Chronic migraine study met all primary and secondary endpoints in
both monthly and quarterly dosing regimens
JERUSALEM--(BUSINESS WIRE)--May 31, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
positive results from a Phase III HALO study of fremanezumab, an
investigational treatment for the prevention of migraine. In the chronic
migraine (CM) study, patients treated with fremanezumab experienced
statistically significant reduction in the number of monthly headache
days of at least moderate severity vs. placebo (-2.5 days) during the 12
week period after first dose, for both monthly (-4.6 days p<0.0001) and
quarterly (-4.3 days p<0.0001) dosing regimens. Similar to the Phase II
trials, both patients that were on monotherapy and stable doses of
prophylactic medications were included in the trial.
In addition, patients treated with fremanezumab experienced significant
improvement compared to placebo on all secondary endpoints for both
monthly and quarterly dosing regimens, including: response rate, onset
of efficacy, efficacy as monotherapy, and disability. The results were
positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of
them, being 0.0004 in the remaining. The most commonly-reported adverse
event in the study was injection site pain, with similar rates in the
placebo and active groups.
“Migraine is a serious, debilitating neurological condition that
substantially impacts all aspects of a person’s life,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva. “Our Phase III clinical trial program has exhibited
extremely encouraging results, including with a quarterly dosing
regimen, for fremanezumab in chronic migraine. We are grateful to the
patients and clinical investigators who participated in this study and
helped to advance our understanding of the potential of fremanezumab as
a preventive treatment option for the millions of people suffering from
migraine.”
“These top-line results reflect our differentiated clinical development
program and add to a growing body of evidence that supports the
development of CGRP targeted therapy in migraine, including patients
with very severe forms of the disease, with flexible dosing regimens,”
said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer & Head of
Specialty Clinical Development at Teva.
“We are excited about our development progress and look forward to
sharing more detailed results with the migraine community at future
scientific conferences,” said Ernesto Aycardi, M.D., Vice President &
Therapeutic Area Head, R&D, Migraine and Headache at Teva.
Based on these results, Teva plans to submit a Biologics License
Application to the U.S. Food and Drug Administration (FDA) for
fremanezumab later this year. Teva’s Phase III HALO study in Episodic
Migraine (EM) will report topline results in the coming weeks.
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 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 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 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. With
more than 1 billion people affected worldwide, migraine is the third
most prevalent illness in the world. More than 38 million Americans have
migraine. Of the approximately 40% of patients suffering from migraine
for whom prevention is appropriate, only 13% are currently receiving
therapy. According to the Migraine Research Foundation, healthcare and
lost productivity costs associated with migraine are estimated to be as
high as $36 billion annually in the U.S. There remains a significant
medical need for treatments designed specifically to prevent migraines.
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 in 100 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 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 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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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