Study evaluated quarterly or monthly dosing for
the preventive treatment of migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that results from the 52-week, multicenter, randomized,
double-blind, parallel group study evaluating monthly or quarterly
AJOVY® (fremanezumab-vfrm) injection in adults with chronic
migraine (CM) or episodic migraine (EM), were published online
ahead of print in Neurology.
“Migraine can be a difficult disease to treat, and is often
debilitating for those who suffer from it,” said Denisa Hurtukova,
MD, Vice President, Head of North America Medical Affairs, Teva.
“We are pleased to publish these results, which add to the growing
body of knowledge on AJOVY and give us further insight into the
potential for AJOVY to improve clinical outcomes with both
quarterly and monthly dosing regimens. These results also
underscore Teva’s commitment to patients with migraine and
providing potential long-term treatment options for this
debilitating disease.”
As the primary purpose of the study was the collection of
long-term safety data for patients treated with AJOVY, the study
was not placebo-controlled. Patients and investigators were both
blinded to the dosing regimen (quarterly vs. monthly) to allow for
comparisons between the two dosing options. The study was conducted
between March 2016 and December 2018, and included 1890 patients
with CM (1,110) and EM (780). Patients who completed either the
HALO CM or HALO EM trials had the option to roll over to this
long-term study, and new patients could also be enrolled. A total
of 312 patients were newly enrolled. Patients were studied at 135
sites, which included clinical research centers, academic medical
centers, and neurology/headache practices in the US, Japan, Czech
Republic, Russia, Canada, Finland, Poland, Israel, and Spain.
The primary objective of the study was to observe the long-term
safety and tolerability of AJOVY over 52 weeks. The most common
adverse events (AEs) leading to discontinuation (3-5 percent of
patients) included injection site erythema, injection site rash,
injection site swelling, injection site pruritis and increased
weight. No clinically significant patterns of AEs or serious AEs
were seen in the current study. No treatment-emergent, clinically
significant laboratory findings were observed.
“Patients with migraine have difficulty remaining on many
migraine preventive therapies for prolonged periods and persistence
rates at 6 months are known to be quite low, with literature citing
lack of efficacy and adverse events as the most common reasons for
discontinuation,” said Peter J. Goadsby, MD, PhD, NIHR-Wellcome
Trust King's Clinical Research Facility, SLaM Biomedical Research
Centre, King's College London, London, UK. “The low rates of
discontinuation in this 12 month extension study due to lack of
efficacy (4 percent of patients) or adverse events (3-5 percent of
patients) suggest the potential that patients may be able to
persist with this medication over a clinically relevant length of
time.”
Although the study was not placebo-controlled, exploratory
efficacy evaluations included mean change from baseline in the
monthly number of migraine days, headache days of at least moderate
severity, headache days of any severity, and days with any acute
headache medication use at months three, six, and 12. Additionally,
for patients with CM, mean change from baseline in headache-related
disability score at months six and 12 was measured by the six-item
Headache Impact Test (HIT-6) and for patients with EM, the mean
change from baseline in headache-related disability score at months
six and 12 was measured by the Migraine Disability Assessment
(MIDAS) questionnaire.
In patients with CM or EM, the monthly number of migraine days
decreased from baseline to month 12 (CM quarterly, –7.2 days; CM
monthly, – 8.0 days; EM quarterly, –5.2 days; EM monthly, –5.1
days). Reductions in monthly number of headache days of at least
moderate severity from baseline to month 12 were observed (CM
quarterly, –6.4 days; CM monthly, –6.8 days; EM quarterly, –4.4; EM
monthly, –4.2 days). Monthly number of headache days of any
severity and monthly number of days of any acute headache
medication use were also reduced across all treatment groups. More
than half of patients with CM and approximately two-thirds of
patients with EM had a ≥ 50 percent reduction in monthly average
number of migraine days from baseline to month 12. Specifically,
the proportions of patients who had a ≥ 50 percent response rate
continued to increase over time. Additionally, the degree of
headache-related disability decreased for both CM and EM patients
from baseline to month 12.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicentre,
randomised, double-blind, placebo-controlled, parallel-group
studies to compare the safety, tolerability, and efficacy of four
dose regimens (two for EM [quarterly and monthly] and two for CM
[quarterly and monthly]), of subcutaneous fremanezumab compared to
placebo in adults with episodic and chronic migraine. The studies
consisted of a screening visit, a 28-day run-in period, and a
12-week (84-day) treatment period, including a final evaluation at
week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after
the final dose of study drug).
- In the EM study, 875 patients were enrolled (294, 291, 290
patients in the placebo, quarterly, and monthly dose groups,
respectively). Patients were randomised in a 1:1:1 ratio to receive
subcutaneous injections of fremanezumab at 225 mg for three months
(monthly dose regimen), fremanezumab at 675 mg at initiation
followed by placebo for two months (quarterly dose regimen), or
three monthly doses of matching placebo. The primary efficacy
endpoint of the EM study was the mean change from baseline (28-day
run-in period) in the monthly average number of migraine days
during the 12-week period after the first dose of
fremanezumab.
- In the CM study, 1,130 patients were randomised (375, 376, 379
patients in the placebo, quarterly, and monthly groups,
respectively). Patients were randomised in a 1:1:1 ratio to receive
subcutaneous injections of fremanezumab at 675 mg at initiation
followed by monthly 225 mg for two months (monthly dose regimen),
fremanezumab at 675 mg at initiation followed by placebo for two
months (quarterly dose regimen), or three monthly doses of matching
placebo. The primary efficacy endpoint of the CM study was the mean
change from baseline (28-day run-in period) in the monthly average
number of headache days of at least moderate severity during the
12-week period after the first dose of fremanezumab.
U.S. Important Safety Information about AJOVY®
(fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, pruritus, drug hypersensitivity, and urticaria were
reported with AJOVY in clinical trials. Most reactions were mild to
moderate, but some led to discontinuation or required
corticosteroid treatment. Most reactions were reported from within
hours to one month after administration. If a hypersensitivity
reaction occurs, consider discontinuing AJOVY and institute
appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5%
and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
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 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 commercial success of AJOVY;
- 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 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: uncertainty
regarding the magnitude, 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;
effectiveness 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: our
ability to successfully defend against the DOJ criminal charges of
a Sherman Act violations; 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;
- 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 Quarterly Reports on Form
10-Q for the first and second quarters 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.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
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