- Teva presents 17 posters and three oral
presentations at EHF 2019 highlighting long-term and FOCUS Phase
IIIb study data
- The poster presentations highlight
FOCUS data in migraine patients who have failed two to four classes
of prior migraine preventive medications; as well as present
further clinical study data regarding the efficacy and safety
results of fremanezumab through 12 months of treatment in patients
with chronic and episodic migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that data from the Phase IIIb FOCUS study, which
evaluated the efficacy and safety of fremanezumab for the
preventive treatment of migraine in adult patients who previously
experienced inadequate response to two to four classes of migraine
preventive treatments, will be available at the 13th European
Headache Federation (EHF) Congress. This European Congress for
healthcare professionals aims to improve the lives of patients
affected by migraine by presenting new scientific evidence on
migraine prevention, associated comorbidities and the pathogenesis
of migraine. EHF is taking place at the ‘Megaron’ Athens
International Conference Centre (MAICC), Athens, Greece on May 30th
- June 1st 2019.
The FOCUS study is the largest study to date in patients who
inadequately responded to multiple classes of preventive migraine
treatments. It is the first study of its type to be conducted in
chronic as well as episodic migraine patients.
Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine
& Headache at Teva said: “Patients with inadequate response to
multiple migraine preventive treatment classes have significant
unmet need for the management of their disabling migraine. The
FOCUS study results demonstrate the benefit of fremanezumab in
addressing the burden of disease in this difficult-to-treat patient
population. Teva is committed to meet the needs of migraine
patients and their families and we will explore undertaking Phase
IV studies with fremanezumab in order to increase our understanding
of the disease.”
Professor of Neurology and Chair of the Leiden Centre for
Translational Neuroscience at Leiden University Medical Centre,
Michel D. Ferrari, MD, PhD, FANA, FRCP said: “The FOCUS study data
convincingly show that patients with difficult to treat migraine,
previously not responding to up to four migraine preventive
treatment classes, might still benefit significantly from treatment
with fremanezumab. I am delighted that this data will be presented
for the first time at the EHF Congress in Athens.”
In the FOCUS study, patients treated with fremanezumab
experienced significant reduction in the monthly average number of
migraine days versus placebo over the 12-week treatment period, for
both monthly and quarterly dosing regimens. In addition, patients
treated with fremanezumab experienced significant improvement
compared to placebo on all secondary endpoints for both quarterly
and monthly dosing regimens. Teva will also host a satellite
symposium on Friday during the congress.
Notes to the Editor
The full set of Teva-sponsored data to be presented
includes:
Oral presentations:
30th May 201912.00pm – 12.15pmPresenter:
Prof. Messoud Ashina
Efficacy and safety of fremanezumab in patients with migraine
and documented inadequate response to 2-4 classes of migraine
preventive treatments: results of the international, multicentre,
randomised, placebo-controlled FOCUS study.
31st May 201914.45pm – 15.00pmPresenter:
Prof. Richard Lipton
Long-term efficacy of fremanezumab in patients who reverted from
a chronic to an episodic migraine classification.
31st May 201915.00pm – 15.15pmPresenter:
Joshua M. Cohen
Efficacy, clinically meaningful responses, and impact on acute
headache medication use with fremanezumab in patients with migraine
and documented inadequate response to 2-4 classes of migraine
preventive treatments: results of the international, multicentre,
randomised, placebo-controlled FOCUS study.
e-Poster presentations
FOCUS Study:The FOCUS Study provides data in migraine
patients who responded inadequately to two to four classes of prior
migraine preventive medications.
Titles of the presentations include:
- Efficacy of fremanezumab in patients
with migraine and documented inadequate response to 2, 3, or 4
classes of migraine preventive treatments: results of the
international, multicentre, randomised, placebo-controlled FOCUS
study
- Early onset of response to fremanezumab
in patients with migraine and a documented inadequate response to
2-4 classes of migraine preventive treatments: results of the
international, multicentre, randomised, placebo-controlled FOCUS
study
- Impact of age and sex on efficacy of
fremanezumab in patients with migraine and documented inadequate
response to 2-4 classes of migraine preventive treatments: results
of the international, multicentre, randomised, placebo-controlled
FOCUS study
Long-Term Study:The following presentations will be
presented:
Efficacy
- Improvement in response over time with
fremanezumab in patients who reverted from a chronic to an episodic
migraine classification
- Long-term impact of fremanezumab on
patients who reverted from a chronic to an episodic migraine
classification
- Long-term efficacy and safety of
fremanezumab in migraine: results of a 1-year study
- Long-term efficacy of fremanezumab in
patients with chronic migraine with concomitant preventive
medication use
- Long-term impact of fremanezumab on
response rates: results of a 1-year study
- Long-term safety of fremanezumab:
results of a 1-year study
- Quarterly administration of
fremanezumab does not show “wearing off” effect during third month
after injection
Comorbidity/Disability
- Long-term efficacy of fremanezumab in
patients with chronic migraine and comorbid moderate to severe
depression
- Long-term impact of fremanezumab on
response rates, acute headache medication use, and disability in
patients with chronic migraine: results of a 1-year study
- Long-term impact of fremanezumab on
headache-related disability, quality of life, and patient
satisfaction in episodic migraine and chronic migraine
- Long-term impact of fremanezumab on
response rates, acute headache medication use, and disability in
patients with episodic migraine: results of a 1-year study
Meta analyses
- Reduction in monthly migraine days
(MMDs) with fremanezumab and erenumab among patients with chronic
migraine (CM) with 2 to 4 prior treatment failures: A Network
Meta-Analysis
- Reduction in monthly migraine days
(MMDs) with fremanezumab and erenumab among patients with episodic
migraine (EM) with 2-4 prior treatment failures: A Network
Meta-Analysis
- Comparison of responder rates between
fremanezumab, erenumab and onabotulinumtoxinA among patients with
migraine with ≥3 prior treatment failures: A Network
Meta-Analysis
Teva Symposium
Migraine Burden in Europe: What Role Can Innovations
Play?
Chair: Professor Dimos D. Mitsikostas, MD, PhD, FEAN
Friday 31st May, 15:45 – 17:00, ‘Megaron’
Athens International Conference Centre (MAICC), Alexandra Trianti
Hall
Educational Symposium Program Overview:Migraine remains a
leading cause of disability in the European Union (EU) and is
associated with a substantial economic and societal burden.
However, the recent introduction of monoclonal antibodies (mAbs)
that target calcitonin gene-related peptide into the treatment
armamentarium offers a potential means to ease the burden of
migraine on both patients and the EU healthcare system. This
program will examine the epidemiology of migraine, along with its
social and financial impacts; explain the scientific advancements
behind the clinical utility of mAbs; and discuss findings from 2
clinical studies of the mAb fremanezumab for migraine prevention; a
long-term study and a study in patients with refractory episodic
and chronic migraine.
The full online programme can be accessed via the congresses
official website: https://www.ehf2019.com/calendar
About FOCUS
The Phase IIIb FOCUS study is a multicenter, randomized,
double-blind, parallel-group, placebo-controlled study that
evaluated the efficacy, safety, and tolerability of quarterly and
monthly treatment with fremanezumab, compared to placebo. Adult
patients with chronic migraine or episodic migraine who have
responded inadequately to two to four classes of prior preventive
treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at
least three months of therapy at a stable dose; or the patient
cannot tolerate the drug; or the drug is contraindicated; or the
drug is not suitable for the patient. The classes of medications
include: beta-blockers, anticonvulsants, tricyclics, calcium
channel blockers, angiotensin II receptor antagonists,
onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients
were randomized in blinded-fashion 1:1:1 into one of three
treatment groups – a quarterly dosing regimen, a monthly dosing
regimen or matching placebo. An open-label extension of three
months (weeks 13-24) followed the placebo-controlled portion of the
study.
About Migraine
Migraine is a disabling neurological disease characterized by
severe head pain, nausea and vomiting.i With more than 1 billion
people affected worldwidei, migraine is the third most prevalent
disease in the world.ii
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 35,000
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
Teva 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 (commercialized as AJOVY®▼), 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 commercial success
of AJOVY®;
- 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; the uncertainty of commercial
success of AJOVY® and AUSTEDO®; 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;
- 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: failure to effectively execute our 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;
- 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 selling 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, 2018,
including the sections thereof captioned "Risk Factors."
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.
▼ Adverse events should be reported. This medicinal
product is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse events.
Reporting forms and information can be
found at https://www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. Adverse events
should also be reported to Teva – please refer to local
numbers.
i Migraine Research Foundation. Migraine Facts.
https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed November 2018.ii Migraine Trust. Facts and Figures.
https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/.
Accessed November 2018.
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AmsterdamFiona Cohen +31 6 2008 2545
United StatesDoris Saltkill +1(913)777-3343
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