JERUSALEM--(BUSINESS WIRE)--Nov. 9, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
that the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy Designation status to SD-809 (deutetrabenazine) for
the treatment of patients with moderate to severe tardive dyskinesia, a
hyperkinetic movement disorder affecting about 500,000 people in the
United States.
Breakthrough Therapy Designation is granted to a drug that is intended
to treat a serious condition and preliminary clinical evidence indicates
that the drug may demonstrate substantial improvement on a clinically
significant endpoint over available therapy or placebo where there is no
available therapy. For SD-809, the designation request included results
from Teva’s Phase II/III study, Aim
to Reduce Movements
in Tardive Dyskinesia
(ARM-TD). In the ARM-TD study, SD-809 was compared to placebo for change
in Abnormal Involuntary Movement Scale (AIMS) score from baseline to end
of therapy.
“The granting of Breakthrough Therapy Designation by the FDA represents
significant progress toward advancing the clinical program for SD-809,
as a potential, much-needed treatment option for the underserved tardive
dyskinesia patient population. We remain excited about studying this
innovative compound across a number of indications,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva.
Tardive dyskinesia, for which there are no approved therapies in the
United States, has been described as a condition characterized by
repetitive and uncontrollable movements of the tongue, lips, face, and
extremities and has been reported with some widely used medications for
psychiatric conditions such as schizophrenia and bipolar disease, as
well as with certain drugs used for treating various gastrointestinal
disorders.
About The ARM-TD Study
The ARM-TD study was a 1:1 randomized, double-blind, placebo-controlled,
parallel-group study of 117 patients (104 patients completed the study)
with moderate to severe tardive dyskinesia. Enrolled patients received
either SD-809 or placebo, which was titrated to optimal dosage over the
course of six weeks, and then administered at that dose for another six
weeks for a total treatment of 12 weeks. For further details on the
ARM-TD study, visit https://clinicaltrials.gov/ct2/show/study/NCT02195700.
The objectives of the study were to evaluate the efficacy of SD-809 in
reducing the severity of abnormal involuntary movements associated with
tardive dyskinesia and to evaluate the safety and tolerability of
titration and maintenance therapy with SD-809 in subjects with tardive
dyskinesia.
About SD-809
SD-809 (deutetrabenazine) is an investigational, 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. SD-809 is being developed for the treatment of
chorea associated with Huntington’s disease, a neurodegenerative
movement disorder that impacts cognition, behavior, and movements. Teva
is investigating the broad potential of SD-809 for treating additional
movements disorders such as tardive dyskinesia and tics associated with
Tourette syndrome.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
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 release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (including
competition from orally-administered alternatives, as well as from
generic equivalents such as the recently launched Sandoz product) and
our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; the
possibility of material fines, penalties and other sanctions and other
adverse consequences arising out of our ongoing FCPA investigations and
related matters; our ability to achieve expected results from the
research and development efforts invested in our pipeline of specialty
and other products; our ability to reduce operating expenses to the
extent and during the timeframe intended by our cost reduction program;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; 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; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris
Beck Codner
Israel
972 (3) 926-7687
or
Denise
Bradley
United States
215-591-8974
or
Nancy
Leone
United States
215-284-0213