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%)>1%)>1%),>1%),>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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