JERUSALEM--(BUSINESS WIRE)--Sep. 14, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the presentation of 12 posters at the upcoming 2017 Psych
Congress, September 16-19 in New Orleans, Louisiana. The clinical and
health economics data to be presented include additional analyses from
two pivotal Phase III trials, AIM-TD and ARM-TD, as well as safety data
evaluating AUSTEDO® (deutetrabenazine) tablets in tardive
dyskinesia (TD).
“Teva’s data at the 2017 Psych Congress shed light on the importance of
recognizing the day-to-day impact of living with tardive dyskinesia,”
said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “We are pleased to provide additional
clinical context to the psychiatric community to demonstrate the
significance of treating this population.”
The full set of Teva-sponsored data to be presented is included below:
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Title
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Authors
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Date/Time
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Deutetrabenazine in Tardive Dyskinesia and Huntington’s Disease
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[Abstract 250] Effect of
Deutetrabenazine on Quality of
Life
in Patients With Tardive
Dyskinesia in AIM-TD, a 12-
Week
Double-Blind, Placebo-
Controlled Study
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S.A. Factor, DO; K.E. Anderson, MD;
M.D. Davis, PhD; R.A.
Hauser, MD,
MBA; L.F. Jarskog, MD; J. Jimenez-
Shahed,
MD; R. Kumar, MD, FRCPC;
S. Ochudlo, MD, PhD; W.G. Ondo, MD;
H.H.
Fernandez, MD
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Sunday, September 17 and
Monday, September 18
from
1:30-2:30 p.m. CT
All posters will also be
presented during the
Poster
Gala on Sunday,
September 17 from
5:30-
7:30 p.m. CT
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[Abstract 232]
Deutetrabenazine for the
Treatment
of Tardive
Dyskinesia: Results From an
Open-Label,
Long-Term Study
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K.E. Anderson, MD; M.D. Davis, PhD;
S.A. Factor, DO; R.A.
Hauser, MD,
MBA; L.F. Jarskog, MD; J. Jimenez-
Shahed,
MD; R. Kumar, MD, FRCPC;
S. Ochudlo, MD, PhD; W.G. Ondo, MD;
H.H.
Fernandez, MD
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[Abstract 233] Long-Term
Safety of Deutetrabenazine for
the
Treatment of Tardive
Dyskinesia: Results From an
Open-Label,
Long-Term Study
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K.E. Anderson, MD; M.D. Davis, PhD;
S.A. Factor, DO; R.A.
Hauser, MD,
MBA; L.F. Jarskog, MD; J. Jimenez-
Shahed,
MD; R. Kumar, MD, FRCPC;
S. Ochudlo, MD, PhD; W.G. Ondo, MD;
H.H.
Fernandez, MD
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[Abstract 238] Improvements
in Clinical Global
Impression of
Change With Deutetrabenazine
Treatment in
Tardive
Dyskinesia From the ARM-TD
and AIM-TD Studies
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H.H. Fernandez, MD; M.D. Davis, PhD;
S.A. Factor, DO; R.A.
Hauser, MD,
MBA; L.F. Jarskog, MD; J. Jimenez-
Shahed,
MD; R. Kumar, MD, FRCPC;
S. Ochudlo, MD, PhD; W.G. Ondo, MD;
K.E.
Anderson, MD
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[Abstract 239] Evaluation of
Patient-Reported Outcomes
in
Tardive Dyskinesia Patients
With Underlying Psychotic
and
Mood Disorders in the ARM-TD
and AIM-TD Trials
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H.H. Fernandez, MD; M.D. Davis, PhD;
S.A. Factor, DO; R.A.
Hauser, MD,
MBA; L.F. Jarskog, MD; J. Jimenez-
Shahed,
MD; R. Kumar, MD, FRCPC;
S. Ochudlo, MD, PhD; W.G. Ondo, MD;
K.E.
Anderson, MD
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[Abstract 237] Cardiovascular
Safety Assessment of
Deutetrabenazine
in Healthy
Volunteers and Implications for
Patients With
Huntington
Disease or Tardive Dyskinesia
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D.S. Cox, PhD; M. Levi, PhD; L.
Rabinovich-Guilatt; D.
Truong, PharmD,
MS; D. Stamler, MD
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Health Economics and Research Outcomes (HEOR)
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[Abstract 236] Healthcare
Utilization and Costs for
Patients
With Tardive
Dyskinesia
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B. Carroll, PharmD; P. Juneau, MS; D.
Irwin, PhD, MSPH
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Sunday, September 17 and
Monday, September 18
from
1:30-2:30 p.m. CT
All posters will also be
presented during the
Poster
Gala on Sunday,
September 17 from
5:30-
7:30 p.m. CT
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[Abstract 255] The Burden of
Tardive Dyskinesia
Secondary
to Antipsychotic Medication Use
Among Patients
With Mental
Disorders
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J. McEvoy, MD; T. Park, PharmD; T.
Schilling, MD; E.
Terasawa, PhD; R.
Ayyagari, PhD; B. Carroll, PharmD
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[Abstract 235] Hospital
Utilization Rates Following
Antipsychotic
Dose Reductions
Among Patients With Bipolar
and Major
Depressive
Disorders
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B. Carroll, PharmD; F. Mu, PhD; R.
Ayyagari, PhD; S. Gandhi,
PhD
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[Abstract 234] Hospital
Utilization Rates Following
Antipsychotic
Dose Reductions
Among Patients With
Schizophrenia
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S.N. Caroff, MD; F. Mu, PhD; R.
Ayyagari, PhD; T. Schilling,
MD; V.
Abler, DO; B. Carroll, PharmD
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[Abstract 252] Tardive
Dyskinesia Among Patients
Using
Antipsychotic
Medications in Customary
Clinical Care in
the United
States
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A.M. Loughlin, PhD, N. Lin, ScD; V.
Abler, DO; B. Carroll,
PharmD
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[Abstract 256] Effect of
Tardive Dyskinesia on Quality
of
Life: Self-reported Symptom
Severity is Associated with
Deficits
in Physical, Mental, and
Social Functioning
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J. McEvoy, MD; B. Carroll, PharmD; S.
Gandhi, PhD; A. Rizio,
PhD; S. Maher,
PhD; M. Kosinski, MA; J. Bjorner, MD,
PhD
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About AUSTEDO®
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease.
Important Safety Information
AUSTEDO® can increase the risk of depression
and suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Anyone considering the use of AUSTEDO®
must balance the risks of depression and suicidality with the clinical
need for treatment of chorea. AUSTEDO® is
contraindicated in patients with Huntington’s disease who are suicidal,
or have untreated or inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic
impairment; patients taking reserpine or within 20 days of discontinuing
reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or
within 14 days of discontinuing MAOI therapy; and patients taking
tetrabenazine (Xenazine) or valbenazine (Ingrezza).
AUSTEDO® may cause a worsening in mood, cognition, rigidity,
and functional capacity in patients with Huntington’s disease.
Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in
the corrected QT (QTc) interval. A clinically relevant QT prolongation
may occur in some patients treated with AUSTEDO® who are
CYP2D6 poor metabolizers or are co-administered a strong CYP2D6
inhibitor or other drugs that are known to prolong QTc. Neuroleptic
Malignant Syndrome has been observed in patients receiving
tetrabenazine. AUSTEDO® may increase the risk of akathisia,
agitation, and restlessness. AUSTEDO® may cause parkinsonism
in patients with Huntington’s disease. Sedation is a common
dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies of
patients with tardive dyskinesia were nasopharyngitis and insomnia. The
most common adverse reactions (>8% of AUSTEDO®-treated
patients and greater than placebo) in a controlled clinical study of
patients with chorea associated with Huntington’s disease were
somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information, including Boxed
Warning: austedo.com/hcp/pi.
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 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
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 AUSTEDO® (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:
-
the uncertainty of commercial success of AUSTEDO®
(deutetrabenazine) tablets;
-
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170914005520/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United
States
Kevin C. Mannix, 215-591-8912
Ran Meir,
215-591-3033
Israel
Tomer Amitai,
972 (3) 926-7656
or
PR Contacts:
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