Teva Announces Priority Review Granted by FDA for SD-809 for Treatment of Tardive Dyskinesia
28 Février 2017 - 2:00PM
Business Wire
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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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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