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JERUSALEM--(BUSINESS WIRE)--Oct. 8, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that new data on COPAXONE® (glatiramer acetate
injection), a product for relapsing forms of multiple sclerosis (RMS),
will be presented at the 34th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Berlin, October 10-12, 2018.
“We are honored to contribute data spanning more than 25 years of
research on COPAXONE® at this year’s ECTRIMS Congress,” Danny
McBryan, M.D., Senior Vice President of Global Medical Affairs and
Pharmacovigilance at Teva. “Teva’s COPAXONE® remains an
important treatment option for RMS patients and this research highlights
our understanding of the established therapeutic profile and complexity
Teva-sponsored data include:
(glatiramer acetate injection)
P589: Twenty-five years of continuous treatment of multiple sclerosis
with glatiramer acetate: long-term clinical results of the US open-label
extension study (Poster Session 1, October 10, 2018, 5:00 - 7:00
p.m. CET) C. Ford, J. Cohen, A. Goodman, J. Lindsey, R. Lisak, C.
Luzzio, A. Pruitt, J. Rose, H. Rus, T. Vollmer, J. Wolinsky, J.
Alexander, O. Barnett-Griness, Y. Stark, US Open-Label Glatiramer
Acetate Study Group
EP1358: A descriptive study of switching patterns among MS patients
who started on Glatopa therapy: a claims database analysis (ePoster) J.
Alexander, J. Kasturi, S. Melamed-Gal, K. Bibeau, R. Ariely, M. Vardi,
Y. Wu, Z. Su, T. Brecht, A. Bryant, E. Hulbert, D. Liassou
EP1664: Genomic profiling and in vivo rat toxicity characterization
of Copaxone and the Synthon European follow-on glatiramer acetate
product (ePoster) S. Kolitz, N. Ashkenazi, B. Timan, J. Zhang, J.
Funt, O. Beriozkin, A. Konya, J. Alexander, P. Loupe, M. Vardi, V.
Weinstein, S. Melamed-Gal, I. Grossman, B. Zeskind, S. Nock, M. Hayden
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
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.
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:
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
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
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Source: Teva Pharmaceutical Industries Ltd.
For Teva Pharmaceutical Industries Ltd.IRKevin
C. Mannix, 215-591-8912orRan Meir, 972 (3) 926-7516orPRUnited
StatesDoris Saltkill, 913-777-3343orIsraelYonatan
Beker, 972 (54) 888 5898