Approval represents the first new treatment option for chorea
associated with Huntington’s disease in nearly a decade
JERUSALEM--(BUSINESS WIRE)--Apr. 3, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) has approved
AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea
associated with Huntington’s disease (HD). Previously referred to by the
developmental name SD-809, AUSTEDOTM is the first deuterated
product approved by the FDA and only the second product approved in HD.
The product was previously granted Orphan Drug Designation by the FDA.
A rare and fatal neurodegenerative disorder, HD affects more than 35,000
people in the United States. Chorea – involuntary, random and sudden,
twisting and/or writhing movements – is one of the most striking
physical manifestations of this disease and occurs in approximately 90%
of patients. “Chorea is a major symptom for many living with Huntington
disease. It impacts patients’ functionality and activities of daily
living, and there have been limited treatment options for these
patients,” said Michael Hayden, M.D., Ph.D., President of Global R&D and
Chief Scientific Officer at Teva. “Based on the results demonstrated in
the clinical development program which supported the approval of
AUSTEDO™ and our ongoing commitment to patients, we feel uniquely
positioned to bring this treatment option forward.”
The FDA approval was based on results from a Phase III randomized,
placebo-controlled study to assess the safety and efficacy of AUSTEDO™
in reducing chorea in patients with HD (First-HD).
“At Teva, we have a long history of establishing comprehensive disease
management programs in chronic disease areas. We have highly skilled
teams experienced in building relationships with patients, their care
partners and healthcare professionals,” said Rob Koremans, MD, President
and CEO of Global Specialty Medicines at Teva. “Bringing a new treatment
forward where the unmet need is so significant is an inspiring
opportunity. Our commercial and medical organizations are well prepared
to make this important treatment available to the HD community.”
“Chorea associated with Huntington’s disease has a significant impact on
those living with the disease and their families,” said Louise Vetter,
Chief Executive Officer of the Huntington’s Disease Society of America.
“The FDA’s approval of AUSTEDO™ represents an important new treatment
option for people with HD and highlights the need for more therapeutic
resources for this underserved patient community.”
Teva’s Shared Solutions® is a free service to provide support
to patients starting or taking AUSTEDOTM at 1-800-887-8100.
Resources include nursing support, disease education, and financial
assistance programs. AUSTEDOTM is expected to be available in
the U.S. within the next 3 weeks.
About AUSTEDOTM
AUSTEDOTM is indicated for the treatment of chorea associated
with Huntington’s disease.
The efficacy of AUSTEDOTM as a treatment for chorea
associated with Huntington's disease was established in a randomized,
double-blind, placebo-controlled, multi-center trial conducted in 90
ambulatory patients with manifest chorea associated with Huntington’s
disease. Total Maximal Chorea Scores for patients receiving AUSTEDOTM
improved by approximately 4.4 units from baseline to the maintenance
period (average of Week 9 and Week 12), compared to approximately 1.9
units in the placebo group. The treatment effect of -2.5 units was
statistically significant (p<0.0001). The Maintenance Endpoint is the
mean of the Total Maximal Chorea Scores for the Week 9 and Week 12
visits. At the Week 13 follow-up visit (1 week after discontinuation of
the study medication), the Total Maximal Chorea Scores of patients who
had received AUSTEDOTM returned to baseline.
Important Safety Information
WARNING: DEPRESSION AND SUICIDALITY. AUSTEDOTM
can increase the risk of depression and suicidal thoughts and behavior
(suicidality) in patients with Huntington’s disease. Anyone considering
the use of AUSTEDOTM must balance the risks of
depression and suicidality with the clinical need for treatment of
chorea. AUSTEDOTM is contraindicated in
patients who are suicidal, and in patients with untreated or
inadequately treated depression.
AUSTEDOTM is also contraindicated in: patients with hepatic
impairment; patients taking monoamine oxidase inhibitors (MAOIs), or
within 14 days of discontinuing MAOI therapy; patients taking reserpine
or within 20 days of discontinuing reserpine; and patients taking
tetrabenazine (XENAZINE®).
VMAT2 inhibitors, including AUSTEDOTM, may cause a worsening
in mood, cognition, rigidity, and functional capacity.
Neuroleptic Malignant Syndrome has been observed in patients receiving
tetrabenazine (a closely related VMAT2 inhibitor). AUSTEDOTM
may increase the risk of akathisia, agitation, and restlessness and may
cause parkinsonism in patients with Huntington’s disease. Sedation is a
common dose-limiting adverse reaction of AUSTEDOTM.
Tetrabenazine causes an increase in the corrected QT (QTc) interval. A
clinically relevant QT prolongation may occur in some patients treated
with AUSTEDOTM who are CYP2D6 poor metabolizers or are
co-administered a strong CYP2D6 inhibitor. Tetrabenazine elevates serum
prolactin concentrations in humans.
Since deutetrabenazine or its metabolites bind to melanin-containing
tissues, it could accumulate in these tissues over time. The most common
adverse reactions (>8% of AUSTEDOTM-treated patients and
greater than placebo) in a controlled clinical study were: somnolence,
diarrhea, dry mouth, and fatigue.
Please click here for full Prescribing Information, including Boxed
Warning: austedo.com/pi.
A copy may be requested from the US Medical Information Contact
Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com
or Teva’s Public Relations or Investor Relations contacts.
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 approximately 200 million
patients in 100 markets 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 the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, which
are based on management’s current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
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our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Actavis Generics; our
ability to realize the anticipated benefits of the acquisition (and
any delay in realizing those benefits) or difficulties in integrating
Actavis Generics; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
-
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to market AustedoTM successfully and
realize its potential, our ability to achieve expected results from
investments in our product pipeline; competition from companies with
greater resources and capabilities; and the effectiveness of our
patents and other measures to protect our intellectual property rights;
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our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make new
investments, and may result in a downgrade of our credit ratings;
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our business and operations in general, including: uncertainties
relating to our recent senior management changes; our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our information
technology systems or breaches of our data security; the failure to
recruit or retain key personnel, including those who joined us as part
of the Actavis Generics acquisition; the restructuring of our
manufacturing network, including potential related labor unrest; the
impact of continuing consolidation of our distributors and customers;
variations in patent laws that may adversely affect our ability to
manufacture our products; adverse effects of political or economic
instability, major hostilities or terrorism on our significant
worldwide operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate and
integrate acquisitions;
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compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
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comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
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other financial risks, including: our exposure to currency
fluctuations and restrictions as well as credit risks; the significant
increase in our intangible assets, which may result in additional
substantial impairment charges; potentially significant increases in
tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”) 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 contained herein,
whether as a result of new information, future events or otherwise. You
are advised to consult any additional disclosures we make in our reports
to the SEC on Form 6-K, as well as the cautionary discussion of risks
and uncertainties under “Risk Factors” in our Annual Report. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those listed
could also materially and adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1995.
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Source: Teva Pharmaceutical Industries Ltd.
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