Data to be presented spans central nervous system disorders, including tardive dyskinesia, multiple sclerosis, Huntington’s disease, and migraine
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced data for five of the Company’s innovative therapies for
central nervous system (CNS) disorders will be presented at the 69th
Annual Meeting of the American Academy of Neurology (AAN) in Boston, MA
from April 22-28, 2017.
The accepted abstracts include data from Teva’s approved and pipeline
products, with three platform and 16 poster presentations. Data for
COPAXONE® (glatiramer acetate injection), a product for
relapsing forms of multiple sclerosis (RMS); as well as Teva’s
investigational therapies including deutetrabenazine tablets – formerly
referred to as SD-809 – for the treatment of tardive dyskinesia (TD),
laquinimod, being developed for relapsing and progressive forms of MS;
pridopidine, under development for the treatment of Huntington’s disease
(HD); and fremanezumab (TEV-48125), under development for the prevention
of migraine, will be featured.
“Teva is dedicated to the ongoing evaluation of its therapies to ensure
the delivery of safe and effective treatments for often under-recognized
or difficult-to-treat CNS disorders,” said Michael Hayden, MD, PhD,
President of Global R&D and Chief Scientific Officer at Teva. “The data
to be presented at AAN highlight our continued progress and
comprehensive research across our CNS portfolio in order to grow our
understanding of the potential of our therapies, and continue delivering
therapies to patients in need.”
The full set of Teva-sponsored data to be presented includes:
COPAXONE® (glatiramer acetate injection):
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[P1.365] Pregnancy Outcomes in Patients with MS Exposed to Branded
Glatiramer Acetate (Poster Session 1, April 23, 2017, 8:30 a.m. to
5:30 p.m.) P. Baruch, S. Melamed-Gal, S. Kolodny, O. Neudorfer
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[P6.357] Predictors of Disability in Relapsing-Remitting Multiple
Sclerosis (RRMS) During the Glatiramer Acetate Low-frequency
Administration (GALA) Study (Poster Session 6, April 28, 2017,
8:30 a.m. to 5:30 p.m.) J. Alexander, D. Daudt, M.D. Davis, N.
Ashtamker, S. Kolodny
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[P3.401] Real-World Monitoring Costs Associated with Initiation of
Disease-Modifying Therapy Among Patients with Multiple Sclerosis (Poster
Session 4, April 25, 2017, 8:30 a.m. to 7:00 p.m.) M.J. Lage, Y. Wu
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[P6.366] Comparison of Adherence and Persistence to Glatiramer
Acetate 40 mg/mL Three-Times Weekly Subcutaneous Injections Versus
Oral Therapies in Multiple Sclerosis (Poster Session 6, April 28,
2017, 8:30 a.m. to 5:30 p.m.) H. Trenz, D. Liassou, R. Wolbeck, R.
Iyer, Y. Wu
Deutetrabenazine:
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[P2.016] Deutetrabenazine Treatment Response by Concomitant
Dopamine-Receptor Antagonists in the Phase III, Randomized,
Double-Blind, Placebo-Controlled AIM-TD Trial in Tardive Dyskinesia
(TD) (Poster Session 2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) J.
Jimenez-Shahed, H. Fernandez, D. Stamler, M.D. Davis, S. Factor, R.
Hauser, J. Isojarvi, W. Ondo, K. Anderson
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[P2.020] Deutetrabenazine is Associated with an Improvement in
Involuntary Movements in Patients With Tardive Dyskinesia (TD) as Seen
by the High Proportion of Responders to Deutetrabenazine Treatment in
the AIM-TD Study (Poster Session 2, April 24, 2017, 8:30 a.m. to
7:00 p.m.) J. Jimenez-Shahed, H. Fernandez, D. Stamler, M.D. Davis,
S. Factor, R. Hauser, J. Isojarvi, W. Ondo, K. Anderson
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[S56.004] Addressing Involuntary Movements in Tardive Dyskinesia
(AIM-TD): Improvements in Clinical Global Impression of Change (CGIC)
with Deutetrabenazine Treatment in Moderate to Severe Tardive
Dyskinesia (TD) (Platform Session 56, April 28, 2017, 4:06 to 4:18
p.m.) H. Fernandez, R. Hauser, M.D. Davis, S. Factor, J. Isojarvi,
J. Jimenez-Shahed, W. Ondo, D. Stamler, K. Anderson
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[S56.006] Addressing Involuntary Movements in Tardive Dyskinesia
(AIM-TD): Effect of Fixed-Dose Deutetrabenazine by Baseline
Comorbidities (Platform Session 56, April 28, 2017, 4:30 to 4:42
p.m.) K. Anderson, S. Factor, M.D. Davis, R. Hauser, J. Isojarvi,
J. Jimenez-Shahed, D. Stamler, W. Ondo, H. Fernandez
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[S56.007] Addressing Involuntary Movements in Tardive Dyskinesia
(AIM-TD): Efficacy, Safety, and Tolerability of Fixed-Dose
Deutetrabenazine for the Treatment of Moderate to Severe Tardive
Dyskinesia (TD) (Platform Session 56, April 28, 2017, 4:42 to 4:54
p.m.) K. Anderson, D. Stamler, M.D. Davis, S. Factor, R. Hauser, J.
Isojarvi, J. Jimenez-Shahed, W. Ondo, H. Fernandez
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[P2.018] Estimation of Epidemiology of Tardive Dyskinesia in the
United States (Poster Session 2, April 24, 2017, 8:30 a.m. to 7:00
p.m.) A. Dhir, T. Schilling, V. Abler, R. Potluri, B. Carroll
Laquinimod:
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[P2.353] Laquinimod modulates central nervous system inflammation
via the aryl-hydrocarbon receptor and is effective in the chronic NOD
progressive EAE model (Poster Session 2, April 24, 2017, 8:30 a.m.
to 7:00 p.m.) J. Kaye, R. Laufer, J. Kenison, V. Rothhammer, F. J.
Quintana
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[P2.354] Disability Progression and Cerebrospinal Fluid Status in
PPMS: Re-Analysis of the ProMiSe Clinical Trial Data Set (Poster
Session 2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) J.R. Steinerman,
M.D. Davis, V. Knappertz, G. Giovannoni, J. Wolinsky
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[P2.355] Laquinimod is a potent arylhydrocarbon receptor dependent
activator of natural killer cells (Poster Session 2, April 24,
2017, 8:30 a.m. to 7:00 p.m.) E. Avendano-Guzman, M. Ott, C.
Wegner, L. Hayardeny, E. Ullrich, M. Schoen, W. Brück, S. Nessler
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[P2.365] Laquinimod targets the aryl hydrocarbon receptor (AhR)
pathway in periphery and brains of naïve and EAE mice (Poster
Session 2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) T. Birnberg, J.
Kaye, K.D. Fowler, B. Weiner, I.S. Caballero, S. Barash, E. Raymond,
I. Ben-Eliezer, I. Fishbein, A. Orbach, D. Laifenfeld, R. Laufer, I.
Grossman
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[P2.366] Direct neuroprotective effect of laquinimod on glutamate
excitotoxicity in experimental multiple sclerosis (Poster Session
2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) F. De Vito, A. Musella,
A. Gentile, S. Bullitta, D. Fresegna, F.R. Rizzo, G. Mandolesi, D.
Centonze
Pridopidine:
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[P2.005] Efficacy, Safety, and Tolerability of Pridopidine in
Huntington Disease (HD): Results from the Phase II, Double-blind,
Placebo-controlled, Dose-Ranging Study, Pride-HD (Poster Session
2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) K. Kieburtz, G.
Landwehrmeyer, R. Reilmann, J. Savola, E. Eyal, I. Grachev, B.
Borowsky, A. McGarry, S. Papapetropoulos, M. Hayden
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[P2.011] Effect of Pridopidine on Total Functional Capacity (TFC)
in Huntington Disease (HD): A Comparison of Open-HART Subjects with
Historical Placebo Controls (Poster Session 2, April 24, 2017,
8:30 a.m. to 7:00 p.m.) A. McGarry, V. Abler, P. Auinger, I.
Grachev, S. Gandhi, S. Papapetropoulos
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[P2.013] Implementation and Validation of a Biometric Solution for
Remote Monitoring of Motor Symptoms in Patients with Huntington’s
Disease in a Phase II Clinical Trial (Poster Session 2, April 24,
2017, 8:30 a.m. to 7:00 p.m.) S. Papapetropoulos, S. Fine, S.
Taylor, K. Blatt, E. Cohen, C. Admati, Y. Dolan, J. Lemieux, I.
Grachev, I. Grossman, M. Hayden
Fremanezumab (TEV-48125):
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[P2.159] What does the humanized monoclonal anti-CGRP antibody
(TEV-48125) teach us about the perception of migraine headache?
(Poster Session 2, April 24, 2017, 8:30 a.m. to 7:00 p.m.) A.
Melo-Carrillo, A. Strassman, A. Schain, R. Reuven-Nir, R. Burstein
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 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 Deutetrabenazine
Deutetrabenazine, an investigational treatment for tardive dyskinesia,
is an oral, small molecule inhibitor of vesicular monoamine 2
transporter, or VMAT2, that is designed to regulate the levels of a
specific neurotransmitter, dopamine, in the brain. Deutetrabenazine is
approved in the United States for the treatment of chorea associated
with Huntington’s disease.
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 developed for the
treatment of relapsing-remitting MS (RRMS), primary-progressive MS
(PPMS) and Huntington disease.
About Fremanezumab (TEV-48125)
Fremanezumab (TEV-48125) is a fully humanized monoclonal calcitonin
gene-related peptide (CGRP) antibody investigational treatment being
developed for the prevention of migraine.
About Pridopidine
Pridopidine is an, oral, small molecule being developed for the
treatment of Huntington’s disease (HD). Pridopidine has a strong
affinity for the Sigma-1-receptor, as implicated in its mechanism of
action.
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 100 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 Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, 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:
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our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Actavis Generics; our
ability to realize the anticipated benefits of the acquisition (and
any delay in realizing those benefits) or difficulties in integrating
Actavis Generics; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
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our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to market AustedoTM successfully and
realize its potential, 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;
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our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make new
investments, and may result in a downgrade of our credit ratings;
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our business and operations in general, including: uncertainties
relating to our recent senior management changes; 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 information
technology systems or breaches of our data security; the failure to
recruit or retain key personnel, including those who joined us as part
of the Actavis Generics acquisition; the restructuring of our
manufacturing network, including potential related labor unrest; the
impact of continuing consolidation of our distributors and customers;
variations in patent laws that may adversely affect our ability to
manufacture our products; 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;
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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;
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other financial risks, including: our exposure to currency
fluctuations and restrictions as well as credit risks; the significant
increase in our intangible assets, which may result in additional
substantial impairment charges; potentially significant increases in
tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”) 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 contained herein,
whether as a result of new information, future events or otherwise. You
are advised to consult any additional disclosures we make in our reports
to the SEC on Form 6-K, as well as the cautionary discussion of risks
and uncertainties under “Risk Factors” in our Annual Report. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those listed
could also materially and adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1995.
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