SD-809 previously categorized with Orphan Drug
Designation by FDA
File acceptance marks important milestone for
Teva’s growing commitment to treatments for rare movement
disorders
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today
announced that the New Drug Application (NDA) for SD-809
(deutetrabenazine) has been accepted by the U.S. Food and Drug
Administration (FDA) for the treatment of chorea associated with
Huntington disease (HD), a rare and fatal neurodegenerative
disorder caused by the progressive breakdown of nerve cells in the
brain that affects about five to seven people per 100,000 in
western countries, according to the World Health Organization.
“The opportunity to bring a new treatment option to those
battling the devastating illness of Huntington disease is an
important first step and an indication of our profound commitment
to improving the lives of patients with this and other debilitating
movement disorders,” said Michael Hayden, M.D., Ph.D., President of
Global R&D and Chief Scientific Officer at Teva. “With this
filing and an ongoing investment in HD research, Teva has further
established itself as a leader in the development of treatments
focusing on movement disorders.”
“Teva plans to commercialize SD-809 in the U.S. by drawing from
vast experience in facilitating therapy initiation and patient
support in other disease areas. Within Global Specialty Medicines,
we have a rich history of demonstrating our commitment to the
patient and bringing value to the neurology community,” said Rob
Koremans, MD, President and CEO of Global Specialty Medicines at
Teva. “People living with neurodegenerative disorders and those
around them often need support and services beyond medications. We
intend to meet these needs with our proven infrastructure and our
focus on the patient.”
The NDA filing is based on positive results from two Phase-III
studies, FIRST-HD and ARC-HD. In the placebo-controlled, randomized
FIRST-HD study, SD-809 reduced chorea in patients with HD. Positive
top-line data from the Phase-III, open-label ARC-HD study
demonstrated that patients were able to safely convert from
tetrabenazine, currently the only approved HD treatment, to SD-809
overnight with continued control of chorea.
SD-809 was granted Orphan Drug Designation for the treatment of
HD by the FDA in November 2014 and became part of Teva’s CNS
portfolio with the acquisition of Auspex Pharmaceuticals in May
2015.
The FDA designates orphan status to drugs and biologics that are
intended for the treatment of rare diseases affecting fewer than
200,000 people in the U.S.
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 disease, a
neurodegenerative movement disorder that impacts cognition,
behavior, and movements. The FIRST-HD study showed a favorable
safety and tolerability profile, including low rates of depression,
somnolence, akathisia/restlessness and anxiety. The safety and
tolerability experience observed in the ARC-HD study was consistent
with the experience observed in the FIRST-HD study. The most
commonly reported adverse events in ARC-HD patients were
somnolence, fall, and nasopharyngitis.
About Huntington Disease
Huntington disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements,
cognitive deterioration and behavioral and/or psychological
problems. The classic onset of HD symptoms typically occurs in
middle age, but the disease also manifests in children and the
elderly. HD is the most common genetic cause of abnormal
involuntary writhing movements called chorea. Disease progression
is characterized by a gradual decline in motor control, cognition
and mental stability and generally results in death within 15‐25
years of clinical diagnosis.
HD is a genetic disease, passed from parent to child through a
gene mutation. Each child of an HD parent has a 50-50 chance of
inheriting the HD gene. If a child does not inherit the HD gene, he
or she will not develop the disease and cannot pass it to
subsequent generations. A person who inherits the HD gene will
sooner or later develop the disease. According to the World Health
Organization, Huntington disease affects about five to seven people
per 100,000 in Western countries.
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 innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our 40 mg/mL version; 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; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate
acquisitions; 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. 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
statement, whether as a result of new information, future events or
otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20150812005421/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, 215-284-0213
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