Teva’s COPAXONE® 40mg – Favorable Response from European Patent Office
April 1, 2019JERUSALEM–(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 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 43,000 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
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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or
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