Zoek in het archief
 
terug

Check the original
News breaking: 2017-11-30

The New England Journal of Medicine Publishes Data from Pivotal Phas..


Previous Article
Teva and Xenon Announce Phase II Study...
The New England Journal of Medicine Publishes Data from Pivotal Phase III Trial of Fremanezumab for the Preventive Treatment of Chronic Migraine

Marks the first Phase III chronic migraine data to be published
within anti-CGRP class

JERUSALEM--(BUSINESS WIRE)--Nov. 29, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the publication of data from the pivotal Phase III HALO study
evaluating the efficacy, safety and tolerability of two subcutaneous
dose regimens of fremanezumab for the preventive treatment of chronic
migraine (CM). These data were published online today by the New
England Journal of Medicine (NEJM) and will appear in a subsequent
print issue.
“The burden of illness faced by those with migraine is immense and can
negatively impact every facet of their lives underscoring a significant
unmet need for new preventive treatment options,” said Stephen D.
Silberstein, M.D., Principal Investigator of the HALO trial, Professor
of Neurology and Director of the Jefferson Headache Center at Thomas
Jefferson University Hospital and lead author of this publication.
“Results from the Phase III study of fremanezumab for the preventive
treatment of chronic migraine highlight the importance of therapies
targeting CGRP as a potential significant advancement in the treatment
of patients suffering from debilitating symptoms.”
“We are very proud that the fremanezumab chronic migraine results are
the first Phase III CM anti-CGRP therapy data published, especially in
such a prestigious and well-renowned peer-reviewed journal,” said
Ernesto Aycardi, M.D., Vice President & Therapeutic Area Head, R&D,
Migraine and Headache at Teva. “In this article, we are pleased to share
with the medical community data from what we believe is a
differentiated, patient-centric clinical development program, and to
advance understanding of the potential of fremanezumab as a preventive
treatment option for the millions of people suffering from migraine.”
The article, “Fremanezumab for the Preventive Treatment of Chronic
Migraine,” reports results of a multicenter, randomized, double-blind,
placebo-controlled, parallel-group Phase III study that evaluated
monthly and quarterly doses of fremanezumab versus placebo for the
preventive treatment of chronic migraine in 1,130 patients. These
findings, along with findings from the HALO Phase III study evaluating
the efficacy, safety and tolerability of two subcutaneous dose regimens
of fremanezumab for the preventive treatment of episodic migraine (EM),
were included in the Biologics License Application (BLA) for
fremanezumab that Teva submitted to the U.S. Food and Drug
Administration (FDA) in October. The most common adverse events reported
in clinical trials include injection site induration, erythema, and
pruritis.
For the full text of this publication, please visit: http://www.nejm.org/doi/full/10.1056/NEJMoa1709038
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 episodic migraine (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 for three months (monthly dose
regimen), fremanezumab at 675 mg (quarterly dose regimen) at
initiation followed by placebo for two months, 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% 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 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 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 obtaining regulatory approvals;
the uncertainty of commercial success of Fremanezumab;
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171129006296/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3) 926-7656orPR
Contacts:Iris Beck Codner, Israel, 972 (3) 926-7208Denise
Bradley, United States, 215-591-8974Michelle Larkin, United
States, 610-786-7335
Share on FacebookShare on LinkedIn