Teva Announces Positive Top-Line Results from AJOVY® (fremanezumab) Clinical Trials in Japan
February 03 2020 - 3:30AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced positive results from two Phase 2/3 trials evaluating
AJOVY® (fremanezumab) in patients in Japan. AJOVY is under
development in Japan by Otsuka Pharmaceutical Co., Ltd. (Otsuka) as
part of a May 2017 exclusive license agreement for development and
sales of AJOVY in Japan.
“This study adds to the wealth of positive AJOVY data we have in
patients globally,” said Joshua M. Cohen, MD, MPH, FAHS, Global
Medical Lead for Migraine & Headache at Teva. “The annual
prevalence of migraine in Japan is 8.4% of adults,1 so we are
pleased to be one step closer to bringing AJOVY to patients in
Japan who could benefit from a preventive treatment.”
Preliminary trial results indicated that primary endpoints were
achieved with both clinical and statistical significance versus
placebo for subjects with chronic migraine and episodic migraine,
respectively. Statistically significant improvements versus placebo
were also demonstrated for all secondary endpoints. AJOVY was well
tolerated with a similar adverse events profile compared to
placebo. Following additional analysis, more detailed results will
be presented at upcoming medical congresses and publications. These
are pivotal studies that will enable filing for Pharmaceuticals and
Medical Devices Agency (PMDA) approval for marketing
authorization.
AJOVY is the first and only anti-CGRP drug approved in the US
and EU that is designed for the preventive treatment of migraine
that offers both quarterly and monthly dosing options.
U.S. Important Safety Information about AJOVY®
(fremanezumab-vfrm) injection
Contraindications: 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 U.S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
Information for Europe about AJOVY® can be found
here.
Adverse events should be reported.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events.
Reporting forms and information can be found at
https://www.hpra.ie. Adverse events should also be reported to Teva
– please refer to local numbers.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at 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 FDA approval of AJOVY® (fremanezumab) injection
Autoinjector, 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 commercial success of AJOVY;
- 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; the uncertainty of commercial
success of AUSTEDO; 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 substantial indebtedness, 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 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;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; 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; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; governmental investigations into selling 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 Quarterly Reports on Form
10-Q for the first, second and third quarter of 2019 and in our
Annual Report on Form 10-K for the year ended December 31, 2018,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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.
References
- Sakai F, Igarashi H. Prevalence of migraine in Japan: a
nationwide survey. Cephalalgia 1997; 17(1): 15-22.
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