Teva’s COPAXONE® 40mg – Favorable Response from European Patent Office
01 Avril 2019 - 9:00AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that a three-member panel of the European Patent Office’s
(EPO) Opposition Division upheld patent EP 2 949 335 covering
Teva’s COPAXONE® 40mg product in Europe. The Opposition Division
will issue its written underlying rationale on the decision within
a few months.
COPAXONE® is a highly complex molecule for which
consistent proprietary manufacturing methods are required.
These determine the composition, purity and batch-to-batch
consistency of COPAXONE®. The patent protects the
three-times-weekly subcutaneous injection of 40 mg/mL (“40mgTIW”)
of glatiramer acetate for the treatment of certain forms of
multiple sclerosis.
Richard Daniell, Executive Vice President Teva Europe noted: “We
are pleased that the EPO agreed with Teva’s stance on the patent
for COPAXONE® 40mg. Teva will continue to robustly defend the
validity of the intellectual property portfolio protecting
COPAXONE® 40mg.” Teva has already obtained preliminary injunction
orders on the basis of European patent EP 2 949 335 to prevent the
commercialization of follow on glatiramer acetate in Belgium,
Denmark and Slovakia.
“We believe in the value of COPAXONE®, a treatment that has been
studied extensively for more than 20 years and has 2.5 million
years of patient experience. We remain strongly committed in
the field of neurosciences and are privileged to improve people’s
lives in the field of multiple sclerosis”.
About COPAXONE®COPAXONE® (glatiramer acetate
injection) is indicated for the treatment of patients with
relapsing forms of multiple sclerosis. The most common side effects
of COPAXONE® are redness, pain, swelling, itching, or a lump at the
site of injection, flushing, rash, shortness of breath, and chest
pain. See additional important information at:
www.CopaxonePrescribingInformation.com. For hardcopy releases,
please see enclosed full prescribing information. The COPAXONE®
brand is approved in more than 50 countries worldwide, including
the United States, Russia, Canada, Mexico, Australia, Israel, and
all European countries.
According to the European Multiple Sclerosis Platform (EMSP)
more than 700,000 people in Europe are affected by MS. The
prevalence of MS in women is more than twice as high as in men.1 MS
is more common among women of childbearing age.2 The average age of
diagnosis is approximately 30 years3
About TevaTeva 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 43,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the European Patent Office’s Opposition decision to
uphold patent EP 2 949 335 covering Teva’s COPAXONE® 40mg product
in Europe, 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 our continued
ability to successfully defend our IP rights relating to COPAXONE®
40mg;
- 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 AJOVY® and 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 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 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 Annual Report on Form 10-K
for the year ended December 31, 2018, including the sections
thereof captioned "Risk Factors." 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 Bevan S et al. Multiple Sclerosis & Employment in Europe –
Literature Summary. The Work Foundation Part of Lancaster
University. 2015.
2 National Multiple Sclerosis Society. Pregnancy and
Reproductive Issues. Available at:
http://www.nationalmssociety.org/Living-Well-With-MS/Family-and-Relationships/Pregnancy.
Last accessed May 2017.
3 University of Maryland Medical Center. Multiple Sclerosis.
Available at:
http://www.umm.edu/health/medical/reports/articles/multiple-sclerosis.
Last accessed May 2017...
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IR Contacts United States Kevin C. Mannix(215)
591-8912orIsraelRan Meir972 (3) 926-7516orPR Contacts
EuropeFiona Cohen+31 620082545orUnited StatesDoris
Saltkill+1 (913) 777-3343orIsrael Yonatan Beker972 (54) 888
5898
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