Data to be Presented at MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting Underscore Tevas
Commitment to Developing Solutions to Meet the Needs of the
Multiple Sclerosis Community
Jerusalem, September 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 years 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 Huntingtons 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 worlds leading generic drug
maker, with a global product portfolio of more than 1,000 molecules and a direct presence in
approximately 60 countries. Tevas Specialty Medicines businesses focus on CNS, respiratory
oncology, pain, and womens 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 managements 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.
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