JERUSALEM--(BUSINESS WIRE)--Sep. 3, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that
more than 20 company-sponsored abstracts including data on COPAXONE®
(glatiramer acetate injection) and laquinimod, an investigational
therapy for multiple sclerosis (MS), will be featured at the MS Boston
2014: Joint ACTRIMS-ECTRIMS Meeting in Boston, Massachusetts, September
10 – 13, 2014.
“Teva takes pride in its well-established presence in the MS community
and on-going efforts to bring convenient, effective therapies to those
living with this disease,” said Michael Hayden, M.D., Ph.D., President
of Global R&D and Chief Scientific Officer at Teva Pharmaceutical
Industries, Ltd. “The data being presented at this year’s joint
ACTRIMS-ECTRIMS meeting continues to demonstrate our commitment to
researching and developing new treatment options to benefit and meet the
needs of this diverse patient population.”
Platform Presentation/Poster Session Details:
COPAXONE®:
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[FC3.2] GLACIER: open-label, randomized safety/tolerability study
of glatiramer acetate 40mg/mL three times weekly versus 20mg/mL daily
in RRMS (Free Communication 3, September 12, 2014, 08:27-08:39) J.
Wolinsky, D. Dietrich, T. Borresen, B. Gilder, J. Steinerman, Y.
Sidi, A. Vainstein S. Kolodny, V. Knappertz, GLACIER Study Group
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[P306] Reduced frequency and severity of injection site reactions
with glatiramer acetate 40mg/mL three times weekly dosing (Poster
Session 1, September 11, 2014, 15:30-17:00) J. Wolinsky, Y.
Sidi, J. Steinerman, V. Knappertz, S. Kolodny, GLACIER Study Group
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[P080] Convenience of glatiramer acetate 40mg/mL three times
weekly: evidence from the GLACIER study (Poster Session 1,
September 11, 2014, 15:30-17:00) J. Wolinsky, T. Borresen,
D. Dietrich, B. Gilder, Y. Sidi, J. Steinerman, V. Knappertz, S.
Kolodny, GLACIER Study Group
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[P053] Comparable clinical and MRI efficacy of glatiramer acetate
40mg/mL TIW and 20mg/mL QD: results of a systematic review and
meta-analysis (Poster Session 1, September 11, 2014, 15:30-17:00) G.
Cutter, J. Wolinsky, G. Comi, D. Ladkani, V. Knappertz, A. Vainstein,
N. Sasson, O. Khan
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[P100] Indirect comparison of glatiramer acetate 40mg/mL TIW and
20mg/mL QD dosing regimen effects on relapse rate: results of a
predictive statistical model (Poster Session 1, September 11,
2014, 15:30-17:00) G. Cutter, J. Wolinsky, G. Comi, D. Ladkani, V.
Knappertz, A. Vainstein, N. Sasson, O. Khan
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[P490] The value of MRS, a novel MRI technique, as a predictor of
disability: analysis at 20 years of RRMS patients treated long-term
with glatiramer acetate (Poster Session 1, September 11, 2014,
15:30-17:00) O. Khan, F. Bao, C. Ford, S. Kolodny, A. Vainstein, Y.
Sidi
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[P475] MRI correlates of disability: neuroimaging substudy at 20
years in the ongoing US glatiramer acetate open-label extension study (Poster
Session 1, September 11, 2014, 15:30-17:00) O. Khan, F. Bao, G.
Ramesh, K. Thakore, C. Caon, C. Santiago, Z. Latif, R. Aronov, I. Zak,
Y. Sidi, S. Kolodny, the MRI Sub-study of the US Open-Label Glatiramer
Acetate Study Group
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[P282] Mechanism of action and safety implications of differently
manufactured glatiramer acetates: gene expression studies of a human
monocyte cell line (Poster Session 1, September 11, 2014,
15:30-17:00) S.E. Kolitz, T. Hasson, F. Towfic, J.M. Funt, S.
Bakshi, K.D. Fowler, D. Laifenfeld, M.N. Artyomov, R. Schwartz, A.
Komlosh, L. Hayardeny, D. Ladkani, M.R. Hayden, B. Zeskind, I. Grossman
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[LBP20] A multi-SNP signature predicts high response to Copaxone
(Glatiramer Acetate) in RRMS patients (Late Breaking News,
September 13, 2014, 10:00-10:30) C. Ross, F. Towfic, D. Laifenfeld,
J. Levy, D. Ladkani, L. Hayardeny, B. Zeskind, V. Knappertz, I.
Grossman, M. Hayden
Laquinimod:
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[FC1.3] Long-term follow-up of laquinimod in patients with
relapsing-remitting multiple sclerosis (Free Communication 1,
September 12, 2014, 08:39-08:51) G. Comi, T.L .Vollmer, N.
Ashtamker, Y. Sidi, D. Ladkani, T. Gorfine, P.S. Sørensen
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[P068] Ambulation benefit with laquinimod in patients with
worsening MS (EDSS over 3) is consistent with reduction in confirmed
disability progression (Poster Session 1, September 11, 2014,
15:30-17:00) T.L. Vollmer, G. Comi, G. Cutter, G. Giovannoni, J.R.
Steinerman, N. Sasson, T. Gorfine, V. Knappertz
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[P062] Clinical efficacy of laquinimod 0.6mg once-daily in
worsening relapsing-remitting multiple sclerosis defined by baseline
EDSS over 3 (Poster Session 1, September 11, 2014, 15:30-17:00) T.L.
Vollmer, G. Comi, L. Kappos, X. Montalban, G. Cutter, J.R. Steinerman,
N. Sasson, T. Gorfine, V. Knappertz
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[P061] Consistent effect of laquinimod on relapse-related and
disability progression-related endpoints (Poster Session 1,
September 11, 2014, 15:30-17:00) G. Comi, T.L. Vollmer, L. Kappos,
X. Montalban, T. Gorfine, N. Sasson, V. Knappertz
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[P070] Laquinimod disability progression effects are maintained
with increasingly rigorous confirmation time intervals (Poster
Session 1, September 11, 2014, 15:30-17:00) G. Comi, T.L. Vollmer,
L. Kappos, X. Montalban, N. Sasson, T. Gorfine, V. Knappertz
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[P963] Laquinimod regulates inflammatory gene induction in a human
model of reactive astrogliosis (Poster Session 2, September 12,
2014, 14:45-16:15) T. Pham, J. Mariani, J. Seto, B. Hartmann, L.
Hayardeny, G.R. John
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[P718] Laquinimod treatment prevents cuprizone-induced
demyelination independent of Toll-like receptor signaling via MyD88
and TRIF (Poster Session 2, September 12, 2014, 14:45-16:15) N.
Kramann, L. Menken, L. Hayardeny, U. Hanisch, W. Brück, Christiane
Wegner
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[P955] Laquinimod reduces CNS autoimmunity by activation of natural
killer cells (Poster Session 2, September 12, 2014, 14:45-16:15) M.
Ott, C. Wegner, L. Hayardeny, E. Ullrich, W. Brück, S. Nessler
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[P387] Laquinimod prevents NMOIg-induced disease exacerbation in a
model of neuromyelitis optica (Poster Session 1, September 11,
2014, 15:30-17:00) A. Argaw, L. Asp, J. Zhang, V. Cogliani, P.
Waters, L. Hayardeny, M. Levy, G.R. John
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[P381] Laquinimod prevents disability progression in a model of
spontaneous chronic EAE and interferes with the development of
follicular helper T-cells (Poster Session 1, September 11, 2014,
15:30-17:00) M. Varrin-Doyer, U. Schulze Topphoff, K. Pekarek, R.A.
Sobel, S.S. Zamvil
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.
COPAXONE® is now 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) and progressive forms of MS.
The global Phase III clinical development program evaluating laquinimod
in MS includes two pivotal studies, ALLEGRO and BRAVO (both 0.6mg). A
third Phase III laquinimod trial, CONCERTO, is evaluating two doses of
the investigational product (0.6mg and 1.2mg) in approximately 2,100
patients for up to 24 months. The primary outcome measure will be time
to confirmed disability progression as measured by the EDSS.
In the ALLEGRO and BRAVO trials, adverse reactions 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.
In addition to the MS clinical studies, studies are planned to evaluate
the efficacy, safety and tolerability of laquinimod in other
neurodegenerative diseases including Huntington’s disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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. Such statements 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 generic versions); 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 successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; 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 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;
uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain executives or
other key personnel; adverse effects of political or economical
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; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation; any failures to comply with complex
Medicare and Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers; significant
impairment charges relating to intangible assets and goodwill; the
potential for significant 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, 2013 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, (215) 591-8912
or
United States
Ran Meir,
(215) 591-3033
or
Israel
Tomer Amitai, 972 (3)
926-7656
or
PR Contacts:
Israel
Iris Beck Codner,
972 (3) 926-7687
or
United States
Denise Bradley,
(215) 591-8974
or
United States
Nancy Leone, (215)
284-0213