Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease
31 Mai 2016 - 1:00PM
Business Wire
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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Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, (215) 591-8912orUnited StatesRan
Meir, (215) 591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR Contacts:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, (215) 591-8974United
StatesNancy Leone, (215) 284-0213
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