FOCUS study met all primary and secondary
endpoints in both the quarterly and monthly dosing regimens in
patients with chronic and episodic migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced positive topline results from the Phase IIIb FOCUS study
that evaluated the efficacy and safety of fremanezumab for the
preventive treatment of migraine in adult patients who previously
experienced inadequate responses to two to four classes of
preventive treatments. In the study of 838 patients, including
those who suffer from either chronic or episodic migraine, patients
treated with fremanezumab experienced highly significant reduction
in the monthly average number of migraine days versus placebo (-0.6
days) over the 12 week assessment period, for both monthly (-4.1
days, p<0.0001) and quarterly (-3.7 days, p<0.0001) dosing
regimens.
In addition, patients treated with fremanezumab experienced
significant improvement compared to placebo on all secondary
endpoints for both quarterly and monthly dosing regimens. There
were no safety signals detected in the study.
“We are pleased to share the topline results of this study,”
said Danny McBryan, M.D., Senior Vice President, Head of Global
Medical Affairs and Pharmacovigilance at Teva. “This study design
is distinct in that it is the largest trial to date in patients who
failed to respond to multiple classes of preventive migraine
treatments, and is the first study of its type to be conducted in
chronic, as well as episodic, migraine patients.”
Teva plans to submit the full results for medical meetings in
2019, as well as peer-reviewed publication.
“With robust effect sizes for the primary endpoint, the FOCUS
trial produced clinically meaningful results that demonstrated the
effectiveness of fremanezumab in a population of patients that are
difficult to treat and who require other treatment options,” said
Matthias Mueller, M.D. MSc, Vice President Global Medical Affairs,
Head of Therapeutic Areas and Scientific Communications at Teva.
“We look forward to bringing forward additional insights from the
study in the future.”
About FOCUSThe Phase IIIb FOCUS study is a multicenter,
randomized, double-blind, parallel-group, placebo-controlled study
that evaluated the efficacy, safety, and tolerability of quarterly
and monthly treatment with fremanezumab, compared to placebo. Adult
patients with chronic migraine or episodic migraine who have
responded inadequately to two to four classes of prior preventive
treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at
least three months of therapy; or the patient cannot tolerate the
drug; or the drug is contraindicated; or the drug is not suitable
for the patient. The classes of medications include: beta-blockers,
anticonvulsants, tricyclics, calcium channel blockers, angiotensin
II receptor antagonists, onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients
were randomized in blinded-fashion 1:1:1 into one of three
treatment groups – a quarterly dosing regimen, a monthly dosing
regimen or matching placebo.
An open-label extension of three months (weeks 13-24) followed
the placebo-controlled portion of the study.
About MigraineMigraine is a disabling neurological
disease characterized by severe head pain, nausea and vomiting.1
With more than 1 billion people affected worldwidei, migraine is
the third most prevalent illness in the world.2
About FremanezumabFremanezumab is a humanized monoclonal
antibody that binds to the calcitonin gene-related peptide (CGRP)
ligand and blocks its binding to the receptor.
In the U.S., it is marketed as AJOVYTM (fremanezumab-vfrm)
injection, indicated for the preventive treatment of migraine in
adults, and available as a 225 mg/1.5mL single dose injection in a
prefilled syringe with two dosing options – 225 mg monthly
administered as one subcutaneous injection, or 675 mg every three
months (quarterly), administered as three subcutaneous injections.
No starting dose is required to begin treatment.
IMPORTANT SAFETY INFORMATIONContraindications:
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 Prescribing Information for AJOVYTM
(fremanezumab-vfrm) injection.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global leader in generic medicines, with
innovative treatments in select areas, including CNS, pain and
respiratory. We deliver high-quality generic products and medicines
in nearly every therapeutic area to address unmet patient needs. We
have an established presence in generics, specialty, OTC and API,
building on more than a century-old legacy, with a fully integrated
R&D function, strong operational base and global infrastructure
and scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 regarding Fremanezumab (commercialized as
AJOVYTM), 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 AJOVYTM;
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; 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; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, 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: failure to effectively execute our restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; 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 failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- 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; governmental investigations
into sales and marketing 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 Annual Report on Form 10-K
for the year ended December 31, 2017, 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.
i. Migraine Research Foundation. Migraine Facts.
https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed November 2018.
ii. Migraine Trust. Facts and Figures.
https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/.
Accessed November 2018.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181217005246/en/
IR ContactsKevin C. Mannix(215) 591-8912orRan Meir972 (3)
926-7516orPR ContactsUnited StatesDoris Saltkill(913)
777-3343orIsraelYonatan Beker972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024