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Two platform presentations and 19 posters explore the potential of
fremanezumab as an investigational treatment option for the prevention
COPAXONE® (glatiramer acetate injection) and
AUSTEDO® (deutetrabenazine) tablets data
highlight Teva’s ongoing clinical research
JERUSALEM--(BUSINESS WIRE)--Apr. 17, 2018--
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:
About COPAXONE® (glatiramer acetate
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
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
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.
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:
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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180417005130/en/
Source: Teva Pharmaceutical Industries Ltd.
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