JERUSALEM--(BUSINESS WIRE)--Jul. 1, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced the
launch of generic Aggrenox® (aspirin/extended-release
dipyridamole) capsules in the United States. Aspirin and
extended-release dipyridamole capsules are used to lower the risk of
stroke in people who have had a mini-stroke (transient ischemic attack
or TIA) or stroke due to a blood clot.
“The National Institutes of Health estimates 185,000 Americans are at
risk of another stroke within 5 years of a previous stroke. Teva
recognizes the devastating impact of a stroke and is pleased to launch
generic aspirin and extended-release dipyridamole capsules as a
treatment option for at-risk stroke patients,” said Brendan O’Grady,
President and CEO, North America Generic Medicines for Teva. “Being able
to make affordable, high-quality generic medicines available to millions
of patients every day is our commitment at Teva.”
A stroke is caused when there is an interruption to the flow of oxygen
rich blood to the brain. Without oxygen, brain cells can become damaged
and die. Sudden bleeding in the brain can also cause a stroke if it
damages brain cells. A stroke can result in brain damage, long-term
disability, or even death.
On average, one American dies from stroke every four minutes. As the
fifth leading cause of death in America, every year, more than 795,000
people have a stroke, and 25% have had a previous stroke. About 130,000
people will die as the result of a stroke each year.
Aggrenox® (aspirin/extended-release dipyridamole) capsules
had annual sales of approximately $457 million in the United States,
according to IMS data as of April 2015.
About Aspirin and Extended-release Dipyridamole
Capsules
Aspirin and extended-release dipyridamole capsules are indicated to
reduce the risk of stroke in patients who have had transient ischemia of
the brain or completed ischemic stroke due to thrombosis.
Important Safety Information
Aspirin and extended-release dipyridamole capsules are contraindicated
in patients with known hypersensitivity to any of the product
components. Aspirin is contraindicated in patients with known allergy to
nonsteroidal anti-inflammatory drug products and in patients with the
syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe
urticaria, angioedema or bronchospasm. Do not use aspirin in children or
teenagers with viral infections because of the risk of Reye syndrome.
Aspirin and extended-release dipyridamole capsules increase the risk of
bleeding. Avoid aspirin in patients with severe renal failure.
Elevations of hepatic enzymes and hepatic failure have been reported in
association with dipyridamole administration.
Because aspirin and extended-release dipyridamole capsules contain
aspirin, aspirin and extended-release dipyridamole capsules can cause
fetal harm when administered to a pregnant woman.
Dipyridamole has a vasodilatory effect. Chest pain may be precipitated
or aggravated in patients with underlying coronary artery disease who
are receiving dipyridamole. For stroke or TIA patients for whom aspirin
is indicated to prevent recurrent myocardial infarction (MI) or angina
pectoris, the aspirin in this product may not provide adequate treatment
for the cardiac indications. Dipyridamole produces peripheral
vasodilation, which can exacerbate pre-existing hypotension.
Aspirin and extended-release dipyridamole capsules are not
interchangeable with the individual components of aspirin and
dipyridamole tablets.
The most frequently reported adverse reactions (>10% and greater than
placebo) in a controlled clinical study were headache, dyspepsia,
abdominal pain, nausea, and diarrhea.
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 to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 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 2014 amounted to $20.3
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 innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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 the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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; 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 generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
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, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. 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 statement, whether as a result of new information,
future events or otherwise.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix, 215-591-8912
United
States
or
Ran Meir, 215-591-3033
or
Tomer
Amitai, 972 (3) 926-7656
Israel
or
PR:
Iris
Beck Codner, 972 (3) 926-7687
Israel
or
Denise
Bradley, 215-591-8974
United States