Presentations include data for deutetrabenazine and pridopidine
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced data for deutetrabenazine tablets for the treatment of tardive
dyskinesia (TD) and chorea associated with Huntington disease (HD), and
pridopidine for the treatment HD will be presented in 18 poster
presentations at the 21st International Congress of
Parkinson’s Disease and Movement Disorders in Vancouver, BC, Canada from
June 4-8.
“Teva has an extensive CNS franchise in movement disorders and
neurodegenerative conditions, and we are pleased to share these
important data in tardive dyskinesia and Huntington disease with
worldwide experts in movement disorders. We look forward to being a part
of research advancements in the field,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
“The broad range of data to be presented at the meeting underscores our
commitment to develop meaningful therapeutic options for patients.”
The full set of Teva-sponsored data to be presented includes:
Deutetrabenazine in Tardive Dyskinesia
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[ABSTRACT 414] Addressing Involuntary Movements in Tardive
Dyskinesia (AIM-TD): Efficacy, Safety and Tolerability of Fixed-Dose
Deutetrabenazine for the Treatment of Tardive Dyskinesia (Poster
Session June 6; 1:45pm-3:15pm) K.E. Anderson, M.D., D. Stamler
M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J.
Isojarvi M.D., Ph.D., J. Jimenez-Shahed M.D., W.G. Ondo, M.D., H.H.
Fernandez, M.D.
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[ABSTRACT 410] Addressing Involuntary Movements in Tardive
Dyskinesia (AIM-TD): Improvements in Clinical Global Impression of
Change (CGIC) with Deutetrabenazine Treatment in Tardive Dyskinesia
(TD) (Poster Session June 6; 1:45pm-3:15pm) J. Jimenez-Shahed,
M.D., H.H. Fernandez, M.D., R.A. Hauser, M.D., MBA, M.D. Davis, Ph.D.,
S.A. Factor, DO, J. Isojarvi, M.D., Ph.D., W.G. Ondo, M.D., D.
Stamler, M.D., K.E. Anderson, M.D.
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[ABSTRACT 409] Deutetrabenazine is Associated with an Improvement
in Involuntary Movements in Patients With Tardive Dyskinesia as Seen
by the High Proportion of Responders to Deutetrabenazine Treatment in
the AIM-TD Study (Poster Session June 6; 1:45pm-3:15pm) J.
Jimenez-Shahed, M.D., H.H. Fernandez, M.D., D. Stamler, M.D., M.D.
Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi,
M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
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[ABSTRACT 406] Deutetrabenazine Treatment Response by Concomitant
Dopamine-Receptor Antagonists in the Phase III, Randomized,
Double-Blind, Placebo-Controlled AIM-TD Trial in Tardive Dyskinesia (Poster
Session June 6; 1:45pm-3:15pm) J. Jimenez-Shahed, M.D., H.H.
Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO,
R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., W.G. Ondo, M.D.,
K.E. Anderson, M.D.
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[ABSTRACT 397] Effect of Deutetrabenazine on QTcF Interval in the
AIM-TD Study: a 12-Week, Phase III, Randomized, Double-Blind,
Placebo-Controlled Study (Poster Session June 6; 1:45pm-3:15pm) K.E.
Anderson, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A., Factor, DO,
R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D.,
J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D.,
Ph.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.
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[ABSTRACT 403] Effect of Deutetrabenazine on Quality of Life in
Patients With Tardive Dyskinesia in AIM-TD, a 12-Week Double-Blind,
Placebo-Controlled Study (Poster Session June 6; 1:45pm-3:15pm) S.A.,
Factor, DO, K.E. Anderson, M.D., D. Stamler, M.D., M.D. Davis, Ph.D.,
R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D.,
J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D.,
Ph.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.
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[ABSTRACT 404] Improvements in Clinical Global Impression of Change
With Deutetrabenazine Treatment in Tardive Dyskinesia From the ARM-TD
and AIM-TD Studies (Poster Session June 6; 1:45pm-3:15pm) H.H.
Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO,
R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D.,
J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D.,
Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
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[ABSTRACT 407] Evaluation of Patient-Reported Outcomes in Tardive
Dyskinesia Patients with Underlying Psychotic and Mood Disorders in
the ARM-TD and AIM-TD Trials (Poster Session June 6;
1:45pm-3:15pm) H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis,
Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D.,
Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D.,
FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
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[ABSTRACT 412] The Effect of Deutetrabenazine by Body Region Score
of the Abnormal Involuntary Movement Scale in Tardive Dyskinesia:
ARM-TD and AIM-TD Studies (Poster Session June 6; 1:45pm-3:15pm) H.H.
Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO,
R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D.,
J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D.,
Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
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[ABSTRACT 402] Long-Term Safety of Deutetrabenazine for the
Treatment of Tardive Dyskinesia: Results From an Open-Label, Long-Term
Study (Poster Session June 6; 1:45pm-3:15pm) K.E. Anderson,
M.D., D. Stamler M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A.
Hauser, M.D., MBA, J. Isojarvi M.D., Ph.D., J. Jimenez-Shahed M.D., R.
Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., H.H.
Fernandez, M.D.
Deutetrabenazine in Chorea Associated with
Huntington Disease
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[ABSTRACT 468] The Long-Term Safety of Deutetrabenazine for Chorea
in Huntington Disease: Updated Safety Results from the ARC-HD Trial (Poster
Session June 6; 1:45pm-3:15pm) S. Frank, M.D., C. Vaughan, M.D.,
M.H.S., D. Stamler, M.D., D. Oakes, Ph.D., M. Davis, Ph.D., S. Eberly,
M.S., E. Kayson, M.S., R.N.C., J. Whaley, J. Goldstein, B.S., C.
Testa, M.D., Ph.D.
Health Economics and Outcomes Research (HEOR)
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[ABSTRACT 413] Healthcare Utilization and Costs for Patients With
Tardive Dyskinesia (Poster Session June 6; 1:45pm-3:15pm) B.
Carroll, PharmD, T. Park, PharmD, D. Irwin, Ph.D., MSPH, S. Gandhi,
Ph.D.
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[ABSTRACT 411] Estimation of Tardive Dyskinesia Incidence and
Prevalence in the United States (Poster Session June 6;
1:45pm-3:15pm) A. Dhir, T. Schilling, M.D., V. Abler, DO, R.
Potluri, B. Carroll, PharmD
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[ABSTRACT 488] Demographic and Clinical Characteristics and
Tetrabenazine (TBZ) Persistence in Patients With Huntington Disease
(HD)-Associated Chorea (Poster Session June 6; 1:45pm-3:15pm) V.W.
Sung, M.D., R. Iyer, Ph.D., MBA, S. Gandhi, Ph.D., V. Abler, DO, B.
Davis, D.E. Irwin, Ph.D., MSPH, K.E. Anderson, M.D.
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[ABSTRACT 486] A Descriptive Analysis of a Real-World Population
With Huntington Disease-Associated Chorea (HDAC) Treated With
Tetrabenazine: Findings From An Electronic Medical Records (EMR)
Database (Poster Session June 6; 1:45pm-3:15pm) R. Iyer, Ph.D.,
MBA, D. Aleyras, Ph.D., S. Gandhi, Ph.D., T. Schilling, M.D., V.
Abler, DO, F. Cao, K.L. Johnson, K.E. Anderson, M.D.
Pridopidine
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[ABSTRACT 489] Efficacy, Safety, and Tolerability of Pridopidine in
Huntington Disease (HD): Results From the Phase II Dose-Ranging Study,
Pride-HD (Poster Session June 6; 1:45pm-3:15pm) R. Reilmann,
M.D., Ph.D., A. McGarry, M.D., G. Bernhard Landwehrmeyer, M.D.,
F.R.C.P, K. Keiburtz, M.D., M.P.H., I. Grachev, M.D., Ph.D., E. Eyal,
M.Sc., J. Savola, M.D., Ph.D., B. Borowsky, Ph.D., S. Papapetropoulos,
M.D., Ph.D., M. Hayden, M.D.
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[ABSTRACT 485] Implementation and Validation of a Biometric
Solution for Remote Monitoring of Motor Symptoms in Patients with
Huntington Disease in a Phase II Clinical Trial (Poster Session
June 6; 1:45pm-3:15pm) S. Papapetropoulos, M.D., Ph.D., S. Fine,
Ph.D., E. Cohen, B.Sc., C. Admati, B.Sc., Y. Dolan, B.Sc., I. Grachev,
M.D., Ph.D., I.Grossman, Ph.D., M. Hayden, M.D.
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[ABSTRACT 484] Effect of Pridopidine on Total Functional Capacity
(TFC) in Huntington Disease (HD): Results of a Cohort Comparison of
Open-HART and Historical Placebo
Subjects (Poster
Session June 6; 1:45pm-3:15pm) A. McGarry, M.D., V. Abler, D.O., P.
Auinger, M.S., I. Grachev, M.D., Ph.D., S. Gandhi, Ph.D., S.
Papapetropoulos, M.D., Ph.D.
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 Pridopidine
Pridopidine is an oral, small molecule being developed for the treatment
of Huntington’s disease. 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
regarding Deutetrabenazine and Pridopidine 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 uncertainty of commercial success of Deutetrabenazine;
• challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals of Deutetrabenazine and Pridopidine ;
• 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 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;
• 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.
