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
JERUSALEM--(BUSINESS WIRE)--Apr. 27, 2018--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180427005875/en/
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts
United States
Kevin C. Mannix,
215-591-8912
Ran Meir, 215-591-3033
Israel
Tomer
Amitai, 972 (3) 926 7656
or
PR Contacts
United
States
Michelle Larkin, 610-786-7335
Israel
Yonatan
Beker, 972 (54) 888 5898