AJOVY Developed by Otsuka in Japan through
Exclusive License Agreement
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the Ministry of Health, Labour and Welfare (MHLW) has
approved the use of AJOVY (fremanezumab) injection for the
preventive treatment of migraine in adults in Japan.
“In Japan, the annual prevalence of migraine is 8.4% of adults1
and now, together with our partner, Teva is able to offer people
living with migraine in Japan this biopharmaceutical treatment with
flexible dosing options to help manage this unpredictable disease,”
said Sven Dethlefs, PhD, Executive Vice President, International
Markets Commercial Region and Global Marketing and Portfolio at
Teva. “Driven by our global mission to improve patients’ lives, we
are pleased to offer this new treatment option to people living
with migraine in Japan.”
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection that is designed for the preventive treatment of migraine
and offers both quarterly and monthly dosing options.2,3,4
AJOVY was developed in Japan by Otsuka Pharmaceutical Co., Ltd.
with the assistance and cooperation of Teva as part of a May 2017
exclusive license agreement. In 2020, the two companies announced
outcomes from two pivotal studies of AJOVY in people living with
episodic and chronic migraine in Japan. 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.
Makoto Inoue, President and Representative Director of Otsuka
Pharmaceutical, commented, “Patients with migraine not only suffer
the pain of headaches, but also endure a range of disabling
symptoms impacting their daily lives, such as the uncertainty of
when the next migraine attack will occur, and the difficulty of
communicating with those around them when they are suffering the
symptoms of an attack. While using the experience we have
accumulated to address the problems faced by patients, we hope to
give support to the lives of many patients by providing AJOVY as a
new treatment option to those in need.”
Teva, who holds (through its Japanese affiliates) with Takeda a
joint business venture in the Japanese market, focuses on
commercializing a selection of complex generics and specialty
assets to address the wide-ranging needs of patients and healthcare
professionals in Japan.
About AJOVY (fremanezumab-vfrm) injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a
prefilled syringe or autoinjector with two dosing options – 225 mg
monthly administered as one subcutaneous injection, or 675 mg every
three months (quarterly), which is administered as three
subcutaneous injections. AJOVY can be administered in office by a
healthcare professional or at home by a patient or caregiver. No
starting dose is required to begin treatment.
Indications and Usage
AJOVY is a calcitonin gene-related peptide antagonist indicated
for the preventive treatment of migraine in adults.
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 AJOVY, 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; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; 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: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; 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; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; costs and delays resulting from the extensive
pharmaceutical regulation to which we are subject or delays in
governmental processing time due to travel and work restrictions
caused by the COVID-19 pandemic; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; 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; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; 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 (including as a result of
potential tax reform in the United States); 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 this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, 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.
1 Sakai F, Igarashi H. Prevalence of migraine in Japan: a
nationwide survey. Cephalalgia 1997; 17(1): 15-22. 2 AJOVY
(fremanezumab-vfrm) injection Current Prescribing Information.
North Wales, PA: Teva Pharmaceuticals USA, Inc. 3 “Long-acting”
defined as efficacy measured over a 12-week period following a 675
mg (225 mg x 3) SC dose. 4 225 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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Kevin C. Mannix (215) 591-8912 Yael Ashman 972 (3) 914-8262
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