Three new
presentations evaluate AUSTEDO tablets for the treatment of tardive
dyskinesia in adults
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that new AUSTEDO® (deutetrabenazine) data will be
presented at the 32nd annual Psych Congress, October 3-6, 2019 in
San Diego, California. Presentations include an additional analysis
of AIMS Global Judgment Components (Items 8-10) in the pivotal
ARM-TD and AIM-TD studies that evaluated AUSTEDO tablets for the
treatment of tardive dyskinesia (TD) in adults; an analysis of the
effect of AUSTEDO on metabolic parameters in the treatment of TD in
the pivotal studies as well as the ongoing long-term study; and an
analysis of the randomized withdrawal study design that evaluated
the persistence of the therapeutic effect of AUSTEDO in TD.
Additional data include two presentations showcasing the results
from the first study to quantify the stigma faced by people with TD
in a variety of professional and social situations will also be
shared.
“These new data add to our understanding of the risk-benefit
profile of AUSTEDO in tardive dyskinesia,” said Daniel McBryan
M.D., Senior Vice President, Head of Global Medical Affairs and
Pharmacovigilance at Teva Pharmaceuticals. “In addition, we look
forward to sharing insights from our research that quantify the
professional and social stigma associated with this condition.”
Data to be presented include:
All posters will be presented at the Poster Pavilion on both
Friday, October 4 and Saturday, October 5 from 1:30-3:00 p.m.
PDT.
- Poster 105: Analysis of AIMS Global Judgment Components
(Items 8-10) in Patients With TD: Results From the ARM-TD and
AIM-TD Studies
- Poster 115: An Experimental Study to Assess the Professional
and Social Consequences of Mild-to-Moderate Tardive
Dyskinesia
- Poster 116: An Experimental Study to Assess the Professional
and Social Consequences of Tardive Dyskinesia
- Poster 117: Impact of Antipsychotic Treatment Switching in
Patients With Schizophrenia, Bipolar Disorder, and Major Depressive
Disorder
- Poster 148: Long-Term Treatment With Deutetrabenazine Is
Associated With Continued Improvement in Tardive Dyskinesia (TD):
Results From an Open-Label Extension Study
- Poster 158: Effect of Deutetrabenazine on Metabolic
Parameters in the Treatment of Tardive Dyskinesia
- Poster 315: Randomized Withdrawal Study Design to Evaluate
the Persistence of the Therapeutic Effect of Deutetrabenazine in
the Treatment of Tardive Dyskinesia
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease. Safety and
effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated
with Huntington’s disease and for the treatment of tardive
dyskinesia in adults.
Important Safety Information
Depression and Suicidality in Patients with Huntington’s
Disease: AUSTEDO® can increase the risk of depression and
suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Balance the risks of depression and
suicidality with the clinical need for treatment of chorea.
Closely monitor patients for the emergence or worsening of
depression, suicidality, or unusual changes in behavior. Inform
patients, their caregivers, and families of the risk of depression
and suicidality and instruct them to report behaviors of concern
promptly to the treating physician. Exercise caution when treating
patients with a history of depression or prior suicide attempts or
ideation. AUSTEDO® is contraindicated in patients who are suicidal,
and in patients with untreated or inadequately treated
depression.
Contraindications: 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®).
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO® may cause a worsening in mood, cognition,
rigidity, and functional capacity. Prescribers should periodically re-evaluate
the need for AUSTEDO® in their patients by assessing the effect on
chorea and possible adverse effects.
QTc Prolongation: 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. Dose reduction may be
necessary. The use of AUSTEDO® in combination with other drugs
known to prolong QTc may result in clinically significant QT
prolongations. For patients requiring AUSTEDO® doses greater than
24 mg per day who are using AUSTEDO® with other drugs known to
prolong QTc, assess the QTc interval before and after increasing
the dose of AUSTEDO® or the other drugs. AUSTEDO® should be avoided
in patients with congenital long QT syndrome and in patients with a
history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported
in association with drugs that reduce dopaminergic transmission,
has been observed in patients receiving tetrabenazine. The risk may
be increased by concomitant use of dopamine antagonists or
antipsychotics. The management of NMS should include immediate
discontinuation of AUSTEDO®; intensive symptomatic treatment and medical
monitoring; and treatment of any concomitant serious medical
problems.
Akathisia, Agitation, and Restlessness: AUSTEDO® may
increase the risk of akathisia, agitation, and restlessness. The
risk of akathisia may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops akathisia, the
AUSTEDO® dose should be reduced; some patients may require
discontinuation of therapy.
Parkinsonism: AUSTEDO® may cause parkinsonism in patients
with Huntington’s disease or tardive dyskinesia. Parkinsonism has
also been observed with other VMAT2 inhibitors. The risk of
parkinsonism may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops parkinsonism,
the AUSTEDO® dose should be reduced; some patients may require
discontinuation of therapy.
Sedation and Somnolence: Sedation is a common
dose-limiting adverse reaction of AUSTEDO®. Patients should not
perform activities requiring mental alertness, such as operating a
motor vehicle or hazardous machinery, until they are on a
maintenance dose of AUSTEDO® and know how the drug affects them.
Concomitant use of alcohol or other sedating drugs may have
additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum
prolactin concentrations in humans. If there is a clinical
suspicion of symptomatic hyperprolactinemia, appropriate laboratory
testing should be done and consideration should be given to
discontinuation of AUSTEDO®.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to
melanin-containing tissues and could accumulate in these tissues
over time. Prescribers should be aware of the possibility of
long-term ophthalmologic effects.
CYP2D6 Metabolism: In patients who are poor CYP2D6
metabolizers or are taking strong CYP2D6 inhibitors, the total
daily dosage of AUSTEDO® should not exceed 36 mg (maximum single
dose of 18 mg).
Common Adverse Reactions: The most common adverse
reactions for AUSTEDO® (>8% and greater than placebo) in a
controlled clinical study in patients with Huntington’s disease
were somnolence, diarrhea, dry mouth, and fatigue. The most common
adverse reactions for AUSTEDO® (4% and greater than placebo) in
controlled clinical studies in patients with tardive dyskinesia
were nasopharyngitis and insomnia.
Please see accompanying full Prescribing Information,
including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 2,400
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at 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®, 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 commercial success of AUSTEDO;
- challenges inherent in product research and development,
including obtaining regulatory approvals for additional indications
for AUSTEDO;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; competition for our specialty products, especially
COPAXONE®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® or AUSTEDO; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; 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 products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to
effectively execute our restructuring plan announced in December
2017; uncertainties related to, and failure to achieve, the
potential benefits and success of our senior management team and
organizational structure; harm to our pipeline of future products
due to the ongoing review of our R&D programs; our ability to
develop and commercialize additional pharmaceutical products;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; compliance with
sanctions and other trade control laws; 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 failure to
recruit or retain key personnel; variations in intellectual
property laws that may adversely affect our ability to manufacture
our products; challenges associated with conducting business
globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; and our
prospects and opportunities for growth if we sell assets ;
- 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; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; governmental investigations into selling and marketing
practices; potential liability for patent infringement; 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 and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
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 Quarterly Reports on Form
10-Q for the first and second quarter of 2019 and in our Annual
Report on Form 10-K for the year ended December 31, 2018, including
in the sections captioned "Risk Factors” and “Forward Looking
Statements.” 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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IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Ran Meir 972 (3) 926-7516
PR Contacts United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
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