Data on COPAXONE® and laquinimod to be
presented in eight company-sponsored abstracts, including one oral
presentation and one late-breaker
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today
announced that data on COPAXONE® (glatiramer acetate injection), a
product for relapsing forms of multiple sclerosis (MS), and
laquinimod, an investigational therapy for relapsing and primary
progressive forms of MS, will be presented at the 32nd Congress of
the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) in London, September 14-17, 2016.
“For more than 30 years, Teva has been dedicated to addressing
the many unmet needs in MS by investigating new compounds and
providing safe and effective treatment options,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “We look forward to showcasing new data
from our MS portfolio at this year’s ECTRIMS.”
In addition to the data being presented, Teva will also host a
Satellite Symposium, “Multiple Disciplines, Common Goals: Just a
Minute! Challenge the Expert Panel,” on September 15, 2016 from
6:00 – 7:00 p.m. GMT.
Teva-Sponsored Data Include:
COPAXONE® (glatiramer
acetate injection):
- [P1.413] Similarities and
differences in the gene expression profiles of Glatopa and
COPAXONE® (Poster Session 1, September 15, 2016, 3:45 –
5:00 p.m.) S. Kolitz
- [P2.1226] Effect of Exposure to
Branded Glatiramer Acetate during Pregnancy on Rates of Pregnancy
Loss (Poster Session 2, September 16, 2016, 3:30 – 5:00 p.m.)
O. Neudorfer, P. Baruch, S. Pery, N. Ashtamker, S. Kolodny, N.
Gavrielov
- [P1.422] Similarities and
differences in the gene expression profiles of COPAXONE®
and Polimunol (Poster Session 1, September 15, 2016, 3:45 –
5:00 p.m.) D. Laifenfeld, T. Hasson, S. Kolitz, K. Fowler, A.
Konya, S. Bakshi, B. Zeskind, I. Grossman, M. Hayden
- [P2.1218] COPAXONE®
Active Registry - Documentation of efficacy, tolerability and
quality of life in outpatients with relapsing remitting multiple
sclerosis (RRMS) treated with glatiramer acetate (Poster
Session 2, September 16, 2016, 3:30 – 5:00 p.m.) U. Faude, D.
Fendji, T. Ziemssen
- [EP1421] Association of a multi-SNP
signature with response to COPAXONE® (glatiramer
acetate) in a subset of patients and in multiple RRMS patient
cohorts (E-posters will be displayed on terminals throughout
the congress; however, they will not be presented at a specific
session) C. Ross, F. Towfic, J. Shankar, D. Laifenfeld, M. Davies,
M. Thoma, B. Zeskind, V. Knappertz, I. Grossman, MR. Hayden
- [EP1560] Efficacy, tolerability,
quality of life, and spasticity in outpatients with relapsing
remitting multiple sclerosis (RRMS) treated with glatiramer acetate
- results of an observational study (E-posters will be
displayed on terminals throughout the congress; however, they will
not be presented at a specific session) U. Faude, D. Fendji, M.
Haupts
Laquinimod:
- [P12.220] A new rodent model of
progressive demyelination and neurodegeneration mimicking
progressive MS (Oral Presentation, Parallel Session 12 – New
Directions in Progressive MS Research, September 16, 2016, 2:52 –
3:04 p.m.) S. Nessler, B. Barette, E. Avendano-Guzman, R. Theiss,
N. Lagumersindez-Denis, L. Hayardeny, C. Stadelmann, K.A. Nave, W.
Brück
- [P2.1639] The Aryl Hydrocarbon
Receptor in the Peripheral Immune System is the Molecular Target of
Laquinimod in MOG induced Experimental Autoimmune
Encephalomyelitis (Poster Session 2, September 16, 2016, 3:30 –
5:00 p.m.) J. Kaye, T. Birnberg, T. Hingaly, E. Raymond, R. Kashi,
V. Piryatinsky, F. Towfic, A. Orbach, I. Grossman, V. Knappertz,
M.R. Hayden, R. Laufer
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis.
The most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing,
rash, shortness of breath, and chest pain. See additional important
information at: www.CopaxonePrescribingInformation.com For hardcopy
releases, please see enclosed full prescribing information. The
COPAXONE® brand 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®
Patients allergic to glatiramer acetate or mannitol should not
take COPAXONE®. Some patients report a short-term reaction right
after injecting COPAXONE®. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with
heart palpitations, anxiety, and trouble breathing. These symptoms
generally appear within minutes of an injection, last about 15
minutes, and go away by themselves without further problems. During
the postmarketing period, there have been reports of patients with
similar symptoms who received emergency medical care. If
symptoms become severe, patients should call the emergency phone
number in their area. Patients should call their doctor right
away if they develop hives, skin rash with irritation, dizziness,
sweating, chest pain, trouble breathing, or severe pain at the
injection site. If any of the above occurs, patients should not
give themselves any more injections until their doctor tells them
to begin again. Chest pain may occur either as part of the
immediate postinjection reaction or on its own. This pain should
only last a few minutes. Patients may experience more than one such
episode, usually beginning at least one month after starting
treatment. Patients should tell their doctor if they experience
chest pain that lasts for a long time or feels very intense. A
permanent indentation under the skin (lipoatrophy or, rarely,
necrosis) at the injection site may occur, due to local destruction
of fat tissue. Patients should follow proper injection technique
and inform their doctor of any skin changes. The most common side
effects of COPAXONE® are redness, pain, swelling, itching, or a
lump at the site of injection, flushing, rash, shortness of breath,
and chest pain. These are not all of the possible side effects of
COPAXONE®. For a complete list, patients should ask their doctor or
pharmacist. Patients should tell their doctor about any side
effects they have while taking COPAXONE®. Patients are encouraged
to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Laquinimod
Laquinimod is a once-daily oral, investigational, CNS-active
immunomodulator with a novel mechanism of action being developed
for the treatment of relapsing-remitting MS (RRMS), primary
progressive MS and Huntington’s disease. The global, Phase III,
clinical development program evaluating laquinimod in MS includes
two completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day).
A third Phase III trial, CONCERTO, has completed patient
enrollment. CONCERTO is a global Phase III (double-blind,
parallel-group, placebo-controlled) clinical trial designed to
evaluate laquinimod (0.6 mg/day) with a primary outcome measure of
time to confirmed disability progression as measured by the
Expanded Disability Status Scale (EDSS).
In the ALLEGRO and BRAVO trials, adverse reactions observed
included headache, abdominal pain, back and neck pain,
appendicitis, and mild, asymptomatic laboratory abnormalities,
including liver enzyme elevations, hematological changes and
elevation of CRP or fibrinogen levels.
About TevaTeva 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 2015
amounted to $19.7 billion. For more information, visit
www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:This release contains
forward-looking statements, which are based on management’s current
beliefs and expectations and involve a number of known and unknown
risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our
ability to develop and commercialize additional pharmaceutical
products; competition for our specialty products, especially
Copaxone® (which faces competition from orally-administered
alternatives and a generic version); our ability to integrate
Allergan plc’s worldwide generic pharmaceuticals business (“Actavis
Generics”) and to realize the anticipated benefits of the
acquisition (and the timing of realizing such benefits); the fact
that following the consummation of the Actavis Generics
acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount
of debt incurred to finance the Actavis Generics acquisition; the
fact that for a period of time following the Actavis Generics
acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; the
possibility of material fines, penalties and other sanctions and
other adverse consequences arising out of our ongoing FCPA
investigations and related matters; our ability to achieve expected
results from investments in our pipeline of specialty and other
products; our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions
as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; governmental
investigations into sales and marketing practices, particularly for
our specialty pharmaceutical products; adverse effects of political
or economic instability, major hostilities or acts of terrorism on
our significant worldwide operations; interruptions in our supply
chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology
systems or breaches of our data security; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; the impact of continuing consolidation
of our distributors and customers; decreased opportunities to
obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets
for sales of generic products prior to a final resolution of
outstanding patent litigation; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2015 and
in our other filings with the U.S. Securities and Exchange
Commission (the "SEC"). 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, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20160907005724/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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