AJOVY data highlight efficacy and safety in
difficult-to-treat migraine
GALA open-label extension study evaluates
7-year efficacy and safety results of COPAXONE
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that new data on AJOVY® (fremanezumab) and the burden of
migraine in Europe will be presented at the 6th Congress of the
European Academy of Neurology (EAN), being held virtually from
23-26 May 2020. Additionally, Teva will present data on the
long-term safety and efficacy of COPAXONE® (glatiramer acetate
injection). This year’s EAN congress is a virtual meeting due to
the global coronavirus pandemic. All Teva abstracts will be
published in a supplement to the European Journal of Neurology.
The new data, shared across nine ePresentations and three
ePosters, reinforce the importance of continuing to study therapies
that impact large patient populations. As the third-most prevalent
disease in the world, affecting over one billion people globallyi,
migraine imposes physical, emotional and societal burdens
worldwideii,iii,iv,v,vi with limited treatment options available to
many patients.
“Teva has a deep history in neurology and these data demonstrate
our continued commitment to advancing solutions for patients with
unmet needs,” said Matthias Mueller, MD MSc, VP Global Medical
Affairs - Global Therapeutic Areas and Scientific Communications,
Teva. “We look forward to presenting these new data, which include
pooled results of our AJOVY Phase 3 trials and a 7-year evaluation
of COPAXONE. We are proud of our ongoing efforts in evaluating the
social impact and burden of migraine. It is critically important to
understand the global impact of migraine and we are committed to
collecting real-world data that can educate the broader healthcare
population. We are also committed to evaluating treatment options
for patients living with multiple sclerosis (MS), as demonstrated
by our analysis of the long-term efficacy and safety of
COPAXONE.”
The AJOVY data highlight data on safety, efficacy and
quality-of-life for patients experiencing difficult-to-treat
migraine as well as challenges posed by comorbidities and advancing
age. The post-hoc analyses to be presented examine the data on
AJOVY as reflected in the pooled analyses:
- Efficacy and safety in patients of advanced age
- Quality-of-life, productivity and satisfaction
- Cardiovascular safety
across the FOCUS, HALO-episodic migraine (EM) and HALO-chronic
migraine (CM) Phase 3 clinical trials.
Teva will host an online symposium “Pathways to Change:
Anti-CGRP Monoclonal Antibodies & the Evolving Migraine
Prevention Landscape,” on Sunday, 24 May from 13:45-14:45 CET. The
symposium will be led by Messoud Ashina, Professor of Neurology in
the Faculty of Health and Medical Sciences, University of
Copenhagen, Denmark, and will review the considerable burden of
migraine from a patient perspective, discussing insights for
targeted prevention that can be gained from the latest research on
the neurovascular pathophysiology of migraine.
Approximately 2.5 million people live with multiple sclerosis
(MS) worldwidevii, and relapsing-remitting is the most common MS
disease courseviii. Teva will also share new long-term efficacy and
safety results of COPAXONE from the 7-year Glatiramer Acetate
Low‑Frequency Administration (GALA) open‑label extension study.
The complete list of Teva presentations to be available at the
congress can be found below. All ePresentations and ePoster
sessions will be recorded in advance and available 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.
Please note presentation times below reflect the schedule at the
time of publication; please refer to the EAN conference website for
the final schedule.
AJOVY and Migraine Data:
Disease Burden
- The humanistic disease burden of episodic and chronic migraine
in France, Spain and the United Kingdom (EPR1095)
- Presenter: S Díaz-Insa; Headache & Pain 1 EPR109, Vienna,
Saturday, 18:30-19:20
- Healthcare resource utilization and economic burden of migraine
in the United Kingdom, France, and Spain: results of a real-world
study (EPR1106)
- Presenter: P Irimia; Headache & Pain 2 EPR110, Lisbon,
Saturday, 18:30-19:20
Efficacy
- Early efficacy in patients ≥60 years of age with episodic or
chronic migraine: pooled results of 3 randomised, double-blind,
placebo-controlled phase 3 studies (EPR1104)
- Presenter: D Holle-Lee; Headache & Pain 2 EPR110, Lisbon,
Saturday, 18:30-19:20
- Efficacy of fremanezumab treatment in patients ≥60 years of age
with episodic or chronic migraine: pooled results of 3 randomised,
double-blind, placebo-controlled phase 3 studies (EPR2077)
- Presenter: SJ Nahas; Headache & Pain 4 EPR208, Oslo,
Sunday, 18:30-19:20
Tolerability
- Pooled analysis of tolerability with fremanezumab treatment in
patients with episodic or chronic migraine and cardiovascular
medication use at baseline (EPR1092)
- Presenter: G Coppola; Headache & Pain 1 EPR109, Vienna,
Saturday, 18:30-19:20
Patient Satisfaction
- Improvements in quality-of-life, productivity, and satisfaction
with fremanezumab in migraine patients ≥60 years of age: pooled
results of 3 randomised, double-blind, placebo-controlled phase 3
studies (EPR2075)
- Presenter: P McAllister; Headache & Pain 4 EPR208, Oslo,
Sunday, 18:30-19:20
- Improvements in headache-related disability with fremanezumab
in patients ≥60 years of age with migraine: pooled results of 3
randomised, double-blind, placebo-controlled phase 3 studies
(EPO2152)
- Presenter: S Joshi; Headache & Pain 2 EPO210, available
throughout the conference
Cardiovascular Safety
- Pooled analysis of cardiovascular safety with fremanezumab
treatment in patients with migraine by number of cardiovascular or
cerebrovascular risk factors (EPR1107)
- Presenter: T Jürgens; Headache & Pain 2 EPR110, Lisbon,
Saturday, 18:30-19:20
- Pooled analysis of cardiovascular safety with fremanezumab
treatment in patients with migraine and concomitant triptan use
(EPR2065)
- Presenter: L Padzera; Headache & Pain 3 EPR207, Main
Auditorium, Sunday, 18:30-19:20
- Pooled analysis of cardiovascular safety of fremanezumab in
patients ≥60 years of age with migraine: pooled results of 3
randomised, double-blind, placebo-controlled phase 3 studies
(EPO3105)
- Presenter: S Naegel; Headache & Pain 3 EPO307, available
throughout the conference
Clinical Trial Protocol
- The PEARL study protocol: a pan-European prospective
observational study of fremanezumab effectiveness in patients with
chronic or episodic migraine in the real world (EPO1144)
- Presenter: M Ashina; Headache & Pain 1 EPO110, available
throughout the conference
COPAXONE Data:
- Long-term follow-up of three-times-weekly glatiramer acetate:
7-year results of the Glatiramer Acetate Low-Frequency
Administration (GALA) open-label extension study (EPR1146)
- Presenter: P Rieckmann; MS & Related Disorders 1 EPR113,
Berlin, Saturday, 18:30-19:30
Teva Online Symposium:
- Pathways to Change: Anti-CGRP Monoclonal Antibodies & the
Evolving Migraine Prevention Landscape
- Presenter: Messoud Ashina, Professor of Neurology in the
Faculty of Health and Medical Sciences, University of Copenhagen,
Denmark, Sunday, 13:45–14:45
Teva Expert Sessions: The
below sessions are available as on-demand video presentations at
the Teva medical affairs virtual booth on the EAN congress
webpage.
- Anti-CGRP monoclonal antibodies for migraine prevention – myths
and facts
- Migraine and comorbid depression: exploring the role of
anti-CGRP monoclonal antibodies
- Disease modifying therapy and COVID-19: Navigating therapeutic
approaches for M S management
- Bridging therapy during the pre-pregnancy period to minimise
disease activation in 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 COPAXONE® COPAXONE® (glatiramer acetate injection)
is indicated for the treatment of patients with relapsing forms of
multiple sclerosis. The most common side effects of COPAXONE® are
redness, pain, swelling, itching, or a lump at the site of
injection, flushing, rash, shortness of breath, and chest pain. See
additional important information at:
https://www.medicins.org.uk/emc/product/7046/smpc. For hardcopy
releases, please see enclosed full prescribing information. The
COPAXONE® brand is approved in more than 50 countries worldwide,
including the United States, Russia, Canada, Mexico, Australia,
Israel, and all European countries.
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 and COPAXONE®,
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 Martelletti
P, et al. J Headache Pain 2018;19:115. iii D'Amico D, Tepper SJ.
Neuropsychiatr Dis Treat 2008;4:1155–67 iv Lipton RB, et al.
Neurology 2007;68:343–9. v Gooch CL, et al. Ann Neurol
2017;81:479–84. vi Linde M, et al. Eur J Neurol 2012;19:703–11. vii
Prevalence and incidence of multiple sclerosis. Multiple Sclerosis
Trust. Updated February 2020. Accessed May 2020. viii Types of MS.
National Multiple Sclerosis Society.
https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed
May 2020.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
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