Presentations Span Teva’s Respiratory Portfolio
– including Rescue, Maintenance Inhalers and Biologic Asthma
Treatment
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that five company-sponsored abstracts will be presented
at the 2017 American College of Allergy, Asthma and Immunology
(ACAAI) Annual Scientific Meeting in Boston, October 26-30,
2017.
Among the accepted abstracts, data from two analyses examined
the efficacy of CINQAIR® IV (reslizumab) Injection, a humanized
interleukin-5 antagonist monoclonal antibody for the treatment of
severe eosinophilic asthma. One abstract presents a post-hoc
analysis, measuring the direct effect of CINQAIR® on spirometric
“lung age,” and the second presents a post-hoc analysis examining
the impact of CINQAIR® on lung function and clinical asthma
exacerbations in patients with low baseline lung function.
A post-hoc analysis studied the efficacy of ArmonAir™
RespiClick® (fluticasone propionate) Inhalation Powder and AirDuo
RespiClick® (fluticasone propionate and salmeterol) Inhalation
Powder in patients previously treated with the same medication
administered in alternative inhalers.
Finally, two abstracts from Teva’s Health Economic and Outcomes
Research team will be presented. One describes a budget impact
model that was developed to assess the economic impact of
Short-Acting Beta-Agonists (SABAs) with integrated dose counters
among Medicare patients with respiratory diseases. The other
describes a retrospective, observational claims-based study that
explores the prevalence of comorbidities associated with poor
device handling in asthma and/or chronic obstructive pulmonary
disease (COPD) patients using SABAs, including ProAir RespiClick®
(albuterol sulfate) Inhalation Powder.
“Nearly 25 million people in the U.S. have asthma1 – and that
number is growing. This is what drives us to constantly evaluate
our treatments – from inhaler therapies with breath-actuated
delivery systems to targeted biologic therapy. Our intent is to
develop therapies that may enable positive treatment outcomes for
patients,” said Dr. Daniel McBryan, MD, Vice President, Respiratory
Global Medical Affairs at Teva Pharmaceuticals. “We are excited to
be here at the ACAAI Annual Scientific Meeting to showcase our
ongoing commitment to scientific research aimed at addressing the
unmet needs that still exist for the respiratory patient
community.”
The following Teva-sponsored data will be presented:
CINQAIR® (reslizumab)
- #P216: Efficacy of reslizumab in
eosinophilic asthma patients with low lung function
- This abstract will be presented as an
ePoster presentation on Saturday, October 28, 2017 at 10:30 AM on
Monitor 5
- #P223: Reslizumab improves
spirometric lung age in patients with severe eosinophilic asthma
- This abstract will be presented as an
ePoster presentation on Saturday, October 28, 2017 at 1:10 PM on
Monitor 5
ArmonAir™ RespiClick® (fluticasone propionate) and
AirDuo RespiClick® (fluticasone propionate and
salmeterol)
- #P209: Fluticasone Propionate
and Fluticasone/Salmeterol Multidose Dry Powder Inhalers in
Patients Previously Treated Through Alternative Devices
- This abstract will be presented as an
ePoster presentation on Friday, October 27, 2017 at 4:50 PM on
Monitor 5
Health Economics Outcomes and Research
- #P236: Comorbidities Associated
with Poor Short-Acting Beta-Agonist Inhaler Handling Among United
States Respiratory Patients
- This abstract will be presented as an
ePoster presentation on Sunday, October 29, 2017 at 1:10 PM on
Monitor 5
- #P235: Budgetary Impact Model on a Medicare Plan
Adopting Short-Acting Beta-Agonist Inhalers with Integrated Dose
Counters
- This abstract will be presented as an ePoster presentation on
Sunday, October 29, 2017 at 1 PM on Monitor 5
About CINQAIR® (reslizumab) Injection
CINQAIR (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 Powder
ProAir 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 AirDuo RespiClick® (Fluticasone
Propionate and Salmeterol) Inhalation Powder
AirDuo™ RespiClick® is indicated for the treatment of asthma in
patients aged 12 years and older. AirDuo RespiClick is only for
patients uncontrolled on an ICS or whose disease severity clearly
warrants an ICS/LABA.
Important Limitation of Use: AirDuo
RespiClick is NOT indicated for the relief of acute
bronchospasm.
IMPORTANT SAFETY INFORMATION
WARNING: ASTHMA-RELATED DEATH
- Long-acting
beta2-adrenergic agonists (LABA), such as salmeterol,
one of the active ingredients in AirDuo RespiClick, increase the
risk of asthma-related death. Data from a large placebo-controlled
US trial that compared the safety of salmeterol with placebo added
to usual asthma therapy showed an increase in asthma-related deaths
in subjects receiving salmeterol (13 deaths out of
13,176 subjects treated for 28 weeks on salmeterol versus
3 deaths out of 13,179 subjects on placebo). Currently
available data are inadequate to determine whether concurrent use
of inhaled corticosteroids or other long-term asthma control drugs
mitigates the increased risk of asthma-related death from LABA.
Available data from controlled clinical trials suggest that LABA
increase the risk of asthma-related hospitalization in pediatric
and adolescent patients
- Therefore, when treating patients
with asthma, physicians should only prescribe AirDuo RespiClick for
patients not adequately controlled on a long-term asthma control
medication, such as an inhaled corticosteroid, or whose disease
severity clearly warrants initiation of treatment with both an
inhaled corticosteroid and a LABA. Once asthma control is achieved
and maintained, assess the patient at regular intervals and step
down therapy (e.g., discontinue AirDuo RespiClick) if possible
without loss of asthma control and maintain the patient on a
long-term asthma control medication, such as an inhaled
corticosteroid. Do not use AirDuo RespiClick for patients whose
asthma is adequately controlled on low- or medium-dose inhaled
corticosteroids
- Contraindications: AirDuo
RespiClick is contraindicated in:
- Primary treatment of status asthmaticus
or other acute episodes of asthma requiring intensive measures
- Patients with known severe
hypersensitivity to milk proteins or any ingredients of AirDuo
RespiClick
- Deterioration of Disease and Acute
Episodes: AirDuo RespiClick should not be initiated in patients
during rapidly deteriorating or potentially life-threatening
episodes of asthma. AirDuo RespiClick is not indicated for the
relief of acute bronchospasm. An inhaled, short-acting
beta2-agonist, not AirDuo RespiClick, should be used to relieve
acute symptoms such as shortness of breath
- Excessive Use and Use with Other
Long acting Beta2-Agonists: AirDuo RespiClick
should not be used more often than recommended, at higher doses
than recommended, or in conjunction with other medicines containing
LABA, as an overdose may result. Clinically significant
cardiovascular effects and fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs.
Patients using AirDuo RespiClick should not use another medicine
containing a LABA (e.g., salmeterol, formoterol fumarate,
arformoterol tartrate, indacaterol) for any reason
- Local Effects of Inhaled
Corticosteroids: Oropharyngeal candidiasis has occurred in
patients treated with AirDuo RespiClick .Advise patients to rinse
the mouth with water without swallowing following inhalation
- Immunosuppression: Patients who
use corticosteroids are at risk for potential worsening of existing
tuberculosis; fungal, bacterial, viral, or parasitic infections; or
ocular herpes simplex. A more serious or even fatal course of
chickenpox or measles may occur in susceptible patients. Use with
caution in patients with the above because of the potential for
worsening of these infections
- Transferring Patients from Systemic
Corticosteroid Therapy: Particular care is needed for patients
who have been transferred from systemically active corticosteroids
to inhaled corticosteroids because deaths due to adrenal
insufficiency have occurred in patients with asthma during and
after transfer from systemic corticosteroids to less systemically
available inhaled corticosteroids. Taper patients slowly from
systemic corticosteroids if transferring to AirDuo RespiClick
- Hypercorticism and Adrenal
Suppression may occur with high doses of inhaled
corticosteroids, including fluticasone propionate, or at the
recommended dose in susceptible individuals. If such changes occur,
discontinue AirDuo RespiClick slowly
- Drug Interactions with Strong
Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome
P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole)
with AirDuo RespiClick is not recommended because increased
systemic corticosteroid and increased cardiovascular adverse
effects may occur
- Paradoxical Bronchospasm and Upper
Airway Symptoms: If paradoxical bronchospasm occurs,
discontinue AirDuo RespiClick immediately and institute alternative
therapy
- Hypersensitivity Reactions,
Including Anaphylaxis: Immediate hypersensitivity reactions
(e.g., urticaria, angioedema, rash, bronchospasm, hypotension),
including anaphylaxis, may occur after administration of AirDuo
RespiClick. Discontinue AirDuo RespiClick if such reactions
occur
- Cardiovascular and Central Nervous
System Effects: Salmeterol, a component of AirDuo RespiClick,
can produce clinically significant cardiovascular effects in some
patients as measured by pulse rate, blood pressure, and/or
symptoms. If such effects occur, AirDuo RespiClick may need to be
discontinued. AirDuo RespiClick should be used with caution in
patients with cardiovascular disorders, especially coronary
insufficiency, cardiac arrhythmias, and hypertension
- Reduction in Bone Mineral Density
(BMD): Decreases in BMD have been observed with long-term
administration of products containing inhaled corticosteroids.
Patients with major risk factors for decreased bone mineral
content, such as prolonged immobilization, family history of
osteoporosis, or chronic use of drugs that can reduce bone mass
(e.g., anticonvulsants, oral corticosteroids) should be monitored
and treated with established standards of care
- Effect on Growth: Inhaled
corticosteroids, as well as poorly controlled asthma, may cause a
reduction in growth velocity, and the long-term effect on final
adult height is unknown. Patients should be maintained on the
lowest dose of inhaled corticosteroid that effectively controls
their asthma. Monitor growth of pediatric patients
- Glaucoma and Cataracts:
Long-term use of inhaled corticosteroids, including fluticasone
propionate, a component of AirDuo RespiClick, may increase the risk
for cataracts or glaucoma. Regular eye exams should be
considered
- Eosinophilic Conditions and
Churg-Strauss Syndrome: Systemic eosinophilic conditions, such
as Churg-Strauss syndrome, may occur. Be alert to eosinophilia,
vasculitic rash, worsening pulmonary symptoms, cardiac
complications, and/or neuropathy
- Coexisting Conditions: Use with
caution in patients with convulsive disorders, thyrotoxicosis,
diabetes mellitus, ketoacidosis, and in patients who are unusually
responsive to sympathomimetic amines
- Hypokalemia and Hyperglycemia:
Be alert to hypokalemia and hyperglycemia
- Adverse Reactions: Most common
adverse reactions (≥3%) in patients taking AirDuo RespiClick 55/14
mcg twice daily, 113/14 mcg twice daily, 232/14 mcg twice daily,
and placebo, respectively, were nasopharyngitis (8.6%, 4.8%, 6.9%,
4.4%), oral candidiasis (1.6%, 2.2%, 3.4%, 0.7%), back pain (3.1%,
0.7%, 0%, 1.8%), headache (5.5%, 4.8%, 2.8%, 4.4%), and cough
(2.3%, 3.7%, 0.7%, 2.6%)
Please click here for full Prescribing Information, including
Boxed WARNING.
About
ArmonAirTM RespiClick® (Fluticasone
Propionate) Inhalation Powder
ArmonAir™ RespiClick® is indicated for the maintenance treatment
of asthma as prophylactic therapy in patients 12 years of age and
older.
Important Limitation of Use:
ArmonAir RespiClick is NOT indicated for the relief of acute
bronchospasm.
IMPORTANT SAFETY INFORMATION
- Contraindications: ArmonAir
RespiClick is contraindicated in:
- Primary treatment of status asthmaticus
or other acute episodes of asthma requiring intensive measures
- Patients with known severe
hypersensitivity to milk proteins or any ingredients of ArmonAir
RespiClick
- Local Effects: Oropharyngeal
candidiasis has occurred in patients treated with ArmonAir
RespiClick. Advise patients to rinse the mouth with water without
swallowing following inhalation
- Acute Asthma Episodes: ArmonAir
RespiClick is not indicated for the relief of acute bronchospasm.
An inhaled, short-acting beta2-agonist, not ArmonAir RespiClick,
should be used to relieve acute symptoms such as shortness of
breath
- Immunosuppression: Patients on
corticosteroids are at risk for potential worsening of existing
tuberculosis; fungal, bacterial, viral, or parasitic infections; or
ocular herpes simplex. A more serious or even fatal course of
chickenpox or measles may occur in susceptible patients. Use with
caution in patients with the above because of the potential for
worsening of these infections
- Transferring Patients from Systemic
Corticosteroid Therapy: Particular care is needed for patients
who have been transferred from systemically active corticosteroids
to inhaled corticosteroids because deaths due to adrenal
insufficiency have occurred in patients with asthma during and
after transfer from systemic corticosteroids to less systemically
available inhaled corticosteroids. Taper patients slowly from
systemic corticosteroids if transferring to ArmonAir
RespiClick
- Hypercorticism and Adrenal
Suppression may occur with high doses of inhaled
corticosteroids, including fluticasone propionate, or at the
recommended dose in susceptible individuals. If such changes occur,
discontinue ArmonAir RespiClick slowly
- Hypersensitivity Reactions,
Including Anaphylaxis: Immediate hypersensitivity reactions
(e.g., urticaria, angioedema, rash, bronchospasm, hypotension),
including anaphylaxis, may occur after administration of ArmonAir
RespiClick. Discontinue ArmonAir RespiClick if such reactions
occur
- Reduction in Bone Mineral Density
(BMD): Decreases in BMD have been observed with long-term
administration of inhaled corticosteroids. Patients with major risk
factors for decreased bone mineral content, such as prolonged
immobilization, family history of osteoporosis, or chronic use of
drugs that can reduce bone mass (e.g., anticonvulsants, oral
corticosteroids) should be monitored and treated with established
standards of care
- Effect on Growth: Inhaled
corticosteroids, as well as poorly controlled asthma, may cause a
reduction in growth velocity, and the long-term effect on final
adult height is unknown. Patients should be maintained on the
lowest dose of inhaled corticosteroid that effectively controls
their asthma. Monitor growth of pediatric patients
- Glaucoma and Cataracts:
Long-term use of inhaled corticosteroids, including ArmonAir
RespiClick, may increase the risk for cataracts or glaucoma.
Regular eye exams should be considered
- Paradoxical Bronchospasm:
Discontinue ArmonAir RespiClick and institute alternative therapy
if paradoxical bronchospasm occurs
- Drug Interactions with Strong
Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome
P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole)
with ArmonAir RespiClick is not recommended because increased
systemic corticosteroid adverse effects may occur
- Eosinophilic Conditions and
Churg-Strauss Syndrome: Systemic eosinophilic conditions, such
as Churg-Strauss syndrome, may occur. Be alert to eosinophilia,
vasculitic rash, worsening pulmonary symptoms, cardiac
complications, and/or neuropathy
- Adverse Reactions: Most common
adverse reactions (≥3%) in patients taking ArmonAir RespiClick 55
mcg twice daily, 113 mcg twice daily, 232 mcg twice daily, and
placebo, respectively, were nasopharyngitis (5.4%, 5.8%, 4.8%,
4.4%), upper respiratory tract infection (5.4%, 4.7%, 5.5%, 4.8%),
oral candidiasis (3.1%, 2.9%, 4.8%, 0.7%), headache (1.6%, 7.3%,
4.8%, 4.4%), and cough (1.6%, 1.8%, 3.4%, 2.6%)
Please click here for full Prescribing Information.
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-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 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 approximately 200
million patients in 100 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 Teva's respiratory portfolio 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 potential benefits and commercial
success of Teva's respiratory portfolio;
- 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.
References
- Centers for Disease Control and
Prevention. Asthma in the U.S.: Vital Signs. May 2011. Available
at: https://www.cdc.gov/vitalsigns/asthma/
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version on businesswire.com: http://www.businesswire.com/news/home/20171026005750/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974Michelle Larkin,
610-786-7335
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