JERUSALEM--(BUSINESS WIRE)--Apr. 27, 2017--
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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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