JERUSALEM--(BUSINESS WIRE)--Feb. 28, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
the U.S. Food and Drug Administration (FDA) has accepted the New Drug
Application (NDA) and granted Priority Review for SD-809
(deutetrabenazine) for the treatment of tardive dyskinesia (TD). The FDA
has assigned a Prescription Drug User Fee Act (PDUFA) goal date of
August 30, 2017.
“Teva is committed to advancing new therapeutic options for patients
with neurological and movement disorders. There remains a significant
unmet medical need in tardive dyskinesia,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
“SD-809 has the potential to reduce the severity of the abnormal
involuntary movements of tardive dyskinesia which lead to social
isolation for these patients. Currently there is no approved therapy in
the U.S. for TD and this important milestone brings Teva one step closer
to making SD-809 available.”
The NDA for SD-809 is based on results from two Phase III studies,
ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD
(Addressing Involuntary Movements in Tardive Dyskinesia). A Priority
Review is an expedited review granted by the FDA that allows for a
faster evaluation of applications for drugs that could be significant
improvements in the safety or effectiveness in the treatment of serious
conditions. SD-809 was previously granted Breakthrough Therapy
Designation by the FDA.
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 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.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This press release contains forward-looking statements, 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 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.
IR:
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Kevin
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or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
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Iris
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or
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Denise
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or
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