JERUSALEM--(BUSINESS WIRE)--Oct. 19, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that new data on its multiple sclerosis (MS) program,
including COPAXONE® (glatiramer acetate injection), a product
for relapsing forms of MS, and laquinimod, an investigational MS
therapy, will be highlighted in 11 presentations at the 7th
Joint Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and
Research in Multiple Sclerosis (ACTRIMS) in Paris, October 25-28, 2017.
“New data from Teva’s MS program further contributes to the scientific
understanding of treating a complex disease like MS,” said Michael
Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at
Teva. “We look forward to showcasing our findings at this year’s joint
ECTRIMS-ACTRIMS meeting.”
In addition to the data being presented, Teva will also host a Satellite
Symposium, “Maintaining ability in the context of disability: can we do
more for patients?” on October 27, 2017 from 12:45 – 1:45 p.m. CET.
Teva-sponsored Data Include:
COPAXONE®
(glatiramer acetate injection)
[P1.765] Pregnancy Outcomes in Patients With Multiple Sclerosis and
Exposure to Branded Glatiramer Acetate During All Three Trimesters
(Poster Session 1, October 26, 2017, 3:30 – 5:00 p.m.) K. Hellwig, O.
Neudorfer, S. Melamed-Gal, P. Baruch
[P2.956] The Effect of Glatiramer Acetate (GA) on Cognitive Function
in an Animal Model of Multiple Sclerosis (Poster Session 1, October
26, 2017, 3:30 – 5:00 p.m.) R. Aharoni, N. Schottlender, D.D. Bar
Lev, M. Tsoory, M. Sela, R. Arnon
[P2.1210] Higher Medication Satisfaction and Treatment Adherence in
Relapsing-Remitting Multiple Sclerosis Patients Treated with Glatiramer
Acetate 40 mg/mL Three-times Weekly Compared with 20 mg/mL Daily:
6-Month Results of the CONFIDENCE Study (Poster Session 2, October
27, 2017, 3:30 – 5:00 p.m.) A. Veneziano, G. Cutter, M. Al-Banna, S.
Rossi, M.N. Zakharova, A. Boyko, S. Gandhi, R. Everts, A. Grinspan
[P2.1273] Multicenter Open-label Non-interventional Study Assessing
the Alteration of Activity in Ambulatory Patients with Relapsing Forms
of MS (RMS) Under Treatment with COPAXONE® 40
mg tiw - Results of an Interim Analysis of the NIS COPTIVITY (Poster
Session 2, October 27, 2017, 3:30 – 5:00 p.m.) T. Ziemssen, U.
Schulze-Topphoff, D. Fendji
[EP1651] Surface Charge Distribution, an Attribute Linked with
Immunogenicity of Nanoparticles, is Different for Follow-on Glatiramer
Acetate Products Approved in EU, Russia, Latin America, and USA Compared
with COPAXONE® (ePosters will be displayed for the
duration of the congress; however, they will not be presented during
specific sessions) A. Komlosh, R. Krispin, G. Papir, T. Molotsky, Y.
Sahly, V. Weinstein, A. Gilbert, S. Melamed-Gal, P. Loupe, I. Grossman,
R. Laufer, M.R. Hayden
[EP1652] Physicochemical and Biological Characterization of the
European Follow-on Glatiramer Acetate Product as Pompared to COPAXONE®
(ePosters will be displayed on terminals for the duration of the
congress, but will not be presented during specific sessions) B.
Timan, A. Komlosh, O. Beriozkin, A. Konya, K. Wells-Knecht, V.
Weinstein, Y. Sahly, A. Gilbert, S. Melamed-Gal, P. Loupe, I. Grossman,
R. Laufer, M.R. Hayden
[EP1809] Efficacy and Treatment Satisfaction After Switching Therapy
in Patients with Relapsing-Remitting Multiple Sclerosis: The
Multicentre, Observational SURFINIA Study (ePosters will be
displayed on terminals for the duration of the congress, but will not be
presented during specific sessions) R. Mantegazza, M. Ulivelli, S.
Cottone, V. Torri Clerici, M.T. Ferrò, D. De Pascalis, A. Veneziano, D.
Cuomo
[EP1843] The Impact of Nurse Advisors and Online Advice Services on
Treatment Adherence in Multiple Sclerosis (MS) (ePosters will be
displayed on terminals for the duration of the congress, but will not be
presented during specific sessions) A. Altenbuchner, S. Haug, C.
Mohr, U. Scorna, K. Weber
Laquinimod
[P1.431] Transcriptomic Analysis of Disease Reversal in EAE:
Comparison of Laquinimod and FTY-720 (Poster Session 1, October 26,
2017, 3:30 – 5:00 p.m.) H. Belinson, S. Barash, J. Kaye, E. Raymond,
D. Laifenfeld, R. Laufer
[P13.233] CONCERTO: A Placebo-Controlled Trial of Oral Laquinimod in
Patients With Relapsing-Remitting Multiple Sclerosis (Oral
Presentation, Parallel Session 13 – Update on relapsing-remitting MS
management, October 27, 2017, 3:04 – 3:16 p.m.) G. Comi, T.L.
Vollmer, A. Boyko, P. Vermersch, T. Ziemssen, X. Montalban, F.D. Lublin,
N. Sasson, Y. Dadon, J.R. Steinerman, V. Knappertz
[EP1778] Laquinimod Regulates Inflammatory Gene Induction in a Human
Model of Reactive Astrogliosis (ePosters will be displayed for the
duration of the congress; however, they will not be presented during
specific sessions) C. Chapouly, J. Mariani, J. Zhang, N. Zach, G.R.
John
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. COPAXONE® is rated as
Pregnancy Category B. There are no adequate and well-controlled studies
in pregnant women. Administration of glatiramer acetate by subcutaneous
injection to pregnant rats and rabbits resulted in no adverse effects on
offspring development. Animal reproduction studies are not always
predictive of human response, therefore COPAXONE® should be
used during pregnancy only if clearly needed. 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, selective aryl
hydrocarbon receptor (AhR) activator targeting neurodegeneration and
inflammation with a novel mechanism of action being studied for the
treatment of relapsing-remitting MS (RRMS), primary-progressive MS
(PPMS) and Huntington disease.
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 approximately 200 million
patients in over 60 markets 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 the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the Company's multiple sclerosis program which are based on
management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that could
cause our future results, performance or achievements to differ
significantly from that expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to:
-
The benefits of Copaxone®;
-
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®
which faces competition from existing and potential additional generic
versions and orally-administered alternatives; our ability to achieve
expected results from investments in our product pipeline; competition
from companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
-
our business and operations in general, including: our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third party
information technology systems or breaches of our data security; the
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products; our
ability to consummate dispositions on terms acceptable to us; adverse
effects of political or economic instability, major hostilities or
terrorism on our significant worldwide operations; and our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
-
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”), including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov
and www.tevapharm.com.
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 contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171019005116/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
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