Data contribute to growing body of evidence supporting the development of deutetrabenazine for the treatment of tardive dyskinesia
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced eight abstracts evaluating deutetrabenazine tablets – formerly
referred to as SD-809 – for the treatment of tardive dyskinesia (TD)
will be presented at the American Psychiatric Association (APA) 2017
Annual Meeting in San Diego, CA from May 20-24. The data to be presented
underscores the company’s efforts to advance research and treatment of
patients with TD.
“The data accepted for presentation offers additional analyses from two
pivotal Phase III trials, demonstrating the potential of
deutetrabenazine in tardive dyskinesia. This type of research is
representative of Teva’s commitment to improve our understanding of how
to treat this debilitating and undertreated condition,” said Michael
Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at
Teva. “The psychiatric community plays a crucial role in identifying and
treating tardive dyskinesia, and we are proud to share these data at the
prestigious APA Annual Meeting.”
The full set of Teva-sponsored data to be presented includes:
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[P7.001] Estimation of Tardive Dyskinesia Incidence and Prevalence
in the United States (Poster Session 7, May 23; 10am-12pm) A.
Dhir, T. Schilling, M.D., V. Abler, DO, R. Potluri, B. Carroll, PharmD.
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[P7.005] The Effect of Deutetrabenazine (DTB) on Individual
Components of the Total Abnormal Involuntary Movement Scale (AIMS) in
ARM-TD (Poster Session 7, May 23; 10am-12pm) H.H. Fernandez,
M.D., S.A. Factor, DO, J. Jimenez-Shahed, M.D., W.G. Ondo, M.D., M.D.
Davis, Ph.D., D. Stamler, M.D., R.A. Hauser, M.D., MBA, K.E. Anderson,
M.D.
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[P7.006] Improvements in Clinical Global Impression of Change With
Deutetrabenazine Treatment in Tardive Dyskinesia From the ARM-TD and
AIM-TD Studies (Poster Session 7, May 23; 10am-12pm) 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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[P7.007] 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 7, May 23; 10am-12pm) 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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[P7.008] Evaluating Fixed-Dose Deutetrabenazine for the Treatment
of Moderate to Severe Tardive Dyskinesia in the AIM-TD Study (Poster
Session 7, May 23; 10am-12pm) K.E. Anderson, M.D., S.A. Factor, DO,
J. Jimenez-Shahed, M.D., W.G. Ondo, M.D., M.D. Davis, Ph.D., D.
Stamler, M.D., R.A. Hauser, M.D., MBA, H.H. Fernandez, M.D.
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[P7.009] Deutetrabenazine for the Treatment of Tardive Dyskinesia:
Results From an Open-Label, Long-Term Study (Poster Session 7, May
23; 10am-12pm) 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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[P7.010] Long-Term Safety of Deutetrabenazine for the Treatment of
Tardive Dyskinesia: Results From an Open-Label, Long-Term Study (Poster
Session 7, May 23; 10am-12pm) 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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[P7.011] 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 7, May 23; 10am-12pm) 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.
About Deutetrabenazine
Deutetrabenazine, an investigational treatment for tardive dyskinesia,
is an oral, inhibitor of vesicular monoamine 2 transporter, or VMAT2,
that regulates the levels of neurotransmitters, in the brain.
Deutetrabenazine is approved in the United States for the treatment of
chorea associated with Huntington’s 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 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 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 deutetrabenazine tablets, 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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challenges inherent in product research and development, including
uncertainty of clinical success and obtaining regulatory approvals;
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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 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 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;
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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;
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.
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