Data Include Pivotal Results for Two
Investigational Treatments for Persistent Asthma and an Oral
Presentation on the Healthcare Utilization Impact of Rescue
Inhalers with Integrated Dose Counters
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that ten company-sponsored abstracts will be presented at
the 2016 American College of Allergy, Asthma & Immunology
(ACAAI) Annual Scientific Meeting in San Francisco, California on
November 10-14, 2016.
Data for presentation include results from three Phase III
studies and one Phase I study of fluticasone propionate/salmeterol
(FS) RespiClick®, a fixed-dose combination inhaled corticosteroid
(ICS) and long-acting beta agonist (LABA) delivered via Teva’s
RespiClick® breath-actuated, multi-dose dry powder inhaler (MDPI)
and for fluticasone propionate (Fp) RespiClick® an ICS monotherapy
also delivered via the RespiClick® device. This will be the first
presentation of the Phase III clinical trial results for FS
RespiClick® and Fp RespiClick®, which are currently under review
with the U.S. Food & Drug Administration for the treatment of
adolescent and adult patients with asthma. Abstracts of note
include two poster presentations examining the efficacy and safety
of Fp RespiClick® and FS RespiClick® at varying doses compared to
placebo, and a poster presentation evaluating long-term safety of
both products in asthmatic patients.
In addition, a retrospective, observational study pertaining to
Teva’s rescue medication, ProAir® HFA (albuterol sulfate)
Inhalation Aerosol from its Health Economics & Outcomes
Research division will be presented via oral presentation. The
study evaluated the impact of rescue inhalers with integrated dose
counters (IDC), specifically ProAir® HFA, on healthcare utilization
among asthmatic patients. Results from the study show how IDCs
significantly contributed to improved outcomes for asthmatic
patients while also reducing respiratory-related healthcare
utilization, specifically hospitalizations and emergency department
visits.
“We look forward to presenting new data and analyses for a
number of products in our growing respiratory portfolio at the
ACAAI Annual Scientific Meeting as we continue our work to help
address the needs of people living with respiratory disease,” said
Tushar Shah, MD, Senior Vice President, Teva Global Respiratory
Research and Development. “When it comes to asthma, there is not a
one-size-fits-all approach for treatment. Whether enhancing
delivery device technology, enabling patients to track remaining
doses in an inhaler with an integrated dose counter, or developing
targeted biologic therapies, Teva is committed to developing and
delivering therapies that will help patients across the severity
spectrum better manage their illness.”
The following Teva-sponsored data will be presented at the 2016
ACAAI Annual Meeting:
Fluticasone Propionate/Salmeterol RespiClick®
and Fluticasone Propionate RespiClick®
- P148: Long-term Safety of
Fluticasone Propionate and Fluticasone Propionate/Salmeterol
Multi-dose Dry Powder Inhalers in Asthmatic Patients
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Friday, November 11, 2016
at 3:40 p.m. on Monitor 8
- P149: Fluticasone Propionate and
Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhaler
Pharmacokinetics in Patients With Persistent Asthma
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Friday, November 11, 2016
at 3:50 p.m. on Monitor 8
- P139: Fluticasone Propionate And
Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers
Compared With Placebo for Persistent Asthma
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016
at 10:15 a.m. on Monitor 7
- P142: Fluticasone Propionate and
Fluticasone Propionate/Salmeterol Delivered via Multi-dose Dry
Powder Inhalers for Persistent Asthma
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016
at 12:50 p.m. on Monitor 8
ProAir RespiClick® (albuterol sulfate)
Inhalation Powder
- P152: Robust Performance of a
Multi-dose Dry Powder Inhaler With Albuterol Sulfate Under Various
Misuse Scenarios
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Friday, November 11, 2016
at 4:20 p.m. on Monitor 8
ProAir® HFA (albuterol sulfate) Inhalation
Aerosol
- O024 Healthcare Utilization in
Asthma Patients Using Albuterol Hydrofluoroalkane Inhalation
Aerosol With/Without an Integrated Dose Counter
- This abstract will be orally
presented on November 13, 2016 at 3:15 p.m. in Room 3024
Beclomethasone dipropionate HFA BAI
- P150: Evaluation of
Beclomethasone Dipropionate (80 and 160 mcg/day) Delivered via
Breath Actuated Inhaler for Persistent Asthma
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Friday, November 11, 2016
at 4:00 p.m. on Monitor 8
- P143: Beclomethasone
Dipropionate Pharmacokinetics Delivered by Breath Actuated Inhaler
and Metered Dose Inhaler in Healthy Subjects
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016
at 1:00 p.m. on Monitor 7
CINQAIR®/CINQAERO® (reslizumab)
Injection
- P154: Indirect Comparison of
Exacerbation Rates Among Patients Treated with Reslizumab Compared
to Omalizumab and Mepolizumab
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Friday, November 11, 2016
at 4:40pm on Monitor 8
- P155: Higher binding affinity
and in vitro potency of reslizumab for interleukin-5 compared with
mepolizumab
- This abstract will be presented during
Asthma, Other Lower Airway Disorders on Saturday, November 12, 2016
at 10:50 am on Monitor 8
About Teva RespiratoryTeva 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 CINQAIR® (reslizumab)
InjectionCINQAIR (reslizumab) Injection is an interleukin-5
antagonist monoclonal antibody (IgG4 kappa) indicated for add-on
maintenance treatment of patients with severe asthma aged 18 years
and older, and with an eosinophilic phenotype.
Limitations of Use: CINQAIR is not indicated for:
- treatment of other eosinophilic
conditions
- relief of acute bronchospasm or status
asthmaticus
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
- Anaphylaxis has been observed with
CINQAIR infusion in 0.3% of patients in placebo-controlled clinical
studies. Anaphylaxis was reported as early as the second dose of
CINQAIR.
- Anaphylaxis can be life-threatening.
Patients should be observed for an appropriate period of time after
CINQAIR administration by a healthcare professional prepared to
manage anaphylaxis. Discontinue CINQAIR immediately if the patient
experiences signs or symptoms of anaphylaxis.
CONTRAINDICATIONS
- CINQAIR is contraindicated in patients
who have known hypersensitivity to reslizumab or any of its
excipients.
WARNINGS AND PRECAUTIONS
- Acute Asthma Symptoms or
Deteriorating Disease: CINQAIR should not be used to treat
acute asthma symptoms or acute exacerbations. Do not use CINQAIR to
treat acute bronchospasm or status asthmaticus. Patients should
seek medical advice if their asthma remains uncontrolled or worsens
after initiation of treatment with CINQAIR.
- Malignancy: In
placebo-controlled clinical studies, 6/1028 (0.6%) patients
receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm
reported compared to 2/730 (0.3%) patients in the placebo group.
The observed malignancies in CINQAIR-treated patients were diverse
in nature and without clustering of any particular tissue type. The
majority of malignancies were diagnosed within less than six months
of exposure to CINQAIR.
- Reduction of Corticosteroid
Dosage: No clinical studies have been conducted to assess
reduction of maintenance corticosteroid dosages following
administration of CINQAIR. Do not discontinue systemic or inhaled
corticosteroids abruptly upon initiation of therapy with CINQAIR.
Reductions in corticosteroid dose, if appropriate, should be
gradual and performed under the supervision of a physician.
Reduction in corticosteroid dose may be associated with systemic
withdrawal symptoms and/or unmask conditions previously suppressed
by systemic corticosteroid therapy.
- Parasitic (Helminth) Infection:
Eosinophils may be involved in the immunological response to some
helminth infections. Treat patients with pre-existing helminth
infections before initiating CINQAIR. If patients become infected
while receiving treatment with CINQAIR and do not respond to
anti-helminth treatment, discontinue treatment with CINQAIR until
infection resolves.
ADVERSE REACTIONS
- Adverse reactions that occurred at ≥2%
incidence and more commonly than in the placebo group included 1
event: oropharyngeal pain (2.6% vs. 2.2%).
- Elevated baseline creatine
phosphokinase (CPK) was more frequent in patients randomized to
CINQAIR (14%) versus placebo (9%). Transient CPK elevations in
patients with normal baseline CPK values were observed more
frequently with CINQAIR (20%) versus placebo (18%) during routine
laboratory assessments.
- Myalgia was reported in 1% (10/1028) of
patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of
patients in the placebo group.
- Immunogenicity: In placebo-controlled
studies, a treatment-emergent anti-reslizumab antibody response
developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg).
The antibody responses were of low titer and often transient. There
was no detectable impact of the antibodies on the clinical
pharmacokinetics, pharmacodynamics, clinical efficacy, and safety
of CINQAIR.
Please click here for full Prescribing Information
About ProAir® RespiClick (albuterol sulfate)
Inhalation PowderProAir® RespiClick (albuterol sulfate)
Inhalation Powder 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
- ProAir RespiClick® (albuterol sulfate)
Inhalation Powder is contraindicated in patients with
hypersensitivity to albuterol or patients with a severe
hypersensitivity to milk proteins. Rare cases of hypersensitivity
reactions, including urticaria, angioedema, and rash have been
reported after the use of albuterol sulfate. There have been
reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
- ProAir RespiClick® can produce
paradoxical bronchospasm that may be life-threatening. Discontinue
ProAir RespiClick® and institute alternative therapy if paradoxical
bronchospasm occurs
- Need for more doses of ProAir
RespiClick® than usual may be a marker of acute or chronic
deterioration of asthma and requires reevaluation of treatment
- ProAir RespiClick® alone may not be
adequate to control asthma in many patients. Early consideration
should be given to adding anti-inflammatory agents, e.g.,
corticosteroids
- ProAir RespiClick®, like other
beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate,
blood pressure, and/or symptoms. If such effects occur, the drug
may need to be discontinued
- ProAir RespiClick®, as with all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders (especially coronary insufficiency,
cardiac arrhythmias, and hypertension), convulsive disorders,
hyperthyroidism, and diabetes
- Fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs in
patients with asthma. Do not exceed the recommended dose
- Immediate hypersensitivity reactions
may occur. Discontinue ProAir RespiClick® immediately
- ProAir RespiClick® may produce
significant hypokalemia in some patients, which has the potential
to produce adverse cardiovascular effects. The decrease is usually
transient, not requiring supplementation
- Potential drug interactions can occur
with beta-blockers, diuretics, digoxin, or monoamine oxidase
inhibitors, and tricyclic antidepressants
- In controlled studies of ProAir
RespiClick® in patients 12 years of age and older, adverse events
that occurred at an incidence rate of at least 1% and greater than
placebo included back pain (2% vs 1%), pain (2% vs <1%),
gastroenteritis viral (1% vs <1%), sinus headache (1% vs
<1%), and urinary tract infection (1% vs <1%)
- In controlled studies of ProAir
RespiClick® in patients 4 to 11 years of age, adverse events that
occurred at an incidence rate of at least 2% and greater than
placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2%
vs 1%), and vomiting (3% vs 1%)
Please click here for Full Prescribing Information
About ProAir® HFA (albuterol sulfate)
Inhalation AerosolProAir® 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
- Inhaled albuterol sulfate can produce
paradoxical bronchospasm that may be life-threatening. It should be
recognized that paradoxical bronchospasm, when associated with
inhaled formulations, frequently occurs with the first use of a new
canister
- Fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs in
patients with asthma
- ProAir HFA, as with all sympathomimetic
amines, should be used with caution in patients with cardiovascular
disorders (especially coronary insufficiency, cardiac arrhythmias,
and hypertension), convulsive disorders, hyperthyroidism, and
diabetes
- Potential drug interactions can occur
with beta-blockers, diuretics, digoxin, or monoamine oxidase
inhibitors, and tricyclic antidepressants.
- Do not exceed the recommended dose
- Adverse events, which occurred at an
incidence rate of at least 3% with ProAir HFA, include headache,
tachycardia, pain, dizziness, pharyngitis, and rhinitis
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
1,800 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 integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are 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 incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following 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, 215-591-8912orRan 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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