Approvals Expand Portfolio of Respiratory
Medicines Delivered in RespiClick® Inhaler Designed to
Eliminate the Need for Hand-Breath Coordination During
Inhalation
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) approved
two products for adolescent and adult patients with asthma. These
products, AirDuoTM RespiClick® (fluticasone propionate and
salmeterol inhalation powder) and ArmonAirTM RespiClick®
(fluticasone propionate inhalation powder), include medication
delivered via Teva’s RespiClick® breath-activated, multi-dose dry
powder inhaler (MDPI) which is used with other approved medicines
in Teva’s respiratory product portfolio.
AirDuoTM RespiClick® is a fixed dose combination product
containing the same active ingredients as Advair®. AirDuo™
RespiClick® is a corticosteroid and a long-acting beta2-adrenergic
agonist (LABA) indicated for the treatment of asthma in patients
aged 12 years and older. ArmonAirTM RespiClick® is an inhaled
corticosteroid (ICS) containing the same active ingredient as
Flovent®, and is indicated for the maintenance treatment of asthma
as prophylactic therapy in patients 12 years and older.
“As a company on the forefront of developing inhaler
technologies for people living with asthma, we are very pleased to
now have two additional RespiClick®-delivered medicines approved
for adolescent and adult patients in the U.S.,” said Michael
Hayden, MD, PhD, President of Global R&D and Chief Scientific
Officer at Teva. “The expansion of our breath-activated product
portfolio underscores Teva’s commitment to developing medicines
that truly meet the needs of patients living with asthma and other
respiratory diseases.”
Rob Koremans, M.D., President and CEO of Global Specialty
Medicines at Teva said, “With these approvals, we now integrate
both fixed dose combination and monotherapy into our core,
breath-activated RespiClick® device. By expanding our RespiClick
portfolio of breath-activated inhalers, we will provide physicians
and their patients with additional treatment options in an inhaler
device that does not require hand-breath coordination during
inhalation.”
AirDuo™ RespiClick® and ArmonAir™ RespiClick® are expected to
become available to patients in the U.S., by prescription, later
this year. Both products have been approved in three strengths. The
approved strengths of AirDuo™ RespiClick® are: 55/14 mcg, 113/14
mcg and 232/14 mcg administered as one inhalation twice daily. The
approved strengths of ArmonAir™ RespiClick® are: 55 mcg, 113 mcg,
and 232 mcg administered as one inhalation twice daily.
“Prescribing the lowest effective dose of a medication is a key
clinical objective in the treatment of asthma. It’s equally
important that patients use their asthma inhalers correctly to
ensure medicine is reaching the lungs,” said Dr. Lyndon Mansfield,
MD, Clinical Professor of Pediatrics, Paul Foster School of
Medicine, El Paso, TX. “With research indicating that a significant
number of patients still do not properly use their metered-dose
inhalers, I am pleased that more asthma treatments and strengths
are now approved in a device that eliminates the need for
hand-breath coordination during inhalation.”
The FDA’s approval of AirDuo™ RespiClick® and ArmonAir™
RespiClick® is supported by data from Teva’s clinical development
program, including three Phase III trials which evaluated the
efficacy and safety of the treatments in adolescent and adult
patients with asthma. In the two double-blind studies, both
therapies showed clinically relevant and greater benefit compared
with placebo in the improvement of lung function after 12 weeks of
treatment as measured by Forced Expiratory Volume in one second
(FEV1). In clinical trials for AirDuo™ RespiClick®, the most common
adverse reactions (incidence ≥3%) were nasopharyngitis, headache,
cough, oral candidiasis and back pain. In ArmonAir™ RespiClick®
clinical trials, the most common adverse reactions (incidence ≥3%)
were nasopharyngitis, headache, cough, oral candidiasis and upper
respiratory tract infection.
About AirDuoTM 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 where intensive measures are
required
- Patients with known severe
hypersensitivity to milk proteins or known hypersensitivity to
fluticasone propionate or any of the excipients
- Deterioration of Disease and Acute
Episodes: Serious acute respiratory events, including
fatalities, have been reported when salmeterol, a component of
AirDuo RespiClick, has been initiated in patients with
significantly worsening or acutely deteriorating asthma. 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, if at all, 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: Because of the possibility of significant systemic
absorption of inhaled corticosteroids, patients treated with AirDuo
RespiClick should be observed carefully for any evidence of
systemic corticosteroid effects. If such effects occur, the dosage
of AirDuo RespiClick should be reduced slowly, consistent with
accepted procedures for reducing systemic corticosteroids, and for
management of asthma symptoms
- Drug Interactions with Strong
Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome
P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir,
clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,
saquinavir, ketoconazole, telithromycin) with AirDuo RespiClick is
not recommended because increased systemic corticosteroid and
increased cardiovascular adverse effects may occur
- Paradoxical Bronchospasm and Upper
Airway Symptoms: AirDuo RespiClick can produce paradoxical
bronchospasm, which may be life-threatening. If paradoxical
bronchospasm occurs following dosing with inhaled fluticasone
propionate/salmeterol medicines, it should be treated immediately
with an inhaled, short-acting bronchodilator; inhaled fluticasone
propionate/salmeterol medicines should be discontinued immediately;
and alternative therapy should be instituted. Upper airway symptoms
of laryngeal spasm, irritation, or swelling, such as stridor and
choking, have been reported
- 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: AirDuo RespiClick should be used with caution
in patients with cardiovascular disorders, especially coronary
insufficiency, cardiac arrhythmias, and hypertension. 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
- 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, including AirDuo RespiClick, may cause a reduction
in growth velocity when administered to pediatric patients. Monitor
the growth of pediatric patients receiving AirDuo RespiClick
routinely (e.g., via stadiometry). Titrate each patient’s dosage to
the lowest dosage that effectively controls his/her symptoms
- Glaucoma and Cataracts:
Glaucoma, increased intraocular pressure, and cataracts have been
reported in patients with asthma following the long-term
administration of inhaled corticosteroids, including fluticasone
propionate. Therefore, close monitoring is warranted in patients
with a change in vision or with a history of increased intraocular
pressure, glaucoma, and/or cataracts
- Eosinophilic Conditions and
Churg-Strauss Syndrome: Systemic eosinophilic conditions, such
as Churg-Strauss syndrome, may occur. These events usually, but not
always, have been associated with the reduction and/or withdrawal
of oral corticosteroid therapy following the introduction of
fluticasone propionate. 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%)
- Drug Interactions:
- Inhibitors of Cytochrome P450
3A4: The use of strong CYP3A4 inhibitors (e.g., ritonavir,
atazanavir, clarithromycin, indinavir, itraconazole, nefazodone,
nelfinavir, saquinavir, ketoconazole, telithromycin) with AirDuo
RespiClick is not recommended because increased systemic
corticosteroid and increased cardiovascular adverse effects may
occur
- Monoamine Oxidase Inhibitors and
Tricyclic Antidepressants: AirDuo RespiClick should be
administered with extreme caution to patients being treated with
monoamine oxidase inhibitors or tricyclic antidepressants, or
within 2 weeks of discontinuation of such agents, because the
action of salmeterol, a component of AirDuo RespiClick, on the
vascular system may be potentiated by these agents
- Beta-Adrenergic Receptor Blocking
Agents: Beta-blockers not only block the pulmonary effect of
beta-agonists, such as salmeterol, a component of AirDuo
RespiClick, but may also produce severe bronchospasm in patients
with asthma. Therefore, patients with asthma should not normally be
treated with beta-blockers
- Non-Potassium-Sparing Diuretics:
The ECG changes and/or hypokalemia that may result from the
administration of non–potassium-sparing diuretics (such as loop or
thiazide diuretics) can be acutely worsened by beta-agonists, such
as salmeterol, a component of AirDuo RespiClick. Caution is advised
in the coadministration of AirDuo RespiClick with
non–potassium-sparing diuretics
- Use in Specific Populations:
Since both fluticasone propionate and salmeterol are predominantly
cleared by hepatic metabolism, impairment of liver function may
lead to accumulation of fluticasone propionate and salmeterol in
plasma. Therefore, patients with hepatic disease should be closely
monitored
Please click here for full Prescribing Information, including
Boxed Warning: http://airduorespiclick.com/assets/pdf/PI.pdf.
Prior to the availability of full Prescribing Information online, a
copy may be requested from the US Medical Information
Contact Center for Teva Specialty Medicines at
888-4-TEVA-RX (888-483-8279)
and USMedInfo@tevapharm.com or Teva’s Public
Relations or Investor Relations contacts.
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:
- the primary treatment of status
asthmaticus or other acute episodes of asthma where intensive
measures are required
- patients with known severe
hypersensitivity to milk proteins or known hypersensitivity to
fluticasone propionate or any of the excipients
- 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, if at all, 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. Slowly taper the dose of
systemic corticosteroids if transferring patients to ArmonAir
RespiClick
- Hypercorticism and Adrenal
Suppression: Because of the possibility of significant systemic
absorption of inhaled corticosteroids, patients on ArmonAir
RespiClick should be observed carefully for any evidence of
systemic corticosteroid effects. If such effects occur, the dosage
of ArmonAir RespiClick should be reduced slowly, consistent with
accepted procedures for reducing systemic corticosteroids, and for
management of asthma symptoms
- 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, including ArmonAir RespiClick, may cause a
reduction in growth velocity when administered to pediatric
patients. Monitor the growth of pediatric patients receiving
ArmonAir RespiClick routinely (e.g., via stadiometry). Titrate to
the lowest dosage that effectively controls symptoms
- Glaucoma and Cataracts:
Glaucoma, increased intraocular pressure, and cataracts have been
reported in patients with asthma following the long-term
administration of inhaled corticosteroids, including fluticasone
propionate. Close monitoring is warranted in patients with a change
in vision or with a history of increased intraocular pressure,
glaucoma, and/or cataracts
- Paradoxical Bronchospasm:
Bronchospasm may occur with an immediate increase in wheezing after
dosing and should be treated immediately with an inhaled,
short-acting bronchodilator; ArmonAir RespiClick should be
discontinued immediately and alternative therapy instituted
- Drug Interactions with Strong
Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome
P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir,
clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,
saquinavir, ketoconazole, telithromycin) 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. These events usually, but not
always, have been associated with the reduction and/or withdrawal
of oral corticosteroids following the introduction of fluticasone
propionate. 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%)
- Drug Interactions: The use of
strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g.,
ritonavir, atazanavir, clarithromycin, indinavir, itraconazole,
nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin)
with ArmonAir RespiClick is not recommended because increased
systemic corticosteroid adverse effects may occur
- Use in Specific Populations:
Since fluticasone propionate is predominantly cleared by hepatic
metabolism, impairment of liver function may lead to accumulation
of fluticasone propionate in plasma. Patients with hepatic disease
should be closely monitored
Please click here for full Prescribing Information:
http://armonairrespiclick.com/assets/pdf/PI.pdf. Prior to the
availability of full Prescribing Information online, a copy may be
requested from the US Medical Information Contact Center for
Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279)
and USMedInfo@tevapharm.com or Teva’s Public
Relations or Investor Relations contacts.
About Asthma
Asthma is a chronic (long term) disease usually characterized by
airway inflammation and narrowing of the airways, which can vary
over time. Asthma may cause recurring periods of wheezing (a
whistling sound when you breathe), chest tightness, shortness of
breath and coughing that often occurs at night or early in the
morning. Without appropriate treatment, asthma symptoms may become
more severe and result in an asthma attack, which can lead to
hospitalization and even death.
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 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
were $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 realize the anticipated benefits of the acquisition
of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”), and the timing of realizing such
benefits; our ability to fully and efficiently integrate Actavis
Generics and to achieve the anticipated cost savings, synergies,
business opportunities and growth prospects from the combination;
the fact that we are now dependent to a much larger extent than
previously on our generic pharmaceutical business; our ability to
develop and launch new generic products from the Actavis Generics
pipeline on the anticipated timelines; potential restrictions on
our ability to engage in additional transactions or incur
additional indebtedness as a result of the substantial amount of
debt we have incurred to finance the Actavis Generics acquisition;
the fact that we will have significantly less cash on hand than
prior to the consummation of the Actavis Generics acquisition,
which could adversely affect our ability to grow; 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, including, in particular, former Actavis
Generics personnel who have transitioned to Teva 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; the possibility of
additional adverse consequences arising from our recent
FCPA-related settlement with the U.S. government, including
limitations on our conduct of business in various countries,
adverse judgments in shareholder lawsuits and fines, penalties or
other sanctions imposed by government authorities in other
countries; 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170130005298/en/
Teva Pharmaceutical Industries Ltd.IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir, 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United StatesorNancy Leone, 215-284-0213United
States
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