SD-809 demonstrates a statistically significant improvement in
Abnormal Involuntary
Movement Scale score in AIM-TD study
Adds to body of data supporting this promising breakthrough
investigational therapy to
address unmet patient need
JERUSALEM--(BUSINESS WIRE)--Sep. 22, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
SD-809 (deutetrabenazine) showed statistically significant results in
the second Phase III registration trial studying the potential of SD-809
for the treatment of tardive dyskinesia (TD). These new results for the
AIM-TD trial follow positive results from the ARM-TD trial announced in
June 2015. Both ARM-TD and AIM-TD were 12 week treatment studies. The
U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy
Designation for SD-809 for the treatment of TD in November 2015. Teva
expects to make a regulatory submission to the FDA by the end of 2016.
“We are delighted to deliver positive results from a second Phase III
study showing the potential for SD-809 to treat the involuntary
movements of tardive dyskinesia. This condition is debilitating and
often leads to isolation of those affected,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at
Teva, adding that “The study results strengthen our resolve to making
this product an option for those patients in need. We are grateful to
the trial participants and study investigators who contributed to this
study.”
In the AIM-TD trial, the primary endpoint was change in Abnormal
Involuntary Movement Scale (AIMS) score from baseline to week 12 for
three fixed doses of SD-809 as compared to placebo. Patients’ abnormal
movements were assessed by blinded central video rating. All doses
improved AIMS scores compared to placebo and at week 12, the 24 mg and
36 mg dose groups of SD-809 demonstrated a significant change from
baseline based on the modified intent-to-treat population.
At week 12, the AIMS rating improved from baseline by -3.3 points for 36
mg (P=0.001), -3.2 points for 24 mg (P=0.003) and -2.1 for 12 mg (P=NS),
compared to -1.4 in placebo. In addition to the primary endpoint, mean
scores on the Clinical Global Impression of Change (CGI) improved by
-0.5 for 36 mg (P=0.011) and by -0.6 for 24 mg (P=0.002) based on the
modified intent-to-treat population. The CGI is a global assessment of
the patient’s abnormal movements made by the treating investigator. For
the protocol-specified secondary endpoint of CGI, in which treatment
success was defined as “much improved” or “very much improved” at Week
12 and missing data were counted as treatment failure, 24 mg was
superior to placebo (P=0.014); the 36 mg dose was superior to placebo,
but did not reach statistical significance (P=0.059). Teva will present
a fuller analysis at a future medical meeting.
“The results from the AIM-TD trial suggest clear efficacy and an
excellent safety profile for SD-809. The remarkably low rates of
neuropsychiatric adverse events observed is particularly important for
this psychiatric patient population” said Hubert H. Fernandez, MD,
Professor of Medicine (Neurology) at the Cleveland Clinic Lerner College
of Medicine and co-Principal Investigator for the trial. “The relevance
of the efficacy data on the AIMS is underscored by the improvement
observed on the Clinical Global Impression of change, which demonstrates
that treating clinicians appreciated the reduction in abnormal movements
experienced by their patients.”
During the 12-week treatment, SD-809 demonstrated a favorable safety and
tolerability profile. The frequency of overall adverse events and
adverse events leading to withdrawal were similar among all treatment
groups. The safety profile of SD-809 was consistent with data from
previously reported clinical trials.
Tardive dyskinesia is a hyperkinetic 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 a result of treatment with
medications used to treat psychiatric conditions such as schizophrenia
and bipolar disease. There are currently no approved medications for
this condition in the United States.
About the AIM-TD Study
AIM-TD was a phase III, randomized, double-blind, placebo-controlled,
parallel group, fixed-dose study of 288 male and female adults with
moderate to severe TD. All patients had a total motor AIMS ≥ 6 at
screening and were randomized at baseline in a 1:1:1:1 ratio to receive
one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24
mg/day, 36 mg/day) or placebo. Patients underwent dose escalation during
the initial 4 weeks, followed by an 8-week maintenance period and a
1-week washout. For further details on the AIM-TD study, visit
https://clinicaltrials.gov/ct2/show/NCT02291861
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 1,800
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 integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are 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 incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160922005418/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, (215) 591-8912
or
Ran Meir, (215)
591-3033
or
Israel
Tomer Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7246
or
United States
Denise
Bradley, (215) 591-8974
or
Nancy Leone, (215)
284-0213