebleeds were more severe in patients treated with
QNASL Nasal Aerosol than in patients who received placebo. Tell your
healthcare provider if you start to have nosebleeds or nasal ulcers
after using QNASL Nasal Aerosol
-
Thrush (Candida), a fungal infection in your nose, mouth, or
throat may occur. Tell your healthcare provider if you have any
redness or white colored patches in your mouth or throat
-
You should avoid using QNASL Nasal Aerosol until your nose is healed
if you have a sore in your nose, you have had recent surgery on your
nose, or if your nose has been injured, because QNASL Nasal Aerosol
may cause slow wound healing
-
Some people who use corticosteroids may have eye problems such as
increased pressure in the eye (glaucoma) or cataracts. If you have a
history of glaucoma or cataracts or have a family history of eye
problems, you should have regular eye exams while you use QNASL Nasal
Aerosol
-
Serious allergic reactions can happen in people taking QNASL Nasal
Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare
provider right away or get emergency help if you experience shortness
of breath or trouble breathing, skin rash, redness, swelling, severe
itching, or swelling of your lips, tongue or face
-
People are more likely to get infections if they have immune system
problems or use drugs, including corticosteroids, which may weaken the
body’s ability to fight infections. Avoid contact with people who have
infections like chickenpox or measles while using QNASL Nasal Aerosol.
Speak to your healthcare provider before using QNASL Nasal Aerosol if
you have tuberculosis or untreated fungal, bacterial, or viral
infections, or eye infections caused by herpes. Symptoms of an
infection include: fever, pain, aches, chills, feeling tired, nausea
and vomiting
-
A condition in which the adrenal glands do not make enough steroid
hormones may occur. Symptoms can include tiredness, weakness,
dizziness, nausea and vomiting. Tell your healthcare provider if you
experience these symptoms
-
Children taking QNASL Nasal Aerosol should have their growth checked
regularly, since corticosteroids may slow growth in children
-
The most common side effects with QNASL Nasal Aerosol 80 mcg in
patients 12 years of age and older are nasal discomfort, nosebleeds,
and headache
-
The most common side effects with QNASL Nasal Aerosol 40 mcg in
patients 4 to 11 years of age are headache, fever, infection of the
nose and throat, and inflammation of the nose and throat
-
Tell your healthcare provider if you have any side effect that bothers
you or that does not go away
-
These are not all of the possible side effects of QNASL Nasal Aerosol.
For more information, ask your healthcare provider or pharmacist
Please
click here or Full Prescribing Information
About ProAir® RespiClick
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 to 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 2014 amounted to $20.3
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® (including
competition from orally-administered alternatives, as well as from
generic equivalents such as the recently launched Sandoz product) and
our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; 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 the
research and development efforts invested in our pipeline of specialty
and other products; our ability to reduce operating expenses to the
extent and during the timeframe intended by our cost reduction program;
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; 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 generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
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, 2014 and in our other filings with the U.S. Securities and Exchange
Commission.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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