UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Teva Pharmaceutical Industries Ltd. |
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(Translation of registrants name into English) | ||||
Israel | ||||
(Jurisdiction of incorporation or organization) | ||||
5 Basel Street, P.O. Box 3190 Petach Tikva 4951033 Israel |
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(Address of principal executive office) |
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: [x] Form 20-F [ ] Form 40-F | ||||
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. |
Teva Pharmaceutical Industries Ltd. | ||
Date: 11/29/2017 | By: |
Michael McClellan |
Name: | Michael McClellan | |
Title: | EVP, CFO | |
Exhibit No. | Description | |
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99.1 | The New England Journal of Medicine Publishes Data from Pivotal Phase III Trial of Fremanezumab for the Preventive Treatment of Chronic Migraine | |
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, November 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 worlds 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. Tevas 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 managements 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.
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