Teva to Present Data for Deutetrabenazine in Tardive Dyskinesia at the American Psychiatric Association 2017 Annual Meeting
May 17 2017 - 8:00AM
Business Wire
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:
- [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.
- [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.
- [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.
- [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.
- [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.
- [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.
- [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.
- [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:
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals;
- 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170517005532/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974Nancy Leone,
215-284-0213
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