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
of COPAXONE®.”
Teva-sponsored data include:
COPAXONE® (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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181008005198/en/
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
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024