Teva Announces Publication of AIM-TD Study Results in The Lancet Psychiatry for the Investigational Use of Deutetrabenazine i...
29 Juin 2017 - 2:00PM
Business Wire
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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version on businesswire.com: http://www.businesswire.com/news/home/20170629005043/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974Nancy Leone,
215-284-0213
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