Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Zetia®1 (ezetimibe) tablets, 10 mg,
in the U.S.
Ezetimibe is a prescription medicine used to lower levels of
total cholesterol and low-density lipoprotein (LDL) cholesterol in
the blood. Ezetimibe tablets are for patients who cannot control
their cholesterol levels by diet and exercise alone. It can be used
by itself or with other medicines to treat high cholesterol.
Ezetimibe tablets work to reduce the amount of cholesterol the body
absorbs.
According to the American Heart Association (AHA), approximately
one third of American adults (73.5 million people) have high LDL
cholesterol.2 Fewer than 50% of these individuals are being treated
for high LDL cholesterol, and approximately 30% have their
condition under control.2,3 People with high blood cholesterol are
at risk of heart disease, which is the leading cause of death in
the United States.
“Despite advances in the treatment of high cholesterol in recent
years, many people are still living with active disease and are in
need of additional generic therapeutic options,” said Dipankar
Bhattacharjee, Teva’s President and CEO, Global Generic Medicines.
“We are excited to add another strong generic to our U.S. portfolio
and see potential to build on its success by leveraging our
expertise in the cardiovascular area.”
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
600 generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market and holds the leading
position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in six generic
prescriptions dispensed in the U.S. is filled with a Teva
product.
Ezetimibe tablets had annual sales of approximately $2.7 billion
in the U.S., according to IMS data as of March 2017.
About Ezetimibe Tablets
Therapy with lipid-altering agents should be only one component
of multiple risk factor intervention in individuals at
significantly increased risk for atherosclerotic vascular disease
due to hypercholesterolemia. Drug therapy is indicated as an
adjunct to diet when the response to a diet restricted in saturated
fat and cholesterol and other nonpharmacologic measures alone has
been inadequate.
Ezetimibe tablets, administered alone, are indicated as
adjunctive therapy to diet for the reduction of elevated total
cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (Apo B), and non-high-density lipoprotein
cholesterol (non-HDL-C) in patients with primary (heterozygous
familial and non-familial) hyperlipidemia. Ezetimibe tablets,
administered in combination with a
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor
(statin), are indicated as adjunctive therapy to diet for the
reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in
patients with primary (heterozygous familial and non-familial)
hyperlipidemia.
Ezetimibe tablets, administered in combination with fenofibrate,
are indicated as adjunctive therapy to diet for the reduction of
elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients
with mixed hyperlipidemia. The combination of ezetimibe and
atorvastatin or simvastatin is indicated for the reduction of
elevated total-C and LDL-C levels in patients with HoFH, as an
adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or
if such treatments are unavailable. Ezetimibe tablets are indicated
as adjunctive therapy to diet for the reduction of elevated
sitosterol and campesterol levels in patients with homozygous
familial sitosterolemia.
Limitations of Use: The effect of ezetimibe tablets on
cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III,
IV, and V dyslipidemias.
Important Safety Information
Statin contraindications apply when ezetimibe is used with a
statin: active liver disease, which may include unexplained
persistent elevations in hepatic transaminase levels; women who are
pregnant or may become pregnant; and nursing mothers. Ezetimibe
tablets are contraindicated in patients with a known
hypersensitivity to any component of this product. Hypersensitivity
reactions including anaphylaxis, angioedema, rash and urticaria
have been reported with ezetimibe.
Concurrent administration of ezetimibe with a specific statin or
fenofibrate should be in accordance with the product labeling for
that medication. Persistent elevations in hepatic transaminase were
reported in controlled clinical combination studies of ezetimibe
initiated concurrently with a statin. Cases of myopathy and
rhabdomyolysis have been reported in patients treated with
ezetimibe coadminstered with a statin; with ezetimibe monotherapy;
and with the addition of ezetimibe to agents known to be associated
with increased risk of rhabdomyolysis, such as fibrates. Risk for
skeletal muscle toxicity increases with higher doses of statin,
advanced age (greater than 65), hypothyroidism, renal impairment,
and depending on the statin used, concomitant use of other drugs.
Due to the unknown effects of the increased exposure to ezetimibe
in patients with moderate to severe hepatic impairment, ezetimibe
is not recommended in these patients.
The most commonly reported adverse reactions (incidence greater
than or equal to 2% and greater than placebo) in the ezetimibe
monotherapy controlled clinical trials were: upper respiratory
tract infection, diarrhea, arthralgia, sinusitis, and pain in
extremity. The most commonly reported adverse reactions (incidence
greater than or equal to 2% and greater than statin alone) in the
ezetimibe plus statin controlled clinical trials were:
nasopharyngitis, myalgia, upper respiratory tract infection,
arthralgia, and diarrhea.
For more information, please see accompanying 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 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 the launch and potential benefits of Teva's generic
version of Zetia®, 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:
- commercial success of Teva's ezetimibe
tablets;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to our recent senior management
changes; 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 failure to recruit or retain key personnel,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; variations in
patent laws that may adversely affect our ability to manufacture
our products; adverse effects of political or economic instability,
major hostilities or terrorism on our significant worldwide
operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and
- 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”)
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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
1 Zetia® is a registered trademark of Merck & Co., Inc.2
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M,
et al. Heart Disease and Stroke Statistics—2015 Update: A Report
from the American Heart Association. Circulation. 2015;131.3 CDC.
CDC National Health Report: Leading Causes of Morbidity and
Mortality and Associated Behavioral Risk and Protective
Factors—United States, 2005–2013. MMWR. 2014;63(4):3-27.
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version on businesswire.com: http://www.businesswire.com/news/home/20170612006146/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213
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