Teva to Present Latest Data in Multiple Sclerosis at 2016 ECTRIMS Congress in London
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 Teva
Teva 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.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer Amitai, 972 (3) 926-7656
or
PR:
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Iris Beck Codner, 972 (3) 926-7687
or
United States
Denise Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213