Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today
announced the publication of results from the Phase II/III study
ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) in Neurology®, the medical
journal of the American Academy of Neurology. The ARM-TD study
evaluated the safety and efficacy of the investigational use of
deutetrabenazine (SD-809) compared to placebo in the treatment of
moderate to severe tardive dyskinesia (TD).
“Tardive dyskinesia is a chronic and debilitating condition that
affects patients who are already suffering from significant primary
psychiatric illnesses,” said Michael Hayden, M.D., Ph.D., President
of Global R&D and Chief Scientific Officer at Teva. “We are
pleased to share this publication with the scientific
community.”
Randomized controlled trial of deutetrabenazine for tardive
dyskinesia was published online ahead of print in Neurology®. The
ARM-TD study and publication was led by Principal Investigators
Hubert Fernandez, M.D., Professor of Neurology at the Center for
Neurological Restoration at the Cleveland Clinic and Karen E.
Anderson, M.D., Associate Professor of Psychiatry & Neurology
at Georgetown MedStar University Hospital.
About the ARM-TD Study
The ARM-TD study was a 1:1 randomized, multi-center,
double-blind, placebo-controlled, parallel-group study of 117
patients in the United States and Europe (104 patients completed
the study) with moderate to severe tardive dyskinesia. Enrolled
patients received either deutetrabenazine or placebo, which was
titrated to optimal dosage over the course of six weeks, and then
administered at that dose for another six weeks for a total
treatment of 12 weeks.
The objectives of the study were to evaluate the efficacy of
deutetrabenazine in reducing the severity of abnormal involuntary
movements associated with tardive dyskinesia and to evaluate the
safety and tolerability of titration and maintenance therapy with
deutetrabenazine in subjects with drug-induced tardive
dyskinesia.
About Tardive Dyskinesia
Tardive dyskinesia, a condition for which there are no approved
therapies in the United States, is a movement disorder
characterized by repetitive and uncontrollable movements of the
tongue, lips, face, trunk and extremities. The often debilitating
disorder affects about 500,000 people in the United States and is
usually a result of treatment with widely used medications for
psychiatric conditions such as schizophrenia and bipolar
disorder.
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 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, 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:
• our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Actavis Generics; our
ability to realize the anticipated benefits of the acquisition (and
any delay in realizing those benefits) or difficulties in
integrating Actavis Generics; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products; price
erosion relating to our generic products, both from competing
products and as a result of increased governmental pricing
pressures; and our ability to take advantage of high-value
biosimilar opportunities;
• 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 market AustedoTM successfully and realize its potential, 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 substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make
new investments, and may result in a downgrade of our credit
ratings;
• our business and operations in general, including:
uncertainties relating to our recent senior management changes; 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
information technology systems or breaches of our data security;
the failure to recruit or retain key personnel, including those who
joined us as part of the Actavis Generics acquisition; the
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; variations in patent laws that may
adversely affect our ability to manufacture our products; adverse
effects of political or economic instability, major hostilities or
terrorism on our significant worldwide operations; and our ability
to successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
• 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;
• other financial risks, including: our exposure to currency
fluctuations and restrictions as well as credit risks; the
significant increase in our intangible assets, which may result in
additional substantial impairment charges; potentially significant
increases in tax liabilities; and the effect on our overall
effective tax rate of the termination or expiration of governmental
programs or tax benefits, or of a change in our business;
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”) 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
contained herein, whether as a result of new information, future
events or otherwise. You are advised to consult any additional
disclosures we make in our reports to the SEC on Form 6-K, as well
as the cautionary discussion of risks and uncertainties under “Risk
Factors” in our Annual Report. These are factors that we believe
could cause our actual results to differ materially from expected
results. Other factors besides those listed could also materially
and adversely affect us. This discussion is provided as permitted
by the Private Securities Litigation Reform Act of 1995.
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version on businesswire.com: http://www.businesswire.com/news/home/20170427005624/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7246orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213
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