JERUSALEM--(BUSINESS WIRE)--Sep. 14, 2018--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) todayannounced that the U.S. Food and Drug Administration (FDA) has approvedAJOVYTM (fremanezumab-vfrm) injection for the preventivetreatment of migraine in adults. AJOVY, a humanized monoclonal antibodythat binds to calcitonin gene-related peptide (CGRP) ligand and blocksits binding to the receptor, is the first and only anti-CGRP treatmentfor the prevention of migraine with quarterly (675 mg) and monthly (225mg) dosing options.
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AJOVY™ (fremanezumab-vfrm) from Teva Pharmaceuticals receives F.D.A. Approval Sept. 14, 2018 (Photo: Business Wire)
“Migraine is a disabling neurological disease that affects more than 36
million people in the United States,” said Stephen Silberstein, MD,
Director, Jefferson Headache Center at Thomas Jefferson University
Hospital, and lead investigator of the Phase III clinical trial program
for AJOVY. “About 40 percent of people living with migraine may be
appropriate candidates for preventive treatment, yet the majority of
them are untreated. I am pleased to have another treatment option that
may allow my patients to experience fewer monthly migraine days.”
AJOVY was evaluated in two Phase III, placebo-controlled clinical trials
that enrolled patients with disabling migraine and was studied as both a
stand-alone preventive treatment and in combination with oral preventive
treatments. In these trials, patients experienced a reduction in monthly
migraine days during a 12-week period. The most common adverse reactions
(≥5 percent and greater than placebo) were injection site reactions.
“This is an important day for Teva and complements our long-standing
history of helping patients living with diseases of the central nervous
system,” said Kåre Schultz, President and CEO of Teva. “The approval of
AJOVY helps us to continue to provide access to important medicines and
to deliver on our commitment to our key stakeholders – patients,
employees and shareholders.”
“With limited availability of preventive treatment options, AJOVY
provides physicians with an important new option for their patients,”
said Hafrun Fridriksdottir, Executive Vice President, Global R&D at
Teva. “This approval furthers our ongoing commitment and experience in
neurological conditions like migraine.”
The U.S. Wholesale Acquisition Cost (WAC) of AJOVY is $575 per monthly
dose and $1,725 per quarterly dose. AJOVY will be available through
retail and specialty pharmacies in approximately two weeks. There is a
savings offer for AJOVY. Commercially insured patients may pay as little
as $0 on prescriptions for AJOVY until the offer expires. Teva Shared
Solutions® is available to provide support services for
patients and offices. Visit AJOVY.com
to learn more.
“Today’s approval is an important step forward for Teva and the migraine
community,” said Brendan O’Grady, Executive Vice President and Head of
North America Commercial at Teva. “Our entire organization is proud to
bring this new biologic product forward at a responsible price, and we
are eager to work with insurers to encourage coverage that provides full
access and availability in this much needed category.”
About AJOVYTM
AJOVY is indicated for the preventive treatment of migraine in adults.
AJOVY is 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. 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.
IMPORTANT SAFETY INFORMATION
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 Prescribing Information for AJOVYTM
(fremanezumab-vfrm) injection.
About Teva
Teva 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.
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 approval of 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,
including the expected launch of the product;
-
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, and 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 the 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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 972 (3) 926-7516
or
PR
Contacts
United States
Doris Saltkill, 913-777-3343
or
Israel
Yonatan
Beker, 972 (54) 888 5898