19 presentations will examine long-term and
real-world AJOVY data as well as AUSTEDO safety and adherence
data
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced 19 presentations examining clinical and real-world data
for AJOVY® (fremanezumab-vfrm) injection and AUSTEDO®
(deutetrabenazine) tablets will be presented at the upcoming 2021
American Academy of Neurology (AAN) Virtual Annual Meeting, taking
place April 17-22.
“We are committed to improving the lives of patients and further
evaluating AJOVY and AUSTEDO so we can continue to help healthcare
professionals and patients make informed treatment decisions,” said
Denisa Hurtukova, MD, VP, Head of North America Medical Affairs.
“The data being presented at this year’s AAN meeting offer
important information on the integrated safety of AUSTEDO as well
as clinical analyses and real-world experience of patients treated
with AJOVY.”
At this year’s AAN, Teva’s neurology portfolio will highlight
integrated safety data for AUSTEDO in the treatment of both tardive
dyskinesia (TD) and chorea associated with Huntington’s disease
(HD). The analysis examined safety by comparing the incidence of
adverse events with AUSTEDO versus placebo in: two pivotal TD
studies (ARM-TD and AIM-TD) and through week 15 of an open-label
extension study (RIM-TD); as well as data in HD patients captured
upon first exposure to AUSTEDO in the First-HD pivotal trial and
through week 15 of a long-term open label extension trial
(ARC-HD).
Other AUSTEDO posters include an analysis of real-world
adherence patterns with AUSTEDO and tetrabenazine among patients
diagnosed with HD, as well as the impact on quality of life of
different severity levels of chorea associated with HD.
AJOVY data being presented include results from clinical and
real-world analyses. The data being presented at the meeting spans
17 posters and include post-hoc Phase 3 data examining the
long-term response of AJOVY in patients who initially did not
respond to treatment, an analysis of real-world treatment patterns
for patients prescribed AJOVY, and a retrospective evaluation of
quarterly and monthly dosing with AJOVY in a real-world
setting.
This year’s annual AAN meeting is fully virtual. Data
presentations can be accessed by registering for the meeting.
The full set of Teva-sponsored neurology portfolio data to be
presented includes:
AJOVY®:
De novo
- P10.023 Long-term Efficacy of Fremanezumab in Patients with
Chronic or Episodic Migraine Who Were Inadequate Responders to
Initial Fremanezumab Treatment
- P10.031 US Real-world Effectiveness of Quarterly and Monthly
Fremanezumab for Reducing Migraine Days and Headache Days in Adult
Patients with Migraine
- P10.088 US Real-World Patient Characteristics, Acute Medication
Use, and Treatment Patterns for Patients Initiating
Fremanezumab
- P10.021 Early Reductions in Headache Severity and Duration With
Fremanezumab Treatment in the Randomized, Double-blind Phase 3b
FOCUS study
- P10.125 Effect of Fremanezumab on the Total Burden of Migraine
in Patients with Episodic or Chronic Migraine: Findings from 3
Randomized, Double-blind, Placebo-controlled Phase 3 Studies
- P10.120 Real-world Reductions in Migraine and Headache Days for
Patients With Chronic and Episodic Migraine Initiating Fremanezumab
in the US
- P10.051 US Real-world Migraine-related Health Care Resource
Utilization and Costs for Patients Initiating Fremanezumab
- P10.122 Baseline Comorbidities and Changes in Acute Medication
Use by Quarterly and Monthly Dosing Regimen in Patients Prescribed
AJOVY in US Physician Practices
- P10.046 Efficacy of Fremanezumab in Patients With Moderate and
Higher Frequency Episodic Migraine
- P10.024 Efficacy of Fremanezumab in Patients With Lower and
Higher Frequency Chronic Migraine
- P10.029 A Phase 2 Study of Fremanezumab as a Treatment for
Posttraumatic Headache in Adult Patients
Encore:
- P10.121 Improvements in Patient-reported Migraine Pain
Intensity and Composite Migraine Symptoms With Fremanezumab in the
Real World
- P10.119 Real-world Adherence, Persistence, Switching, and
Reinitiation in Patients Prescribed AJOVY in US Physician
Practices
- P10.123 Real-World Adherence, Persistence, Switching, and
Reinitiation by Quarterly and Monthly Dosing Regimen in Patients
Prescribed AJOVY in US Physician Practices
- P10.118 Number Needed to Treat/Harm for Fremanezumab in
Patients Who Had Inadequate Response to 2-4 Prior Migraine
Preventive Medication Classes
- P10.034 Cardiovascular Safety of Fremanezumab in Patients With
Migraine and Cardiovascular Medical History or Risk Factors: a
Pooled Analysis of Phase 3 Studies
- P10.007 Efficacy in Patients Switching from Quarterly to
Monthly Fremanezumab or Maintained on Monthly Fremanezumab
Treatment Over 6 Months in the Phase 3b FOCUS Study
AUSTEDO®:
De novo:
- P14.136 Incidence of Adverse Events Associated With
Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea
Associated With Huntington’s Disease
Encore health economic data:
- P14.047 Real-World Adherence to Tetrabenazine or
Deutetrabenazine Among Patients With Huntington’s Disease
- P14.044 Defining Utility Values for Chorea Health States in
Patients With Huntington’s Disease
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a
prefilled syringe or autoinjector with two dosing options – 225 mg
monthly administered as one subcutaneous injection, or 675 mg every
three months (quarterly), which is administered as three
subcutaneous injections. AJOVY can be administered in office by a
healthcare professional or at home by a patient or caregiver. No
starting dose is required to begin treatment.
Indications and Usage
AJOVY® is a calcitonin gene-related peptide antagonist indicated
for the preventive treatment of migraine in adults.
U.S. Important Safety Information about AJOVY®
(fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, pruritus, drug hypersensitivity, and urticaria were
reported with AJOVY in clinical trials. Most reactions were mild to
moderate, but some led to discontinuation or required
corticosteroid treatment. Most reactions were reported from within
hours to one month after administration. If a hypersensitivity
reaction occurs, consider discontinuing AJOVY and institute
appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5%
and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
About AUSTEDO® (deutetrabenazine) Tablets
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease. Safety and
effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated
with Huntington’s disease and for the treatment of tardive
dyskinesia in adults.
Important Safety Information
Depression and Suicidality in Patients with Huntington’s
Disease: AUSTEDO can increase the risk of depression and
suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Balance the risks of depression and
suicidality with the clinical need for treatment of chorea.
Closely monitor patients for the emergence or worsening of
depression, suicidality, or unusual changes in behavior. Inform
patients, their caregivers, and families of the risk of depression
and suicidality and instruct them to report behaviors of concern
promptly to the treating physician. Exercise caution when treating
patients with a history of depression or prior suicide attempts or
ideation. AUSTEDO is contraindicated in patients who are suicidal,
and in patients with untreated or inadequately treated
depression.
Contraindications: AUSTEDO is contraindicated in patients
with Huntington’s disease who are suicidal, or have untreated or
inadequately treated depression. AUSTEDO is also contraindicated
in: patients with hepatic impairment; patients taking reserpine or
within 20 days of discontinuing reserpine; patients taking
monoamine oxidase inhibitors (MAOIs), or within 14 days of
discontinuing MAOI therapy; and patients taking tetrabenazine
(Xenazine®) or valbenazine (Ingrezza®).
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO may cause a worsening in mood,
cognition, rigidity, and functional capacity. Prescribers
should periodically re-evaluate the need for AUSTEDO in their
patients by assessing the effect on chorea and possible adverse
effects.
QTc Prolongation: AUSTEDO may prolong the QT interval,
but the degree of QT prolongation is not clinically significant
when AUSTEDO is administered within the recommended dosage range.
AUSTEDO should be avoided in patients with congenital long QT
syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal
symptom complex reported in association with drugs that reduce
dopaminergic transmission, has been observed in patients receiving
tetrabenazine. The risk may be increased by concomitant use of
dopamine antagonists or antipsychotics. The management of NMS
should include immediate discontinuation of AUSTEDO; intensive
symptomatic treatment and medical monitoring; and treatment of any
concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO may
increase the risk of akathisia, agitation, and restlessness. The
risk of akathisia may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops akathisia, the
AUSTEDO dose should be reduced; some patients may require
discontinuation of therapy.
Parkinsonism: AUSTEDO may cause parkinsonism in patients
with Huntington’s disease or tardive dyskinesia. Parkinsonism has
also been observed with other VMAT2 inhibitors. The risk of
parkinsonism may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops parkinsonism,
the AUSTEDO dose should be reduced; some patients may require
discontinuation of therapy.
Sedation and Somnolence: Sedation is a common
dose-limiting adverse reaction of AUSTEDO. Patients should not
perform activities requiring mental alertness, such as operating a
motor vehicle or hazardous machinery, until they are on a
maintenance dose of AUSTEDO and know how the drug affects them.
Concomitant use of alcohol or other sedating drugs may have
additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum
prolactin concentrations in humans. If there is a clinical
suspicion of symptomatic hyperprolactinemia, appropriate laboratory
testing should be done and consideration should be given to
discontinuation of AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine
or its metabolites bind to melanin-containing tissues and could
accumulate in these tissues over time. Prescribers should be aware
of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse
reactions for AUSTEDO (>8% and greater than placebo) in a
controlled clinical study in patients with Huntington’s disease
were somnolence, diarrhea, dry mouth, and fatigue. The most common
adverse reactions for AUSTEDO (4% and greater than placebo) in
controlled clinical studies in patients with tardive dyskinesia
were nasopharyngitis and insomnia.
Please see accompanying full Prescribing Information,
including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding AJOVY and AUSTEDO, 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:
- the commercial success of AJOVY;
- the commercial success of AUSTEDO;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO, AJOVY and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
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 this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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 cautioned not to
put undue reliance on these forward-looking statements.
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IR Contacts United States Kevin C. Mannix (215)
591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
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