Additional analyses examine the impact of
migraine in France, Spain and the United Kingdom
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
presented a wide range of important new data on AJOVY®
(fremanezumab) and the societal and economic impact of migraine in
Europe at the 6th Congress of the European Academy of Neurology
(EAN). This year’s EAN congress was a virtual meeting due to the
global coronavirus pandemic.
The fremanezumab data included pooled analyses of the AJOVY
Phase 3 clinical trials (FOCUS, HALO-episodic migraine (EM) and
HALO-chronic migraine (CM)) which focused on the safety, efficacy
and improved quality-of-life for patients experiencing
difficult-to-treat migraine. Post-hoc analyses were also evaluated
in patients who may experience challenges when managing their
migraine due to comorbidities.
Migraine creates a significant disease and economic burden. With
more than one billion people impacted globallyi, migraine is the
second leading global cause of years lived with disabilityii and
annual costs of the disease in the U.S. and EU are $200
billion.iii,iv
“Migraine imposes physical, emotional and societal burdens
worldwide and yet available treatment options are often
unsatisfactory for many patients,” said Joshua M. Cohen, MD, MPH,
FAHS, Senior Director, Global Medical Affairs – Therapeutic Area
Lead Migraine & Headache, Teva. “As a leader in neurology and
migraine treatment, Teva’s goal is to continue evaluating the
impact of AJOVY across various patient populations to ensure that
reliable and relevant information is available to healthcare
professionals when considering treatment options.”
Pooled Analysis Shows Impact of AJOVY in Patients with
Migraine
Pooled analyses of the Phase 3 FOCUS, HALO-EM and HALO-CM
clinical trials in patients 60 years of age or older with EM or CM,
examined treatment with fremanezumab versus placebo over 12 weeks.
Reductions from baseline in monthly migraine days, headache days of
at least moderate severity, and days with acute headache medication
use over 12 weeks were significantly greater with quarterly and
monthly fremanezumab versus placebo (all P≤0.0103).
The analyses also examined early onset of efficacy and improved
headache-related disability, health-related quality-of-life,
productivity, and satisfaction in this patient population.
Additionally, the analyses looked at cardiovascular adverse events
in fremanezumab and placebo treated patients in this group,
regardless of whether or not they had a cardiovascular medical
history.
Cardiovascular Safety of AJOVY
Additional pooled analyses of the Phase 3 trials were also
conducted to examine cardiovascular safety across all patients. The
analyses were performed in migraine patients with
cardiovascular/cerebrovascular risk factors (e.g., diabetes
mellitus, hyperlipidemia, obesity, hypertension, hormonal birth
control pill use) (n=499). The overall incidence of cardiovascular
adverse events in these patients were low and comparable between
fremanezumab and placebo treated groups. An increase in the number
of risk factors did not seem to correlate with an increase in
frequency of cardiac and vascular adverse events. Additionally, the
analyses examined patients with migraine using cardiovascular
medications at baseline (n=280), and patients using concomitant
triptans (n=1,123) with those who did not use triptans. Similar to
the overall trial populations, the most common adverse events
reported in all of these subgroups were injection site
reactions.
Disease and Economic Burden of Migraine in Europe
Two analyses evaluated the economic and disease burden of
migraine across patients in the United Kingdom, France and Spain.
The first analysis found that CM patients experienced greater
disability caused by migraine versus EM patients. CM patients also
reported lower health status than EM patients for their most recent
migraine. The second evaluation, which included examining
electronic medical records from 84,266 adult patients with EM and
CM, found CM patients had more migraine-related consultations with
their general practitioners than EM patients. Additionally, average
quarterly treatment costs were higher for CM patients in all three
countries.
These results point to substantial migraine disability and unmet
treatment needs across the three countries. They also associate
migraine with a significant healthcare and economic burden that
includes higher costs for CM patients.
Accessing Teva EAN Presentations
The ePresentations and ePosters shared by Teva at EAN can be
accessed by healthcare professionals through the EAN conference
website. The sessions will be available at no cost and will also be
on-demand for EAN members from 27 May onward.
Additional resources on migraine, including articles, videos,
publications summaries, podcasts and webinars can be accessed on
Neurologybytes. Neurologybytes is a platform published by Teva to
support neurologists in accessing timely, bite-sized content on the
latest research developments and clinical care perspectives in the
world of migraine and multiple sclerosis (MS).
Information for Europe about AJOVY®▼can be found
here.
▼ 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.hpra.ie. Adverse events should also be reported to Teva
– please refer to local numbers.
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 3,500
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.
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 new analysis of fremanezumab Injection 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 uncertainties inherent in research and development,
including clinical trial results and additional analysis of
existing clinical data;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; 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;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations and the effectiveness of our
patents and other measures to protect our intellectual property
rights;
- our business and operations in general, including: duration,
and geographic reach of the COVID-19 pandemic and its impact on our
business, financial condition, operations, cash flows, and
liquidity and on the economy in general; interruptions in our
supply chain, including due to potential effects of the COVID-19
pandemic on our operations and business in geographic locations
impacted by the pandemic and on the business operations of our
customers and suppliers; adequacy of and our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith;
implementation of our restructuring plan announced in December
2017; challenges associated with conducting business globally,
including adverse effects of the COVID-19 pandemic, political or
economic instability, major hostilities or terrorism; our ability
to attract, hire and retain highly skilled personnel; our ability
to develop and commercialize additional pharmaceutical products;
compliance with anti-corruption sanctions and trade control laws;
manufacturing or quality control problems; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; significant sales to a
limited number of customers; our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject or delays in
governmental processing time including due to modified government
operations due to the COVID-19 pandemic and effects on product and
patent approvals; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M 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;
and other factors discussed in our Quarterly Report on Form 10-Q
for the first quarter of 2020 and our Annual Report on Form 10-K
for the year ended December 31, 2019, including in the sections
captioned "Risk Factors” and “Forward Looking Statements.”
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.
__________
i Global Burden of Disease 2016 Disease
and Injury Incidence and Prevalence Collaborators. Lancet
2017;390:1211–59.
ii Saylor D, Steiner TJ. The Global Burden
of Headache. Semin Neurol 2018 Apr;38(2):182-190.
iii Gooch CL, et al. Ann Neurol
2017;81:479–84.
iv Linde M, et al. Eur J Neurol
2012;19:703–11.
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