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”.
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
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:
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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