Teva Announces New Drug Application Filing in Japan for AJOVY® (fremanezumab) Injection
July 29 2020 - 8:00AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced Otsuka Pharmaceutical Co., Ltd. has submitted an
application to the Pharmaceuticals and Medical Devices Agency of
Japan to obtain manufacturing and marketing approval in Japan for
AJOVY® (fremanezumab) injection for the preventive treatment of
migraine.
“This is an exciting milestone that delivers on our global
mission to improve patients’ lives by advancing potential new
treatment options,” said Gianfranco Nazzi, Executive Vice
President, International Markets at Teva. “Driven by the aspiration
to bring high-value products to patients, we are pleased to be one
step closer to making AJOVY available as a treatment option to
patients in Japan living with migraine.”
AJOVY is under development in Japan by Otsuka as part of a May
2017 exclusive license agreement for development and sales of AJOVY
in Japan. Earlier this year, the two companies announced outcomes
from two pivotal studies of AJOVY in Japan in patients with
episodic and chronic migraine. The primary endpoints were achieved
in both trials with clinical and statistical significance versus
placebo. Statistically significant improvements versus placebo also
were demonstrated for all secondary endpoints. AJOVY was well
tolerated with a similar adverse events profile compared to
placebo.
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection approved in the US and EU that is designed for the
preventive treatment of migraine and offers both quarterly and
monthly dosing options.i,ii,iii
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 new drug application filing in Japan for AJOVY®
(fremanezumab) injection, 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:
- challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals for Ajovy in Japan;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; 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;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations 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: duration,
and geographic reach of the COVID-19 pandemic and its impact on our
business, financial condition, operations, cash flows, and
liquidity and on the economy in general; interruptions in our
supply chain, including due to potential effects of the COVID-19
pandemic on our operations and business in geographic locations
impacted by the pandemic and on the business operations of our
customers and suppliers; adequacy of and our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith;
implementation of our restructuring plan announced in December
2017; challenges associated with conducting business globally,
including adverse effects of the COVID-19 pandemic, political or
economic instability, major hostilities or terrorism; our ability
to attract, hire and retain highly skilled personnel; our ability
to develop and commercialize additional pharmaceutical products;
compliance with anti-corruption sanctions and trade control laws;
manufacturing or quality control problems; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; significant sales to a
limited number of customers; our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject or delays in
governmental processing time including due to modified government
operations due to the COVID-19 pandemic and effects on product and
patent approvals; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M 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 Report on Form 10-Q
for the first quarter of 2020 and our Annual Report on Form 10-K
for the year ended December 31, 2019, 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.
_____________________ i AJOVY(fremanezumab-vfrm) injection
Current Prescribing Information. North Wales, PA: Teva
Pharmaceuticals USA, Inc. ii “Long-acting” defined as efficacy
measured over a 12-week period following a 675 mg (225 mg x 3) SC
dose. iii 225 mg monthly administered as one subcutaneous
injection, or 675 mg every three months (quarterly), which is
administered as three subcutaneous injections.
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