JERUSALEM--(BUSINESS WIRE)--Nov. 7, 2016--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced approval of generic Tribenzor®1(olmesartan
medoxomil, amlodipine and hydrochlorothiazide) tablets in the U.S. and
is in the final stages of launch preparation. Teva also recently
received approval and launched generic Azor®2 (amlodipine and
olmesartan medoxomil) tablets in the U.S. These products enhance Teva’s
antihypertensive portfolio.
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a
combination of an angiotensin II
receptor blocker, a dihydropyridine calcium channel blocker and a
thiazide diuretic indicated for the treatment of hypertension, to lower
blood pressure.
Amlodipine and olmesartan medoxomil tablets are a dihydropyridine
calcium channel blocker and angiotensin II receptor blocker combination
product indicated for the treatment of hypertension, alone or with other
antihypertensive agents, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
Many patients will require more than one drug to achieve their blood
pressure goals.
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. These products
enhance Teva’s already comprehensive product portfolio.
Teva has over 300 product registrations pending FDA approval 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 generic
product.
Tribenzor® had annual sales of approximately $240 million in
the U.S. and Azor® had annual sales of approximately $354.1
million in the U.S., according to IMS data as of August 2016.
About Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are
indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
These benefits have been seen in controlled trials of antihypertensive
drugs from a wide variety of pharmacologic classes including the class
to which this drug principally belongs. There are no controlled trials
demonstrating risk reduction with olmesartan medoxomil, amlodipine,
hydrochlorothiazide tablets.
Control of high blood pressure should be part of comprehensive
cardiovascular risk management, including, as appropriate, lipid
control, diabetes management, antithrombotic therapy, smoking cessation,
exercise, and limited sodium intake.
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are not
indicated for the initial therapy of hypertension.
Important Safety Information
WARNING: Fetal Toxicity. When pregnancy is detected, discontinue
olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets as
soon as possible. Drugs that act directly on the renin-angiotensin
system can cause injury and death to the developing fetus.
Because of the hydrochlorothiazide component, olmesartan medoxomil,
amlodipine, and hydrochlorothiazide tablets are contraindicated in
patients with anuria or hypersensitivity to other sulfonamide-derived
drugs. Do not coadminister aliskiren with olmesartan medoxomil,
amlodipine, and hydrochlorothiazide tablets in patients with diabetes.
Other serious adverse reactions that may occur include: hypotension,
particularly in volume- or salt-depleted patients; increased angina
and/or myocardial infarction; impaired renal function; electrolyte and
metabolic imbalances; hypersensitivity reactions; exacerbation or
activation of systemic lupus erythematosus; acute transient myopia and
acute angle-closure glaucoma; sprue-like enteropathy; and vasodilation.
Increased drug exposure may occur in patients with hepatic impairment.
Avoid use in patients with severely impaired renal or hepatic function.
Most common adverse reactions (incidence ≥ 2%) in a controlled clinical
trial: dizziness, peripheral edema, headache, fatigue, nasopharyngitis,
muscle spasms, nausea, upper respiratory tract infection, diarrhea,
urinary tract infection, and joint swelling.
For more information, please see accompanying full Prescribing
Information, including Boxed Warning.
About Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and olmesartan medoxomil tablets are indicated for the
treatment of hypertension, alone or with other antihypertensive agents,
to lower blood pressure. Lowering blood pressure reduces the risk of
fatal and nonfatal cardiovascular events, primarily strokes and
myocardial infarctions. These benefits have been seen in controlled
trials of antihypertensive drugs from a wide variety of pharmacologic
classes including the class to which this drug principally belongs.
There are no controlled trials demonstrating risk reduction with
amlodipine and olmesartan medoxomil tablets.
Control of high blood pressure should be part of comprehensive
cardiovascular risk management, including, as appropriate, lipid
control, diabetes management, antithrombotic therapy, smoking cessation,
exercise, and limited sodium intake.
Amlodipine and olmesartan medoxomil tablets may also be used as initial
therapy in patients who are likely to need multiple antihypertensive
agents to achieve their blood pressure goals.
Important Safety Information
WARNING: Fetal Toxicity. When pregnancy is detected, discontinue
amlodipine and olmesartan medoxomil tablets as soon as possible. Drugs
that act directly on the renin-angiotensin system can cause injury and
death to the developing fetus.
Do not coadminister aliskiren with in patients with diabetes. The 10
mg/20 mg amlodipine and olmesartan medoxomil tablets contain FD&C Yellow
No. 5 (tartrazine) which may cause allergic-type reactions (including
bronchial asthma) in certain susceptible persons and frequently seen in
patients who also have aspirin hypersensitivity.
Other serious adverse reactions that may occur include: hypotension,
particularly in volume- or salt-depleted patients; vasodilation;
increased angina and/or myocardial infarction; impaired renal function;
and sprue-like enteropathy. Increased drug exposure may occur in
patients with hepatic impairment Initial therapy with amlodipine and
olmesartan medoxomil tablets is not recommended in hepatically impaired
patients or patients ≥ 75 years old.
Most common adverse reaction in a controlled clinical trial (incidence ≥
3%): edema.
For more information, please see accompanying full Prescribing
Information, including Boxed Warning.
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 amounted to $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 integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following the Actavis Generics acquisition, we will
have significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; 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, 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; 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.
1 Tribenzor® is a registered trademark of Daiichi
Sankyo Company.
2 Azor® is a registered trademark of Daiichi
Sankyo, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161107005524/en/
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts:
Kevin C. Mannix, 215-591-8912
United States
or
Ran
Meir, 215-591-3033
United States
or
Tomer
Amitai, 972 (3) 926-7656
Israel
or
PR Contacts:
Iris
Beck Codner, 972 (3) 926-7687
Israel
or
Denise
Bradley, 215-591-8974
United States
or
Nancy
Leone, 215-284-0213
United States