One late breaker, three platform presentations and 23 posters showcase fremanezumab as an investigational treatment for the prevention of migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced 23 abstracts, one late-breaking poster and three oral
presentations of fremanezumab for the preventive treatment of migraine
which will be presented at the American Headache Society’s (AHS) 60th
Annual Scientific Meeting in San Francisco from June 28-July 1, 2018.
This is the first time that one-year analyses of fremanezumab are being
presented. The new data include long-term response rates, acute headache
medication use, and disability. Additional data presentations from
clinical trials of fremanezumab examine efficacy, safety,
quality-of-life impact, and reversion of patients from chronic to
episodic migraine. Fremanezumab is an investigational therapy currently
under review by the U.S. Food and Drug Administration (FDA) as a
quarterly or monthly injection for the preventive treatment of migraine
in adults.
“Migraine remains a challenging disease with considerable unmet need,
due to availability of few therapeutic innovations over the past 25
years,” said Tushar Shah, M.D., Senior Vice President, Head of Global
Specialty Clinical Development at Teva. “Teva is committed to developing
novel treatments for patients with migraine headaches. We are excited to
share additional data at the meeting on fremanezumab, particularly over
the long-term, which is critical to patients.”
Antibodies targeting calcitonin gene-related peptides (anti-CGRPs), such
as fremanezumab, are a new class of therapies developed for the
prevention of migraine in adults.
Teva-sponsored abstracts at the AHS Annual Scientific Meeting include:
Late-Breaking Poster Presentation:
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Response Over Time with Fremanezumab in the Treatment of Chronic and
Episodic Migraine (Poster PF111)
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Friday, June 29, poster Q&A, 1:15 - 2:15 pm PT
Platform Presentations:
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The Impact of Fremanezumab on Medication Overuse in Patients with
Chronic Migraine (IOR07)
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Saturday, June 30, 8:00 am - 10:00 am PT
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Presentation time: 9:00 am - 9:10 am PT
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Response with Fremanezumab in the Treatment of Chronic Migraine (IOR11)
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Saturday, June 30, 8:00 am - 10:00 am PT
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Presentation time: 9:40 am - 9:50 am PT
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Reversion of Patients with Chronic Migraine to an Episodic Migraine
Classification with Fremanezumab Treatment (OR15)
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Saturday, June 30, 2:15 pm - 3:45 pm PT
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Presentation time: 2:15 pm - 2:25 pm PT
Long-Term Impact of Fremanezumab Posters (Yerba
Buena Ballroom in the San Francisco Marriott Marquis):
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Long-Term Impact of Fremanezumab on Response Rates, Acute Headache
Medication Use, and Disability in Patients with Chronic Migraine:
Interim Results of a One-Year Study (Poster PF14)
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Friday, June 29, 1:15 - 2:15 pm PT
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Fremanezumab Long-Term Efficacy and Safety: Interim Results of a
One-Year Study (Poster PS30)
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Saturday, June 30, 1:15 - 2:15 pm PT
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Long-Term Impact of Fremanezumab on Response Rates, Acute Headache
Medication Use, and Disability in Patients with Episodic Migraine:
Interim Results of a One-Year Study (Poster PS35)
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Saturday, June 30, 1:15 - 2:15 pm PT
Friday, June 29 Poster Sessions (Yerba Buena
Ballroom in the San Francisco Marriott Marquis); presentations between
1:15 - 2:15 pm PT
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Impact of Fremanezumab on the Number of Days with Use of Acute
Headache Medications in Chronic Migraine (Poster PF08)
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Efficacy of Fremanezumab in Patients with Chronic Migraine Who Had
Prior Use of Topiramate or OnabotulinumtoxinA (Poster PF09)
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The Impact of Fremanezumab on Headache-related Disability in Patients
with Chronic Migraine Using the Headache Impact Test (HIT-6) (Poster
PF12)
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The Impact of Fremanezumab on Symptoms Associated with Migraine in
Patients with Chronic Migraine (Poster PF15)
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Onset of Action with Fremanezumab versus Placebo for the Preventive
Treatment of Chronic Migraine (Poster PF19)
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The Impact of Fremanezumab on Migraine-specific Health-related Quality
of Life and Overall Health Status in Chronic Migraine (Poster PF23)
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Efficacy of Fremanezumab on Migraine Frequency and Depression in
Patients with Chronic Migraine and Comorbid Moderate to Moderately
Severe Depression (Poster PF24)
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The Impact of Fremanezumab on Work Productivity and Activity
Impairment in Patients with Chronic Migraine (Poster PF33)
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Onset of Action with Fremanezumab versus Placebo for the Preventive
Treatment of Episodic Migraine (Poster PF43)
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Impact of Fremanezumab on the Number of Days with Use of Acute
Headache Medications in Episodic Migraine (Poster PF44)
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Burden of Illness Among Treated Migraine Patients with ≥4 Headache
Days in the past Month (Poster PF79)
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The Impact of Fremanezumab on Headache-related Disability in Patients
with Episodic Migraine Using the Migraine Disability Assessment
(Poster PF82)
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The Impact of Fremanezumab on Migraine-Specific Health-Related Quality
of Life in Episodic Migraine (Poster PF87)
Saturday, June 30 Poster Sessions; (Yerba Buena
Ballroom in the San Francisco Marriott Marquis); presentations between
1:00 - 2:15 pm PT
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Relationship Between Fremanezumab Exposure and Efficacy in Preventive
Therapy of Chronic Migraine in Adults (Poster PS31)
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Relationship Between Fremanezumab Exposure and Efficacy in Preventive
Therapy of Episodic Migraine in Adults (Poster PS32)
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Efficacy of Fremanezumab in Patients with Episodic Migraine Who Had
Prior Use of Topiramate or OnabotulinumtoxinA (Poster PS34)
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Overview of Fremanezumab Pooled Safety Data from Placebo-Controlled
Phase 2 and 3 Studies (Poster PS40)
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Fremanezumab Cardiovascular Safety Profile: Pooled Data from
Placebo-controlled and Long-term Studies (Poster PS41)
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Lack of Relationship Between Fremanezumab Exposure and Cardiovascular
Adverse Events in Phase 2 and 3 Data Including Chronic and Episodic
Migraine Patients (Poster PS47)
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The Impact of Fremanezumab on Symptoms Associated with Migraine in
Patients with Episodic Migraine (Poster PS59)
About Fremanezumab
Fremanezumab is an investigational therapy currently under review by the
FDA as a quarterly or monthly injection for the preventive treatment of
migraine in adults.
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.
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 Fremanezumab, 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 uncertainty of obtaining regulatory approvals for Fremanezumab;
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the uncertainty of commercial success of Fremanezumab;
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our ability to successfully compete in the marketplace, including:
that we are substantially dependent on our generic products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives;
competition from companies with greater resources and capabilities;
efforts of pharmaceutical companies to limit the use of generics
including through legislation and regulations; consolidation of our
customer base and commercial alliances among our customers; 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 products, both
from competing products and increased regulation; delays in launches
of new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage of
high-value opportunities; the difficulty and expense of obtaining
licenses to proprietary technologies; 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 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 restructuring plan announced in December 2017;
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 ongoing 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;
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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;
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;
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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.
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