JERUSALEM--(BUSINESS WIRE)--Sep. 1, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced
that ZECUITY®, the first and only patch system designed to
provide relief from migraine, is now available by prescription through
specialty pharmacies. ZECUITY® is a single-use, disposable
patch system that delivers sumatriptan through the skin. The
device is designed to be worn for a four-hour period either on the upper
arm or thigh.
Approximately 36 million people in the United States suffer from
migraine and its various characteristics. According to the American
Migraine Study II, 85 percent of respondents experience throbbing pain,
80 percent experience sensitivity to light, 76 percent experience
sensitivity to sound and 73 percent experience nausea.
“Migraine sufferers experiencing nausea as part of their migraine may
delay or avoid treatment and may seek non-oral treatment options,” said
Dr. Michael Hayden, President, Global R&D and Chief Scientific
Officer. “At Teva, we are committed to delivering innovative
treatments that improve patient care and are proud to offer ZECUITY®
to people looking for a different route to migraine relief.”
In a clinical study, at two hours following application, significantly
more patients using ZECUITY® versus a non-medicated patch
system reported, as the study’s primary endpoint, no headache pain (18
percent versus 9 percent). The secondary endpoints of the study showed
that, at two hours following application, significantly more patients
reported no nausea (84 percent versus 63 percent), no sensitivity to
sound (55 percent versus 39 percent), no sensitivity to light (51
percent versus 36 percent), or headache pain relief (53 percent versus
29 percent). The most common side effects reported for ZECUITY® included
pain, tingling, itching, warmth, discomfort or a change in the skin
color at the application site of ZECUITY®.
In conjunction with the availability of ZECUITY®, Teva is
launching Migraine Support SolutionsSM to provide migraine
education and assistance with ZECUITY® including a
special offer that could save patients money on their prescriptions. To
contact Migraine Support SolutionsSM, call 1-855-ZECUITY
(1-855-932-8489).
ZECUITY® is a prescription medicine used for the acute
treatment of migraine headaches with or without aura in adults. ZECUITY®
is used for people who have been told by a healthcare provider that they
have migraine headaches. ZECUITY® is not used to prevent or
decrease the number of migraine headaches you have.
Important Safety Information
ZECUITY® can cause serious side effects, including heart
attack and other heart problems, which may lead to death. Stop using
ZECUITY® and get emergency medical help right away if you
have symptoms of a heart attack. ZECUITY® is not for people
with risk factors for heart disease unless a heart exam is done and
shows no problem. Do not use ZECUITY® if you have:
-
heart problems or a history of heart problems; had a stroke, transient
ischemic attacks (TIAs), or problems with your blood circulation;
narrowing of blood vessels to your legs, arms, stomach, or kidney;
uncontrolled high blood pressure
-
hemiplegic migraines or basilar migraines; taken any triptan, ergot,
or ergot-type medicines in the last 24 hours. Ask your doctor if you
are not sure.
-
severe liver problems; or an allergy to sumatriptan, the medicine in
ZECUITY®, or any of the components in ZECUITY®.
ZECUITY® may cause other serious side effects including:
-
injury during a Magnetic Resonance Imaging (MRI). ZECUITY®
contains metal parts and must be removed before an MRI.
-
allergic contact dermatitis—a serious skin reaction where ZECUITY®
is applied.
-
changes in color or sensation in your fingers and toes
-
stomach and intestinal problems
-
problems with blood circulation to your legs and feet
-
medication overuse headaches
-
serotonin syndrome—a rare but serious problem that can happen in
people using ZECUITY®, especially when used with
anti-depressant medicines called SSRIs or SNRIs.
-
increases in blood pressure
-
serious allergic reactions. Get medical help right away if you have
any of these symptoms: swelling of your face, lips, mouth, or tongue;
trouble breathing; wheezing; severe itching; skin rash, redness, or
swelling; dizziness or fainting; fast heartbeat or pounding in your
chest; or sweating.
-
seizures.
The most common side effects of ZECUITY® include pain,
tingling, itching, warmth, discomfort or a change in the skin color at
the application site of ZECUITY®.
For full Prescribing Information, please visit ZECUITY.com/PDF/ZECUITY_PI.pdf
For more information, visit www.ZECUITY.com
or call 855-ZECUITY (855-932-8489)
About Migraine
Migraine is defined as recurring attacks of moderate to severe pain, and
the International Headache Society’s diagnostic criteria for migraine
include experiencing at least 5 attacks, lasting 4-72 hours if
untreated, in addition to nausea and/or vomiting, or sensitivity to
light or sound. Approximately 36 million people in the United States
suffer from migraine. Migraine is three times more common in women than
in men and affects more than 10 percent of people worldwide. There is no
absolute cure for migraine since its pathophysiology has yet to be fully
understood. Sumatriptan is the most widely prescribed migraine
medication, based on the number of prescriptions for migraine/IMS
National Rx Audit, July 2014/All Rights Reserved by IMS.
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:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris Beck
Codner, 972 (3) 926-7687
or
United States
Denise Bradley,
215-591-8974
Nancy Leone, 215-284-0213