Late-Breaking Data Presented at IHC Highlight
Primary and Secondary Outcome Measure Results from Chronic and
Episodic Migraine Phase III Clinical Trials
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) has
presented new data evaluating fremanezumab, an investigational
treatment for the prevention of migraine, at the 18th Congress of
the International Headache Society (IHC) in Vancouver, Canada. Data
presented across two platform presentations and five late-breaking
abstracts featured detailed, positive efficacy results from pivotal
Phase III HALO studies of fremanezumab in chronic (CM) and episodic
migraine (EM), as well as data from patient-reported outcomes tools
in the chronic migraine trial.
“We developed a clinical program for fremanezumab that was
patient-centered, and closely mimicked the real-world experience of
people living with the debilitating effects of migraine,” said
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “We are very proud to be a leader in
the development of this new type of preventive treatment for
migraine, which we believe holds tremendous potential to make a
meaningful difference in the lives of the millions of people around
the world suffering from migraine.”
“The statistically significant results from the CM and EM trials
across multiple measures of migraine burden, including improvement
in quality of life and disability, highlight the potential of
fremanezumab to provide patients with meaningful relief,” said
Marcelo Bigal, M.D., Ph.D., Chief Medical Officer & Head of
Specialty Clinical Development at Teva. “After validating the
target for CM and EM in the Phase II clinical trials, we are
thrilled to present these results to the migraine community,
providing a deeper view into the pivotal trial design and full
results of the HALO program.”
Across the Phase III HALO studies in chronic and episodic
migraine, fremanezumab achieved statistically significant and
clinically meaningful results for all 25 primary and secondary
analyses in both monthly and quarterly dosing regimens. In the
chronic migraine study, endpoint analyses presented at IHC
include:
- Significant reduction in the number of
monthly headache days of at least moderate severity during the
12-week period after 1st dose for both dosing regimens [monthly
(-4.6 days) and quarterly (-4.3 days) versus placebo (-2.5 days);
p<0.0001]
- Statistically significant reduction in
the number of monthly migraine days during the 12-week period after
the 1st dose, for both dosing regimens [monthly (-5.0 days from a
baseline of 16.0 days) and quarterly (-4.9 days from a baseline of
16.2 days) versus placebo (-3.2 days from a baseline of 16.3 days);
p<0.0001], and during the 4-week period after 1st dose, for both
dosing regimens (p<0.0001)
- Improvement in Migraine-Specific
Quality of Life scores for both dosing regimens [least-squares mean
± standard error differences versus placebo: monthly (6.3±1.4) and
quarterly (5.6±1.4); p<0.0001]
- Improvement in overall health status as
measured by the EuroQol 5-dimension 5 response level (EQ-5D-5L)
questionnaire for both dosing regimens [quarterly (4.6±1.1;
p=0.0402) and monthly (4.8±1.1; p=0.0291) versus placebo
(2.2±1.1)]
- Significant reduction in the weekly
number of headache days of at least moderate severity at week 1
(-1.1 days; p<0.0001) versus placebo (-0.5 days)
- Larger reductions from baseline in
overall work productivity loss (composite of absenteeism and
impairment while working [presenteeism]) compared with placebo
(–16.6%±2.09% [quarterly] and –15.9%±2.02% [monthly] vs –9.1%±2.02%
[placebo]), resulting in significant treatment differences for each
fremanezumab treatment arm versus placebo (quarterly: –7.5%±2.24%,
P=0.0009; monthly: –6.8%±2.26%, P=0.0026) in patients with CM
- Significant reduction in impairment of
activity outside of work in the quarterly dosing arm of the study
compared with placebo (–15.0%±1.70% vs –11.0%±1.7%; treatment
difference of –4.0%±1.85%, P=0.0311) in patients with CM
- Reduction in the number of monthly days
of acute headache medication use for both dosing regimens [monthly
(-4.2 days) and quarterly (-3.7 days) versus placebo (-1.9 days);
p<0.0001]
- Improvement of a >50% reduction in
monthly average number of headache days of at least moderate
severity with both dosing regimens [monthly (40.8%) and quarterly
(37.6%) versus placebo (18.1%); p<0.0001]
- Improvement in disability as measured
by the 6-item Headache Impact Test (HIT-6) with both dosing
regimens [monthly (-6.8; p<0.0001) and quarterly (-6.4;
p=0.0001) versus placebo (-4.5)]
In episodic migraine, endpoint analyses presented at IHC
include:
- Reduction in the number of monthly
migraine days during the 12-week period for both dosing regimens
[monthly (-3.7 days from a baseline of 9.2 days) and quarterly
(-3.4 days from a baseline of 8.9 days) versus placebo (-2.2 days
from a baseline of 9.1 days); p<0.0001] and during the 4-week
period after 1st dose, for both dosing regimens
- Reduction in the number of monthly
headache days of at least moderate severity during the 12-week
period for both dosing regimens [monthly (-2.9 days) and quarterly
(-3.0 days); vs placebo (-1.5 days); p<0.0001)] and during the
4-week period after 1st dose, for both dosing regimens
(p<0.0001)
- Significant reduction in the number of
monthly days of acute headache medication use for both [monthly
(-3.0 days) and quarterly (-2.9 days versus placebo (-1.6 days) );
p<0.0001]
- A ≥50% reduction in monthly average
number of migraine days of least moderate severity for both dosing
regimens [monthly (47.7%) and quarterly (44.4%) versus placebo
(27.9%); p<0.0001]
- Improvement in disability as measured
by the Migraine Disability Assessment (MIDAS) for both dosing
regimens [monthly (-24.6; p=0.0021) and quarterly (-23.0; p=0.0023)
versus placebo (-17.5)]
The most commonly-reported adverse event in the episodic and
chronic migraine trials was injection site pain, with similar rates
in the placebo and active groups.
“The results we have presented at IHC are truly exciting and
reflect Teva’s commitment to developing and delivering medicines to
meet the needs of patients around the world living with chronic
diseases,” said Ernesto Aycardi, M.D., Vice President &
Therapeutic Area Head, R&D, Migraine and Headache at Teva.
“With our full CM and EM pivotal results presented to the migraine
community, we now look forward to filing a BLA in the U.S. later
this year, bringing us one step closer to potentially bringing a
new, preventive migraine treatment option to patients.”
About Fremanezumab (TEV-48125)
Fremanezumab is a fully-humanized monoclonal antibody targeting
the CGRP ligand, a well-validated target in migraine. With limited
availability of preventive treatment options, fremanezumab
represents a potential new option to address a significant unmet
medical need.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies are 16-week, multicenter,
randomized, double-blind, placebo-controlled, parallel-group
studies to compare the safety, tolerability, and efficacy of four
dose regimens of subcutaneous fremanezumab compared to placebo in
adults with episodic and chronic migraine. The studies consist 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 randomized in a
1:1:1 ratio to receive subcutaneous injections of fremanezumab at
225 mg (monthly dose regimen) for three months, 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
randomized (around 376 patients per treatment group). Patients were
randomized 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.
About Migraine
Migraine is an unpredictable neurological condition with
symptoms such as severe head pain and physical impairment that can
impact quality of life and productivity. There are two clinical
manifestations of migraine – chronic, where patients suffer 15 or
more headache days per month, and episodic, where patients have 14
or less headache days per month. Worldwide, approximately 90%
percent of people diagnosed with migraine have episodic migraine
and 10% have chronic migraine.
With more than 1 billion people affected worldwide, migraine is
the third most prevalent illness in the world and the 6th most
disabling illness in the world. In the U.S., EU5 and Japan, nearly
75 million people suffer from episodic and chronic migraine – more
than 38 million in the U.S. alone. Of the approximately 40% of
patients suffering from migraine for whom prevention is
appropriate, only 13% are currently receiving therapy. There
remains a significant medical need for treatments designed
specifically to prevent migraine. According to recent analysis, the
economic burden for migraine patients reaches approximately $78
billion per year in the U.S.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients over 60 markets every day. Headquartered in
Israel, Teva is the world’s largest generic medicines producer,
leveraging its portfolio of more than 1,800 molecules to produce a
wide range of generic products in nearly every therapeutic area. In
specialty medicines, Teva has the world-leading innovative
treatment for multiple sclerosis as well as late-stage development
programs for other disorders of the central nervous system,
including movement disorders, migraine, pain and neurodegenerative
conditions, as well as a broad portfolio of respiratory products.
Teva is leveraging its generics and specialty capabilities in order
to seek new ways of addressing unmet patient needs by combining
drug development with devices, services and technologies. Teva's
net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Statements Regarding Forward-Looking
Information:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the potential benefits and commercialization of
Fremanezumab, 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 Fremanezumab;
- challenges inherent in product research
and development, including uncertainty of obtaining regulatory
approvals;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; 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 restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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
Annual Report on Form 20-F for the year ended December 31, 2016
(“Annual Report”), including in the section captioned “Risk
Factors,” and in our other filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov and
www.tevapharm.com. 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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Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
MannixUnited States(215) 591-8912orRan MeirUnited
States(215) 591-3033orTomer AmitaiIsrael972 (3) 926-7656orPR
Contacts:Iris Beck CodnerIsrael972 (3) 926-7208orDenise
BradleyUnited States(215) 591-8974
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