Two platform presentations and 19 posters
explore the potential of fremanezumab as an investigational
treatment option for the prevention of migraine
COPAXONE® (glatiramer acetate injection) and
AUSTEDO® (deutetrabenazine) tablets data highlight Teva’s ongoing
clinical research
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced 38 scientific abstracts across five difficult-to-treat
disorders of the central nervous system will be presented at the
70th Annual Meeting of the American Academy of Neurology (AAN) in
Los Angeles from April 21-27, 2018. The breadth of data spans a
diverse set of patient populations including migraine, multiple
sclerosis, tardive dyskinesia and Huntington’s disease.
“Teva’s data at AAN embodies our expertise in researching and
developing highly complex treatments for CNS disorders, especially
those for which there is still an enormous unmet patient need,”
said Tushar Shah, M.D., Senior Vice President, Head of Specialty
Clinical Development and Medical Affairs at Teva. “Our ongoing
research reflects Teva’s goal of developing innovative therapeutic
solutions that aim to help enable people to live better days.”
Among the 21 accepted migraine abstracts to be presented, 19
include additional data from the Phase III HALO clinical trial
program for fremanezumab, a monoclonal antibody targeting the CGRP
(calcitonin gene-related peptide) ligand, currently being
investigated as a preventive treatment for migraine. These data
examined the overall efficacy, safety and tolerability profile of
fremanezumab in both chronic and episodic migraine. Studies
included patients on fremanezumab alone or in combination with
other preventive medications.
Additional data further contribute to the scientific
understanding of the efficacy, safety and tolerability of Teva’s
COPAXONE® (glatiramer acetate injection) for the treatment of
relapsing multiple sclerosis (RMS), including up to seven-year
results from the Glatiramer Acetate
Low-Frequency Administration (GALA) study and an
abstract assessing pregnancy outcomes in RMS patients exposed to
COPAXONE® 20 mg/mL during all three trimesters. Teva will also
present AUSTEDO® (deutetrabenazine) tablets data providing clinical
and real-world insights into the applicability of use across chorea
associated with Huntington’s disease and tardive dyskinesia in
adults, two often underserved and overlooked movement
disorders.
The full set of Teva-sponsored data to be presented
includes:
Fremanezumab:
- [S32.005] Efficacy of Two Dose
Regimens of Subcutaneous Fremanezumab Versus Placebo for the
Preventive Treatment of Chronic Migraine (Platform Session 32,
April 25, 2018, 1:00 - 3:00 p.m. PT)
- [S32.007] The Impact of Fremanezumab
on Work Productivity and Activity Impairment in Patients with
Chronic Migraine (Platform Session 32, April 25, 2018, 1:00 -
3:00 p.m. PT)
- [P3.139] The Impact of Headache Free
Days on Quality of Life and Costs Among People with Migraine with
>4 Headache Days in the Past Month (Poster Session 3, April
24, 2018, 11:30 - 7:00 p.m. PT)
- [P3.144] Burden of Illness Among
Treated Migraine Patients with ≥4 Headache Days in the Past
Month (Poster Session 3, April 24, 2018, 11:30 - 7:00 p.m.
PT)
- [P4.093] Efficacy and Safety of 2
Dose Regimens of Subcutaneous Administration of Fremanezumab Versus
Placebo for the Preventive Treatment of Episodic Migraine
(Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.095] The Impact of Fremanezumab
on Headache-Related Disability in Patients with Episodic Migraine
using the Migraine Disability Assessment (Poster Session 4,
April 25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.097] Efficacy of Fremanezumab in
Patients With Chronic Migraine and Comorbid Moderate to Moderately
Severe Depression (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.099] Efficacy of Fremanezumab in
Patients With Chronic Migraine With or Without Concomitant Use of
Preventive Medication (Poster Session 4, April 25, 2018, 11:30
- 7:00 p.m. PT)
- [P4.101] Impact of Fremanezumab on
the Number of Days with Use of Acute Headache Medications in
Chronic Migraine (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.102] Onset of Action with
Fremanezumab Versus Placebo for the Preventive Treatment of Chronic
Migraine (Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m.
PT)
- [P4.104] Efficacy of Fremanezumab in
Patients With Chronic Migraine Who Had Prior Use of Topiramate or
OnabotulinumtoxinA (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.106] Impact of Fremanezumab on
the Number of Days With Use of Acute Headache Medications in
Episodic Migraine (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.107] Onset of Action with
Fremanezumab Versus Placebo for the Preventive Treatment of
Episodic Migraine (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.109] The Impact of Fremanezumab
on Headache-Related Disability in Patients with Chronic Migraine
Using the Headache Impact Test (HIT-6) (Poster Session 4, April
25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.110] Efficacy of Fremanezumab in
Patients With Episodic Migraine Who Had Prior Use of Topiramate or
OnabotulinumtoxinA (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
- [P4.111] Fremanezumab for Decreasing
Migraine Symptoms such as Nausea, Vomiting, Photophobia and
Phonophobia and Reducing the Need for Acute Medications in the
First Week of Treatment in the HFEM Study (Poster Session 4,
April 25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.112] Reversion of Patients With
Chronic Migraine to an Episodic Migraine Classification With
Fremanezumab Treatment (Poster Session 4, April 25, 2018, 11:30
- 7:00 p.m. PT)
- [P4.113] Response with Fremanezumab
in the Treatment of Chronic Migraine (Poster Session 4, April
25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.114] Fremanezumab for Reducing
Headache Pain within the First Week of Beginning Treatment in the
Phase 2 Episodic Migraine Study (Poster Session 4, April 25,
2018, 11:30 - 7:00 p.m. PT)
- [P4.115] The Impact of Fremanezumab
on Migraine-Specific Health-Related Quality of Life in Episodic
Migraine (Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m.
PT)
- [P4.117] The Impact of Fremanezumab
on Migraine-Specific Health-Related Quality of Life and Overall
Health Status in Chronic Migraine (Poster Session 4, April 25,
2018, 11:30 - 7:00 p.m. PT)
COPAXONE®:
- [P1.370] Integrated Transcriptomic
and Physicochemical Characterization of Glatiramer Acetate Products
(Copaxone and Glatopa) Available in the United States (Poster
Session 1, April 22, 2018, 11:30 - 5:30 p.m. PT)
- [P1.400] Physicochemical and
Biological Characterization of both Copaxone and the European
Follow-On Glatiramer Acetate Product (Poster Session 1, April
22, 2018, 11:30 - 5:30 p.m. PT)
- [P3.415] Defining Glatiramer
Acetate: The USA Definition of Sameness and the EU Definition of
Similarity (Poster Session 3, April 24, 2018, 11:30 - 7:00 p.m.
PT)
- [P3.416] Bayesian Analysis of
Glatiramer Acetate 40 mg/mL TIW Treatment Effect in Reducing
Relapse Rate (Poster Session 3, April 24, 2018, 11:30 - 7:00
p.m. PT)
- [P4.362] Pregnancy Outcomes in
Patients with Multiple Sclerosis and Exposure to Branded Glatiramer
Acetate During all Three Trimesters (Poster Session 4, April
25, 2018, 11:30 - 7:00 p.m. PT)
- [P6.378] Long-term Efficacy, Safety,
and Tolerability of Three-times Weekly Dosing Regimen of Glatiramer
Acetate in Relapsing-Remitting Multiple Sclerosis Patients: 5-year
Results of the Glatiramer Acetate Low-Frequency Administration
(GALA) Open-label Extension Study (Poster Session 6, April 27,
2018, 11:30 - 5:30 p.m. PT)
AUSTEDO®:
- [P4.040] Initial Deutetrabenazine
Compliance, Satisfaction, and Patient Perception of Change in
Huntington Disease Symptoms (Poster Session 4, April 25, 2018,
11:30 - 7:00 p.m. PT)
- [P4.044] Healthcare Utilization and
Costs for Huntington Disease Patients Prescribed Tetrabenazine
(Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m. PT)
- [P4.050] Experience of Individuals
With Huntington Disease and Chorea (Poster Session 4, April 25,
2018, 11:30 - 7:00 p.m. PT)
- [P4.075] Confirmed Safety of
Deutetrabenazine for Tardive Dyskinesia in a 2-Year Open-Label
Extension Study (Poster Session 4, April 25, 2018, 11:30 - 7:00
p.m. PT)
- [P4.076] Long-Term Treatment With
Deutetrabenazine is Associated With Continued Improvement in
Tardive Dyskinesia (TD): Results From an Open-Label Extension
Study (Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m.
PT)
- [P4.077] Effect of Tardive
Dyskinesia on Quality of Life: Patient-reported Symptom Severity is
Associated with Deficits in Physical, Mental, and Social
Functioning (Poster Session 4, April 25, 2018, 11:30 - 7:00
p.m. PT)
- [P4.080] Cardiovascular Safety
Assessment of Deutetrabenazine in Healthy Volunteers and
Implications for Patients With Huntington Disease or Tardive
Dyskinesia (Poster Session 4, April 25, 2018, 11:30 - 7:00 p.m.
PT)
- [P4.081] Tardive Dyskinesia Among
Patients Using Antipsychotic Medications in Customary Clinical Care
in the United States (Poster Session 4, April 25, 2018, 11:30 -
7:00 p.m. PT)
Laquinimod:
- [S8.003] ARPEGGIO: A
Placebo-controlled Trial of Oral Laquinimod in Primary Progressive
Multiple Sclerosis (Platform Session 8, April 22, 2018, 3:30 -
5:30 p.m. PT)
Pridopidine:
- [P3.324] Pridopidine Treatment
Recovers Gait Abnormalities and Rescues Impaired BDNF Expression in
a Rett Syndrome Mouse Model (Poster Session 3, April 24, 2018,
11:30 - 7:00 p.m. PT)
- [P4.048] Loss of the Sigma-1
Receptor Disrupts Pridopidine-induced Gene Expression (Poster
Session 4, April 25, 2018, 11:30 - 7:00 p.m. PT)
About COPAXONE® (glatiramer acetate
injection)
COPAXONE® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis. Please click here for U.S.
Full Prescribing Information:
www.CopaxonePrescribingInformation.com. COPAXONE® is approved in
more than 50 countries worldwide, including the United States,
Russia, Canada, Mexico, Australia, Israel, and all European
countries.
Important Safety Information about COPAXONE®
COPAXONE® is contraindicated in patients with known
hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL
compared to 4% of those on placebo, and approximately 2% of
patients exposed to COPAXONE® 40 mg per mL compared to none on
placebo experienced a constellation of symptoms that may occur
within minutes after injection and included at least 2 of the
following: flushing, chest pain, palpitations, tachycardia,
anxiety, dyspnea, throat constriction, and urticaria. In general,
these symptoms have their onset several months after the initiation
of treatment, although they may occur earlier, and a given patient
may experience 1 or several episodes of these symptoms. Typically,
the symptoms were transient and self-limited and did not require
treatment; however, there have been reports of patients with
similar symptoms who received emergency medical care.
Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL
patients compared to 6% of placebo patients, and approximately 2%
of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While
some episodes of chest pain occurred in the context of the
Post-Injection Reaction described above, many did not. The temporal
relationship of this chest pain to an injection was not always
known. The pain was usually transient, often unassociated with
other symptoms, and appeared to have no clinical sequelae. Some
patients experienced more than 1 such episode, and episodes usually
began at least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection
site skin necrosis may occur. Lipoatrophy may occur at various
times after treatment onset (sometimes after several months) and is
thought to be permanent. There is no known therapy for
lipoatrophy.
Because COPAXONE® can modify immune response, it may interfere
with immune functions. For example, treatment with COPAXONE® may
interfere with recognition of foreign antigens in a way that would
undermine the body’s tumor surveillance and its defenses against
infection. There is no evidence that COPAXONE® does this, but there
has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were injection site
reactions (ISRs), such as erythema (43% vs 10%); vasodilatation
(20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain
(13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were ISRs, such as
erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to
discontinuation of COPAXONE®. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy,
occurred at a higher rate with COPAXONE® than placebo.
About AUSTEDO® (deutetrabenazine)
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.
Important Safety Information
AUSTEDO® can increase the risk of
depression and suicidal thoughts and behavior (suicidality) in
patients with Huntington’s disease. Anyone considering the use of
AUSTEDO® must balance the risks of depression
and suicidality with the clinical need for treatment of chorea.
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®).
AUSTEDO® may cause a worsening in mood, cognition,
rigidity, and functional capacity in patients with Huntington’s
disease. Tetrabenazine (a closely related VMAT2 inhibitor) causes
an increase in the corrected QT (QTc) interval. A clinically
relevant QT prolongation may occur in some patients treated with
AUSTEDO® who are CYP2D6 poor metabolizers or are
co-administered a strong CYP2D6 inhibitor or other drugs that are
known to prolong QTc. Neuroleptic Malignant Syndrome has been
observed in patients receiving tetrabenazine. AUSTEDO® may
increase the risk of akathisia, agitation, and restlessness.
AUSTEDO® may cause parkinsonism in patients with Huntington’s
disease. Sedation is a common dose-limiting adverse reaction of
AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies
of patients with tardive dyskinesia were nasopharyngitis and
insomnia. The most common adverse reactions (>8% of
AUSTEDO®-treated patients and greater than placebo) in a controlled
clinical study of patients with chorea associated with Huntington’s
disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information,
including Boxed Warning: austedo.com/hcp/pi.
About Fremanezumab
Fremanezumab is a monoclonal antibody targeting the CGRP
(calcitonin gene-related peptide) ligand, currently being
investigated as a preventive treatment for migraine. With limited
availability of preventive treatment options, fremanezumab
represents a potential new option to address a significant unmet
medical need.
Fremanezumab is also being investigated for the prevention of
chronic and episodic cluster headache as part of the Phase III
ENFORCE clinical research program, which has been granted fast
track designation by the FDA. Fast track designation is
intended to facilitate development and expedite review of drugs to
treat serious or life-threatening conditions. Additionally, Teva
has also recently initiated a fremanezumab Phase II clinical
program for the treatment of post-traumatic headache disorder.
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 2017 were $22.4 billion. For
more information, visit 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 Teva's innovative therapeutic solutions, 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:
- commercial success of the various
Teva's innovative therapeutic solutions;
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals;
- 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 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;
- 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 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: failure to effectively execute the recently announced
restructuring plan; uncertainties related to, and failure to
achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the expected review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; 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
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; 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: 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; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; 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 our Annual Report on Form 10-K
for the year ended December 31, 2017, including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180417005130/en/
IR ContactsUnited StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033IsraelTomer Amitai, 972
(3) 926 7656orPR ContactsUnited StatesMichelle
Larkin, 610-786-7335IsraelYonatan Beker, 972 (54) 888
5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024