[October 06, 2015] |
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Teva Reinforces Focus on Advancing Multiple Sclerosis Treatment at 31st ECTRIMS Congress
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
that data on COPAXONE® (glatiramer acetate injection), the
most prescribed therapy for relapsing forms of multiple sclerosis (MS)
globally, and laquinimod, an investigational therapy being evaluated in
relapsing and progressive forms of MS, will be featured at the 31st
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) Congress in Barcelona, October 7-10, 2015.
"New COPAXONE® data at this year's Congress underscore the
safety and efficacy of the three-times-a-week treatment, as well as
explore the decreased incidence of adverse events for COPAXONE®
40 mg/mL patients, while laquinimod data focus on long-term measures
such as disability progression," said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva. "The data
being presented emphasizes our dedication to better understanding the
long-term benefit of COPAXONE® and potential for laquinimod."
Teva will host a booth, called "Hope in the Code," for its personalized
medicine program during this year's Congress.
In addition, Teva will also host a Satellite Symposium, "Discovering a
New World in MS," on Thursday, October 8, 2015 from 19:15 - 20:15 CEST.
Teva-sponsored data to be presented include:
COPAXONE® (glatiramer acetate injection)
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[P314] Efficacy and safety of a three-times weekly dosing regimen
of glatiramer acetate in relapsing-remitting multiple sclerosis
patients: 3-year results of the glatiramer acetate low-frequency
administration (GALA) open-label extension study (Poster Session
1, October 8, 2015, 15:45 - 17:00) O. Khan, P. Rieckmann, S. Kolodny,
MD. Davis, N. Ashtamker, JR. Steinerman, R. Zivadinov
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[P656] Disease-modifying therapy improved depression symptoms in
multiple sclerosis patients: the POSIDONIA study (Poster Session
1, October 8, 2015, 15:45 - 17:00) E. Montanari, M. Conti, D. Maimone,
V. Torri Clerici, K. Plewnia, M. Frigo, A. Francia, A. Pala, A.
Veneziano
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[EP1319] Comparison of physicochemical, biological and genomic
characteristics of differently manufactured glatiramoids to ensure MS
patient safety (e-Poster Session 1, October 8, 2015, 15:45 -
17:00) A. Komlosh, T. Hasson, K. Wells-Knecht, T. Molotsky, R.
Krispin, G. Papir, D. Pinkert, H. Cooperman, S. Bakshi, S. Kolitz, F.
Towfic, B. Weiner, B. Zeskind, D. Laifenfeld, D. Ladkani, V.
Weinstein, I. Grossman, M.R. Hayden
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[P1150] Statistical comparison of adverse events for glatiramer
acetate 20mg vs 40mg for the treatment of relapsing-remitting multiple
sclerosis (Poster Session 2, October 9, 2015, 15:30 - 17:00) F.J.
Zagmutt, Y. Wu, A. Grinspan, S. Kolodny, S. Gandhi
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[P1173] Evaluating the effect of enhanced physical activity and
energy management on fatigue in patients suffering from multiple
sclerosis: the MS TeleCoach study (Poster Session 2, October 9,
2015, 15:45 - 17:00) M. D'hooghe, G. Van Gassen, D. Kos, B. Van
Wijmeersch, B. Willekens, D. Decoo, M. Cambron, I.-K. Penner, P.
Vanderdonckt, J. Debruyne, R. Crols, A. Lysandropoulos, S. Elsankari,
P. Seeldrayers, A. Mélin, P. Laloux, O. Bouquiaux, R. Reznik, G. Nagels
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[P1507] The Glatiramer acetate pregnancy database (Poster
Session 2, October 9, 2015, 15:30 - 1700) O. Neudorfer, M.
Sandberg-Wollheim, P.K. Coyle, B. Weinstock-Guttman, A. Perrin Ross,
A. Grinspan
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[P1517] Glatiramer acetate slows disability progression - results
from a 6-year analysis of the UK Risk Sharing Scheme (Poster
Session 2, October 9, 2015, 15:30 - 17:00) G. Giovannoni, P. Brex, M.
Sumra, E. Walters, K. Schmierer
Laquinimod
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[P319] Long-term follow-up of laquinimod in patients with
relapsing-remitting multiple sclerosis (Poster Session 1, October
8, 2015, 15:45 - 17:00) G. Comi, T.L. Vollmer, F.D. Lublin, Y. Dadon,
T. Gorfine, M.D. Davis, P.S. Sørensen, V. Knappertz
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[P542] Effects of laquinimod on microglia and monocytes following
traumatic brain injury (Poster Session 1, October 8, 2015, 15:45 -
17:00) A. Katsumoto, A.S. Miranda, O. Butovsky, Z. Fanek, R.M.
Ransohoff, B.T. Lamb
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[P651] Effect of laquinimod, a novel immunomodulator in development
for treatment of multiple sclerosis, on cardiac repolarization in
healthy subjects: a thorough QT/QTc study (Poster Session 1,
October 8, 2015, 15:45 - 17:00) A. Elgart, D. Mimrod, L.
Rabinovich-Guilatt, E. Eyal, J. Morganroth, O. Spiegelstein
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[P919] Disability outcome and sample size considerations for PPMS
clinical trial efficiency (Poster Session 2, October 9, 2015,
15:30 - 17:00) M.D. Davis, J.R. Steinerman, N. Sasson, V. Knappertz
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[P1089] Laquinimod reduces CNS pathology and demyelination induced
by B lymphocytes from multiple sclerosis patients in a novel brain
slice model of MS (Poster Session 2, October 9, 2015, 15:30 -
17:00) D.E. Harlow, S. Selva, K.E. Saul, L.J. Jackson, W.B. Macklin,
T.L. Vollmer
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[P1090] Laquinimod is protective to oligodendrocytes during
lysolecithin-induced demyelination in a murine brain slice model (Poster
Session 2, October 9, 2015, 15:30 - 17:00) D.E. Harlow, K.E. Saul,
W.B. Macklin, T.L. Voller
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[FC153] MRI measures and disability progression in PPMS: analysis
of the PROMiSe clinical trial dataset (Free Communications 1,
October 9, 2015, 9:39 - 9:51) M.W. Koch, J.R. Steinerman, V.
Knappertz, M.D. Davis, G. Giovannoni, G.R. Cutter, J.S. Wolinsky
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 post injection 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), 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, is currently ongoing and evaluating two doses of laquinimod
(0.6mg and 1.2mg/day) in 2,199 patients for up to 24 months. The primary
outcome measure is time to three-month 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 Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world's largest generic medicines
producer, leveraging its portfolio of more than 1,000 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 2014 amounted to $20.3
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 innovative
products, especially Copaxone® (including
competition from orally-administered alternatives, as well as from
potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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 the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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; 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 generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
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, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. 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 statement, whether as a result of new information,
future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151006005774/en/
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