Teva to present new fremanezumab FOCUS Clinical Study Data for the first time at the 13th European Headache Federation Congress
May 29, 2019-
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
JERUSALEM–(BUSINESS WIRE)–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 2019
12.00pm – 12.15pm
Presenter:
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 2019
14.45pm – 15.00pm
Presenter:
Prof. Richard Lipton
Long-term efficacy of fremanezumab in patients who reverted from a
chronic to an episodic migraine classification.
31st May 2019
15.00pm – 15.15pm
Presenter:
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 |
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.
Contacts
Amsterdam
Fiona Cohen +31 6 2008 2545
United States
Doris Saltkill +1(913)777-3343
