These results include reduction in monthly
average migraine days; reduction in migraine related symptoms; and
improvements in depression status; work productivity and activity
impairment.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
is proud to present the FOCUS exploratory endpoints results at the
5th Congress of the European Academy of Neurology (EAN), Oslo,
Norway from June 29th - July 2nd, 2019.
These endpoints, which were shared for the first time at EAN,
conclude the presentation of pre-specified study endpoints from the
Phase IIIb FOCUS study. This study evaluated the efficacy and
safety of fremanezumab for the preventive treatment of migraine in
adult patients who previously experienced inadequate responses to
two to four classes of preventive treatments.
Director of the Headache Clinical Unit and Research Group at
Vall d’Hebron Hospital and Institute of Research (VHIR), Patricia
Pozo Rosich, MD, PhD, said: “The FOCUS study results demonstrate
the potential of fremanezumab in addressing the burden of migraine
in this difficult-to-treat patient population and I am glad to see
the exploratory data being presented at EAN which includes quality
of life and disability results, which also improved in these
patients who have a substantial daily burden due to their
migraine.”
“Migraine is the second leading cause of years lived with
disability worldwide with profound impact on patients, their
families and friends, and on society as a whole. Data from the
FOCUS study disclose the results of fremanezumab on a range of
quality of life and disability measures as well as demonstrating a
significant reduction in the number of headache hours and days
suffered by patients and on a spectrum of associated symptoms”,
commented Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for
Migraine & Headache.
During the EAN Congress, Teva presented FOCUS exploratory
endpoints results which include:
Reduced Migraine Days
Data on efficacy and clinically meaningful responses to
fremanezumab showed reductions in the monthly average number of
migraine days and sustained ≥50% response rates over three months
were significantly greater with fremanezumab versus placebo in the
study.
Migraine-related Symptoms
In the FOCUS study data being presented at EAN, both monthly and
quarterly fremanezumab dosing reduced migraine-related symptoms of
nausea or vomiting and photophobia and phonophobia versus placebo
in the study cohort.
Disability
The impact of fremanezumab on headache-related disability was
assessed using internationally regarded questionnaires as
exploratory endpoints of the FOCUS trial. Substantial improvements
in headache-related disability were seen in those patients taking
the active drug compared with placebo - with both fremanezumab
dosing regimens - and reductions from baseline in the disability
score were greater compared with placebo.
Quality of Life
Migraine invariably has a negative effect on quality of life and
the study looked at the effect of fremanezumab on migraine-specific
health-related quality of life and health status in patients as
exploratory endpoints. Mean changes from baseline using
internationally regarded quality of life questionnaires were seen
four weeks after the third dose. Improvements were seen from
baseline in all domains, and scores were greater with both
fremanezumab dosing regimens versus placebo.
Depression
Migraine patients are estimated to be approximately 2-4 times
more likely to have depression than the general population.
Depression status was evaluated as an exploratory endpoint in the
study. Improvements in depression status were observed with monthly
fremanezumab versus placebo, and to a lesser degree with the
quarterly dose.
Productivity
Work productivity and activity impairment were evaluated using a
globally accepted questionnaire to ascertain whether fremanezumab
had a positive impact. During the 4 weeks after the third study
drug dose, greater improvements from baseline were observed with
both fremanezumab dosing regimens versus placebo (nominal p-values
all P<0.05) assessing absenteeism and presenteeism.
Medication Use
The use of any medication, and migraine-specific acute headache
medication such as triptans and ergot compounds, respectively, were
evaluated and results show that both dosing regimens of
fremanezumab significantly reduced acute headache medication use of
either kind.
The study also investigated the efficacy of fremanezumab in
patients who had previously failed topiramate or
onabotulinumtoxinA. Reductions from baseline in the monthly average
number of migraine days during the 12-week treatment period were
significantly greater with both fremanezumab regimens versus
placebo in this subset of patients.
The full results of the FOCUS study will be submitted for
publication later in 2019.
The full EAN online programme can be accessed via the congresses
official website:
https://www.ean.org/oslo2019/Schedule.3659.0.html
Notes to Editors: About FOCUS The Phase IIIb FOCUS study
of fremanezumab was the first and largest study of a migraine
preventive treatment in a difficult-to-treat population of adults
with episodic or chronic migraine (EM or CM) who had documented
inadequate response to 2-4 classes of migraine preventive
medications. The 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 worldwide, 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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version on businesswire.com: https://www.businesswire.com/news/home/20190701005377/en/
IR Contacts Global Kevin C. Mannix (215)
591-8912
PR Contacts US Doris Saltkill (+1)
816-391-8881
Europe Fiona Cohen (31) 6 2008 2545
Israel Yonatan Beker 972 (54) 888 5898
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