JERUSALEM--(BUSINESS WIRE)--Sep. 11, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced new data
from the open-label Phase IIIb GLatiramer Acetate low
frequenCy safety and patIent ExpeRience
(GLACIER) study, comparing the safety and tolerability of
three-times-a-week COPAXONE® (glatiramer acetate injection)
40 mg to daily COPAXONE® 20 mg in patients with
relapsing-remitting multiple sclerosis (RRMS). During a platform
presentation this week, the results from the GLACIER study were shared
at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in
Boston, Massachusetts.
The primary endpoint of the GLACIER study, the adjusted mean annualized
rate of injection-related adverse events (IRAEs), was achieved with a 50
percent reduction with the three-times-a-week COPAXONE® 40 mg
dosing regimen versus the daily COPAXONE® 20 mg regimen. In a
post-hoc analysis, a similar reduction in moderate/severe IRAEs was
observed with the less frequent, three-times-a-week COPAXONE®
40 mg arm relative to the daily COPAXONE® 20 mg arm.
“We’re pleased these results provide supportive data that fewer
injections with three-times-a-week COPAXONE® 40 mg resulted
in half as many reported IRAEs compared to the number of IRAEs with the
COPAXONE® 20 mg once-daily dosing regimen,” said Michael
Hayden, Teva’s President of Global R&D and Chief Scientific Officer.
In the GLACIER study, 209 patients who had received daily COPAXONE®
20 mg for an average of 6.7 years, from 30 U.S. sites were randomized to
receive COPAXONE® 40 mg (n=108) or COPAXONE® 20 mg
(n=101). Patients were then assessed in the open-label design at months
1, 2 and 4. IRAEs included all local injection-site reactions (ISRs) and
symptoms related to immediate post-injection reactions (IPIR; e.g.,
flushing, palpitations, anxiety, dyspnea) and were determined through
patient diaries. Patient reported ISRs were classified as mild, moderate
or severe. One patient in the 40 mg COPAXONE® arm withdrew
due to injection site necrosis. The overall safety was consistent with
prior experience, and the study results will be submitted to a
peer-reviewed publication.
“The less frequent IRAEs resulting from the reduction of dosing
frequency from daily to three-times-a-week is an additional
consideration for patients when making treatment decisions,” said Dr.
Jerry Wolinsky, Bartels Family and Opal C. Rankin Professor of Neurology
at The University of Texas Medical School at Houston and principal
investigator of the GLACIER study. “This is useful data for physicians
counseling their patients interested in transitioning from a daily to
three-times-a-week injection schedule.”
ABOUT COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. See additional important
information at: www.CopaxonePrescribingInformation.com
For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries
worldwide, including the United States, Russia, Canada, Mexico,
Australia, Israel, and all European countries.
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take
COPAXONE®. Some patients report a short-term reaction right
after injecting COPAXONE®. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally
appear within minutes of an injection, last about 15 minutes, and go
away by themselves without further problems. During the postmarketing
period, there have been reports of patients with similar symptoms who
received emergency medical care. If symptoms become severe, patients
should call the emergency phone number in their area. Patients
should call their doctor right away if they develop hives, skin rash
with irritation, dizziness, sweating, chest pain, trouble breathing, or
severe pain at the injection site. If any of the above occurs, patients
should not give themselves any more injections until their doctor tells
them to begin again. Chest pain may occur either as part of the
immediate postinjection reaction or on its own. This pain should only
last a few minutes. Patients may experience more than one such episode,
usually beginning at least one month after starting treatment. Patients
should tell their doctor if they experience chest pain that lasts for a
long time or feels very intense. A permanent indentation under the skin
(lipoatrophy or, rarely, necrosis) at the injection site may occur, due
to local destruction of fat tissue. Patients should follow proper
injection technique and inform their doctor of any skin changes. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. These are not all of the possible
side effects of COPAXONE®. For a complete list, patients
should ask their doctor or pharmacist. Patients should tell their doctor
about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 45,000 people around the world and reached $20.3 billion
in net revenues in 2013.
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. Such statements 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 generic versions); 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 successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; 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 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;
uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain executives or
other key personnel; adverse effects of political or economical
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; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation; any failures to comply with complex
Medicare and Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers; significant
impairment charges relating to intangible assets and goodwill; the
potential for significant 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, 2013 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
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Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
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Iris
Beck Codner, 972 (3) 926-7687
or
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