JERUSALEM--(BUSINESS WIRE)--May 31, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
that it has received a Complete Response Letter (CRL) from the U.S. Food
and Drug Administration (FDA) regarding the New Drug Application (NDA)
for SD-809 (deutetrabenazine) tablets for the treatment of chorea
associated Huntington disease (HD). This is the first deuterated product
to be reviewed by the FDA. The FDA has asked Teva to examine blood
levels of certain metabolites. These metabolites are not novel, and are
the same seen in subjects who take tetrabenazine or deutetrabenazine. No
new clinical trials have been requested.
“Teva will continue to work closely with the FDA to bring SD-809 to the
market as quickly as possible,” said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva. “We know
that many people in the HD community are waiting for this new medicine.
We understand there are very limited treatment options for HD patients
and their families, hence we are accelerating the re-analysis process we
were asked to conduct. We plan to submit our response to the CRL in Q3
2016."
HD is a rare and fatal neurodegenerative disorder caused by the death of
nerve cells in the brain that affects about one in 7,000 – 10,000 people
in western countries. Chorea—abnormal, involuntary writhing movements—is
one of the most striking physical manifestations of this disease and it
occurs in approximately 90% of patients at some point in the course of
their illness.
In addition to HD, Teva’s programs for the development of SD-809 for the
treatment of patients with tardive dyskinesia (TD) and Tourette syndrome
(TS) are ongoing. Teva is currently conducting a Phase III efficacy and
safety study in patients with moderate to severe TD known as AIM-TD
(Addressing Involuntary Movements in Tardive Dyskinesia) and expects
additional data from this study later in 2016, with regulatory
submission to follow as planned. SD-809 has also been granted orphan
drug designation for the treatment of TS in the pediatric population
(defined as up to 16 years of age) and is planning further evaluation of
SD-809 as a treatment for tics associated with TS.
About SD-809 (deutetrabenazine) Tablets
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule
inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being
developed for the treatment of chorea associated with Huntington disease
(HD). Deutetrabenazine has been granted Orphan Drug Designation for the
treatment of HD by the U.S. Food and Drug Administration (FDA). Teva is
also investigating the potential of deutetrabenazine for treating
tardive dyskinesia, for which the FDA has granted a breakthrough therapy
designation, and for tics associated with Tourette syndrome, for which
the FDA has granted orphan status for pediatric use. Deutetrabenazine
uses Teva’s deuterium technology.
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 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 2015 amounted to $19.7 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® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the timing of
realizing such benefits); the fact that following the consummation of
the Actavis Generics acquisition, we will be dependent to a much larger
extent than previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt we will incur to finance the Actavis Generics acquisition; the fact
that for a period of time following the consummation of the Actavis
Generics acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; 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
investments in our pipeline of specialty and other products; 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; competition for our generic products, both
from other pharmaceutical companies and as a result of increased
governmental pricing pressures; 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 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, 2015 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, whether as a
result of new information, future events or otherwise.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United
States
Kevin C. Mannix, (215) 591-8912
or
United
States
Ran Meir, (215) 591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, (215) 591-8974
United States
Nancy Leone,
(215) 284-0213