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
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
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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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version on businesswire.com: http://www.businesswire.com/news/home/20160922005418/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, (215) 591-8912orRan Meir, (215)
591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7246orUnited StatesDenise Bradley, (215)
591-8974orNancy Leone, (215) 284-0213
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