Teva Announces U.S. Launch of Autoinjector for AJOVY® (fremanezumab-vfrm) Injection
April 27 2020 - 8:00AM
Business Wire
Teva Pharmaceuticals USA, Inc., an affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that the autoinjector device for AJOVY®
(fremanezumab-vfrm) injection is now available in the U.S. AJOVY is
indicated for the preventive treatment of migraine in adults and is
the only anti-CGRP (calcitonin gene-related peptide) preventive
migraine treatment with quarterly (675 mg) and monthly (225 mg)
subcutaneous dosing options.
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“We are pleased to offer the migraine community the option of an
autoinjector device for their AJOVY treatment,” said Brendan
O’Grady, Executive Vice President, North America Commercial, Teva.
”Continuing to advance treatment flexibility for people who suffer
from debilitating migraines is another way that we are able to
advance the mission of Teva to improve patient lives.”
AJOVY is the only long-acting anti-CGRP injection with the
option of dosing four times per year using either the autoinjector
or prefilled syringe. The new Teva autoinjector also has several
features that make it easy-to-use1 including a button-free,
push-down mechanism; audible cues that signal progress of
administration; and, a window that displays when the dose has been
delivered. Additionally, the autoinjector is for one-time use only
and locks after use.
Patients should consult their healthcare professionals about how
to take AJOVY using the autoinjector. Patients can also visit
AJOVY.com for step-by-step instructions for using the autoinjector,
or to speak with a nurse to help answer questions about taking
AJOVY using the autoinjector. Samples will be made available to
healthcare professionals.
The Wholesale Acquisition Cost (WAC or “list price”) for the
AJOVY autoinjector is $603.20. Actual costs to individual patients
and providers for the autoinjector are anticipated to be lower than
WAC because WAC does not account for additional rebates and
discounts that may apply. Savings on out-of-pocket costs may vary
depending on the patient’s insurance payer and eligibility for
participation in the assistance program.
In addition to the U.S., the AJOVY autoinjector is currently
available in Germany and should soon be available in other select
European markets.
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.
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 the U.S. launch of Autoinjector for 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; 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 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:
implementation of our restructuring plan announced in December
2017; 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;
interruptions in our supply chain including due to potential
effects of the COVID-19 outbreak on our operations in geographic
locations impacted by the outbreak and on the business operations
of our customers and suppliers; disruptions of information
technology systems; breaches of our data security; variations in
intellectual property laws; 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; 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; 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 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.
1 Two Human Factor studies assessed evaluators’ ability to
complete critical tasks in order to demonstrate use of the AJOVY
Autoinjector in simulated-use sessions. When asked “Was the
autoinjector easy to use?”, 97% in study 1 (N=30) and 98% in study
2 (N=47) answered “Yes.” Data on file, Parsippany, NJ Teva
Pharmaceuticals USA, Inc.
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