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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
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”.
(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
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
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:
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
1 Bevan S et al. Multiple Sclerosis & Employment in Europe –
Literature Summary. The Work Foundation Part of Lancaster University.
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...
View source version on businesswire.com:
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
Source: Teva Pharmaceutical Industries Ltd.