Up to 7-year efficacy, safety and tolerability
results from the GALA open-label extension study presented at the
70th Annual Meeting of the AAN
Over seven years, COPAXONE® 40 mg/mL provides
consistent, long-term efficacy and safety
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced up to 7-year efficacy, safety and tolerability results
from the Glatiramer Acetate Low-Frequency
Administration (GALA) open-label extension study of
COPAXONE® (glatiramer acetate injection) 40 mg/mL administered
subcutaneously three-times-a-week for the treatment of relapsing
forms of multiple sclerosis (RMS). The study, including the
open-label phase of the largest pivotal trial ever conducted for
COPAXONE®, examined the long-term effects up to seven years of
early start (ES) and delayed start (DS) treatment of COPAXONE® 40
mg/mL. Results show that favorable annualized relapse and
disability progression rates are observed in both patients
continuing COPAXONE® 40 mg/mL and patients switching from placebo
to COPAXONE® 40 mg/mL. Additionally, no new or unexpected adverse
events emerged in patients receiving the treatment.
“The continued long-term efficacy, safety and tolerability
observed in the GALA open-label extension study is encouraging,”
said Daniel McBryan, M.D., Head of Global Medical Affairs at Teva.
“The results reinforce COPAXONE 40 mg/mL as an effective and safe
treatment option for patients with RMS.”
Efficacy analysis included exposure data from randomization
until the last available observation for both the ES and DS groups
(median glatiramer acetate exposure of 5.5 and 4.5 years,
respectively). Annualized relapse rate for the entire long-term
follow-up period since randomization was 0.26 for ES and 0.31 for
DS groups (P=.041), and approximately 50% of patients were
relapse-free in both groups. Time to first confirmed relapse was
longer in ES vs DS patients (HR=0.815; 95% CI: 0.693-0.959);
P=0.0135). Time to 6-month confirmed disability progression (CDP)
and to EDSS 4.0 was similar between ES and DS groups, and
approximately 81% of patients in both groups were free from 6-month
CDP.
No new or unexpected adverse events emerged in patients
receiving COPAXONE 40 mg/mL for up to 7 years. Adverse events were
generally mild and consistent with the well-established safety
profile of COPAXONE.
The poster, “Long-term efficacy, safety, and tolerability of
three-times weekly dosing regimen of glatiramer acetate in
relapsing-remitting multiple sclerosis patients: Up to 7-year
results of the Glatiramer Acetate Low-Frequency Administration
(GALA) open-label extension study,” will be on display during
Poster Session 6 on Friday, April 27 from 11:30 a.m. to 5:30 p.m.
PT.
About COPAXONE®
COPAXONE® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis. Please click here for U.S.
Full Prescribing Information:
www.CopaxonePrescribingInformation.com. COPAXONE® is 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®
COPAXONE® is contraindicated in patients with known
hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL
compared to 4% of those on placebo, and approximately 2% of
patients exposed to COPAXONE® 40 mg per mL compared to none on
placebo experienced a constellation of symptoms that may occur
within minutes after injection and included at least 2 of the
following: flushing, chest pain, palpitations, tachycardia,
anxiety, dyspnea, throat constriction, and urticaria. In general,
these symptoms have their onset several months after the initiation
of treatment, although they may occur earlier, and a given patient
may experience 1 or several episodes of these symptoms. Typically,
the symptoms were transient and self-limited and did not require
treatment; however, there have been reports of patients with
similar symptoms who received emergency medical care.
Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL
patients compared to 6% of placebo patients, and approximately 2%
of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While
some episodes of chest pain occurred in the context of the
Post-Injection Reaction described above, many did not. The temporal
relationship of this chest pain to an injection was not always
known. The pain was usually transient, often unassociated with
other symptoms, and appeared to have no clinical sequelae. Some
patients experienced more than 1 such episode, and episodes usually
began at least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection
site skin necrosis may occur. Lipoatrophy may occur at various
times after treatment onset (sometimes after several months) and is
thought to be permanent. There is no known therapy for
lipoatrophy.
Because COPAXONE® can modify immune response, it may interfere
with immune functions. For example, treatment with COPAXONE® may
interfere with recognition of foreign antigens in a way that would
undermine the body’s tumor surveillance and its defenses against
infection. There is no evidence that COPAXONE® does this, but there
has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were injection site
reactions (ISRs), such as erythema (43% vs 10%); vasodilatation
(20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain
(13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were ISRs, such as
erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to
discontinuation of COPAXONE®. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy,
occurred at a higher rate with COPAXONE® than placebo.
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 2017 were $22.4 billion. For
more information, visit www.tevapharm.com.
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 benefits of COPAXONE® 40 mg/mL, 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 relating to:
- commercial success of COPAXONE® 40
mg/mL, which faces competition from existing and potential
additional generic versions, orally-administered and other
alternatives;
- our specialty medicines business,
including: our ability to achieve expected results from investments
in our product pipeline; competition from companies with greater
resources and capabilities; and the effectiveness of our patents
and other measures to protect our intellectual property
rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and may result in
a further downgrade of our credit ratings; and our inability to
raise debt or borrow funds in amounts or on terms that are
favorable to us;
- our business and operations in general,
including: failure to effectively execute the recently announced
restructuring plan; uncertainties related to, and failure to
achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the expected review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2017, including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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
put undue reliance on these forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20180427005875/en/
IR ContactsUnited StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033IsraelTomer Amitai, 972
(3) 926 7656orPR ContactsUnited StatesMichelle
Larkin, 610-786-7335IsraelYonatan Beker, 972 (54) 888
5898
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