Data in Huntington Disease, Tardive Dyskinesia and Tourette Syndrome
to Be Presented
JERUSALEM--(BUSINESS WIRE)--Jun. 20, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced new data for SD-809 (deutetrabenazine) tablets will be
presented at the 20th International Congress of Parkinson’s
Disease and Movement Disorders (MDS) in Berlin, June 19-23, 2016.
Teva-sponsored data evaluating SD-809 in patients with chorea associated
with Huntington disease, tardive dyskinesia and tics associated with
Tourette syndrome will be highlighted in clinical, preclinical and
health economics data poster presentations. In addition, Teva will host
a Corporate Symposium entitled, “Emerging Technologies and Therapies in
Movement Disorders,” on Thursday, June 23, 2016 from 1:30 to 2:30 p.m.
CEST.
“There is a significant unmet medical need, as limited options are
currently available for the treatment of neurological disorders such as
Huntington disease, tardive dyskinesia and Tourette syndrome,” said
Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific
Officer at Teva. “Data planned for presentation at this year’s MDS
Congress demonstrates Teva’s commitment to research and helping improve
the lives of patients and caregivers in these severely underserved
patient communities.”
Teva-sponsored data to be presented include:
-
Evaluation of Quality of Life (QoL), Patient- and
Clinician-Reported Outcomes with Deutetrabenazine Treatment of Chorea
in Huntington Disease in First-HD (C. Testa, D. Claassen, D.
Oakes, D. Stamler, V. Sung, S. Frank)
-
Alternatives for reducing chorea in Huntington disease, a long-term
trial (ARC-HD): Updated Week 8 results for the switch cohort (D.
Stamler)
-
Maintenance of balance function in patients with HD treated with
deutetrabenazine, as measured by Berg balance test (BBT) in First-HD (D.
Claassen, D. Oakes, D. Stamler, V. Sung, C. Testa, S. Frank)
-
Evaluating Swallowing Function in Patients with Huntington Disease
Enrolled in the First-HD Study (D. Claassen, S. Frank, V. Sung,
S. Janicki, C. Vaughan, D. Stamler, D. Oakes, C. Testa)
-
A randomized, double-blind, placebo-controlled trial of
deutetrabenazine for the treatment of tardive dyskinesia (ARM-TD) (H.
Fernandez, S. Factor, R. Hauser, J. Jimenez-Shahed, W. Ondo, M.
LeDoux, D. Shprecher, T. Simuni, D. Stamler, K. Anderson)
-
A Randomized Double-blind Placebo- and Positive-Controlled
Crossover Study to Evaluate the Effects of Single Doses of SD-809
(Deutetrabenazine) and Tetrabenazine on the Corrected QT Interval (D.
Stamler, E. Offman, M. Bradbury, L. De Boer)
-
A Pilot Study of SD-809 (deutetrabenazine) in Tics Associated with
Tourette Syndrome (J. Jankovic, J. Jimenez-Shahed, C. Budman,
B. Coffey, T. Murphy, D. Shprecher, D. Stamler)
-
Indirect comparison of tolerability of deutetrabenazine and
tetrabenazine in the First-HD and TETRA-HD trials (D. Claassen,
B. Carroll, L. De Boer, E. Wu, R. Ayyagari, S. Gandhi, D. Stamler)
-
Temporal course of the UHDRS chorea score in Huntington disease (T.
Felong, P. Auinger, S. Gandhi, V. Abler, K. Biglan, S.
Papapetropoulous, C. Venuto, R. Dorsey)
-
Temporal course of the Total Motor Score in Huntington disease (P.
Auinger, T. Felong, S. Gandhi, V. Abler, K. Biglan, S.
Papapetropoulous, C. Venuto, R. Dorsey)
-
Epidemiology and economic burden of falls and fractures in patients
with Huntington's disease (D. Claassen, P. Donga, S.
Rajagopalan, L. De Boer, B. Carroll, S. Gandhi)
About SD-809
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule
inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being
developed for the treatment of chorea associated with Huntington disease
(HD). Deutetrabenazine has been granted Orphan Drug Designation for the
treatment of HD by the U.S. Food and Drug Administration (FDA). Teva is
also investigating the potential of deutetrabenazine for treating
tardive dyskinesia, for which the FDA has granted a breakthrough therapy
designation, and for tics associated with Tourette syndrome, for which
the FDA has granted orphan status for pediatric use. Deutetrabenazine
uses Teva’s deuterium technology.
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 millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U.S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
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faces competition from orally-administered alternatives and a generic
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efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 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, whether as a
result of new information, future events or otherwise.

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Source: Teva Pharmaceutical Industries Ltd.
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