Safety results from the open-label extension
study of the original U.S. COPAXONE® pivotal trial presented at the
2018 ECTRIMS Annual Meeting in Berlin
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced safety and tolerability results representing 25 years of
data from the open-label extension study of the original U.S.
pivotal trial of COPAXONE® (glatiramer acetate injection) for the
treatment of relapsing forms of multiple sclerosis (RMS). The
extension study initially examined the safety of COPAXONE® 20 mg/mL
daily and then also the 40 mg/mL three times weekly formulation
when it became available approximately 20 years later. Patients who
participated in the original 36-month, randomized
placebo-controlled U.S. trial were eligible to proceed to the
open-label extension, in which patients receiving COPAXONE®
continued their treatment, while those who received placebo were
switched to COPAXONE®. Results show that for study patients who
continued to take COPAXONE®, long-term treatment has an acceptable
safety and tolerability profile with low rates of serious adverse
events (SAEs) and immediate post-injection reactions (IPIRs).
“COPAXONE® is unique in being the only treatment for RMS
that has been studied in patients who were closely and
prospectively monitored for more than two decades,” said Danny
McBryan, M.D., Senior Vice President of Global Medical Affairs and
Pharmacovigilance at Teva. “The safety profile demonstrated by
COPAXONE® is reassuring, as it remains our priority to
deliver a safe and effective treatment option for patients with
RMS.”
In addition to these 25-year data, the clinical effectiveness
and safety of this study were also reported at 2 and 3 years, and
at 6, 8, 10, 15 and 20 years. These findings should be considered
within the context of the disease course of these patients, who are
now approaching 35 years with their illnesses, and also in
conjunction with the existing evidence regarding the safety and
tolerability of COPAXONE® as described in previous studies. Data on
the long-term neurological disease course and effectiveness of
COPAXONE® will be presented at a future meeting.
“Teva’s unwavering dedication to serve the MS community is
deeply rooted in the commitment to carry out this study,” said lead
author and board-certified neurologist Dr. Corey Ford, University
of New Mexico Health Sciences Center. “We are grateful for the
contributions of the study participants and their families that
have allowed us to secure the clinical evidence to reinforce
COPAXONE® as a safe and tolerable treatment option for those living
with RMS.”
The poster, “Twenty-five years of continuous treatment of
multiple sclerosis with branded glatiramer acetate: long-term
clinical results of the US open-label extension study,” will be on
display during Poster Session 1 on Wednesday, October 10 from 5:00
p.m. to 7:00 p.m. CET.
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.
Important Safety Information
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
immediately (within seconds to minutes, with the majority of
symptoms observed within 1 hour) 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
Immediate 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 global leader in generic medicines, with innovative treatments
in select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at 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 COPAXONE®, 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:
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; the commercial
success of our products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our business and operations in general,
including: failure to effectively execute the recently announced
restructuring plan; uncertainties relating to the potential
benefits and success of our new organizational structure and recent
senior management changes; our ability to develop and commercialize
additional pharmaceutical products; 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
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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;
and other factors discussed in our Annual
Report on Form 20-F for the year ended December 31,
2016 (“Annual Report”), 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/20181010005336/en/
IR ContactsKevin C. Mannix, (215) 591-8912orRan Meir, 972
(3) 926-7516orPR ContactsUnited StatesDoris Saltkill,
(913) 777-3343orIsraelYonatan Beker, 972 (54) 888 5898
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