JERUSALEM--(BUSINESS WIRE)--Jun. 29, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the publication of results from the Phase III study, AIM-TD (Addressing
Involuntary Movements
in Tardive Dyskinesia),
in the medical journal, The Lancet Psychiatry. The AIM-TD study
evaluated the safety, efficacy and tolerability of the investigational
use of fixed-dose deutetrabenazine (SD-809) compared to placebo for the
treatment of tardive dyskinesia (TD).
“TD is a chronic condition that affects patients who are suffering from
primary psychiatric illnesses, which are already debilitating and can be
socially isolating,” 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 psychiatry and movement disorder
community, who play a critical role in the identification and treatment
of hyperkinetic movement disorders like TD.”
Deutetrabenazine
for treatment of involuntary movements in patients with tardive
dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled,
phase 3 trial was published online ahead of print in The
Lancet Psychiatry. The AIM-TD study and publication was led by
Principal Investigators Karen E. Anderson, M.D., Associate Professor of
Psychiatry & Neurology at Georgetown MedStar University Hospital, and
Hubert Fernandez, M.D., Professor of Neurology at the Center for
Neurological Restoration at the Cleveland Clinic.
About the AIM-TD Study
AIM-TD was a Phase III, randomized, double-blind, placebo-controlled,
parallel group, fixed-dose study that evaluated 222 male and female
adults with moderate to severe TD. All patients had a total motor
Abnormal Involuntary Movement Scale (AIMS) ≥ 6 at screening and were
randomized at baseline in a 1:1:1:1 ratio to receive one of three
fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, or 36
mg/day) or placebo. Patients underwent dose escalation during the
initial 4 weeks, followed by an 8-week maintenance period and a 1-week
washout.
About Tardive Dyskinesia
Tardive dyskinesia 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 or the gastrointestinal agent, metoclopramide.
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 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, 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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
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Nancy Leone, 215-284-0213