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News breaking: 2017-09-10

Teva Announces FDA Approval of AUSTEDO® (deutetrabenazine) Tablets ..

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Teva Announces FDA Approval of AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults

AUSTEDO® is the first and only FDA-approved product
to treat both tardive dyskinesia in adults and chorea associated with
Huntington’s disease

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) has approved
AUSTEDO® (deutetrabenazine) tablets for the treatment of
tardive dyskinesia in adults. AUSTEDO® was previously
approved for the treatment of chorea associated with Huntington’s
disease in April 2017.
Tardive dyskinesia is a debilitating and often irreversible movement
disorder characterized by repetitive and uncontrollable movements of the
tongue, lips, face, trunk and extremities. The condition affects about
500,000 people in the United States and can be caused by certain
medications used to treat mental health conditions or gastrointestinal
“We are pleased to bring forward this second indication for AUSTEDO®
to treat the underserved tardive dyskinesia population,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva. “We believe physicians treating tardive dyskinesia will
appreciate the therapy’s dosing flexibility and the ability to focus on
directly treating the movement disorder and not disrupt the ongoing
treatment for the underlying condition.”
The approval was based on results from two Phase III randomized,
double-blind, placebo-controlled, parallel group studies assessing the
efficacy and safety of AUSTEDO® in reducing the severity of
abnormal involuntary movements associated with tardive dyskinesia
(AIM-TD and ARM-TD).
“Our medical and commercial teams are looking forward to bringing this
new treatment to patients and physicians working to manage tardive
dyskinesia,” said Rob Koremans, M.D., President and CEO of Global
Specialty Medicines at Teva. “The launch of AUSTEDO®
demonstrates our continued commitment to the treatment of movement
Teva offers Shared Solutions®, a free service to provide
support to patients starting or taking AUSTEDO®. The
toll-free number for Shared Solutions® is 1-800-887-8100.
AUSTEDO® is indicated for the treatment of tardive dyskinesia
in adults. AUSTEDO® is also indicated 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 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170830006180/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3) 926-7656orPR
Contacts:Iris Beck Codner, Israel, 972 (3) 926-7687Denise
Bradley, United States, 215-591-8974
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