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JERUSALEM--(BUSINESS WIRE)--Jun. 12, 2017--
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
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
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
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,
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
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
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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Source: Teva Pharmaceutical Industries Ltd.
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